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Apr-26-2008FDA Panel Urges More Data on Laser Vision Surgery(topic overview)
CONTENTS:
- The Food and Drug Administration, working with doctors' groups and the National Eye Institute, plans to study how Lasik affects patients' quality of life no later than next year, Daniel Schultz, head of the agency's medical devices center, said today. (More...)
- According to the FDA about 5 percent of patients are not happy with the surgery, prompting the agency to embark on a detailed study on Lasik eye surgery patients. (More...)
- Federal health officials were witness to complaints from patients, disappointed with the quality of vision after lasik eye surgery. (More...)
- Dr. Colman Kraff uses a pachymeter to measure the thickness of patient Steve Parker's cornea prior to creating the Lasik flap at Kraff's offices in Chicago as part of Parker's eye surgery Nov. 1, 2005. (More...)
- Wouldn't you rather live as if you had a set of never-care contacts that never had to be cleaned or taken out, and were never uncomfortable? I had LASIK 7 years ago, and after a year of dry eyes at night (eyedrops at about 3 am), I am very happy with my results. (More...)
- Some who have the procedure achieve better than 20/20 vision. (More...)
- About 700,000 Americans a year undergo the elective laser surgery. (More...)
- All people who get laser eye surgery want is to be able to see well in the morning without putting on glasses or contacts. (More...)
- Jagged Pill I had lasik done almost 2 weeks ago. (More...)
- According to the FDA, it could take as many as three to six months for vision to stabilize after surgery. (More...)
- The U.S. News eye and vision center offers advice on taking care of your eyes. (More...)
- The remaining 5 percent end up with strange effects including double vision, night blindness, star bursts and halos. (More...)
- Since it was first approved in the mid-1990s, more than 12 million Americans have undergone LASIK by some estimates. (More...)
- "If you look at the research submitted to the FDA, I'd say the quality of life data wasn't that good," Davis added. (More...)
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The Food and Drug Administration, working with doctors' groups and the National Eye Institute, plans to study how Lasik affects patients' quality of life no later than next year, Daniel Schultz, head of the agency's medical devices center, said today. Identifying why complications occur will help those considering Lasik make more educated choices, he said. More than 12 million people in the U.S. have had Lasik to improve their vision since the procedure was approved in 1995, and 5 percent say they aren't satisfied with the results, according to the American Society of Cataract and Refractive Surgery. [1] Blurred vision, dry eyes, glare and double-vision have led to depression and in some cases suicide, several patients told a U.S. Food and Drug Administration advisory panel. "Since LASIK, I am visually handicapped," said patient David Shell, adding that he has near constant eye pain and depression. "My eyes never feel comfortable. 10 years have passed and I still suffer from this problem." Millions of Americans have had successfully undergone LASIK, or laser-assisted in-situ keratomileusis, which uses a laser to reshape the eye's cornea, making them less dependent on glasses or contact lenses. Surgeons and other industry representatives told the FDA's outside advisers most LASIK patients are satisfied with their vision. They noted depression is a complex condition and that no studies show a direct link to laser eye surgery.[2] Patients and family members of patients who underwent laser surgery to improve their eyesight today described struggling with double vision, blurry vision and other complications at a hearing organized by the Food and Drug Administration to assess the scope of problems following the procedure. "Since LASIK, I am visually handicapped," patient David Shell told a panel of outside experts the agency convened for a day-long meeting to hear from patients and make recommendations about whether those considering the procedure should receive better information about the risks. "My eyes never feel comfortable. 10 years have passed and I still suffer from this problem," Shell said, according to the Reuters news agency.[3] WASHINGTON (AP) — Patients harmed by Lasik eye surgery alternated between fury and despair Friday as they told federal health officials of suffering years of eye pain, blurred or double vision — even of people driven to suicide. "Too many Americans have been harmed by this procedure and it's about time this message was heard," said David Shell of Washington, D.C., who had Lasik in 1998 and says he has "not experienced a moment of crisp, good quality vision since." Colin Dorrian was a college student when he was told he wasn't a good Lasik candidate, but went ahead anyway — and his father, Gerald, described six years of eye pain and blurred vision before reading his son's suicide note to a Food and Drug Administration panel: "I can't and won't continue facing this horror." Matt Kotsovolos actually worked for the Duke Eye Center when he had a more sophisticated Lasik procedure in 2006, and said doctors classified him as a success because he now has 20-20 vision — something Kotsovolos charged is a deceptive industry practice.[4] Updated Fri. Patients who experienced painful side effects after undergoing Lasik eye surgery are airing their grievances in front of a U.S. Food and Drug Administration panel on Friday. David Shell of Washington, D.C. told the panel that after undergoing the eye surgery he has "not experienced a moment of crisp, good quality vision since." One patient's father even told of his son's suicide six years after having the popular vision-correcting procedure. Gerald Dorrian described to the panel the six years of pain and blurred vision his son Colin endured before ending his life. Colin had been told he wasn't a good candidate for the surgery but went ahead with the procedure anyway. "I can't and won't continue facing this horror," Colin Dorrian's suicide note said.[5]
The FDA advisers recommended that the agency make clearer the warnings regarding LASIK surgery. The recommendations include: adding photographs to illustrate what people suffering certain side effects actually see, such as the glare that can make oncoming headlights a "starburst" of light; clarifying how often patients suffer certain side effects, such as dry eye; and making clearer the conditions that should disqualify someone from LASIK, such as large pupils or severe nearsightedness, theAPreported. "The FDA has called this a quality-of-life issue, because patients are complaining that their vision isn't sharp, they have poor night vision, some have glare or halos, some complain that their eyes are dry," said Dr. Robert Cykiert, associate professor of ophthalmology at New York University Langone Medical Center. Some of those disgruntled patients were on hand for Friday's FDA hearing. "Too many Americans have been harmed by this procedure, and it's about time this message was heard," said David Shell of Washington, D.C., who had the surgery in 1998 and said he has "not experienced a moment of crisp, good quality vision since," theAPreported.[6] The FDA is holding a public inquiry to investigate consumer complaints about Lasik and to determine if the information provided to patients about the risks and benefits is sufficient. The FDA is also working on a study to investigate why some patients develop such negative side effects, while others don't. While most people who undergo Lasik end up with 20/20 vision and no side effects, a few come out with eye problems such as dry eyes, glare or compromised night vision. "Clearly there is a group who are not satisfied and do not get the kind of results they expect," Dr. Daniel Schultz, the FDA medical device chief, told The Associated Press. The study should "help us predict who those patients might be before they have the procedure." Health Canada spokesperson Paul Duchesne said that the federal department won't act on the findings of the inquiry if it's a matter of how the procedure is performed.[5] Some unhappy patients have urged the FDA in citizen petitions to rescind approval of lasers linked to side effects and phase out older devices as new technology is introduced. People who say they've had unsuccessful surgery air their complaints on Web sites such as lasikcomplications.com, which lists the "Top 10 Reasons Not to Have Lasik surgery.'' Barbara Berney, 54, of Rockford, Illinois said she often feels as if she is viewing the world through wax paper since undergoing Lasik surgery in 2001. She had the surgery because she was no longer able to read and her doctor said Lasik would solve that, she said. Her vision constantly changes, she can't see in some lighting conditions and can no longer drive at night and her eyes are dry, said Berney, a graphic designer who composes digital art on a computer. "You only get one pair of eyes,'' she said in a telephone interview. "And once they're gone, you're done. There is no getting them back. You can't undo this.''[1]
There are no guarantees of 20/20 vision and the long-term safety of the procedure is still unknown. The society of eye surgeons who perform Lasik says 95 percent of patients are satisfied with their results. The group is expected to tell regulators later this week that most side effects from Lasik surgery are rare and temporary. FDA will hear from Lasik eye surgeons as well as disgruntled patients at a meeting Friday of its outside panel of eye experts.[7] The panel also recommended that the FDA's LASIK Web site should include photographic illustrations of visual disability, detailed statistics as to risk of side-effects or complications, and an expanded explanation of the benefits of LASIK, i.e. that improving distance vision will mean the need for reading glasses. The advisory panel set aside the entire morning for public testimony, much of it dominated by patients and family members of patients who claimed that LASIK surgery left them disabled, depressed, and in some cases suicidal. A father told the story of his son, a law student who had LASIK because he had developed dry eye as a result of contact lens use. Before LASIK, the son was successful, outgoing, with no history of mental health issues, his father said.[8] Eye doctors are hoping that the study will shed light on the incidence of dissatisfaction with laser eye surgery and lead to ways to shrink the risk of poor outcomes. Past studies generally have found that 95 percent of Lasik patients are satisfied with their surgery. "We all have a lot of friends who say it's the best thing that ever happened to them," says Frederick Ferris III, the eye institute's clinical director. He says, that's no consolation when "the fickle finger of fate points to you," bringing negative consequences. Matt Kotsovolos, of Raleigh, N.C., says he has had debilitating dry eye, facial pain and migraine headaches since undergoing Lasik nearly two years ago. He says he was until then a "completely healthy" 37-year-old working as director of finance at Duke University's eye center, which paid for his surgery. Like most people, he says, he expected Lasik to be "a piece of cake." Mr. Kotsovolos now has a different administrative job at Duke, from which he is intermittently on leave because of his medical condition. He says he plans to testify at this week's FDA meeting.[9] April 25, 2008 -- The FDA should do more to warn patients about the risks of popular laser vision corrective surgery, an expert panel has concluded. The recommendations came after more than a dozen LASIK patients or their family members testified Friday about severe reactions to the surgery. Most said their doctors did not adequately warn them that vision loss or eye dryness could persist, in some cases, for years. "For a small minority, their regret is profound," said Todd Krouner, a New York attorney who represents about half a dozen LASIK patients, including the wife of a former police officer who Krouner said blamed a botched LASIK surgery for his suicide. "It is not about the 20 minutes in surgery, it's about what came before it and what has come after it. It's about a lack of solution for them," said Rebecca Petris, a former LASIK patient who now runs a network of dissatisfied patients.[10]
The U.S. Food and Drug Administration's Ophthalmic Devices Panel convened Friday to discuss post-LASIK quality-of-life issues. Its recommendation at day's end: That the FDA warn more clearly about the risks of the increasingly popular surgery, theAssociated Pressreported. "This is ground-breaking. It's the first time anything like this has happened around refractory, or LASIK, eye surgery," said Dr. Christopher Starr, co-director of Cornea, Cataract and Refractive Surgery at New York-Presbyterian Hospital/Weill Cornell Medical College in New York City. "I think it's a good thing, because I know that the surgery, when done on the right patients, is a great, great surgery with phenomenally good outcomes."[6] The potential benefits and hazards of Lasik eye surgery will be brought into sharp focus on Friday when the U.S. Food and Drug Administration meets with patients and surgeons in Maryland. The FDA panel will assess if educational materials provided to patients should be revised and updated, the agency said on its website.[11] What was clear by day's end: The vast majority of people undergoing laser eye surgery benefit and are happy, but a small fraction ' perhaps fewer than 1 percent ' suffer serious, life-changing side effects: worse vision, painful dry eye, glare, inability to drive at night. Advisers to the Food and Drug Administration heard about a dozen of those stories Friday ' including a father reading his son's suicide note ' and then concluded today's warnings for would-be Lasik recipients should be clarified. 'This is a referendum on the performance of Lasik by some surgeons who should be doing a better job,' said Dr. Jayne Weiss of Detroit's Kresge Eye Institute, who led the panel.[12] A small fraction, perhaps 1 percent or fewer, suffer serious, life-changing side effects: worse vision, severe dry eye, glare, inability to drive at night. "Too many Americans have been harmed by this procedure and it's about time this message was heard," David Shell of Washington told the Food and Drug Administration's scientific advisers before their recommendation that the FDA provide clearer warnings. Shell held up large photographs that he said depict his blurred world, showing halos around objects and double vision, since his 1998 Lasik. "I see multiple moons," he said angrily. Colin Dorrian was in law school when dry eye made his contact lenses so intolerable that he sought Lasik, even though a doctor noted his pupils were pretty large. Both the dry eye and pupil size should have disqualified Dorrian, but he received Lasik anyway — and his father described six years of eye pain and fuzzy vision before the suburban Philadelphia man killed himself last year. "As soon as my eyes went bad, I fell into a deeper depression than I'd ever experienced, and I couldn't get out," Gerard Dorrian read from his son's suicide note. Matt Kotsovolos, who worked for the Duke Eye Center when he had a more sophisticated Lasik procedure in 2006, said doctors classify him as a success because he now has 20-20 vision. He said, "For the last two years I have suffered debilitating and unremitting eye pain.[13]
After receiving reports of double vision, night blindness, dry eye and halos, the FDA is now preparing a nationwide study with the National Eye Institute, the American Society of Cataract and Refractive Surgery and the American Academy of Opthalmology to measure how the 700,000 patients who undergo Lasik each year in the United States fare after the surgery.[14] "Patients do not want to continue to exist as helpless victims with no voice." A decade after Lasik hit the market, the FDA is taking a new look at whether warnings about its risks are appropriate — and pairing with eye surgeons for major study to better understand who has bad outcomes and why. Most Lasik recipients do walk away with crisper vision, and the American Society for Cataract and Refractive Surgery reviewed studies showing about 95 percent of patients say they're satisfied with their outcome.[4] Lasik eye surgery was approved by the FDA in the mid 90's, but now after about 12 millions Americans have had the surgery, the FDA is taking a closer look at the side effects, but not everyone is convinced the scrutiny is necessary. Dr. Gelinas does pre-op and post-op at Eye Care Associates in Woodruff for patients that are interested in getting lasik eye surgery, and for those who have had it. He can't believe the FDA, which approved the surgery in the mid 90's, is taking a new look at the risks and benefits of the surgery. Dr. Michel Gelinas says "It's a little bit surprising to me to see that this has been raised as an issue because I don't know of any surgeon who really has any problem recommending lasik."[15] Ten years after Lasik eye surgery first made an impact in the market, patients suffering from the wide range of side effects of the procedure have finally begun to complain about the procedure to federal health officials. FDA officials are now initiating a public hearing Friday as part of its efforts to find out whether the patients receive adequate and appropriate warnings about the risks associated with the procedure before opting to go through with it.[16] Today we now read that the FDA is beginning to look into the "risks" associated with Lasik surgery. This, after a decade of patients/victims suffering from life altering side effects, including worse vision, dry eye, pain, glare and others. One law school student, Colin Dorrian, committed suicide last year after suffering from a deep depression associated with his eye pain. Does anyone think, or believe, that these conditions and risks were not known ten years ago. They were. Interestingly, a well known oncologist that I recently worked with on a cancer diagnosis case told me he wouldn't have Lasik surgery if they did it for free. He also would not allow anyone in his family to have the surgery.[17] Lasik side effects include blurred vision, dry eyes and halos around lights when seen at night. FDA will also ask its panel of eye experts to consider these issues Friday and whether patients need to be given more information before deciding to undergo surgery.[18] Industry experts and doctors agree most patients are satisfied, but the FDA has received some complaints of blurred vision, dry eye and other side effects. In an FDA memo released on Wednesday, the agency said it would ask its outside experts to discuss what information is currently available for patients considering or undergoing LASIK and whether changes must be made.[19]
The procedure costs on average about $2,000 per eye. The FDA says its decision to invite Lasik critics to this week's meeting was spurred by patient complaints over the years. "There are people raising questions about the information" available to those who are deciding whether to have surgery, says Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. The agency says its "Learning about Lasik" Internet site is one of the most frequently visited federal government sites, underscoring the large public interest in the procedure. It's difficult to know before surgery whether a patient could experience negative results. It's a subject worth discussing with your doctor.[9] With a public hearing Friday, the FDA is beginning a new effort to determine if warnings about Lasik's risks are appropriate. The agency also is pairing with eye surgeons for a major study expected to enroll hundreds of Lasik patients to better understand who has bad outcomes and exactly what their complaints are. "Clearly there is a group who are not satisfied and do not get the kind of results they expect," FDA medical device chief Dr. Daniel Schultz said Thursday. The study should "help us predict who those patients might be before they have the procedure."[20] How big are the risks? The FDA agrees that about 5 percent of patients are dissatisfied with Lasik. How many struggle daily with side effects? How many are less harmed but unhappy that they couldn't completely ditch their glasses? The range of effects on patients' quality of life is a big unknown — and the reason the FDA help a public hearing Friday as part of its new move. "Clearly there is a group who are not satisfied and do not get the kind of results they expect," said Dr. Daniel Schultz, the FDA medical device chief. The study should "help us predict who those patients might be before they have the procedure."[4]
Solomon estimates that fewer than 1 percent of patients have severe complications that leave poor vision. Other side effects, however, are harder to pin down. Dry eye, for instance, can range from an annoyance to so severe that people suffer intense pain and need surgery to retain what little moisture their eyes form. That's the kind of question the FDA's new study is being designed to answer.[20] Most people who have had their eyes zapped are thrilled with their vision. Some patients say that as a result of the surgery they developed such problems as painful dry eyes and fuzzy or double vision that can't be corrected with glasses. Such complaints have circulated on Internet sites, but have rarely drawn widespread public exposure. Now, the FDA has invited consumers to air their grievances at Friday's regular meeting of its ophthalmic devices division in Gaithersburg, Md. The full-day event will focus on laser-assisted in situ keratomileusis, or Lasik, the most common type of vision-correction surgery.[9] Most recipients of the surgery walk away with better vision, but not every eye is a great candidate, and some people walk away with poor vision, painful dry eyes, glare issues or problems seeing at night. While more than 12 million people in the U.S. have has Lasik, about 5% of them are not satisfied with the results according to the FDA.[21] Doctor Suggs takes three things into consideration when picking good candidates. He will not operate on someone with large pupils, thin corneas or anyone with dry eyes. That's because they could suffer complications, like night-vision problems. "We're real careful at looking at those things and maybe not choosing LASIK surgery for them but maybe choosing an alternative surgery that will be safer for them now and the future," Dr. Suggs said. The FDA has a list of possible LASIK complications on its website and warns the results may not be lasting. Doctor Suggs said vision usually starts worsening only for those who have diabetes, glaucoma or cataracts. That's why he agrees with the FDA that ophthalmologists should increase testing prior to surgery. something a lot of doctors are overlooking.[22]
"I have halos, I have starbursts, I have glare, my eyes are dry," stated LASIK patient, Abby Ellin. "This is not a success." It's been a year since Abby Ellin underwent LASIK surgery. She says she can now see without glasses, but only if she squints, and her eyes bother her constantly. "It's just painful and feels like there is a film around my eye all the time," said Ellin. Doctors who perform LASIK say, as with any operation, there is a risk, but they insist it's a very small percentage of patients who have serious complications. The industry says studies show 95% of patients are satisfied with their results. Given the millions who had the procedure, that still leave hundreds of thousands who may regret their decision.[23] WASHINGTON -- A decade after approving the Lasik laser eye procedure for vision correction, federal health officials moved Friday to explore potential risks in what's become one of the country's most popular surgeries. Almost 8 million Americans have had the procedure, and most ended up discarding their eyeglasses or contact lenses without long-term complications, according to doctors and health officials. A small fraction complain of serious side effects that have left their eyes painfully dry and their vision marred by ghostly shadows or starbursts of color. Some say their sight is so poor they can't watch a movie or drive at night.[24] Patients that went through Lasik surgery informed the U.S. regulators at a meeting of their current side effects such as blurred vision, dry eyes, glare and double-vision, and even suffering of depression leading to suicides. In this Nov. 1, 2005 file photo, Dr. Colman Kraff docks the femtosecond laser, flattening the cornea, of patient Steve Parker as the initial step in creating the Lasik flap during Parker's eye surgery at Kraff's offices in Chicago. A decade after Lasik eye surgery hit the market, patients left with fuzzy instead of clear vision are airing their grievances before federal health officials.[25]
The surgery permanently reshapes the cornea; there are no guarantees of 20/20 vision and the long-term safety of Lasik remains unknown. The FDA will hear from Lasik eye surgeons and dissatisfied patients at a meeting Friday with its outside panel of eye experts and will ask the panel whether educational materials provided to patients considering Lasik require change or update.'' Regulators agreed to hold the meeting after years of complaints from some patients who say their eyesight has been permanently damaged by Lasik.''[26]
While LASIK eye surgery has been hailed by many as a revolutionary technique that goes a long way in correcting vision, there have also been some who have raised their voice against the after-effects of the surgical procedure, some of which can be life-altering, in a negative way. The Ophthalmic Devices Panel of the U.S. Food and Drug Administration on Friday organized a discussion to talk about issues related to the life of patients after they have had LASIK eye surgery.[27] The patients urged the Food and Drug Administration at a panel to act more to avoid negative results from the surgery, which according to statistics is performed in 700,000 patients in the U.S. each year. "Too many Americans have been harmed by this procedure and its about time this message was heard," says David Shell a patient who had LASIK in 1998 adding "since LASIK, I am visually handicapped."[25]
WASHINGTON -- Rare side effects reported with laser eye-correcting surgery will get a closer look from the Food and Drug Administration Friday. Millions of Americans have undergone Lasik surgery to improve their eyesight since FDA first approved lasers for the procedure a decade ago.[18] According to the Associated Press, in ten years since it has been approved by the Food and Drug Administration, millions of Americans have had the Lasik eye surgery done and 140 of them have complained about its side effects.[28] WASHINGTON -- The Food and Drug Administration today took a close look at Lasik eye surgery amid concerns that the procedure can have disastrous side effects that are more common than some might suggest.[29]
In collaboration with eye surgeons, the agency is attempting a major study on patients who have undergone the procedure. Through this study, the agency hopes to be able to work with hundreds of patients who have undergone the Lasik eye surgery procedure to know more about who suffers from the side effects and what the effects actually are in different individuals.[16]
Double vision, night-vision disturbances and dry eye are among the side effects outlined in literature given to Lasik patients, but Kantis and others say physicians often gloss over the risks. "Just before the procedure they shove the informed consent form in front of you, but you just sign it and no one reads the fine print," Kantis said.[7] "My life is a blur," Dean Kantis said. "When I look at a computer screen, I see two pages; when I look up at the moon, I see three of them."'' Double vision, night-vision disturbances and dry eye are among the side effects listed in literature given to Lasik patients; however, Kantis and others argue that physicians don'''t generally focus on these risks.'' "Just before the procedure, they shove the informed consent form in front of you, but you just sign it and no one reads the fine print," Kantis said.[26]
While many people walk away from LASIK vision correction surgery with 20/20 vision or better, others are left with such side effects as glare, poor vision, dry eyes, and problems seeing at night, reports the Associated Press.[30] The FDA advisers recommended that the agency clarify the warnings it already provides about lasik. Add photos that illustrate what people suffering certain side effects actually see, such as glare or a "starburst" of light. Clarify how often patients suffer different side effects, such as dry eye. Clarify the conditions that should disqualify someone from lasik, such as large pupils or severe nearsightedness. Spell out that anyone whose nearsightedness is fixed by lasik is guaranteed to need reading glasses in middle age, something that might not be needed if they skip lasik. Times staff writer Lisa Greene contributed to this report.[31]
The FDA panel will also advise the full agency about how to conduct a $1.2 million study that the agency is planning with the National Eye Institute and the American Society of Cataract and Refractive Surgery to determine patients' quality of life after LASIK, theWashington Postreported.[6] The panel will also counsel the agency about how to conduct a $1.2 million study that the FDA is planning with the National Eye Institute and the American Society of Cataract and Refractive Surgery to better assess the quality of life of patients after the operations. There are faultfinding persons who criticize this campaign and express their skepticism about the effort the organization makes.[28] The panel will also advise the agency about how to conduct a $1.2 million study that the agency is planning with the National Eye Institute and the American Society of Cataract and Refractive Surgery to better assess the quality of life of patients after the operation. "There really is a need to develop better-quality information," he said.[3]
The FDA has launched a new national study of patient outcomes, along with the National Eye Institute and the American Society of Cataract and Refractive Surgery (ASCRS) to try to compile more information on the rate of poor LASIK results.[10] The FDA, the National Eye Institute, the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology are further assessing patient quality of life after LASIK. "This is not about safety and effectiveness of LASIK surgery at all," Solomon said. "This is about trying to take a very safe and very successful procedure and trying to learn as much as we can about trying to make it more successful."[32] For instance, a test that measures tear production could suggest whether a person may be prone to dry eye. Malvina Eydelman, director of the FDA's ophthalmic and ear, nose and throat devices division, told a meeting of eye surgeons in Chicago this month that "the vast majority of patients are indeed satisfied with their outcome" from laser eye surgery. She added, few studies have focused on how patients' quality of life is affected. To research this angle, the FDA enlisted the participation of the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery, in addition to the National Eye Institute.[9] While laser surgeons also are expected to testify, the session likely will be dominated by consumers critical of the procedure. In a related move, the FDA recently recruited the National Eye Institute, part of the National Institutes of Health, to study how patients' quality of life has been affected by laser eye surgery, beyond helping to correct their vision.[9] Patients who say their vision was marred, rather than improved by laser eye surgery, aired their grievances before an FDA panel convened today to assess the problems from the common procedure.[33] The FDA is paying greater attention to consumers' concerns about laser eye surgery. A small number of patients complain of problems such as chronic dry eyes and fuzzy vision after surgery.[9]
Wachovia analyst Larry Biegelsen said Friday's FDA meeting could prove beneficial for the industry if it shows patient outcomes are relatively positive. In a note earlier this month, Biegelsen wrote that a new analysis of 2,200 Lasik patients should provide "a good defense" for companies and physicians. The results, which eye doctors will present Friday, show 95 percent of patients across 19 studies were satisfied with their vision following surgery.[7] The FDA isn't saying what percentage of patients have complaints after the surgery. Dr. Gelinas and his staff say they don't think too many people are unsatisfied, and if they are, it might be because they weren't good candidateS for lasik in the first place. Jean Moats, a Technician at Eye Care Associates, says "Why would they want to take and recommend you for surgery if you weren't a good candidate? You're just going to get negative results." Dr. Gelinas says "In my experience it's not the norm it's the exception. The majority of people, the great majority of people that have this procedure are very pleased and very happy with the results. They've been very successful." Dr. Gelinas says that he himself had the procedure done just last summer and he's had great results and he knows a lot of other people who have been happywith the surgery as well.[15] About 700,000 Americans a year undergo the elective laser surgery, but about one in four people seeking Lasik is not a good candidate, and the FDA agrees with eye surgeons' findings that about 5 percent of Lasik recipients wind up unsatisfied. 'Too many Americans have been harmed by this procedure, and it's about time this message was heard,' David Shell of Washington testified, holding up large photographs that he said depict his blurred world.[12] The FDA asked the American Academy of Ophthalmology, the government-funded Eye Institute and the cataract surgery society in July to review published data on Lasik surgery and make a recommendation as to whether additional research was needed to examine patients' quality of life. A joint task force, formed of representatives from the four groups, reported in March that its analysis of 19 studies in the past 10 years found a 95 percent satisfaction rate among 2,199 patients worldwide.[1]
An FDA spokeswoman said the FDA has no authority over physician handling of patients; however, regulators have agreed to work with the American Society of Cataract and Refractive Surgery on a large-scale study of patients' post-surgical quality of life.'' As part of the study to examine the relationship between Lasik complications and quality of life issues, are plans to look at psychological problems such as depression.''[26] Lasik is quick and, if no problems occur, painless: Doctors cut a flap in the cornea — the clear covering of the eye_ aim a laser underneath it and zap to reshape the cornea for sharper sight. The vast majority of patients, 95 percent, see better and are happy they had Lasik, said Dr. Kerry Solomon of the Medical University of South Carolina, who led a review of Lasik's safety for the American Society of Cataract and Refractive Surgery.[20] Now the agency plans to collect detailed information to have real results of how the ophthalmic services are performing, since it determined the existing data is insufficient and there is no way to know the quality of life of the patients who went through the surgery. The American Society for Cataract and Refractive Surgery, which represents the doctors who make the procedures, revealed 95 percent of patients are satisfied with the results settling its basis in studies. Other representatives from industries have said depression has different causes and it hasnt been proved its direct related to LASIK.[25]
Reuters wrote the agency is planning to start a study on LASIK patient satisfaction next year in conjunction with the National Eye Institute and two industry groups: the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology.[33] The agency is planning to conduct a study on Lasik patent satisfaction along with National Eye Institute and two industry groups. Some analysts said negative patient testimony could weigh on shares of LASIK device makers such as Advanced Medical Optics Inc, Alcon Inc and Bausch & Lomb, as well as LASIK providers such as TLC Vision Corp and LCA-Vision Inc. This will add to the 5 to 15 percent decline in Lasik procedures expected to take place this year as the costs between $1,500 and $5,000 won't fit the pockets of many U.S. consumers in these days of financial crisis.[34] As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it." Lasik laser manufacturers, which include Advanced Medical Optics Inc., Alcon Inc., and Bausch and Lomb are under analyst radar as Lasik procedures are expected to decline five to 15 percent this year because it cost'''between $1,500 and $5,000'''may not be affordable to many consumers. This entry was posted on Thursday, April 24th, 2008 at 11:53 am and is filed under Legal News, Health Concerns.[26]
GAITHERSBURG, Maryland (Reuters) - Patients unhappy with their laser eye surgery urged U.S. health regulators to do more to limit poor results, saying complications from the LASIK procedure have taken a toll on their sight and emotions.[2] Laser eye surgery has been around since the mid 90s, and millions have undergone the procedure. The question is, 'Is it right for you?' Today, we talked to a local doctor about Lasik surgery, and he says even though the surgery is a success the majority of the time, it's not always right for everyone. Robert Jones, Ophthalmologist: "Every surgery has its risks involved and possible complications. With eye surgery, there are some problems that can occur, but they are very very rare."[35]
News & Observer, The (Raleigh, NC) (KRT) - Apr. 26, 2008 Apr. 26--GAITHERSBURG, Md. -- After listening to hours of patient horror stories Friday, an advisory panel recommended that federal regulators strengthen safety warnings for vision-correcting laser eye surgery. The panel recommended that laser manufacturers add several risk factors to their patient information and that the Food and Drug Administration improve its online consumer information about who is not a good candidate for the surgery.[36] WASHINGTON (Reuters) - The U.S. Food and Drug Administration plans to seek advice from a panel of outside experts over whether to provide more information to patients about laser eye surgery, according to documents released on Wednesday.[19]
Following complaints of blurry vision and dry eyes and other complications several patients encountered after having eye surgery, the U.S. Food and Drug Administration plans to take a closer look at laser eye surgery and the possible dangers that come with it.[34] NEW YORK (Associated Press) - A decade after it first approved devices for laser eye-correcting surgery, the Food and Drug Administration is taking a closer look at grievances from patients, including blurred vision and dry eyes.[7]
After receiving reports of double vision, night blindness, dry eye and halos, the Food and Drug Administration is taking another look at LASIK. On April 25, experts will hear from patients and review what's known about the experiences of approximately 700,000 patients who undergo LASIK each year in the United States.[32] The U.S. Food and Drug Administration (FDA) is finally going to review complaints from patients who underwent Lasik eye-correcting surgery and who have suffered from a variety of issues, including blurred vision and dry eyes.''[26] ROCKFORD - The Food and Drug Administration spends the day hearing from people who haven't had crisp vision since Lasik surgery. Among that testimony, a Rockford woman's which is why the FDA wanted her statement.[37]
Washington -- The federal government is taking a second look at Lasik eye surgery following 140 patient complaints filed with the Food and Drug Administration in the past few years.[38] A day after The New York Times reported a decline in Lasik eye surgeries due to the slowing economy, the Food and Drug Administration is holding a hearing with some unhappy patients.[39]
"No one has received full-informed consent for Lasik," Burch said. "If anyone knew what this procedure really does to their eyes, they wouldn't have it." The Food and Drug Administration will hear from patients to learn more about their experiences.[14]
Laser vision surgery has helped millions of people see better without corrective lenses. A small number of patients have experienced troubling aftereffects from the procedure, and the Food and Drug Administration has begun taking a closer look at their complaints.[9]
Some 12 million have had the procedure since it was approved in the mid-1990's. Most patients are thrilled with the results but some say the surgery has ruined their eyesight and destroyed their lives, and this week they're taking their complaints straight to the FDA. This is the kind of eyesight some LASIK patients say they are left with - starbursts, halos, double vision, night blindness - after a surgery often touted as quick, easy and problem free.[23] The FDA is taking another look at the surgery after receiving 140 reports of side effects and device malfunctions between 1998 and 2006. The FDA wants its panelists' advice on what information it would add to its website or product labeling to help those considering undergoing LASIK. "Most of the patients who are having these procedures are fairly satisfied and are doing well. Clearly there is a group who are not satisfied and do not get the kind of results they expect," Daniel Schultz, head of the FDA's device center, told reporters on Thursday ahead of the meeting.[2] From 1998 to 2006, the FDA received 140 reports of serious side effects. Early this year, the American Society of Cataract and Refractive Surgery, which represents Lasik physicians, reviewed almost 3,000 journal articles on Lasik and found that 95% of patients reported satisfaction with the outcome of their surgery.[24] The various bodies that make up the task force include the FDA, the American Academy of Ophthalmology, the U.S. National Eye Institute and the American Society of Cataract and Refractive Surgery. The review discussion held on Friday was an attempt by the FDA to do a follow-up on the complaints from the people suffering from side effects, even though they are a minority.[27]
According to the FDA about 5 percent of patients are not happy with the surgery, prompting the agency to embark on a detailed study on Lasik eye surgery patients. [40] Michael Patterson, of Maryland, is among 5 percent of Lasik eye surgery patients that say they are dissatisfied with the procedure. Patterson says it ruined the vision in one of his eyes.[38] Chevy Chase Eye Surgeon Dr. Roy Rubinfeld has not only performed Lasik eye surgery on thousands of patients in the Washington area, he's also dealt with the complications of that same procedure.[29] Some eye surgeons say 31 percent of Lasik patients have some degree of dry eye before surgery, and it worsens for about 5 percent afterward. Other studies say 48 percent of Lasik recipients suffer some degree of dry eye months later. Make more understandable the conditions that should disqualify someone from Lasik, such as large pupils or severe nearsightedness. Spell out that anyone whose nearsightedness is fixed by Lasik is guaranteed to need reading glasses in middle age, something that might not be needed if they skip Lasik.[38] A potentially contentious issue could be the choice of quality-of-life factors to be studied. Lasik surgeons tout the procedure's lifestyle benefits, such as freedom from glasses and improved sports performance. Lasik critics say that past studies generally haven't measured such aftereffects as chronic dry eye and clinical depression that can lead to suicidal thoughts. Some patients complain that they have been abandoned by surgeons who refuse to believe their problems are real. Refractive surgeons discount such criticisms.[9]
My eyes were worse than -9 in each eye, and the average person getting the surgery I was told has vision of about -2 to -3. I had a lot to gain if it worked since I was almost blind without contacts (or glasses), but when I read the contract I had to sign it did say blindness was possible, wrinkles from rubbing eyes, halos which might not go away, the fact that I would need to wear my reading glasses for sure for close-up (whereas I managed without them before), and dryness could be a problem. I do have dry eyes, but I had it done 2 years ago and am now 51, so one of the reasons I got lasik was because I could no longer tolerate contacts all day at work and had them in so long that my eyes were very dry and sore. I got bad halos from the surgery but over a period of time they have gone away. If I use a halogen desk lamp as they advised, for reading or work at my computer it mitigates the need for wearing reading glasses, but I definitely need them to try to decifer someone's handwritting at work.[5] Rush As a recipient of Lasik surgery I would like to share that I prefer occational dry eye (particularly when I am tired) over needing glasses to see every waking moment. Roger T Thank goodness I didn't participate in this surgery proceedure. Last year I went for a consultation and they over quoted me and was pretty aggressive at pursuing the surgery appointment for me. I never really trust these surgery anyways. Better to stick with contacts even thought it's a little bit annoying but the question remains "Want To see or not to see"?[5] Randy I had the lasik surgery in 1998, I ended up with better than 20/20 however from day one following the surgery I suffered from dry eyes and halos, especially at night. I had never experienced either of these prior to the surgery and had worn hard contacts for about 30 years.[5]
A small fraction, perhaps 1 percent or fewer, suffer serious, life-changing side effects: worse vision, severe dry eye, glare, inability to drive at night. Three men in Maryland are among those who say Lasik surgery damaged their vision.[38] A small fraction, perhaps 1 percent or fewer, suffer serious side effects: worse vision, severe dry eye and inability to drive at night. Colin Dorrian was in law school when dry eye made his contact lenses so intolerable that he sought lasik, even though a doctor noted that his pupils were pretty large. Both the dry eye and his pupil size should have disqualified Dorrian, but he received lasik anyway and his father described six years of eye pain and fuzzy vision before the suburban Philadelphia man killed himself last year. "As soon as my eyes went bad, I fell into a deeper depression than I'd ever experienced, and I couldn't get out," Gerard Dorrian read from his son's suicide note.[31]
Lasik promises perfect vision and has delivered for about 95 percent of patients, but the other 5 percent end up with problems like double vision, night blindness, starbursts and dry eyes.[41]
The FDA agrees with eye surgeons' studies that only about 5 percent of patients are dissatisfied with Lasik. What's not clear is exactly how many of those suffer lasting severe problems and how many just didn't get quite as clear vision as they had expected.[13] The sober testimonies illustrated that a decade after lasik hit the market, there still are questions about just how often patients suffer bad outcomes from the procedure, which costs about $2,000 per eye. St. Petersburg ophthalmologist Stephen A. Updegraff said he welcomes new studies by the FDA. Such studies could determine whether problems are more frequent with older lasik technology or with less-skilled surgeons, he said.[31] The sober testimonies illustrated that a decade after Lasik hit the market, there still are questions about just how often patients suffer bad outcomes from the $2,000-per-eye procedure. One thing is clear, said Dr Jayne Weiss of Detroit's Kresge Eye Institute, who chairs the FDA advisory panel: "This is a referendum on the performance of Lasik by some surgeons who should be doing a better job."[13] "Even with the stats we have, we have info that the vast majority of patients who have LASIK do very well," said Jayne S. Weiss, MD, who chaired the advisory panel. "It is really a referendum on the performance of LASIK by some surgeons who should really be doing a better job," said Weiss, a professor of ophthalmology at Wayne State University in Detroit. Experts also recommended that both patient information and FDA's LASIK web site contain photos of potential vision problems. "We do want something that people will read and see if they have the opportunity to," Weiss said.[10] Agency officials, who held an all-day hearing as a first step to examining the problem, also intend to look into whether prospective patients need more and better information about the risks. "The technology has evolved -- it's gotten better; it's safer -- but we still have a percentage of patients who are having unsatisfactory results," said Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health. "Now it's a question of whether there are concrete steps the FDA can take to minimize the number of people who are having these bad experiences." Americans have flocked to Lasik since its approval in 1998.[24] During that time, the agency notes that people may experience glare and halos, and have a difficult time driving at night. The FDA also outlines the risks associated with LASIK on its Web site. Patients like Burch said the problems persisted much longer and said clinical trials failed to inform her that LASIK patients were losing contrast sensitivity, which enables people to distinguish an object from its background.[32]
Today, several patients will ask FDA regulators at a Gaithersburg, Md., public hearing to require stronger warnings about the surgery's risks, better tracking of complications and stronger monitoring of lasik surgeons' advertisements to detect false claims.[42] Patterson and others asked the FDA to stop lasik, which stands for laser-assisted In situ keratomileusis. They also asked for stronger warnings about the surgery's risks and urged the FDA to better track complications and to monitor false claims in surgeon's advertisements.[43]
A panel of outside experts has been summoned by the FDA, with the purpose of holding a public hearing Friday. This hearing is an outset in their analyzing whether warnings and complaints about Lasik's risks are well founded or not. They also intend to find out if patients need to be offered more information before they decide to undergo this surgery.[28] Now the FDA plans to study how the eye surgery affects patients' quality of life by no later than next year. It will also ask a panel of eye experts to consider these issues on Friday and whether patients should be given more information before deciding to do the surgery.[21] Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said today that the clinical study will help get a large, reliable data set that documents quality of life for Lasik patients. Though the FDA has data from when the laser devices went to market, there is no post-market data on how the people who used them have fared.[14] Guidelines for surgery Also in the lineup of speakers is Malvina Eydelman, an ophthalmologist with the FDA's Center for Devices and Radiological Health, which regulates lasik equipment. Eydelman has acknowledged that clinical data about complications from lasik and their effect on patients' quality of life is incomplete, at best.[42]
For years, patients dealing with health problems after having lasik surgery have asked the FDA for stricter regulations.[42]
Henrichs says, "All the easy things I used to be able to do really quick are hard now." The program "Focus on Independence" gave her the surgery to help her regain some self-sufficiency. Friday, two years after the surgery, Courtney tells her story on Capitol Hill. She's one of just a few to appear and testify about the benefits of the surgery. Henrichs says, "I told them it gave me more independence. from using contacts and trying to put them in, or cleaning glasses." Others who testified were not so thrilled with their outcomes following the ten minute procedure. The FDA estimates they makeup only about 5-percent of those who get lasik. Their complaints of double vision, night blindness, starbursts and halos were enough for the FDA to investigate.[44]
"Since LASIK, I am visually handicapped," David Shell, told the panel, according to Reuters. "My eyes never feel comfortable 10 years have passed and I still suffer from this problem." Nearly 8 million Americans have undergone LASIK eye surgery to correct their vision.[33] Friday's hearing was part of a larger review to see if new warnings about LASIK surgery are needed to alert consumers to the possibility of eye pain, dry eyes, blurred or double vision, and other problems.[6] In Roger Davis' experiences, many people are unhappy due to complications from the surgery. Davis, a researcher with a Ph.D. in clinical psychology, said he often hears from patients who are battling depression and thoughts of suicide after surgery. Davis had LASIK surgery in 1998 and now experiences dry eyes, irregular astigmatism and some ghosting in his right eye.[32] You take risks with any kind of surgery. Be aware that intraocular eye pressure cannot be correctly measured post lasik - should you need cataract surgery this would be a major issue. The flap 'heals' to only 2% of its pre surgical strength. Retinal detachment is not unheard of - particularly for those of us with high prescriptions.I could go on - educate yourselfs - don't take a Lasik Centres word for it. Just wanted to add that I know several people that are 'happy' with their surgeries - none of them drive at night - and when pressed will admit that dry eye is a major nuisance/debilitation. Let's face it - no one wants to admit that they are unhappy with a decision they willingly made and paid for - it's called cognitave dissonance and many people will just suck it up and learn to adjust.[5] The lasik surgeon mismeasured my daughter's pupils by more than 1mm smaller than they are. He also did surgery knowing of her extreme dry eyes. Sure she knew the risks but if Tiger Woods went to "the best" well so could she. The surgeon doesn't pick up the pieces when she's suicidal. He doesn't offer comfort or encouragement for the disability or pain. He never even said "I'm so sorry." No, he's off to Pebble Beach with his golf clubs.[33]
Your mileage may vary. Dry Eyes Hurt If you are considering this procedure I suggest you ask about the consequences of DRY EYE SYNDROME, a very debilitating and expensive side effect of Lasik's surgery. Don't let them tell you it is a nuisance disease, because it's MUCH more than that, let me tell you.[5] The FDA will begin examining the side effects of Lasik surgery more than a decade after approving the procedure.[41] The FDA will continue studying the side effects of Lasik surgery and work for better pre-op screenings and warnings.[45]
About five percent of all Lasik surgery patients have some sort of complication or side effect.[46]
The American Society of Cataract and Refractive Surgery has said that only about 3 percent of lasik patients experience complications, but other data and research suggest problems may be more common and long-lasting. [email protected] or (919) 829-8992 To see more of The News & Observer, or to subscribe to the newspaper, go to http://www.newsobserver.com.[43] About 95 percent of patients report being satisfied with the outcome, said Dr. Kerry Solomon of the Medical University of South Carolina, who led a review of Lasik's safety for the American Society of Cataract and Refractive Surgery.[34]
About 95 percent of patients report being satisfied with the outcome, according to the American Society of Cataract and Refractive Surgery, which represents doctors who perform the procedure.[3] About 95 percent of patients report being satisfied with the results, reports the Washington Post, citing figures from the American Society of Cataract and Refractive Surgery. Critics estimate that many more patients have problems, such as "starbursts" and "halos" that make it difficult to see.[33]
Federal health officials were witness to complaints from patients, disappointed with the quality of vision after lasik eye surgery. They complained of great pain and discomfort. Some of them also experienced double vision and blurred vision post surgery. According to a patient's really bad experience, since 1998 when he underwent Lasik eye surgery, the patient had "not experienced a moment of crisp, good quality vision since." [40] WASHINGTON (AP) — A decade after Lasik eye surgery hit the market, patients left with fuzzy instead of clear vision are airing their grievances before federal health officials.[20] WASHINGTON (AP) — In fury and despair, patients harmed by Lasik eye surgery told federal health advisers Friday of severe eye pain, blurred vision and even a son's suicide.[13]
Lasik eye surgery has come in for some flak by a few patients who are unhappy with their vision, post surgery.[40]
Most of us have heard of LASIK eye surgery. It's a procedure that helps improve vision so people can get rid of contacts or glasses.[22] WASHINGTON In fury and despair, people harmed by lasik eye surgery told federal health advisers Friday of severe eye pain, blurred vision and even a son's suicide.[31] Lasik is purely elective surgery basically the same as plastic surgery entirely unnecessary for eye health or vision. Anyone who goes ahead knowing that five out of every hundred people end up with permanent problems is out of their mind.[39]
While frustration and sadness can result from any unsuccessful surgery, when left with constant eye pain or permanently impaired vision, the response can be severe.'' For instance, Colin Dorrian, 28, a patent lawyer and aspiring medical student from Philadelphia committed suicide last summer, six years after Lasik surgery left him with visual distortions.''[26] The prospect of perfect vision in the blink of an eye has attracted thousands of patients to Dr. Roy Rubinfeld's office for Lasik surgery.[14]
A panel of medical advisers mostly eye doctors wearing glasses listened to tales of woe and wonder Friday from people who sought to get rid of their specs through Lasik surgery.[47] Lasik is quick and, if no problems occur, painless: Doctors cut a flap in the cornea — the clear covering of the eye_ aim a laser underneath it and zap to reshape the cornea for sharper sight. Doctors advise against Lasik for one in four people who seek the surgery, said Dr. Kerry Solomon of the Medical University of South Carolina, who led a review of Lasik's safety for the ASCRS. Their pupils may be too large or corneas too thin or they may have some other condition that can increase the risk of a poor outcome.[4] Dr. Kerry Solomon, a Charleston, S.C., eye surgeon who led the association review, expressed support for a national study but said there was no need to rewrite the warning information because doctors are careful to inform patients about potential problems. In his practice at the Medical University of South Carolina's Storm Eye Institute, Solomon said he spends two hours briefing a prospective patient on the risks and testing their eyes to make sure the operation has a high chance of success. Based on the results, Solomon said, he turns away every fourth patient.[24]
The surgeons recently reviewed 19 studies measuring patient satisfaction. After the results of the review came out last month, Kerry Solomon of the Medical University of South Carolina's Storm Eye Institute said he planned to report first results of the literature review at the public hearing. Of about 2,000 patients who participated in the 19 studies, an average 4.8 percent were not satisfied with the outcome of their laser eye surgery.[42]
While working at Duke University, Burch received a mailing to employees that touted the benefits of the university's laser eye surgery. A senior medical researcher, Burch did her homework before undergoing the LASIK procedure, which stands for Laser-Assisted In Situ Keratomileusis, in March 2004. She read the clinical trials with interest and combed the Internet for details. She says, she didn't get the whole story.[32] Nine years after it approved vision-correcting laser eye surgery, the Food and Drug Administration is coming under increasing pressure to step up oversight of the procedure.[42] The Food and Drug Administration advisers recommended that the government warn more clearly about the risks of the hugely popular operations. About 700,000 Americans a year undergo the elective laser surgery, hoping to throw away their glasses, just as the ads say.[31] Obviously there are some risks associated with all surgery, but now the U.S. Food and Drug Administration (FDA) will be launching a full scale study in the safety issues.[46]
Now the Food and Drug Administration plans to launch a national study assessing the rate of side effects among Lasik patients.[24] How big are the risks? The Food and Drug Administration thinks about 5 percent of patients are dissatisfied with Lasik. How many struggle daily with side effects? How many are just unhappy that they couldn't completely ditch their glasses? The range of effects on patients' quality of life is a big unknown.[20]
The Food and Drug Administration estimates that about 5 percent of patients who get LASIK are unhappy with the results.[30]
Learn how to maintain seamless business continuity while migrating from traditional voice mail, to unified communications. In the first hour of a public hearing, more than a dozen patients and patient advocates stepped to the microphone to tell an advisory panel of the Food and Drug Administration about their years of eye pain, night driving problems and suicidal thoughts.[43] David Shell showed a chart of his vision after having Lasik surgery while speaking at a Food and Drug Administration hearing Friday in Gaithersburg, Md.[47]
Matthew Kotsovolos, who experienced debilitating complications after lasik surgery, called the hearing a sham. He referred to a news release put out by a trade group for laser surgeons claiming that the FDA considers lasik to be safe and effective. Beth Kotsovolos told the panel that because of lasik, her children almost lost their father.[43] Today's hearing is the first the FDA has scheduled to hear how patients' quality of life has been affected by lasik surgery.[42]
The FDA thinks about 5 percent of patients are dissatisfied and is pairing with eye surgeons for a major study involving hundreds of Lasik patients.[48] The FDA study will enroll hundreds of Lasik patients along with eye surgeons, as part of a focus group that will take a closer look at the complaints.[49]
No one is considering restrictions on Lasik, but the FDA is working with eye surgeons to begin a study next year to better understand who has bad outcomes. Microsoft Corp. is no closer to buying Yahoo Inc. than when it made its $44.6 billion bid nearly three months ago, leaving the software maker in a quandary over whether the deal is still worth pursuing.[47] The FDA is pairing with eye surgeons to begin a major study next year to better understand which Lasik-surgery patients have bad outcomes.[38]
"I've had experience having treated patients over many many years, who've had problems sometimes elsewhere, sometimes in other countries and that gives me a unique perspective," Rubinfeld said. While most agree the chance of a complication from Lasik is small, one study reports that about 5 percent of patients say they're dissatisfied. When complications do occur they can be devastating, and the FDA says they're not sure how often this is happening.[29] GAITHERSBURG, Maryland ' The FDA Ophthalmic Devices Panel heard public testimony both in favor of and sometimes vehemently opposed to LASIK at a post-market LASIK meeting here. The Ophthalmic Devices Panel heard a number of impassioned presentations opposing LASIK. The testimony ranged from individuals who had suffered adverse LASIK-related complications, therapists and other specialists who had treated patients for depression following adverse complications, optometrists, ophthalmologists and attorneys representing those patients with significant post-LASIK complications. Some called upon the FDA to impose a moratorium on LASIK procedures until more is known about the alleged psychological damage inflicted upon those who have experienced debilitating complications.[50] The purpose of the panel meeting according to an FDA executive summary was to present regulatory background and history of refractive lasers, evaluate the American National Standards Institute refractive laser standard, review the Post-market Issue Action Team's assessment of quality of life for LASIK patients, explore cost-effective means of executing patient reported outcomes in clinical trials and discuss the feasibility of a large multicenter clinical trial of LASIK and quality of life.[50] After hearing from patients, doctors and experts today, an FDA advisory panel recommended that the government make more clear the warnings it already provides for Lasik patients.[29] At a public hearing Friday in Maryland, FDA officials heard horror stories about side effects, and questions about whether Lasik patients receive enough pre-operative warning about what can go wrong.[45] The FDA got 140 reports of side effects with Lasik from 1998 to 2006. "Clearly there is a group that aren't satisfied and don't get the results that they expect,'' Schultz told reporters on a conference call. Studying these patients "is very, very high on the agency's priority list.''[1]
Just remember: Today'''s happy 20/20 LASIK patient may regress and be tomorrow'''s LASIK casualty driving a school bus picking up YOUR children. Number Two: What is '''True Informed Consent'''? I have submitted a complete pamphlet to this panel that gives the patient '''True Informed Consent''' with full color pictures illustrating the known side effects. Please consider mandating this pamphlet for yours is antiquated. Then educate the consumer on the Statute of Limitations so they know the '''timeframe to sue their doctor''' starts from the date of the procedure NOT the date of discovery.[39]
The agency is planning to conduct a study on LASIK patient satisfaction along with the National Eye Institute and two industry groups. Friday's meeting is expected to draw testimony from patients with strong opinions on the procedure, either because they suffered a mishap, or because their lives have improved without having to use glasses or contacts.[19] When things go wrong, patients can end up with poor vision even with glasses, pain, glare or painful dry eyes. Remember this: Lasik isn't for everyone.[51] At night I use oily eye ointments several few times. It's $2000 - $3000 a year for the OTC meds plus the cost of goggles, which can run up to $1000. There is a website out of the USA called Dry Eye Zone, which has thousands of dry eye suffers on it discussing this issue, many former Lasik's patients.[5] I have severe dry eyes, but not from Lasik surgery, to the point where I wear moisture chamber goggles and put drops in my eyes every 10 minutes, which I have been doing for 15 years.[5] Berney's not alone. Abby Ellin says Lasik surgery left her with chronically dry eyes. "It's just painful and I feel like there is a film around my eye all the time," she said.[51]
From Friday's public hearing Berney wants to see the FDA be open and honest allowing centers to give the "real" risks of surgery. Brightbill/Erickson Eye Associates here in Rockford says they do. Dr. Mitul Vakharia says, "For those that are good candidates we have a long discussion with them about all the risks of surgery including dry eye, and glare and hallos around lights at night."[37] The FDA says there have been some complications reported after surgery including '''migration of the flap''', inflammation and / or infection. This may require intensive treatments with eye drops. The FDA says these complications could lead to either temporary loss of sight or '''irreversible''' blindness. Doctors should screen their patients and the risks should always be explained, according to the FDA.[46] The FDA has become increasingly concerned about reports of severe complications but has acknowledged that it does not have enough studies to know how often severe reactions occur. Those reports, which include debilitating eye dryness, blurred vision, and other vision disruptions, could suggest doctors are not doing enough to inform patients about the potential risks, the agency said.[10]
Experts also urged the agency to include more warnings about the potential risks of LASIK in women using hormone replacement therapy since the drugs can alter the cornea. They called for more warnings for doctors who evaluate which patients may not be candidates for the procedure.[10] The FDA wants to hear from more patients who've had a bad experience with Lasik so that it can decide if the warning about the risks involved with the procedure need to be updated.[51]
The procedure, can be effected as an outpatient procedure by any competent opthamalic surgeon.it is very similar to cataract surgery, and is 100% reversible. the cost is approximately $2000/eye for the procedure. Why is this not available in USA? Because the same people who own the patents on the lasik machines, own the patents for the implant lenses, and they wont request approval by the FDA for use of these lenses in america., because they wont make as much money selling the lenses, as they do selling the million dollar lasik machines. This alternative to lasik is available to anybody anywhere outside FDA jurisdiction, and is especially efficacious for high degrees of correction and astigmatism that lasik cannot correct.[39] Each of the two professional physician groups has agreed to contribute $500,000 of the estimated $1.2 million cost of the study. Such a joint government-physician study is unusual, says Dr. Ferris, the eye institute's clinical director. "This is very difficult research" that will require a large study of more than a thousand people, he says. Lasik critics are upset about the collaboration because it includes surgeons who make their living from refractive surgery.[9]
"No one has received full informed consent for LASIK," Burch said. "If anyone knew what this procedure really does to their eyes, they wouldn't have it." 28.3 million people worldwide have decided to undergo the surgery since the mid-'90s to improve their sight.[32]
Dozens of people talked about having double vision or severe dry eye. One family explained how their father became depressed after having lasik. Others discussed how their life has been negatively altered since the procedure.[52] Factors that may rule out LASIK include large pupils, thin corneas and extremely dry eyes. There are clearly those who find success with LASIK, including the world's greatest golfer. Tiger Wood trusted his sight and his career to the procedure. Those who are suffering say all the successes don't diminish the failures.[23]
Dry-eye specialist Dr. Craig Fowler of the University of North Carolina says other research suggests 48 percent of patients experience some degree of dry eye at least temporarily after Lasik. Cutting the corneal flap severs nerves responsible for stimulating tear production, and how well those nerves heal in turn determines how much dry eye lingers long-term, he said.[20] Perfect vision in the blink of an eye is the promise and the outcome for about 95 percent of Lasik patients.[51]
WASHINGTON -- Federal health officials heard stories Friday pain and frustration from patients harmed by Lasik eye surgery.[48] Federal health officials are taking a closer look at the safety of Lasik eye surgery.[49]
"The technology has advanced to the point that there has never been a better time to undergo LASIK eye surgery. Our outcomes are better and these procedures are safer."[32] April 24 (Bloomberg) -- Complaints about Lasik eye surgery using lasers made by companies including Advanced Medical Optics Inc. and Alcon Inc. are a priority for U.S. regulators, a government official said today.[1] Laser makers are confident that demand for surgery will rebound along with consumer confidence. "We don't think anyone has changed their mind about Lasik, but people are holding off until they have a better sense of how their stock portfolios will do or what their mortgage interest rates will reset to," says Sheree Aronson, a vice president at Advanced Medical Optics Inc., a Santa Ana, Calif. -based device maker with the largest share of the U.S. Lasik market.[9]
"I deal with people every day who are miserable and depressed after Lasik surgery." After receiving such complaints, the FDA began trying to get an accurate assessment of the scope of the problems.[3] The FDA received 140 reports of Lasik surgery injuries between 1998 and 2006, according to an agency spokeswoman.''[26]
Nathan I got 20/15 vision(better than 20/20) after my lasik surgery and I have had no side effects in 8 years. But! But, I was never told that there were nerves in my cornea that they would be cutting, I just found that out now. I see clearly now the rain is gone It's not called vanity, it's called quality of life.[5] The most meticulous studies come from the military, where far less than 1 percent of Lasik recipients suffer serious side effects, said Dr. David Tanzer, the Navy's Medical Corps commander. That research prompted Lasik to be cleared last year both for Navy aviators and NASA astronauts. "The word from the guys that are out there standing in harm's way, whose lives depend on their ability to see, are asking you to please not take this away," said Lt. Col. Scott Barnes, a cornea specialist at Fort Bragg who described Army troops seeking Lasik after losing their glasses in combat.[13]
Dr. Walter J. Stark, director of cataract and cornea services at Johns Hopkins' Wilmer Eye Institute, agrees that doctors must take time to make sure patients have realistic expectations. Chances for night glare and other side effects have been reduced, he said, but he still stresses there's a 1% risk of serious side effects.[24] I have friends who have had the procedure whose results have been ok, but less than stellar. They report issues with driving at night and are once again wearing glasses for many tasks. My feeling is that this procedure is likely most optimal for people with relatively minor vision deficits. Those of us with very strong prescriptions are much less likely to have truly optimal results and should take careful note of the "fine print" about risks and possible side effects and ask lots of questions about the true benefit in our circumstance.[5]
I put laser eye surgery right down there with any other cosmetic procedure. It's not necessary surgery, it's based solely in vanity or convenience for most people so don't take the risk if you can't face the consequences. I wear glasses and would never risk my sight on this foolishness.[5] The heightened focus on potential problems from laser eye surgery comes at a time when the industry is suffering a slowdown partly because of the weakening economy. Dave Harmon, president of research firm Market Scope LLC, forecasts a 17 percent decline in U.S. laser vision-correction procedures this year. Surgery volumes peaked in 2000 at about 1.4 million and have been flat in recent years, he says.[9] The possibility of FDA action comes as the economic slowdown is expected to hit companies that sell laser equipment or operate lasik centers. Research firm Market Scope projects a 17 percent decline in the number of lasik procedures this year as consumers cut back on expenses.[42] Investors will also be watching Friday's meeting to gauge what impact concerns could have on Lasik laser manufacturers, which include Advanced Medical Optics Inc., Alcon Inc. and Bausch and Lomb. Analysts already expect Lasik procedures to decline 5 to 15 percent this year as economic conditions make the procedure, which can cost between $1,500 and $5,000, less financially feasible for many consumers. The industry's largest player, Advanced Medical Optics, cut its 2008 earnings outlook earlier this year on the expectation of fewer procedures.[18] Investors will be eyeing Friday's meeting to see what impacts could affect Lasik laser manufacturers. Some analysts already expect the eye procedures to drop this year as economic conditions make the procedure less attractive to consumers.[21]
One patient, Matthew Kotsovolos of Raleigh, wants the agency to temporarily stop the surgeries until more safety data are available. He experienced debilitating complications after having lasik at Duke Eye Center two years ago. He has started a patient support group and will be among about two dozen speakers at the hearing. "I hope they'll do the right thing," Kotsovolos said. "My hope is that they not ignore what people who stood up said and move on to business as usual."[42] The agency will ask the expert panel whether educational materials given to patients considering Lasik need to be changed or updated, according to documents posted to the agency's Web site Wednesday. Regulators agreed to hold the meeting after years of complaints from a small group of patients who say their eyesight has been irreparably damaged by the surgery.[7] I don'''t know of any other procedure where hundreds of patients have created websites, warning the public about the unpredictability and corruption of LASIK surgery. I have outlined (5) KEY Emergency Points which should be thoroughly answered by this Panel, to ensure that the LASIK industry does not continue to DUPE the misinformed public.[39] The Federal Drug Association says many patients have complained about lasik surgery, asking them to update the procedure's warnings.[52]
Lasik surgery patient Barbara Berney says, "If anyone had said to me you might not every drive at night again or had showed me a picture of what my vision looks like now I would have run for the door.[37] In the meantime, experts said information given to patients considering LASIK surgery should warn more clearly of the possibility of long-term vision disruptions, including "halos," "starbursts," blurriness, and multiple vision.[10]
The panel agreed that LASIK labeling should include additional information or guidance about postoperative intraocular pressure, additional guidance for implant measurement for post LASIK cataract surgery, and stronger cautionary language concerning risks in patients with a strong history of keracatonis.[8] The panel will also comment on a proposed study looking at patients' expectations of Lasik surgery.[18] The panel will also examine a proposed study that will look at expectation of Lasik surgery from patients.[21]
Dr. Colman Kraff uses a pachymeter to measure the thickness of patient Steve Parker's cornea prior to creating the Lasik flap at Kraff's offices in Chicago as part of Parker's eye surgery Nov. 1, 2005. [14] An estimated 6 million Americans have undergone Lasik surgery, which permanently reshapes the cornea, a clear layer covering the eye.[7] LASIK doctors say complications from the eye surgery are rare, and a study published in January's American Journal of Ophthalmology showed the benefits of LASIK can last a decade.[32]
"I was 20/80 before today," said Lori Hill, who recently underwent Lasik eye surgery. "They told me it was 20/15, and it's just the day after surgery. It's been wonderful so far." Officials for the Society of Eye Surgeons said they have a 95 percent satisfaction rate.[38] - if you get the surgery -- REST your eyes as directed and use the drops faithfully. One friend of mine went to Halifax from Moncton (because it was cheaper) and drove himself home with one eye closed after the op! Nuts! He still has problems to this day. Jean I'd like to thank everyone who has shared their experiences, good or bad, with their Lasik eye surgeries.[5] The surgery was conducted at a Lasik center in Canada that has since closed.'' "If I cannot get my eyes fixed, I'm going to kill myself," he wrote in a note police found, adding, "I have other problems like most people do.'' This is something else.''[26]
Before anyone undergoes Lasik eye surgery, it's important to know the risks involved, because not everyone is a candidate.[35] Doctors advise against Lasik for one in four people who seek the surgery. Their pupils may be too large or corneas too thin or they may have some other condition that can increase the risk of a poor outcome.[20] "I've got a good friend who will give you a discount if you have your surgery the same week as your first exam. It's that philosophy, strike while the iron's hot," Dr. Suggs said. Dr. Suggs promises that's not the kind of treatment you'll get at his center. They turn down 1 out of every 4 people who walk in for a consultation. "We may see them 4 or 5 times, we may see them for 6 months to a year before we decide this is a safe operation for them," He said. Doctor Suggs feels if you're a candidate for LASIK, it's a great life changing operation.[22] The flaps cut in Aptheker's cornea literally became wrinkled during the surgery, blocking vision and causing severe pain. It took seven additional surgeries over four years to restore his vision, which Aptheker says still isn't quite as good as before his Lasik in 2000.[20] In Lasik, surgeons use a laser to reshape the cornea to improve vision. It's been used for more than 10 years to help with astigmatisms, nearsightedness and farsightedness. Clarksburg resident Luis Velarde said he wished he knew more about the possible dangers related to Lasik before he underwent the procedure in his native Bolivia five years ago.[29] Lasik stands for Laser-Assisted In Situ Keratomileusis, and is a procedure designed to change the shape of the cornea to correct vision in people who are dependent on corrective glasses or contact lenses. It involves cutting a flap out of the cornea, which is pulled aside so a computer-controlled laser can vapourize a portion of the middle section of the cornea, called the stroma.[5]
Device makers and operators of Lasik surgery centers including TLC Vision Corp., of Mississauga, Ontario, and LCA- Vision Inc., of Cincinnati, insist the procedures are safe.[1] "There is no foolproof medication, no foolproof procedure," said Rubinfeld, who himself had Lasik surgery in 1995. "But the safety profile of this procedure, in my medical experience over a long period of time, has been unparalleled."[14]
Patterson claimed Huang failed to follow safe lasik procedures during surgery. Among those attending were lasik patient Matthew Kotsovolos and his wife, Beth, of Raleigh.[43] Solomon says that 31 percent of Lasik patients have some degree of it before the surgery and that about 5 percent worsen afterward.[20]
Critics believe there is a higher proportion of patients encountering problems after a Lasik surgery.[34] The agency received 140 reports of Lasik-related problems between 1998 and 2006, according to an agency spokeswoman. Dean Kantis, who is scheduled to speak Friday, says his vision has suffered since his Lasik surgery in 1998.[7] In 2001, Berney underwent Lasik surgery in Wisconsin. She needed a 2nd surgery to correct what didn't take. Now she has glasses for every state of her vision that she says changes daily based on her surroundings.[37] Matt Kotsovolos of Raleigh takes fish oil to help him produce tears and wears gogglelike glasses to counter severe dryness in his eyes, conditions he blames on lasik surgery.[42]
Lasik stands for laser-assisted-in-situ-keratomileusis and consists of a surgery that uses laser to reshape the eyes cornea and correct sight defects.[25] Lasik is marketed as quick and painless: Doctors cut a flap in the cornea — the eye's clear covering — aim a laser underneath it and zap to reshape the cornea for sharper sight.[13]
"You have one pair of eyes, and it is a very important part of your life, and so doing your homework and seeking someone who you can trust is critical," explained LASIK surgeon, Dr. Rubenfeld. That also means finding a doctor who will do the tests to ensure that you 're a good candidate.[23] At a public hearing Friday, officials heard stories of eye pain and blurred or double vision because of the procedure. One man who had Lasik in 1998 said he has "not experienced a moment of crisp, good quality vision since."[48] Las Vegas ophthalmologist and Lasik surgeon, Jon Sims believes that a major study of the procedure will prove to be beneficial. "I think it's good the FDA is actually looking at this because, quite honestly, I think it's going to be beneficial for Lasik. They're going to see how good Lasik is, how effective it is, how safe it is."[49] LASIK (which stands for laser-assisted in situ keratomileusis) is performed in more than 700,000 U.S. patients each year. One study published last month by a trade group representing LASIK surgeons suggested about 95% of all patients are satisfied with their procedure.[10] All the warnings have been provided to each and every patient. Now people who have been "injured" by this revenue generating procedure that provides lots of jobs want money because they aren't perfectly satisfied with the outcome. We need special federal legislation to immediately slam the door on all these malingerers who want a payday due to what is probably their own lack of judgment. This lasik litigation is the perfect opportunity for us to slam the door shut on these freeloaders. If they are truly "injured" let their own health insurance take care of them. To learn more about how to slam the door shut on those who would prey on corporate America, call your representative at the United States Chamber of Commerce.[33] Okay people take a deep breath, calm down, and remind yourself that there are two sides to every issue. Loads of LASIK clinics out there are overselling the procedure and, more importantly, the industry is doing nothing to refine its patient selection criteria. A little nudge, particularly toward understanding bad outcomes and reducing them through better evaluation criteria, would not be a bad thing.[33] LASIK's industry group insists patients are satisfied by the results of the procedure. "When we look at outcomes of LASIK - 20/20 rates - our outcomes of LASIK today are better than they have ever been," said Dr. Kerry Solomon, professor of ophthalmology at the Medical University of South Carolina.[32]
The FDA's comments come ahead of a public meeting set for Friday to discuss patient satisfaction with the LASIK procedure that some analysts said could cloud an industry already pinched by weakening demand amid a slowing U.S. economy.[19] The FDA's announcement on Wednesday comes before a public meeting scheduled for Friday to discuss patient satisfaction with the LASIK procedure.[34]
To prevent such events from happening again, the FDA said it would ask its outside experts to discuss what information is currently available for patients considering or undergoing Lasik and whether changes must be made. "Panel members will be asked to recommend modifications/additions to the FDA's patient labeling and LASIK Website," the FDA wrote on its Web site.[34] The FDA has called an Emergency Panel Discussion to speak to hurt LASIK patients.[23] "Panel members will be asked to recommend modifications/additions to the FDA's patient labeling and LASIK Website," the FDA wrote.[19]
Although many confronted the FDA with problems, a group of surgeons from "The Society of Eye Surgeons" say 95 percent of patients are satisfied with the results.[52] Eye surgeons who use lasers are willing to learn from patients' experiences, Richard Lindstrom, co-chairman of the group of surgeons collaborating with the FDA, wrote in an e-mail message. We "are listening, we hear them, we care, and we are responding in a tangible and constructive fashion," he wrote.[42]
The panel could listen to the speakers -- about half are patients or patient advocates, and at least six are laser eye surgeons -- and do nothing.[42]
Jayne Weiss, M.D., of the Kresge Eye Institute in Detroit, who chairs the panel, said that based on available information "the vast majority of patients with LASIK do very well and are very happy and see very well."[8] Kerry D. Solomon, a professor of ophthalmology at the Medical University of South Carolina who works with the eye doctors' group, said the study will provide valuable information. "This study will give us invaluable insight on the many and diverse factors that make up quality of life," he said. "This new knowledge will ultimately be a great benefit to patients and doctors alike."[3]
When I began to speak out against LASIK years ago, I encountered a severe backlash. My own doctor, Nick Caro of Saint George in Chicago, tried to sue me for $2 million dollars for exposing his 40+ LAWSUITS. He then caused my family to get a divorce last year by harassing my wife attempting to get her fired from her nursing profession. How is it that a doctor in this country can have 40+ lawsuits with NO KNOWN DISCIPLINARY ACTION? I feel that my '''second opinion''' doctors also lied to me, and I know they are the problem. After submitting complaints on these same doctors to the Department of Regulation, backed by solid evidence, I soon found all were DENIED. They all went up to '''Probable Cause,''' and there at the top sits a Medical Doctor in order to '''cover a fellow doctor.'''[39] I mainly got it done to better my quality of life as well to save in further expensive glasses. My vision was so bad that if something was 10 feet away from me I wouldn't be able to tell if they were talking to me or something else without my glasses. It's only been almost a week and I'm obviously having no problem using my computer. I have some trouble reading close up but it's improving by the day. I agree with the person who said that the specialists at Lasik always inform it's clients about the risks, etc. I was told that I could do the regular Lasik but the chance of regression was higher than if I used the Zyoptic version.[5] Myself, I have 20/10 vision (better than 20/20), with no problems. I shudder to now think how I could have spent my life with dealing the expense and awkwardness of glasses (contacts btw really took a serious health toll on my eyes, so why not ban those, Ance?).[5]
Constant dry burning eyes compound the problem as the cornea dries and distorts my vision. ALL THAT ASIDE, I am still able to function very well apart from these problems and own 3 types of glasses for specific situations - after all the expense.[5] Not everyone's a good candidate, and an unlucky few do suffer life-changing side effects: poor vision, painful dry eyes, glare or problems seeing at night.[20] Not everyone's a good candidate, and an unlucky fraction do suffer life-changing side effects: poor vision even with glasses, painful dry eyes, glare or inability to see or drive at night.[4]
Possible side effects include dry eye, double or blurry vision, difficulty seeing at night, or seeing halos or rings.[29] Add photographs that illustrate what people suffering certain side effects actually see, such as the glare that can make oncoming headlights a huge "starburst" of light. Clarify how often patients suffer different side effects, such as dry eye.[38]
Though most patients are happy with the surgery and experience sharper vision, there are still many grappling serious side effects like poor vision and abysmal nocturnal vision.[40] Most side effects are rare and temporary, said Dr. Michael Kelly, an ophthalmologist who performs Lasik surgery in Raleigh.[38] Most Lasik recipients do walk away with crisper vision, but others suffer life-changing side effects like poor vision even with glasses or the inability to see or drive at night.[48]
Wouldn't you rather live as if you had a set of never-care contacts that never had to be cleaned or taken out, and were never uncomfortable? I had LASIK 7 years ago, and after a year of dry eyes at night (eyedrops at about 3 am), I am very happy with my results. [5] Risks of the procedure include loss of vision, dry eye syndrome and poor night vision.[11] Complications after surgery can include dry eye, blurriness and even loss of vision.[1] According to the father, after surgery the son had large starbursts and halos at night, triple overlapping images, and ghosting off white objects in low light, as well as painful dry eye. The father read a suicide letter in which his son wrote that he fell into a suicidal depression because of his eye problems.[8] Dry eye is common even among people who never have eye surgery, and increases as people age.[20] Jason I had considered Lasik but after hearing that a certain percentage of people suffer from very dry eyes, I decided against it.[5]
"Blurred vision, dry eyes, glare and double-vision have led to depression and in some cases suicide," Reuters quoted patients as saying.[39] The most frequent unpleasant outcomes are blurred vision, dry eyes and halos around lights when seen at night.[28]
I can't drive at night. When I look across my living room, it's like looking through used wax paper," said Barbara Berney, who underwent the procedure in 2001 and now is president of the Vision Surgery Rehab Network, which helps patients who have experienced complications.[3] Dr. Roy Rubenfeld, who has done thousands of LASIK operations and has even had the surgery himself, says patients should not take the procedure lightly.[23] One Lasik surgeon said many problems with the procedure could be avoided long before patients enter the operating room.[45] I went to an Optometrist who had extensive experience with patients who had the Lasik procedure and went to see a surgeon in Toronto who was a Pioneer in the field.[5]
That's a big reason why Weiss, the glasses-wearing ophthalmologist, won't get Lasik even though she offers it to her patients. "I can read without my glasses and. operate without my glasses, and I love that," she said. "The second aspect is I would not tolerate any risk for myself. Does that mean Lasik is good or not good? It means Lasik is good but not for everyone."[13] The agency is holding a public hearing today to figure out if the warnings issued about the risks of LASIK are appropriate. The FDA will be involved in a major study intended to determine how often such complications occur.[30] GAITHERSBURG, Md., April 25 -- Laser-assisted in situ keratomileusis (LASIK) is safe and well accepted, an FDA advisory panel concluded today. Although overzealous marketing may lead to inappropriate use of LASIK, such questionable clinical decision-making does not detract from the device's overall safety, found the agency's Ophthalmic Devices Advisory Committee after a day of hearings.[8] Despite the often dramatic testimony, the FDA panel was not convened as a referendum on LASIK, according to Dr. Weiss. 'I think some of you came here today, and I know that some of the press had touted this meeting as a referendum on LASIK,' Dr. Weiss said. 'It appears to me from hearing what was said today that this really has been a referendum on the performance of LASIK by some surgeons who should be doing a better job.[50] The testimony suggested that there was "inadequate informed consent and the fact that some patients were poor candidates. That comes under malpractice and that is something that the field should monitor." She said the day's hearing was "really a referendum on the performance of LASIK by some surgeons who should be doing a better job."[8]
Some who have the procedure achieve better than 20/20 vision. Though ophthalmologist Dr. Robert Cykiert said the FDA has received 140 complaints from unhappy patients, he said he's still a believer and recommends it for those who are a good fit. [48] Some of the patients boast of a 20/20 vision after the corrective procedure. Even though the FDA has received about 140 complaints from disappointed patients, ophthalmologist Dr. Robert Cykiert enthusiastically supports the treatment and is positive of its benefits for those who meet with the requirements of such a procedure.[40]
Did the patient know about all the risks before a medication was prescribed or a procedure was recommended? Did the FDA have all the information that should have been provided by the manufacturer? Simple but essential questions.[17] I am the editor of TexasLasik.net and our traffic for LASIK information and inquiries is up due to the fear that the FDA might put restrictions on this procedure reducing availability or removing it as an alternative all together.[39]
Someday, the medical community and the FDA will learn that patients have the right to know. It is the patients right to have the information required to make an "informed decision" about whether or not to take a medication or have a procedure.[17] The Washington Post reported earlier that Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, told journalists during a telephone briefing yesterday: "Our sense is that most of the patients who are having the procedures are reasonably satisfied and are doing fairly well. Clearly there is a group that is not satisfied and do not get the kind of results that they expect.[33] WHAT'S NEXT: The panel could recommend changing the regulatory guidelines for vision-correcting lasers, including monitoring of surgery results and consumer information. It could also tell the FDA that more health studies are needed. Or it could recommend no changes.[42] According to the American Society of Cataract and Refractive Surgery, surgeries are not successful in two to three per cent of cases. Dean Kantis, who will address the FDA panel on Friday, said since his surgery in 1998, he has struggled with poor vision.[11] Lindstrom is also president of of the American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery.[42] Regulators have agreed to work with the American Society of Cataract and Refractive Surgery on a large-scale study of patients' quality of life after surgery.[7]
About 700,000 Americans a year undergo the elective laser surgery. Like golf star and famed Lasik recipient Tiger Woods, they're hoping to throw away their glasses, just as the ads say. [13] About 7.6 million Americans have had laser corrective surgery, including lasik.[52] Lasik was approved a decade ago and an estimated six million Americans have undergone Lasik surgery.''[26] The surgery was first approved in the mid-'90s and since then more than 12 million Americans have undergone Lasik by some estimates.[34]
In all, about 7.6 million Americans have undergone Lasik, which costs about $2,500 per eye.[3] About 7.6 million Americans have undergone some form of laser vision correction, including the $2,000-per-eye Lasik.[20]
"Millions of patients have benefited" from Lasik, said Dr. Peter McDonnell of Johns Hopkins University, a spokesman for the American Academy of Ophthalmologists. "No matter how uncommon, when complications occur, they can be distressing.[13]
Several important discussion points will be the patients informing the FDA, ASCRS, and LASIK doctors that the FLAP NEVER HEALS. another clandestine fact.[23] The FDA relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients. This entry was posted on Wednesday, April 23rd, 2008 at 11:52 am and is filed under Legal News, Defective Medical Devices.[53] Philips' shares were off 44 cents'''over one percent'''at $37.87 in late morning trading on the New York Stock Exchange and were down about 1 percent on the Amsterdam exchange. In February, researchers from the University of California, San Francisco (UCSF) argued that medical devices are not subject to the same rigorous review process as pharmaceuticals and this needs to change to improve health outcomes and found once a device receives FDA approval, an independent technology review could help identify which devices are beneficial.'' According to the team, this data would improve health professionals' awareness of the potential promise and pitfalls of new technology.''[53] In fiscal year 2008, FDA reduced review time for 90 percent of new animal drug applications to 180 days. If reauthorized, ADUFA is expected to generate $98 million in user fees over the next five years to support FDA review of these new animal drug applications.[54] First authorized in 2003, ADUFA created a framework by which drug manufacturers pay fees that supplement the agency's appropriations and animal drug reviewers meet demanding performance deadlines. The ADUFA program, which must be reauthorized by Congress every five years, has enabled the FDA to dramatically reduce its review time of new animal drugs, bringing medications to the market more quickly while maintaining high standards for safety and efficacy.[54]
The F.D.A. is gearing up for a study to examine the complaints. "Clearly there is a group that aren't satisfied and don't get the results that they expect," Daniel Schultz, an F.D.A. official, told reporters on Thursday. Studying these patients "is very, very high on the agency's priority list."[39] The FDA has informed a panel that will begin cataloguing the complaints of patients who've had bad experiences with the procedure.[41] The F.D.A. and industry representatives agreed that 95 percent of patients are satisfied with the procedure.[39] The recommendations fell short of patient requests. Some want the FDA to temporarily stop the procedures or include stronger precautions, such as warnings about slow and incomplete healing of the surgical incision and.[36]
Among the production problems cited were an inadequate system to manage production changes as well as problems with software to check device and also said Philips Medical Systems did not properly maintain certain investigative records and failed to set up proper procedures to handle complaints.'' According to the FDA, Philips Medical has taken some steps to correct the problems since the inspection; however, Philips Medical has yet to address them all.''[53] According to a letter released by the U.S. Food and Drug Administration (FDA), one of the problems cited includes Philips Medical'''s failure to oversee proper medical device design.''[53] Merck, like many other drug companies, has been found to have suppressed and manipulated certain critical data that misled the regulatory body the U.S. Food and Drug Administration (FDA).[55]
Now more than a decade after approving the procedure, the Food and Drug Administration is preparing a nationwide study to see how patients are doing in post-surgery.[51] WHAT'S HAPPENING TODAY: A panel of experts formed by the Food and Drug Administration will hear from patients and surgeons.[42] In initial trials, Merck hid the fact that the drug was killing patients ''' a fact that was lost in papers handed to America'''s drug regulator, the Food and Drug Administration, in 2004.[56] The Food and Drug Administration Amendment Act (FDAAA) passed last year has made it compulsory for the industry to submit trial results in a publicly accessible registry.[55]
The procedure is gaining popularity, but the U.S. Food and Drug Administration is sending out a warning.[22]
All people who get laser eye surgery want is to be able to see well in the morning without putting on glasses or contacts. [5] I had laser eye surgery because I needed an alternative to contacts, and a variety of contacts advertised as more lubricating to the eyes, was over a thousand dollars a year with all of the upkeep and bother of contacts, which I might not have been able to wear anyways.[5]
I doubt that people who get laser eye surgery want to "look better", maybe see better but not look better.[5]
An estimated 1.4 million surgeries were performed in North America in 2007, according to Lasik MD ''' a provider of laser eye correction.[11] When patients undergo vision-correcting laser eye surgery'''such as Lasik'''they sign a release form with an extensive list of risks; however, researchers and former patients say a potential complication is not mentioned:'' Depression leading to suicide.''[26]
Dr. Gelinas says "I have a brother, a brother in law, that have had it done. They're very pleased and I've had a large number of patients who we've followed over the years who have been very pleased with their results." LaVonne Timmons, an Optician at Eye Care Associates, says "I think it's wonderful. I've seen a lot of great people come through that have worn glasses from childhood on and all of a sudden they're like wow I don't need them."[15] Now in 2008, I'm back wearing glasses as the surgery results did not last more than seven years. I have plugs in my tear ducts, to try and keep some moisture in my eyes and to this day I use drops throughout the day and a viscous gel at night.[5] Jennifer Like Howard I too did my research and went the most expensive route and had Wavefront Lasik with the best most experienced Dr I could find in Toronto. Its been three years June 3 and although I do have to use eye drops here and there its a small price to pay to be able to drive at night and go skiing without having to crawl around on snow looking for my contacts. Before lasik I would spend an hour in the bathroom trying to put contacts in my eyes just so I would have to take them out as soon as I got to my destination.[5]
Bob I just had an eye exam last week, 10 years to the day after my Lasik was performed.[5] Cass I had LASIK in one eye (-9) and an implanted contact lens (-12) inserted in the other 10 years ago.[5]
Jagged Pill I had lasik done almost 2 weeks ago. Painless surgery!! Anyone curious about it should definitly go check out a clinic. they put everything there up front; risks and all. Those of you who so vehemently defend your decisions as not "vanity" but "making myself feel better" or "less self consious" etc etc etc. guess what. [5] Ryan-Ann Nann I took a risk on Lasik surgery 2 months ago and have not regretted it. Ance, as you obviously don't have any experience to base your opinions on, I would like to share that my decision to have this surgery had nothing to do with vanity and everything to do with wanting to see unaided.[5]
Lasik surgery is dangerous''' people don'''t know that you are removing tissue to reshape the cornea. This tissue will never grown back.[39] To be sure, Lasik is one of the world's most popular elective surgeries. About 28.3 million people worldwide have decided to undergo the surgery since the mid-'90s to improve their sight.[14] Experts say one out of four people looking for Lasik should not have the surgery.[51]
I'm sorry that some people had bad experiences but that is an possible side effect of surgery. That risk was made clear to me by my optometrist before I even went to the Gimble Clinic.[5] No side effects. I suggest you put your faith in a surgeon who has credentials and not these fly-by-night shops that close as quickly as they open. It is SURGERY afterall.[5]
"My life is a blur," Kantis told the Associated Press. "When I look at a computer screen, I see two pages; when I look up at the moon, I see three of them." Kantis said he failed to fully understand the risks associated with the eye-correcting surgery. "Just before the procedure, they shove the informed consent form in front of you, but you just sign it and no one reads the fine print," he said.[11] "There is no surgical procedure or contact lens that you can wear or aspirin tablet that you can take that doesn't entail some risk,'' said Roy Rubinfeld, an ophthalmologist in Chevy Chase, Maryland, who has performed more than 20,000 Lasik surgeries, in a phone interview. "I hope that this hearing will validate what has been my personal experience, that Lasik is perhaps one of the greatest surgical procedures.''[1]
As with any operation there are risks, as any person should know, and the doctor will inform you of this before having it done. People need to accept responsibility for the choices they make. I had Lasik done this summer and it was the best investment I have ever made.[5]
I am one of the attendees. Other discussion points will include how hurt LASIK patients are going to 2nd opinion doctors and being lied to, thus pushing the hurt patient out past the Statute of Limiations to sue the doctor for a breach of standard of care.[23] My pupils were measured off the charts at 9mm, yet my doctor told me '''I was the perfect patient candidate for LASIK.'''[39]
Not everyone is eligible to have Lasik done. Every patient that comes in has to go through an exam to determine if they qualify for the procedure.[35] The agency regulates the LASIK devices but not the surgeons or clinics that make the procedure.[25] While the agency does not regulate LASIK, or laser-assisted in situ keratomileusis, it does oversee the equipment used in the procedure.[19]
About 700,000 Americans each year undergo the procedure, known as Lasik (laser-assisted in situ keratomileusis).[3] It's one of the most popular elective surgeries, with 700,000 Americans having Lasik each year. Lured by the promise of 20/20 vision, it's one of the world's most popular elective surgeries.[32]
If I get a few years of good vision without glasses, the cost of the surgery compares to the glasses/perscription sunglasses I would have had to purchase.[5] About one in four of the 700,000 Americans who undergo the elective laser surgery each year is not a good candidate for it.[38]
The FDA believes that some 5-precent of the more than seven million Americans who've had the surgery are dissatisfied with the results.[49] Although it seems as though only a small amount of people are unhappy with the results of lasik, the FDA's still meeting today to decide whether or not stricter standards are necessary.[15] The panel cited three major concerns -- the possibility of cataracts, endothelial cell loss, and induced astigmatism. It recommended that these concerns be reflected in the LASIK label. The panel said that intraoperative complications such as flap complications should be differentiated from postoperative complications in the list of adverse events that must be reported to the FDA. Moreover, adverse events should include halos and glares as well as significant loss of visual acuity.[8] At the end of the day, one thing was clear: there needed to be clearer warning messages from the FDA about the risks involved in the procedure. That was the recommendation that the panel issued after the discussion was over.[27] Though it was in possession of the high mortality risk data as early as 2001, the actual submission to the FDA was made only two years later. It used a variety of counting methods, including on-treatment rather than intention-to-treat analysis, an approach that minimized the appearance of the mortality risk," the authors concluded.[55]
Unfortunately, the FDA investigation comes years too late for many patients that have suffered permanent damage.[17] An FDA spokeswoman pointed out the agency has no authority over how physicians handle patients.[7] The agency determined that existing data were insufficient and that there was no reliable method for assessing patients' quality of life after the procedure.[3]
"There's no question that a lot of the things that would have occurred even in 2000 would be impossible today," said Updegraff, who has performed lasik on more than 40,000 patients.[31] According to the LASIK Study Task Force, formed in 2007, studies indicate a 95.4 percent satisfaction rate among patients worldwide.[6] As physicians we've taken the Hippocratic oath," says Kerry Solomon, director of cataract, refractive and cornea services at South Carolina's Storm Eye Institute and co-chair of the Lasik joint study task force.[9] Practicing eye surgeons are working with the FDA to establish guidelines for the study. At least two will speak at the hearing.[42] Dr. Schultz of the FDA says the study "will be done with an eye toward objectivity to make sure we don't pre-specify any kind of outcome."[9]
According to the FDA, it could take as many as three to six months for vision to stabilize after surgery. [32] Berney is the president of the Vision Surgery Rehab Network, a non-profit dedicated to patient advocacy and rehabilitation of vision surgery complications.[1] The surgery improves the vision in patients who have nearsightedness, farsightedness, and astigmatism.[40]
Patients, who each pay from several hundred to several thousand dollars for the surgery, spend $2.5 billion a year, according to industry analyst Market Scope.[24] If I want to have a nap I can close my eyes without having to worry about the contacts gluing to my eyes, causing cataracts and very red eyes. I think its worth it. It is a very big step to take and the worse part for me was not sleeping after deciding to get it, because of the fear of the Dr. cutting your eyes while you are awake and lasering them. It is over very quick. Tim My wife and I both had it done 3 yrs ago, best $8000 we ever spent. Angie Cosmetic surgery is often not about vanity, it's used in many cases such as reconstructive surgery after accidents, burns etc. The last thing this world needs are ignorant people and laws controlling people's own decisions about their lives.[5] "The stories that a lot of other people told were eye opening and scary, but I see the positive side." The 20-year-old, now studying at UW Marshfield, says she'd hate to see the surgery ruled out for those who truly need it. "If they did ban it, it would be terrible for those with limited mobility."[44]
Jason. Wow, what happens now with applicants for police force like the RCMP where they request a certain standart. This may come as a shock to them since not everyone has 20/20 eye vision thus they need the surgery for the application.[5] Matt Kosovulos wasn't as lucky. After undergoing the surgery, he now has such dry eyes that he needs to use drops and goggles to trap the moisture. "It's a throbbing, aching pain, to my face, my cheekbone," he said.[29] Most people experience dry eyes that could last anywhere from a couple of days to a couple of months. Other complications can occur, but most of them can be corrected.[35] I was forever getting severe headaches from the weight and pressure of the frames. I tried contact lenses but experienced severe dry eye and a problem developed with my eyes not getting enough oxygen from wearing them so often.[5] I did suffer with dry eyes for quite a while after the op, but'suffer' is a bit of a stretch -- I handled it well with drops a couple of time a day.[5] To put it bluntly.The post traumatic stress disorder of symptoms of severe dry eye and unmerited eye pain almost destroyed our family."[52]
The U.S. News eye and vision center offers advice on taking care of your eyes. The Department of Veterans Affairs intends to call about 570,000 recent combat veterans to make them aware of the health services available to them, the agency announced yesterday. [30] A public hearing got underway Friday with officials hearing stories of eye pain and double vision caused by the procedure.[49]
Elaine I used to be reluctant to have laser eye surgery until my brother had it successfully, and someone else I knew had it done successfully.[5] I too paid a premium - $5000 ("Acme" discount eye surgery didn't appeal to me).[5] Howard I had laser surgery about 5 years ago, but I chose to pay quite a lot at the time - about $6,000.[5] I wish NYT would do an informative article on the relative advantages/disadvantages of soft contact lenses, laser vision correction, and clear lens replacement (which is basically cataract surgery for people who don't have cataracts). For the latter, there's some controversy over blue-spectrum light and increased chance of age-related macular degeneration.[39] I only experienced a couple of weeks of dry eyes/sensitive immediately after the surgery but since then I have had better than 20/20 vision. It is amazing to be able to see my kids at the swimming pool without squinting etc. This surgery was the best money I ever spent.[5] Surgery doesn't necessarily create perfection (though my vision is great better then 20/20 now) but any improvements are still improvements.[5]
Make no mistake: Most Lasik recipients do walk away with crisper vision, some better than 20/20.[20] We're dedicated to doing everything in our power to make the Lasik procedure even better for all our patients."[13] Dr. Roy Rubenfeld has performed thousands of Lasik operations. He insists complications are rare. "The safety profile of this procedure, in my medical experience over a long period of time, has been unparalleled," he said.[51]
"Lasik is a surgery. It's not a haircut and like any surgery, it depends on the skill and experience of the surgeon."[29] FRIDAY, April 25 (HealthDay News) -- Golf great Tiger Woods lauds vision-correcting LASIK surgery as "life changing."[6] When the surgery goes wrong, it can change a person's life forever. That's why the federal government is taking a closer look at Lasik.[51]
"Frankly, some of the marketing that has been done with respect to Lasik makes it sound like you go to the grocery store and you come out and see perfectly. That's not good. This is real surgery," he said.[24] While the vast majority benefit — most see 20-20 or even better — about one in four people who seeks Lasik is not a good candidate.[13]
There was a large body of evidence presented that showed the benefits of LASIK and high-patient satisfaction. Kerry D. Solomon, MD, presented a worldwide retrospective literature review of LASIK that found 95.4% of patients were satisfied with their post-LASIK results.[50] "You have a serious problem on your hands," said Michael Patterson, a lasik patient from Atlanta.[43] THE STORY SO FAR: The small percentage of patients who experienced problems after lasik vision-correction surgeries want federal regulators to improve oversight and bolster safety rules.[42] "I don't think anything is going to come out of it," David Hartzok, a Chambersburg, Pa., optometrist who treats patients who have had problems after Lasik and is executive director of Berney's group, told the Washington Post.[28]
The industry in many hurt LASIK patient's opinions, is reporting false and skewed success rates.[23]
The panel also heard testimony from a number of patients and surgeons who praised the surgery.[8] Bob In response to Ian: sorry that you have negative vision in darkness. For those considering this surgery, you need to do a lot of homework, get the BEST SURGEON AVAILABLE, and a highly competent optometrist.[5] Customers are attracted to the quick recovery times and the prospect of experiencing little pain afterward. The surgery isn't for everyone, and there can be complications, such as impaired night vision.[24] Ian While I have 20/20 after Lasik it came at a cost. My night vision is severly impaired (halos, starbursts) and had I known this is what I would be left with I would have opted out.[5] ADVICE??? Ask LOTS of questions. John Hey ance, try informing yourself a bit before making such ridiculous statements. Many people suffer from very poor vision, for them lasik is a miracle.[5] If you get the opposite (some people's pupils dilate more than 8mm), part of the light entering is transiting through untreated area, or scar tissue from the cut. Starbursts, halos, etc. You really need to ask all of these questions, IMO. Lasik changed my life.[5] I am so dependent on my glasses and several years of wearing contacts have already caused some slight damage. Contrary to what people may think, I'm not doing this for cosmetic reasons - I'm doing this to improve my quality of life. Damian It's all statistics and probability until you draw the sample, and you're either on side A or side B. If something "bad" happens to you, it happens 100%, regardless how unlikely the chance was. That fact that the probability was low does not mitigate the effect/outcome.[5]
Cinder My glasses are part of who I am. I feel naked and exposed without them. They're just, me. But. this kind of makes me glad I never really wanted Lasik in the first place (even though my mom made me go a number of years ago and they told me I was a perfect candidate).[5]
"As long as you know any ophthalmologist that's wearing glasses, don't get it done," says Steve Aptheker, 59, a Long Island lawyer who was lured by an ad for $999 Lasik.[20] Typical american boondoggle: There is an alternate procedure to lasik to correct eyesbut it doesn't involve a $1,000,000- machine.[39] The Lasik (Laser-Assisted in Situ Keratomileusis) procedure employs laser beams to reshape the cornea to improve near-sightedness, far-sightedness and astigmatism.[11] A U.S. FDA spokeswoman said that between 1998 and 2006, 140 reports of problems linked with the laser procedure have been filed with the FDA.[11] The FDA does not regulate marketing, but I agreed that it is a problem." Another issue, she said, was patient selection.[8] Internal papers reported 34 deaths among the 1,069 Alzheimer'''s patients taking the drug, and yet the studies sent to the FDA said there were 11 '''non-drug related''' deaths.[56] The registry where the results are available are required to be linked to results information that includes: FDA summary documents, FDA assessments of clinical trial results, FDA public health advisories regarding the drug among other things.[55] We want to provide people with accurate, timely information to help people make decisions,' Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, told reporters during a telephone briefing, according to the Washington Post.[34]
Of the 7.6 million people who have undergone the procedure in the United States since the mid-1990s, 140 have written letters of complaint to the FDA. Now the FDA has followed up on those complaints.[6] The FDA approved the product and the procedure! Why all the concern now? This is grandstanding by the FDA to illustrate concern.[33]
"Long-term data is not available. Phakic lenses are a new technology and have only recently been approved by the FDA. Therefore, there may be other risks to having phakic lenses implanted that we don't yet know about."[39] Out of thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the type of scrutiny required for new drugs.'' Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved.''[53]
The FDA is also planning on collecting information from a national network of medical facilities to get a better picture of the number of complications. This material may not be published, broadcast, rewritten or redistributed.[29] The agency plans to collect detailed information about the complications from a national network of 350 medical facilities already organized to alert the agency about problems with other medical treatments. "This should really help to give us a better view of how ophthalmic devices are performing in the real world," Schultz said.[3] The agency seeks to gather information about side effects from a national network of 350 medical facilities which are already meant to alert the agency about problems with other medical treatments.[28]
The FDA received over a hundred reports of side effects and device malfunctions since 1998 to 2006.[25]
The FDA panel could recommend changing regulatory guidelines for the vision-correcting laser or it could do nothing.[43] An FDA advisory panel will discuss the planned study at a public hearing tomorrow in Gaithersburg, Maryland.[1] The FDA's major study should provide a better understanding about who has bad outcomes and why.[37]
Philips Medical System is a unit of Philips Electronics NV. FDA inspectors visited Philips' Cleveland, Ohio plant this past September and October 2007 and found more than one dozen production problems at the facility.''[53] Philips Medical Systems Inc. has been warned by U.S. health regulators about a wide variety of problems with its manufacturing procedures at an Ohio plant.''[53]
Robert Jones, Ophthalmologist: "Occasionally a patient will have an under-correction or over-correction, which we can go back and do a minor correction to fix." It's also important to let you doctor know about any health problems you might have. Robert Jones, Ophthalmologist: "It's important to let your doctor know about any disease that you might have, especially connective tissue disease like lupus and rheumatoid arthritis, because this could affect the patient's ability to heal."[35] How more than 5 of patients are having problems and how each eye of a person is considered an individual patient.[23] I only need drops first thing in the morning when I wakeup, otherwise the eyes are great, with 20/20 in each. I think people need to put these horror stories into perspective, and realize that it is extremely unlikely you will have any problems if you have this done.[5] I would do it over again -- but only after a lot of research. Good luck to all of you who have experienced problems, and to those of you considering taking the leap. Another thing: when my optometrist examined my eyes last week, she said that she could only faintly make out the flap scars, and that was because she was looking for them.[5]
"I was not able to see clear, everytime I was losing more of my vision and I was having headaches because I was forcing one eye, not the other one," Velarde said. Velarde suffered from a condition in which cells started to grow over the cornea, blocking his vision.[29] Older technology uses a blade to cut a flap in the cornea before a laser reshapes the eye surface.[31] The surgery involves cutting a flap on the surface of the cornea and zapping the underlying corneal tissue with a laser to give it a new shape, in order to correct nearsightedness, farsightedness or astigmatism.[28]
Shares of Advanced Medical Optics closed 1.40 percent up to $20.33 in Fridays closing trading in the New York Stock Exchange.TLC Vision shares closed down 1.64 percent to $1.20 a share in Nasdaq on Friday.[25] Vioxx went on to become a blockbuster drug in the five years that it was in the market. New evidence published in the reputed Journal of the American Medical Association (JAMA) confirms that the company was well aware of its dangers even before it withdrew the drug in 2004.[55] Japanese researchers from Keio University School of Medicine in Tokyo and colleagues from the National Institute for Child Health and Development in Tokyo, Tokyo Women's Medical University, and. A study of middle-aged Americans reveals that there is a clear link between wealth and health not that this would be something new.[34]
Money can't buy you love or happiness, but it may protect you from having a stroke, Michelle Andrews reports. That's the takeaway from a new study in the journal Stroke, released yesterday. Researchers found that the least wealthy were three times more likely to have a stroke between ages 50 and 64 compared with those who were in the top 75th to 89th percentile in wealth (the very wealthiest outliers were excluded). Once people hit 65, however, all bets were off, and wealth no longer afforded them protection.[30] Anesthesiology researchers from University of Toronto have come to the aid of people suffering from obstructive sleep apnea (OSA), as they are at high risk for respiratory complications during and. Although smoking is the No. 1 cause of lung cancer, viruses may also contribute to the development of this fatal disease, new research suggests.Dr. Arash Rezazadeh and colleagues from the University.[34]
Prospective patients should discuss the risks of the procedure with a doctor.[9] Rubinfeld said a main cause of the complications are inexperienced surgeons. "Any surgeon that tells you that they can do a procedure on you or prescribe a medication for you without risk is simply not telling you the truth," he said.[29]
With all surgeries come risks, if you don't accept the risk, and haven't done your homework, don't have the surgery.[5] Sure there are risks, but life is risk. Do you not visit your parents or go to a movie because you might crash your car and die on route? Because those kind of odds seem more like a certainty in comparison to this LESS THAN TEN MINUTE surgery.[5]
As someone who's had to wear "cokebottle-bottom" glasses for many years, your comments have helped me to decide that the potential negative effects years down the road are not worth the risk.[5] My eyes have continued to deteriorate (as forewarned) and I'll have to wear glasses for driving in a few years.[5] If I wake up in the middle of the night now I don't have to fumble for glasses in order to find my way across the dark room; during power failures I don't have to fumble contacts into my eyes by candle light.[5]
The remaining 5 percent end up with strange effects including double vision, night blindness, star bursts and halos. That's what life looks like for artist Barbara Berney. [51] My name is Dean Andrew Kantis, founder of LifeAfterLasik.com. For the past 9 years, I have spent $30,000 seeking restoration of my ruined vision only to find out there is NO CURE. Through my website, hundreds of victims have contacted me expressing their suicidal thoughts.[39] The drug, the COX-2 painkiller Vioxx (rofecoxib), was finally taken off the market in 2004 after it was found to cause heart attack.'' Industry commentators reckon around 60,000 people may have suffered a heart attack after taking the drug, and, earlier this year, Merck made a $4.85 billion settlement to victims''' families to end the largest civil suit in legal history.[56]
I have a hard time feeling sorry for people who have bad results from this ELECTIVE surgery.[39] 'Our sense is that most of the patients who are having the procedures are reasonably satisfied and are doing fairly well. Clearly there is a group that is not satisfied and do not get the kind of results that they expect.[34] The doc used the best quality blades (the blades are VERY expensive) and uses new blades for every patient -- another thing I inquired about. I've heard of some cheaper procedures where the docs reuse blades! So they get dull, and tear.[5]
The study showing the highest satisfaction rate had no dissatisfied patients.[42] In the study that showed the lowest satisfaction rate, more than 12 percent of patients were unhappy.[42]
Since it was first approved in the mid-1990s, more than 12 million Americans have undergone LASIK by some estimates. [19] Someone who has a very thin cornea and is very nearsighted would not be a good candidate for Lasik."[35] Dr. Gelinas stresses the importance of doing research on the surgeon who's performing the operation. He says it's important to accept it if a doctor tells you you're not a good candidate for the surgery.[15] For that I had the surgery performed by a world-renowned surgeon in Toronto, and I came out with 20/15 eyesite (better than 20/20, just in case I wrote that backwards).[5]
Although doctors need to do a better job reporting cases of adverse events, Stark said, the most important step the government and medical profession could take is to curb marketing hype. "It is important that doctors not trivialize the procedure.[24]
"If you look at the research submitted to the FDA, I'd say the quality of life data wasn't that good," Davis added. [32]
SOURCES
1. Bloomberg.com: Science
2. Unhappy LASIK patients urge FDA to take action | U.S. | Reuters
3. Lasik Patients Describe Complications at FDA Hearing - washingtonpost.com
4. The Associated Press: FDA takes closer look at Lasik complaints
5. CTV.ca | Lasik patients air grievances in front of FDA panel
6. FDA Panel Urges Stronger Warnings for LASIK Surgery - washingtonpost.com
7. FDA examines vision problems reported with Lasik surgery
8. Medical News: FDA Advisers Find LASIK Safe But Oversold - in Dermatology, Laser Surgery from MedPage Today
9. FDA to give patients of laser eye surgery a forum | WSBT South Bend - Your Local News Leader | Your Health Matters
10. Experts Advise New Warnings for LASIK
11. FDA to review Lasik eye surgery
12. Patients tell of horrors from eye surgery | PoughkeepsieJournal.com | Poughkeepsie Journal
13. The Associated Press: Federal panel seeks clearer warnings on Lasik eye surgery
14. ABC News: 20/20 Vision in the Blink of an Eye
15. WJFW TV-12, WJFWDT 12.1 and Newswatch 12 - Stories
16. FDA to Study Complaints from Lasik Patients - The Money Times
17. Lasik and the Patients Right to Know
18. Ahead of the Bell: FDA examines Lasik surgery side effects | Chron.com - Houston Chronicle
19. FDA to seek panel's advice on LASIK | Health | Reuters
20. The Associated Press: FDA takes closer look at complaints from Lasik customers
21. RTTNews - Breaking News, financial breaking News, Positive EPS Surprises, Stock research .
22. FDA Questioning Long-Term Effects Of LASIK | KAUZ News Channel 6 Texoma | Local Top Stories
23. Some LASIK Patients Angry over Results
24. FDA to review Lasik eye surgery side effects - Los Angeles Times
25. LASIK Patients address Complaints to FDA - International Business Times -
26. FDA to Hear from Lasik Surgeons, Unhappy Patients
27. More Warnings for LASIK Required, Says FDA - The Money Times
28. FDA and Counsel Panel to Investigate Effects of Lasik
29. FDA Recommends More Warnings For Lasik - Health News Story - WRC | Washington
30. Health Buzz: LASIK Surgery Woes and Other Health News - US News and World Report
31. Health: Clearer warnings on lasik eye surgery recommended
32. abc7chicago.com: A blurry outlook for LASIK? 4/24/08
33. Health Blog : LASIK Patients Tell Their Woes to FDA
34. FDA to Discuss Patient Satisfaction with Lasik Procedure
35. NBC Newschannel 6 Where News Comes First - What You Should Know About Lasik Eye Surgery
36. Therapeutics Daily
37. News::Rockford Woman Testifies in Front of FDA on Lasik Surgery
38. Lasik Eye Surgery Scrutinized :: WRAL.com
39. More Bad News for the Lasik Business - The Lede - Breaking News - New York Times Blog
40. FDA Plans to Study the Outcome of Lasik Eye Surgery in Patients
41. Lasik Surgery Study || WXYZ.com | WXYZ-TV / Detroit | Detroit News, Weather, Sports and More
42. newsobserver.com | Lasik alums talking to FDA
43. Lasik patients complain to panel
44. News::Medford-Area Woman Testified Before FDA
45. Corpus Christi, TX | KRISTV.COM |FDA Officials Hold Public Hearing To Address Lasik Concerns
46. FDA To Begin Investigating Lasik Eye Surgery Complaints ''' Safety Issues Explained By Food And Drug Administration | Best Syndication
47. www.kansascity.com | 04/25/2008 | National business briefs: Lasik testimony
48. Patients Share Stories Of Lasik Problems - Health News Story - KXAS | Dallas
49. Las Vegas Now | Public Hearing Held to Hear Lasik Eye Surgery Complaints
50. FDA panel hears public testimony for, against LASIK
51. Lasik is forever, for better or worse | KOMO-TV - Seattle, Washington | Consumer News
52. News::Lasik: Not All Positive
53. FDA Warns Philips Medical Systems Over Manufacturing Procedures
54. FDA Proposes Recommendations for Two Animal Drug Funding Programs
55. The Hindu : Sci Tech : Vioxx safety data manipulated
56. Killer Drug: Company hid deaths from regulator | What Doctors Don't Tell You
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