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 | Apr-28-2008FDA Panel Urges More Data on Laser Vision Surgery(topic overview) CONTENTS:
- The FDA advisers recommended that the agency make clearer the warnings regarding LASIK surgery. (More...)
- The agency is holding a public hearing today to figure out if the warnings issued about the risks of LASIK are appropriate. (More...)
- One Lasik surgeon said many problems with the procedure could be avoided long before patients enter the operating room. (More...)
- Complications after surgery can include dry eye, blurriness and even loss of vision. (More...)
- More than 700,000 U.S. patients each year have laser vision corrective surgery. (More...)
- Heparin is an anticoagulant (blood thinner) that is commonly administered intravenously or subcutaneously. (More...)
- "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. (More...)
- With all surgeries come risks, if you don't accept the risk, and haven't done your homework, don't have the surgery. (More...)
- The FDA panel could recommend changing regulatory guidelines for the vision-correcting laser or it could do nothing. (More...)
- 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. (More...)
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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. [1] 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.[2] 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.''[3]
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.[4] 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.[5] 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.[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.[6] 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.[2]
Friday'''s discussion looked at the adequacy of currently existing warnings about LASIK surgery. It looked at whether more alerts regarding side effects of the procedure, such as eye pain, double or blurred vision, dryness of the eyes, and other related problems was necessary. Speaking about the discussion, Dr. Christopher Starr, the co-director of New York-Presbyterian Hospital/Weill Cornell Medical College'''s Cornea, Cataract, and Refractive Surgery in New York, said, '''This is ground-breaking. It's the first time anything like this has happened around refractory, or LASIK, eye surgery.''' Dr. Starr said, '''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.'''[7] 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."[1]
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.[8] 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.[9]
"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.[6] 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."[10] 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. In a statement on Thursday, Dr. Daniel Schultz, the medical device chief of the FDA, said, '''Clearly there is a group who are not satisfied and do not get the kind of results they expect. The study should "help us predict who those patients might be before they have the procedure.'''[11] 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."[12] 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.[11] 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.[13] 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.[14] 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.[10]
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. "I think it's blown out of proportion because it's a very small group of people who have had difficulties for various reasons out of millions of patients that have been done," Spivack said. He said everyone asks for LASIK because that is what is advertised, even though that may not be the best procedure for the patient. Spivack said that if a patient goes to a place that only does LASIK, that's what they are going to get.[15] 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.[16]
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.[17] 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.[18] 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. The Food and Drug Administration 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.[19]
Hollywood (dbTechno) - The U.S. Food and Drug Administration is looking into the side effects of Lasik eye surgery. There have been complaints filed with the FDA about Lasik and their laser eye surgery procedures, prompting a full investigation by the FDA.[20] 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.[14] 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.[21] 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.[22]
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.[7] Preliminary results of the USAEyes Competence Opinion Relative to Expectation (CORE) patient survey are being presented to the U.S. Food and Drug Administration during a special hearing today. "The USAEyes CORE survey is designed to determine if patients are getting what they expect from Lasik and similar eye surgery," says Glenn Hagele, Executive Director of the nonprofit patient advocacy that conducted the study.[23]
As a result of the hearing 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) in an attempt to compile more information on LASIK results.[24] 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.[1] 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.[21] 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.[5]
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.[25]
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.[15] 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.[12] LASIK is an excellent procedure as proven by millions of satisfied people who've had this procedure done in the USA in the last decade. That's why NASA has aproved LASIK for astronauts http://www.prnewswire.com/mnr/intralase/29864/docs/29864AMO_NASA_Infograph_FINAL.pdf and other branches of the military have approved LASIK for people in the armed forces. No procedure is perfect, and there are always risks to any surgery, just as there are risks to driving a car or flying in a plane (although those risks are not told to people who buy cars or fly in planes ' it is assumed by the auto and airline industry that travelers know that). The FDA has apparently received 140 complaint letters from patients in the last 8 years citing various forms of dissatisfaction with their LASIK results.[25] The FDA says it is concerned that doctors are not adequately informing patients about the potential risks. Recent research suggests that 95% of all patients who undergo LASIK are satisfied with their procedure, but Dr. Jayne S. Weiss, who chaired the advisory panel says some surgeons could be doing a better job. Experts recommend that both patient information and FDA's LASIK web site contain photos of potential vision problems so people have the opportunity to understand the risks and say more warnings are needed about the potential risks in women using hormone replacement therapy since the drugs can alter the cornea. They have also called for more warnings for doctors who evaluate which patients may not be candidates for the procedure.[24] "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.[8]
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.[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.[27]
The surgery involves cutting the outer layer of the cornea (epithelium) with a fine blade, alcohol is then used to loosen and lift it and a laser beam is directed at tissue under the epithelium removing just enough to reshape the cornea which corrects the vision. An expert panel of federal health advisers has heard accounts from LASIK patients and their families about severe reactions to the surgery which included on-going vision problems, severe dry eye, severe eye pain, blurred vision, glare, an inability to drive at night and even suicide.[24] 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.[25]
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.[18] Every year approximately 700,000 Americans undergo elective eye laser surgery. It is said that LASIK is not advised for one in four people and the FDA agrees fully with the studies finding that roughly five percent of LASIK recipients''' wind up unsatisfied.[28]
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.[3] There have been even a number of suicides reported to the FDA. The majority of patients who undergo the Lasik procedure report improved vision, and according to a study by the American Society of Cataract and Refractive Surgery as many as 95 percent of the patients report they are happy with the outcome of their surgery.[29] 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.[16] 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.[4] 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."[6] While officials at the Food and Drug Administration put the number of patients who have been hit by the side effects at a miniscule 5 percent, there has been no official record of the magnitude of the risks associated with the procedure, the actual number of patients hit by the side-effects, the impact of the effects on a patient'''s life, and other related issues. This is where the FDA'''s new study will be of help. It will be able to provide details on the issues mentioned above.[11]
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.[30] 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.[31] DENVER (AP/CBS4) 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 Friday, including blurred vision and dry eyes. A Denver area eye doctor said he'll be watching the hearings closely.[15]
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.[32] The FDA is sponsoring a series of public hearings to gather information on the controversial eye operation. About one in four people who seek Lasik surgery are advised not to have the procedure, and many of the people who are now suffering are among those advised not to have the surgery, but who go ahead anyway.[29]
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.[16] 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.[33] 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.[21]
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.[34]
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] 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.[4] More than 99% of patients report their quality of life after laser vision correction surgery is as they had expected or better, even though 2% report complications with lasik eye surgery that are frequently or always problematic, according to a national patient survey conducted by the nonprofit Council or Refractive Surgery Quality Assurance (USAEyes).[23] There is no doubting the fact that Lasik eye surgery works wonders for a majority of the patients who opt for it. There have been instances of patients having better than 20/20 vision after they have undergone the procedure.[11] 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.[36]
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.[31] 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.[37] 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.[38] 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.''[3]
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.[39]
Many people are lining up to have their vision corrected while others are trying to get the FDA to outlaw the procedure. People who have suffered side effects such as blurred or double vision, testified about the dangers in the surgery. Although 95% effective, they say that does not outweigh the risks. It is highly unlikely that the procedure will be outlawed, but perhaps will put more pressure on the doctors themselves to do a better job. Many people have the surgery so they don't have to deal with the hassle of glasses or contacts and not because of their vision itself.[40] There is a small minority that is hit by the side effects, some of which can be drastic, including reduced night vision, reduced vision, and also dryness and pain in the eyes. Doctors, however, advise one in four patients against undertaking the procedure, mainly because of structural problems with their cornea itself or some other associated physical condition that could maximize the risk of side effects after the procedure.[11] 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.[16]
Statistically, the majority of people who go under the laser experiencing the benefits from laser-eye surgery and are happy. There is a small segment of people, probably less than one percent, who face severe life-changing side effects such as painful dry eye, night blindeness, glare and worsened vision.[28] 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.[36]
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.[1] 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.[2] "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.[25]
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.[36] On another note The wonder lasik eye surgery has people who have not been satisfied with the vision results.'' The Food and Drug Administration will hear complaints from people who have not had the results they thought they would get.''[23]
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."[37] 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.[10] 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.[17]
WASHINGTON (AP) - Federal health officials are hearing stories of pain and frustration from patients harmed by Lasik eye surgery.[19]
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.[22] 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.[36] 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.[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.[17] "In my experience if a patient is properly selected, and the operation is properly done, complications are going to be very rare," said Dr. Lawrence Spivack of the Spivack Vision Center. FDA will hear from Lasik eye surgeons as well as disgruntled patients at a meeting Friday of its outside panel of eye experts.[15]
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."[17] 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.[38]
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.[15]
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.[10] 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.[6]
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.[16]
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.[33] According to Medical University of South Carolina'''s Dr. Kerry Solomon, leader of a review of the degree of safety associated with Lasik for the American Society of Cataract and Refractive Surgery the number of patients suffering from poor eyesight as a result of severe post-Lasik complications is less than one percent.[11] 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.[34]
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.[31] 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.[5] 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.[25]
The survey was mailed to 1,800 vision correction surgery patients of six doctors throughout the U.S., with a 31% response rate. "It is not surprising that the vast majority of Lasik patients are satisfied with their results, but what was unexpected was that many would have the surgery again despite reporting complications," reports Hagele. Of those who reported complications that were "seldom problematic", 91% would have the surgery again.[23] 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.[8] 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.[42]
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.[26] 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.[43] 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.[44] The FDA is pairing with eye surgeons to begin a major study next year to better understand which Lasik-surgery patients have bad outcomes.[36]
The FDA is planning a huge study, along with laser eye surgeons to try and see the full picture of the surgery, what in entails, and what the risks are.[20] The FDA is pairing up with hightly experienced surgeons in order to study more about the risks that one can suffer from LASIK surgery.[28] 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.[34]
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.[33] For years, patients dealing with health problems after having lasik surgery have asked the FDA for stricter regulations.[33] The experts say the study will take years to complete so any information given to patients considering LASIK surgery should clearly warn of the possibility of long-term vision problems.[24] 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.[8]
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.[32] 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.[45] 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.[38] 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.[2] 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"?[2]
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.[43] Washington, D.C. (WiredPRNews.com) The Associated Press reported that a medical adviser'''s panel of doctors, most of them wearing glasses, eavesdropped on laments of people who wanted to remove their specs completely by means of LASIK surgery on Friday.[28]
Advisers of the Drug and Food Administration listened to loads of stories of people wants to undergo LASIK surgery. Dr. Jayne Weis of Detroit'''s Kresge Eye Institute in Michigan said, "This is a referendum on the performance of LASIK by some surgeons who should be doing a better job.'''[28] The FDA has stated that 5% of all people who take part in Lasik eye surgery end up uwith some form of a problem related to the surgery.[20] 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.[46] 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."[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.[2] 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.[25]
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.[2] An outside panel is going to be brought in to review data based on the results of the Lasik eye surgery. They will be looking into things such as side effects, success rate of the surgeries, etc.[20]
About five percent of all Lasik surgery patients have some sort of complication or side effect.[42] The FDA will begin examining the side effects of Lasik surgery more than a decade after approving the procedure.[45] The FDA will continue studying the side effects of Lasik surgery and work for better pre-op screenings and warnings.[39]
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.[7]
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.[47] Though Lasik eye surgery is costly, almost $2,000 per procedure, so far 7.6 million Americans have undergone it.[11]
Lasik eye surgery has come in for some flak by a few patients who are unhappy with their vision, post surgery.[37] 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.[38] 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.[47]
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."[33] 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.[47] 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.[34]
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.[33] 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.[38] 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.[42] Now experts in the U.S. are calling for the Food and Drug Administration (FDA) to warn patients about the risks of the increasingly popular operation.[24]
Now the Food and Drug Administration plans to launch a national study assessing the rate of side effects among Lasik patients.[16] 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.[10]
The Food and Drug Administration estimates that about 5 percent of patients who get LASIK are unhappy with the results.[27]
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.[43] Today's hearing is the first the FDA has scheduled to hear how patients' quality of life has been affected by lasik surgery.[33] 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.[22] 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.[48] 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.[48]
"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.[22] The surgery involves reshaping the cornea to correct patient's vision. In the past few years however, the FDA has received 140 reports of complaints from those saying the surgery damaged their vision.[49]
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.[15] 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.[9] 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.[47] The Federal Drug Association says many patients have complained about lasik surgery, asking them to update the procedure's warnings.[50]
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.[8] 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] 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.[13]
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.[47]
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.[31] Washington, D.C.- A number of patients that have undergone the Lasik Eye treatment are now sounding off to a panel of the FDA regarding their failed eye treatment.[29]
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.[2] 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.[2] 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]
An estimated 6 million Americans have undergone Lasik surgery, which permanently reshapes the cornea, a clear layer covering the eye.[15] 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.[2] 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.[17]
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.[47] The discussion on Friday also included some of the patients who had suffered side effects after the LASIK procedure. This is what David Shell of Washington, D.C., had to say, '''Too many Americans have been harmed by this procedure, and it's about time this message was heard.''' He had undergone the procedure in 1998, and has been constantly plagued by problems ever since.[7]
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.[2] 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.[2] All people who get laser eye surgery want is to be able to see well in the morning without putting on glasses or contacts.[2]
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.[3] Associated Press - April 25, 2008 1:13 AM ET WASHINGTON (AP) - Not everyone is a good candidate for Lasik eye surgery and the government plans to take a closer look at complaints including lost[19]
"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.[36] Before anyone undergoes Lasik eye surgery, it's important to know the risks involved, because not everyone is a candidate.[35] Federal health officials are taking a closer look at the safety of Lasik eye surgery.[44]
- 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.[2] "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.[5] 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.[15] Millions have had Lasik surgery to see without glasses. Some patients report they've seen nothing but trouble.[52] The panel will also comment on a proposed study looking at patients' expectations of Lasik surgery.[14] The panel will also examine a proposed study that will look at expectation of Lasik surgery from patients.[26]
Critics believe there is a higher proportion of patients encountering problems after a Lasik surgery.[31]
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.[34] Solomon says that 31 percent of Lasik patients have some degree of it before the surgery and that about 5 percent worsen afterward.[10] Perfect vision in the blink of an eye is the promise and the outcome for about 95 percent of Lasik patients.[51] 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] 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.[50] At a public hearing today, officials heard stories of eye pain and blurred or double vision because of the procedure. One man who had Lasik in 1998 says he has "not experienced a moment of crisp, good quality vision since."[19]
The 2nd type of dissatisfaction occurs because of less than meticulous pre-LASIK screening of patients. There are multiple parameters that must be evaluated before a patient is determined to be a good candidate for LASIK. These include the degree of nearsightedness, farsightedness and astigmatism that requires correction, the curvature of the central and peripheral cornea and the expected postoperative corneal curvature, the corneal thickness, the pupil size in light and dark environment, the degree of dryness of the eye if any, and several other eye health and systemic health criteria.[25] 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.[10] 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.[22] 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.[2] More and more people are having laser vision corrective surgery (LASIK surgery) in the hope that their vision will be restored to such an extent that glasses will no longer be needed.[24]
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.[17]
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.[33] 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.[32] 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.[3]
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.[5] 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.[37] 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.[41] Possible side effects include dry eye, double or blurry vision, difficulty seeing at night, or seeing halos or rings.[22] 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.[36]
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.[10] 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.[50] 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.[33] 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.[33]
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."[9]
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.[8] 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.[25] 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.[25]
Though immensely popular, LASIK is not a procedure all can undergo. Patients with conditions such as a misshapen cornea, extremely thin cornea, large pupils, premature cataract formation, or other conditions like rheumatoid arthritis and lupus are advised not to undergo the procedure.[7] 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."[12] 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.[2] 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.[2] 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.[2]
There were others as well. Present at the meeting was Gerald, the father of Colin Dorrian, who finally committed suicide after continuously experiencing blurred vision and pain in the eye for six years after he got the procedure done. In his suicide note, Colin wrote, '''I can't and won't continue facing this horror,''' according to an Associated Press report. Colin had been told he was not a suitable candidate for the surgery, but went ahead with it anyway.[7] 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.[26] 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.[14] 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.[33]
The FDA's announcement on Wednesday comes before a public meeting scheduled for Friday to discuss patient satisfaction with the LASIK procedure.[31] 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.[41] 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.[37]
The FDA has informed a panel that will begin cataloguing the complaints of patients who've had bad experiences with the procedure.[45]
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.[13]
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.[33] '''We cannot be the quality-control unit for the world,''' Janet Woodcock, director of FDA'''s Center for Drug Evaluation and Research, told the Senate Education, Labor, Health and Pensions Committee. While the FDA welcomes additional resources to improve its inspection of foreign manufacturing facilities, additional improvements ''' such as a better information technology system and a registry of all manufacturers producing products imported into the United States ''' are necessary to help improve efforts to stop contaminated drugs from entering the country, Woodcock said. She also told the panel that manufacturers must assume greater responsibility for the quality of their products.[53] The Center for Drug Evaluation and Research (CDER) has received commitments from the major U.S. heparin manufacturers/suppliers to perform the recommended screening tests on all heparin active pharmaceutical ingredient (API) that is received ( http://www.fda.gov/cder/drug/infopage/heparin/default.htm#screening ). FDA's Center for Devices and Radiological Health (CDRH) has issued a letter requesting medical device manufacturers and distributors to determine if they market unfinished or final form products that contain heparin or utilize heparin in their processing, and if so, to ensure that the products are contaminant-free before they are released for distribution ( http://www.fda.gov/cdrh/safety/heparin-notice.html ). FDA continues to actively monitor its post-market safety database for cases of heparin-related adverse events.[54]

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. [27] 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.[9] 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.[48] 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."[9]

One Lasik surgeon said many problems with the procedure could be avoided long before patients enter the operating room. [39] 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."[44] Practicing eye surgeons are working with the FDA to establish guidelines for the study. At least two will speak at the hearing.[33]
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. CBS4 medical editor Dr. Dave Hnida said he doesn't expect any dramatic changes to come out of the hearing. Hnida expects more research at this time.[15] 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."[5]
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.'''[47] 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.[2] 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?).[2]
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.[2] 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.[10] 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.[6]

Complications after surgery can include dry eye, blurriness and even loss of vision. [3] Dry eye is common even among people who never have eye surgery, and increases as people age.[10] I doubt that people who get laser eye surgery want to "look better", maybe see better but not look better.[2] 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.[2] Laser eye surgery was first approved in the U.S. in the 1990s and since, more than 10 million Americans have had the surgery. It is believed though that the thoughts that laser eye surgery is always perfect are all myths.[20] 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.[33]
Recent complaints and concern over Lasik eye surgery has the government stepping in for a closer look.[49]
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.[10] Lasik surgery is dangerous''' people don'''t know that you are removing tissue to reshape the cornea. This tissue will never grown back.[47]
The group is expected to tell regulators that most side effects from Lasik surgery are rare and temporary.[15] Most side effects are rare and temporary, said Dr. Michael Kelly, an ophthalmologist who performs Lasik surgery in Raleigh.[36]
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.[2] 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.[2] 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.[2]
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."[17] "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.''[3] Jason I had considered Lasik but after hearing that a certain percentage of people suffer from very dry eyes, I decided against it.[2]
In all, about 7.6 million Americans have undergone Lasik, which costs about $2,500 per eye.[5] About 7.6 million Americans have undergone some form of laser vision correction, including the $2,000-per-eye Lasik.[10] About 7.6 million Americans have had laser corrective surgery, including lasik.[50] The surgery was first approved in the mid-'90s and since then more than 12 million Americans have undergone Lasik by some estimates.[31]
"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.[17]
In the blink of an eye. It's a promise that has delivered for about 95 per cent of Lasik patients.[52] 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.[17] Lasik is a relatively simple procedure where a flap is cut in the cornea with a laser, and the cornea is shaped with a laser through the flap to try and correct vision problems.[29] Lasik is performed with a laser by taking off the top layer of the cornea and reshaping the cornea underneath, which will in turn correct vision.[40]

More than 700,000 U.S. patients each year have laser vision corrective surgery. [24] Berney is the president of the Vision Surgery Rehab Network, a non-profit dedicated to patient advocacy and rehabilitation of vision surgery complications.[3] The surgery improves the vision in patients who have nearsightedness, farsightedness, and astigmatism.[37]
"Blurred vision, dry eyes, glare and double-vision have led to depression and in some cases suicide," Reuters quoted patients as saying.[47] 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.[9] 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.[22]
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.[2] If you're like me (there's lots of us out there), when you're 45 that's bound to have an impact on the effectiveness of the eye surgery you had when you were 25.[2] 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.[2] I too paid a premium - $5000 ("Acme" discount eye surgery didn't appeal to me).[2] 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.[2] "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."[46]
Experts say one out of four people looking for Lasik should not have the surgery.[51] "Lasik is a surgery. It's not a haircut and like any surgery, it depends on the skill and experience of the surgeon."[22] 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.[2] Before we discuss dissatisfaction with LASIK, we must define what we mean by dissatisfaction. There are several possibilities for why patients may not be satisfied with the results of their LASIK procedure. Some of these are preventable and some are not.[25] "Our sense is that most of the patients who are having the procedures are reasonably satisfied and are doing fairly well," Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, told reporters during a telephone briefing yesterday. "But clearly there is a group that is not satisfied and do not get the kind of results that they expect.[5] 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."[47] An FDA spokeswoman pointed out the agency has no authority over how physicians handle patients.[15]
The F.D.A. and industry representatives agreed that 95 percent of patients are satisfied with the procedure.[47] 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.[30]
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] According to the LASIK Study Task Force, formed in 2007, studies indicate a 95.4 percent satisfaction rate among patients worldwide.[1] 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.[33] A top Food and Drug Administration (FDA) official told a Senate panel Thursday that the increasingly large number of pharmaceutical ingredients manufactured abroad makes it nearly impossible for the agency to ensure the safety of all drugs sold in the United States.[53] Reports should be sent to Food and Drug Administration, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002. Although user facilities are not required by law to report drug-related adverse events to FDA, we are asking that when you become aware of any such event related to use of a heparin injectable drug, you submit a Voluntary Report Form FDA 3500 directly to us.[54]
ROCKVILLE, Md., April 25, 2008--The Food and Drug Administration is summarizing important information relating to medical products that contain potentially contaminated heparin and is seeking assistance from healthcare facilities and providers in identifying and reporting adverse events related to these products.[54]

Heparin is an anticoagulant (blood thinner) that is commonly administered intravenously or subcutaneously. It is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis (DVT) and pulmonary emboli. These products are typically sold in concentrations of 1000 U/mL or greater. [54] 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.[16] 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.[2] About one in four of the 700,000 Americans who undergo the elective laser surgery each year is not a good candidate for it.[36]
The FDA believes that some 5-precent of the more than seven million Americans who've had the surgery are dissatisfied with the results.[44] 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.[12] 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.[9] 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.[7] "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."[47]
Enzi said the agency should be allowed to first absorb new authorities Congress gave it last year in an overhaul measure (PL 110-85) before Congress adds any new responsibilities. Elements of generic drugs may be manufactured in 15 different facilities, she said, '''The FDA of the last century is not constructed''' to regulate that kind of marketplace, Woodcock said.[53] House Energy and Commerce Chairman John D. Dingell, D-Mich., has proposed draft legislation that would assess user fees for all domestic and foreign drug and food producers, with the funds directed toward a new FDA inspections and safety corps.[53]
The FDA approved the product and the procedure! Why all the concern now? This is grandstanding by the FDA to illustrate concern.[25] There are a significant amount of problems with people who have undergone the procedure. They are taking their complaints to the FDA to help resolve their pain and suffering.[29] 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.[1]
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.[31] 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.[22] 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.[5] 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.[21]
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.[2]
The panel also heard testimony from a number of patients and surgeons who praised the surgery.[9] A surprising 22% of patients who reported complications that were "frequently" or "always" problematic would have the surgery again, according to patients who responded to the survey.[23]
"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.[16] I've always dreamed of a way to have normal eyes my entire life, and Lasik seemed like a good solution.[47]
Bob I just had an eye exam last week, 10 years to the day after my Lasik was performed.[2] Cass I had LASIK in one eye (-9) and an implanted contact lens (-12) inserted in the other 10 years ago.[2]
About 700,000 Americans each year undergo the procedure, known as Lasik (laser-assisted in situ keratomileusis).[5] Typical american boondoggle: There is an alternate procedure to lasik to correct eyesbut it doesn't involve a $1,000,000- machine.[47]
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] We're dedicated to doing everything in our power to make the Lasik procedure even better for all our patients."[17] Just so you all know, one non-vain reason people choose LASIK is for law enforcement jobs that require 20/200 UNcorrected vision.[47] 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.[2]
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.[2] My pupils were measured off the charts at 9mm, yet my doctor told me '''I was the perfect patient candidate for LASIK.'''[47] 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.[48] "You have a serious problem on your hands," said Michael Patterson, a lasik patient from Atlanta.[34] 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.[33] "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.[21]
"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.[38] Make no mistake: Most Lasik recipients do walk away with crisper vision, some better than 20/20.[10] 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.[2] The most frequent unpleasant outcomes are blurred vision, dry eyes and halos around lights when seen at night.[21] 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.[27] A public hearing got underway Friday with officials hearing stories of eye pain and double vision caused by the procedure.[44]
The FDA will hold a hearing to determine the real danger behind the surgery.[49] An FDA advisory panel will discuss the planned study at a public hearing tomorrow in Gaithersburg, Maryland.[3]
Unfortunately, the FDA investigation comes years too late for many patients that have suffered permanent damage.[13] The FDA does not regulate marketing, but I agreed that it is a problem." Another issue, she said, was patient selection.[9]
Two facts: The FDA recommends that one eye ONLY be operated on at a time, however, it states that the ultimate judgement be left to the surgeon.[25]
A 95% satisfaction rate isn't anywhere near acceptable for something as serious as elective eye surgery.[47] FRIDAY, April 25 (HealthDay News) -- Golf great Tiger Woods lauds vision-correcting LASIK surgery as "life changing."[1] 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.[47] 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.[2] Surgery doesn't necessarily create perfection (though my vision is great better then 20/20 now) but any improvements are still improvements.[2]
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.[16] 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.[2] 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.[12] There are plenty of bad doctors who don't really guide you are really determine if you will be a good lasik candidate.[13] 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.[17] 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.[2] 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.[2] 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).[2] I heard it was quick, would free me from my contacts, and very safe if I had the financial means, I probably would've gone for Lasik already. Now that it seems like it's not, I'll keep looking for some other way to get rid of these contacts and glasses.[47]
The problems with Lasik seem like they can get pretty bad and I feel very, very sorry for those who have experienced these problems.[47] 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] Patient Abby Ellin says, "My vision is a lot like looking through a wrinkled piece of dirty plastic."[46] 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] Contacts are more expensive. Not only that, but if you rub your eye the wrong way you can tear them or rub them right out (and they can be VERY hard to find). You also can't easily put them back in without having clean hands and your contact solution. I've had to put them back in under non-ideal circumstances before and let me tell you, it can feel like you're sticking a freakin hot pepper in your eye until you shed so many tears your eyes wash them clean again. You have to take them out every night and put them back in every morning (else they get gunky, deprive your eyes of oxygen all night, and can cause eye infections not something you want to do often). This might not seem like a big deal, but it means that you have to think ahead for where you're going to sleep to make sure you have contact fluid and a case with you.[47] 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.[2] 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.[2]
Getting your eyes fixed is NOT, by any means, equivalent to getting a nose job or something. Please, try to have some sympathy for those poor people who reached for their dream only to find out that they were lied to about the risks.[47] Biologist Fiona Mathews and her colleagues surveyed. 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.[31] 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.[27]
The study showing the highest satisfaction rate had no dissatisfied patients.[33] The agency determined that existing data were insufficient and that there was no reliable method for assessing patients' quality of life after the procedure.[5] 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.[2] '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.[31] Each patient has to sign an arbitration agreement. Lawyers have difficulty skirting these, the surgeons' often negligent behavior is well protected, young people typically feel invulnerable and "know" nothing bad will result.[25] I have a hard time feeling sorry for people who have bad results from this ELECTIVE surgery.[47]
Howard I had laser surgery about 5 years ago, but I chose to pay quite a lot at the time - about $6,000.[2] 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.[21] Older technology uses a blade to cut a flap in the cornea before a laser reshapes the eye surface.[38] "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.[22]
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.[2]
My eyes have continued to deteriorate (as forewarned) and I'll have to wear glasses for driving in a few years.[2] 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.[2]

"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. [10] Someone who has a very thin cornea and is very nearsighted would not be a good candidate for Lasik."[35]

With all surgeries come risks, if you don't accept the risk, and haven't done your homework, don't have the surgery. [2] 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.[2] Like most surgeries, I took a risk and was pleased with the result. It was a choice that I made and I knew I would have to live with my decision, whether the procedure worked or not.[2] 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.[22]
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.[2] We argued that, even though research regarding AIDS was not completed, that the medical community still had a responsibility to inform the families of children receiving clotting concentrate of the potential risk of AIDS. Although we could not prove what lot of concentrate killed our client, the jury found one defendant physician negligent for failing to adequately disclose known risks. I would certainly feel honored if this case, on which I worked for 6 years, turned out to be my legacy.[13] A new study by dermatologist Christine Brown at Baylor University Medical Center in Dallas found that the shiny lip glosses, which many women are so fond of, may increase the risk of skin. A new survey by the University of Exeter in England reveals that women's pre-pregnancy eating habits can influence the gender of their child.[31]
N ews- M edical. N et provides this medical news service in accordance with these terms and conditions. Please note that medical information found on this website is designed to support, not to replace the relationship between patient and physician/doctor and the medical advice they may provide.[24] The information in this report will help me diagnose and treat patients effectively.[9]
In the study that showed the lowest satisfaction rate, more than 12 percent of patients were unhappy.[33] "Relevant questions ask if the patient's results were 'as expected', or degrees of 'better than expected' or 'worse than expected'."[23] 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).[2] After years of refinement, options for vision correction are better and more varied than in the past, U.S. News's Michelle Andrews reports.[27] 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.[47]

The FDA panel could recommend changing regulatory guidelines for the vision-correcting laser or it could do nothing. [34] User facilities such as hospitals and nursing homes are required to report suspected medical device-related deaths to both FDA and the manufacturer, if known, and medical device-related serious injuries to the manufacturer or to FDA, if the manufacturer is unknown. Again, please note that heparin lock flush solutions and in vitro diagnostic tests are considered medical devices and are therefore subject to these reporting requirements. These reports must be made on the MedWatch Mandatory Form FDA 3500A (available at www.fda.gov/medwatch/getforms.htm ).[54] You can obtain the form at www.fda.gov/medwatch/getforms.htm. These reports should be provided to FDA using the methods described above for healthcare providers. If your facility participates in FDA's Medical Product Safety Network (MedSun) program, please submit your reports for both device and drug-related heparin reactions to the MedSun website, as you currently do for your device reports.[54]
Scrutiny of FDA'''s ability to inspect foreign drug-manufacturing plants has increased on Capitol Hill after the blood-thinning drug heparin, produced in China, was found to be contaminated and may have been a factor in up to 81 deaths. Senate HELP Chairman Edward M. Kennedy, D-Mass., said the FDA needs more resources to monitor products produced overseas, but manufacturers also must use better tests to detect impurities and contaminants in their products. '''Even the most up-to-date manufacturing processes won'''t ensure safety if manufacturers can'''t guarantee the ingredients aren'''t contaminated,''' he said.[53] The FDA's major study should provide a better understanding about who has bad outcomes and why.[32]
There are clearly complications which can arise, and that is what the FDA is looking into. Share and Enjoy: These icons link to social bookmarking sites where readers can share and discover new web pages.[20]

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. [16]
SOURCES
1. FDA Panel Urges Stronger Warnings for LASIK Surgery - washingtonpost.com 2. CTV.ca | Lasik patients air grievances in front of FDA panel 3. Bloomberg.com: Science 4. Unhappy LASIK patients urge FDA to take action | U.S. | Reuters 5. Lasik Patients Describe Complications at FDA Hearing - washingtonpost.com 6. The Associated Press: FDA takes closer look at Lasik complaints 7. More Warnings for LASIK Required, Says FDA - The Money Times 8. Experts Advise New Warnings for LASIK 9. Medical News: FDA Advisers Find LASIK Safe But Oversold - in Dermatology, Laser Surgery from MedPage Today 10. The Associated Press: FDA takes closer look at complaints from Lasik customers 11. FDA to Study Complaints from Lasik Patients - The Money Times 12. WJFW TV-12, WJFWDT 12.1 and Newswatch 12 - Stories 13. Lasik and the Patients Right to Know 14. Ahead of the Bell: FDA examines Lasik surgery side effects | Chron.com - Houston Chronicle 15. cbs4denver.com - Food And Drug Administration Examines Laser Eye Surgery Complaints 16. FDA to review Lasik eye surgery side effects - Los Angeles Times 17. The Associated Press: Federal panel seeks clearer warnings on Lasik eye surgery 18. Patients tell of horrors from eye surgery | PoughkeepsieJournal.com | Poughkeepsie Journal 19. KMPH Fox 26 Central San Joaquin Valley News Source in Fresno, California Entertainment, News, Sports and Weather | FDA takes closer look at Lasik complaints 20. FDA Launches Full Study Into Safety Of Lasik Eye Surgery : dBTechno 21. FDA and Counsel Panel to Investigate Effects of Lasik 22. FDA Recommends More Warnings For Lasik - Health News Story - WRC | Washington 23. FDA Hears USAEyes' Lasik Quality of Life Survey - Eye and Vision 24. Laser eye surgery comes under close scrutiny 25. Health Blog : LASIK Patients Tell Their Woes to FDA 26. RTTNews - Breaking News, financial breaking News, Positive EPS Surprises, Stock research . 27. Health Buzz: LASIK Surgery Woes and Other Health News - US News and World Report 28. Explicit risks of LASIK 29. Lasik Eye Complaints Examined By FDA - EON 30. Therapeutics Daily 31. FDA to Discuss Patient Satisfaction with Lasik Procedure 32. News::Rockford Woman Testifies in Front of FDA on Lasik Surgery 33. newsobserver.com | Lasik alums talking to FDA 34. Lasik patients complain to panel 35. NBC Newschannel 6 Where News Comes First - What You Should Know About Lasik Eye Surgery 36. Lasik Eye Surgery Scrutinized :: WRAL.com 37. FDA Plans to Study the Outcome of Lasik Eye Surgery in Patients 38. Health: Clearer warnings on lasik eye surgery recommended 39. Corpus Christi, TX | KRISTV.COM |FDA Officials Hold Public Hearing To Address Lasik Concerns 40. WGRZ News - Is Lasik Eye Surgery Worth the Risks? 41. Patients Share Stories Of Lasik Problems - Health News Story - KXAS | Dallas 42. FDA To Begin Investigating Lasik Eye Surgery Complaints ''' Safety Issues Explained By Food And Drug Administration | Best Syndication 43. www.kansascity.com | 04/25/2008 | National business briefs: Lasik testimony 44. Las Vegas Now | Public Hearing Held to Hear Lasik Eye Surgery Complaints 45. Lasik Surgery Study || WXYZ.com | WXYZ-TV / Detroit | Detroit News, Weather, Sports and More 46. News::Medford-Area Woman Testified Before FDA 47. More Bad News for the Lasik Business - The Lede - Breaking News - New York Times Blog 48. FDA panel hears public testimony for, against LASIK 49. WLNS TV 6 Lansing Jackson Michigan News and Weather - WLNS.COM | Government Investigating Lasik Surgery Complaints 50. News::Lasik: Not All Positive 51. Lasik is forever, for better or worse | KOMO-TV - Seattle, Washington | Consumer News 52. FDA questions safety of Lasik surgery | NECN 53. CQ Politics | Drug Safety Rests Greatly With Pharmaceutical Makers, FDA Official Says 54. PharmaLive: Update to Healthcare Facilities and Healthcare Professionals about Heparin and Heparin-containing Medical Products

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