LASIK in the News
Many newspapers and television stations across the United States have carried stories exposing the risks of LASIK and the dark side of the lucrative practice of LASIK. Even the nation's more prestigious investigative news sources have sought to expose truths about the LASIK industry, often using very frank terminology. The Washington Post, for example, concludes: "Trust No One, Not Even Your Eye Doctor."
LASIK surgeon Philip Gabriele found dead of self-inflicted gunshot wound - South Bend Tribune 6/16/2009
A two-year investigation into ophthalmologist Dr. Philip Gabriele and his wife, Marcella, came to a shocking end Monday morning when police found the couple dead inside their business with apparent gunshot wounds. The Gabrieles, of Granger, were indicted last week by a federal grand jury on suspicion of health care fraud, wire fraud and criminal conspiracy charges. They were supposed to turn themselves in to authorities Monday afternoon.
LASIK surgeon Philip Gabriele faces criminal indictment - WSBT South Bend 6/12/2009
A federal grand jury has indicted a local eye doctor and his wife on health care fraud, wire fraud and criminal conspiracy charges, prosecutors announced Friday. Philip J. Gabriele, 44, and his wife, Marcella Gabriele, both of Granger, are accused of falsely and fraudulently diagnosing cataracts and other disorders in patients and performing unnecessary surgeries, according to a statement issued by assistant U.S. attorney Donald Schmid... These patients then underwent further surgeries and procedures in an effort to improve their sight, including further refractive and laser procedures, prosecutors said... The couple also made false claims in their advertising, such as, "100 percent of patients who have undergone Wavescan Custom Lasik at Gabriele Eye Institute see 20/20 or better after their first procedure," the indictment alleges. Marcella Gabriele falsely documented patients’ eye sight ability following Lasik procedures to, among other things, support those advertising claims, the indictment alleges.
LCA-Vision (LasikPlus) Procedure Volume Drops 45% In April, May - Wall Street Journal 6/2/2009
LCA-Vision Inc. (LCAV) said Tuesday that procedure volume in April and May at its laser-vision corrective services centers declined about 45% compared with the same time last year and it expects the softness to continue through 2009 amid the slowdown in U.S. discretionary spending... The volume drop in the first quarter was 37% and just above 50% in the second half of 2008... LCA said Tuesday during its annual meeting that it is considering closing underperforming facilities and reducing marketing expenses.
LASIK ads must warn consumers of risks: FDA - Reuters 5/22/2009
From the article: Doctors, clinics and others promoting corrective eye surgery known as LASIK need to make sure their advertisements tell consumers about possible risks, U.S. regulators said in a letter released on Friday. The Food and Drug Administration, which has been investigating patient complaints over the procedure, told healthcare providers that commercials and other promotions that do not convey necessary warnings, side-effects and other precautions are deceptive.
Letter sent to U.S. Congress seeking moratorium on LASIK.- LasikNewswire 5/21/2009
From the article: FDA clinical trial study design for LASIK lacked sufficient duration of follow-up to detect late onset complications, such as corneal ectasia, a serious sight-threatening complication of LASIK that may occur years after the procedure. The small patient population and short-term follow-up did not allow for thorough examination of adverse events and long-term consequences of LASIK... I believe the FDA Center for Devices and Radiologic Health (CDRH) and Office of Device Evaluation (ODE) has not maintained the distance from the LASIK devices industry required for impartiality.
Professional golfer, Peter Lonard, having vision problems after two LASIK surgeries - PGA.org.au 5/19/2009
From the article: Peter Lonard, who twice has had laser treatment to improve his eyesight, now is hoping that contact lenses can arrest his recent poor form. Lonard is having his worst year since joining the US Tour in 2002... "One thing I have done that might make a further difference is that I have had my eyesight checked again and had contacts fitted. I played today for the first time with the contacts and the difference was quite amazing. I did have Lasik eye surgery a few years back but it was not all that successful and the last couple of years my eyesight has gotten worse."
Atlanta Braves catcher, Brian McCann, vision problems after LASIK - The Atlanta Journal-Constitution 5/16/2009
From the article: Dealing with a sense so delicate and wondrous as sight was a little different than trying to shake off a sprain... Since his 2007 Lasik surgery, McCann’s eyes had changed. He didn’t really begin to notice, he said, until the start of this season. But the change was drastic... “Until we got the two eyes equalized, it was not going to be better,” said Alan Kozarsky, the Atlanta ophthalmologist who did the Lasik, and one of several doctors on the case this month... The McCann boys had been taught early by their father to play through most any injury. But this was something else. There was no gutting out this type of problem... “I was more concerned with him mentally,” McCann’s father said. “He was miserable."
Related articles: Trouble with eye after LASIK affecting McCann, McCann wearing contact lenses after LASIK, McCann's eyesight has diminished since LASIK surgery, McCann scratched from lineup with eye discomfort, McCann placed on disabled list due to blurred vision after LASIK, McCann rubs his face and eyes in the dugout, More LASIK last resort for McCann, McCann trying glasses, McCann looking to avoid more LASIK, McCann to give new glasses test run
TLC closes its laser eye center in Roanoke County - WDBJ7.com 5/7/2009
From the article: "I think the national numbers for Lasik are probably down 30 to 40 percent and we're seeing that also here in Roanoke," said Albright... Until July 31st TLC will provide follow-up care for patients through an affiliate doctor or at the Roanoke location. After that patients must get annual exams through their eye doctor or visit another TLC location to maintain their TLC Lifetime Commitment... Link to article
Earlier related article:
Will TLC Laser Eye Centers survive to honor its "lifetime commitment"? - LASIK Newswire 9/24/2008
From the article: LASIK eye surgery volumes are declining... Especially hard hit are LASIK chains, sometimes referred to as "LASIK mills", such as LasikPlus and TLC Laser Eye Centers. TLC continues to advertise its "lifetime commitment" to patient follow-up care, yet the company's financial picture is grim... Link to article
LasikPlus reports first-quarter loss of 2.8 million, surgeries down 37% - Reuters 4/28/2009
From the article: LCA-Vision Inc, a provider of laser vision correction services, swung to a first-quarter loss on lower revenue resulting from a 37 percent drop in procedure volumes.
Auditor to raise "going concern" about TLC's ability to continue - St. Louis Business Journal 3/31/2009
From the article: An auditor plans to raise a “going concern” about TLC Vision Corp.’s ability to continue... For 2008, the company lost $98 million on revenue of $276 million, compared to a loss of $42 million on revenue of $298 million in 2007.
Also see Reuters 4/3/2009: TLCVision gets limited waiver on credit facility
Update 4/24/2009: TLC Vision CEO departs; restructuring chief named
Update 5/15/2009: TLC Vision cuts execs, reports loss
Laser eye surgery clinics described as "stack 'em high and sell’ em cheap"- IrishHealth.com 3/27/2009
From the article: Mr. Michael O’Keeffe, consultant at the Mater and Temple Street Hospitals in Dublin, claims some of these clinics operate on the basis of "stack 'em high and sell’ em cheap" and are selling what is a complex and sometimes hazardous procedure as if they were selling “cans of beans or handbags.”... Dr. Schallhorn rejected Mr. O'Keeffe's assertion that having a doctor providing all the care is the best model.
'Poor advice and hard-sell tactics' on laser surgery - News.Scotsman.com 3/26/2009
The consumer magazine Which? said that, in some cases, clinics run by firms including Optical Express, Optimax and Ultralase were giving inappropriate advice to those seeking information about treatment. Undercover researchers visited 18 clinics across the UK to assess the advice they were given before having laser surgery. Which? said 11 gave unsatisfactory advice, and none of the consultations were rated as "good" by its panel of experts, which included a laser-eye surgeon... Steve Schallhorn, chief medical director of Optical Express, said the Which? article was "misleading and poorly researched".
Back to Glasses - Daily Mail 3/26/2009
After 20 years of wearing glasses for long-sightedness, Margaret Grimshaw dreamed of throwing them away for good. Unfortunately laser surgery didn't make her dreams come true. Her vision became blurred after the operation and her eyes were constantly dry. Two years on, the dryness and soreness remain. She cannot see properly in the distance and has night glare - lights look blurry at night. No improvements have been delivered by further surgery.
Professional Golfer, Retief Goosen; Complications from laser eye surgery - PGATour.com 3/30/2009
From the article: Regardless of the outcome, he provided a great storyline and we certainly weren't cheated with the winner, Goosen, who had struggled over the last year due to complications from laser eye surgery. Source
Retief Goosen; Eyesight loss, more laser eye surgery - Golf.com 3/23/2009
From the article: The victory, the 40-year-old Goosen's seventh on the PGA Tour and second at the Transitions, ended a four-year drought that had all the markings of a midlife crisis. There was weight gain, eyesight loss and a desperate fling with the belly putter... Two weeks ago he had laser surgery on his right eye... Source
Retief Goosen withdraws from tournament citing problem with his left eye - Qatar-Masters.com 1/23/2008
From the article: "The defending champion was left frustrated after suffering blurred vision following recent corrective laser surgery. Despite a whistle-stop flight for an appointment with a specialist in Dubai, the problem persisted resulting in the champion’s withdrawal just 24 hours before the start of the $2.5 million tournament. 'I’m obviously very sad that I am unable to defend my title,' said Goosen. 'I came all this way to play but unfortunately the eye is causing a problem. I thought it would come good but it hasn’t. I went to Dubai yesterday and the advice was to go to London for treatment'. 'I have had laser treatment before, seven years ago, and felt I needed a touch up which I had done ten days ago. But there has been a bit of growth with a fibre in the left eye.' " Source
Why did my fabulous laser eyes go lazy again? - Mail Online 3/8/2009
From the article: By the next morning I had full and fantastic vision. No hitches, no pain and I honestly thought I would never look back. On a good day, I could see for miles. Fast-forward to 2009, and here I am wearing specs again. I can't even drive without them.
Former LCA-Vision Inc. (LasikPlus) auditor alleges surge in treatment errors - Business Courier 2/23/2009
From the article: Among Matter’s allegations: LCA recorded 71 wrong treatments in the 18 months ended Oct. 31, 2008, triple its annual average from 2004 through 2006. An LCA surgeon requested an emergency audit of a Chicago center last summer after discovering what the surgeon claimed was a dirty operating room and an uncertified technician assigned to operate a surgical laser.
Lawmakers target inferior Lasik eye procedures - Las Vegas Review-Journal 2/21/2009
From the article: AB196 adds to existing law regulating refractive eye surgery centers by requiring that ophthalmologists be licensed to perform the procedures through the Nevada State Health Division. The bill also requires that facilities that offer refractive surgery ensure that a licensed ophthalmologist perform those procedures and that the ophthalmologist is available for preoperative and postoperative care. The bill also authorizes the state’s health division to issue a cease and desist order if it learned a refractive surgery facility is operating without a license.
Read the bill AB 196.
Tiger Woods' surgeon, Mark E. Whitten, to pay $850,000 for LASIK malpractice - Post-Gazette.com 11/21/2008
From the article: A North Huntingdon man won more than $1 million in a malpractice lawsuit in which he contended his laser eye surgery was botched. A jury in Allegheny County Common Pleas Court on Wednesday ordered Dr. Mark E Whitten, of Rockville, Md., to pay $850,000 to David N. Cantalupo, on whom the doctor performed surgery in 2001 at The Laser Center in Wexford. Mr. Cantalupo also received settlements from three other defendants named in the suit --The Laser Center and two optometrists -- bringing the total he is to receive to more than $1 million... Dr. Whitten is best known for performing laser surgery on golfer Tiger Woods.
Story also available at this link.
Restraining Order Issued Against Valley Eye Center, Vikas Jain - LasVegasNow.com 11/14/2008
From the article: A judge has just signed an order to stop the practice of medicine at the Valley Eye Center... The District Court order suspends the medical licenses of Valley Eye surgeons Doctors Stella Chou, Paul Cutarelli and Valley Eye owner Dr. Anamika Jain. The board has also accused Jain's husband, clinic administrator Dr. Vikas Jain of practicing medicine without a license... According to the board's petition, 30 people claim to have suffered vision damage as the result of their Lasik procedures at Valley Eye... Also Friday the State Optometry Board decided to proceed with its case against Valley Eye Optometrist Dr. Elise Millie.
Follow up article 11/20/2008: Attorney Files Motion To Withdraw As Counsel In Valley Eye Case
Follow up article 3/23/2009: Valley Eye Center Files Bankruptcy
Valley Eye Center, LASIK Class Action Lawsuit - Las Vegas Review-Journal 11/12/2008
From the article: The lawsuit, which is expected to eventually include dozens of plaintiffs, also targets former surgeon Stella Chou, alleging that she allowed Jain to perform pre-operative tests while knowing he was not a certified laser surgeon. Dr. Vikas Jain, also known as Ken Johnson, lost his medical license in Ohio in 2005, then moved to Nevada and used his wife's medical license to open the Valley Eye Center on Tenaya Way the next year... More than 20 patients suffered "substantial harm," and Jain's peers deemed him to be unqualified to perform refractive surgery, according to a report by the Nevada State Board of Medical Examiners, which is also investigating Valley Eye Center... The lawsuit filed Monday in District Court claims the Jains' center in Las Vegas was "an assembly line" where surgery was done in a "cattle call environment."
Related links: LASIK Company Investigated by State, Contact 13 Investigation Follow Up: Valley Eye Center, An Eye for an Eye, Nevada Board of Medical Examiners complaint, License Revoked For Valley Eye Doctors
Woman Blinded by Botched LASIK - Campus Times Online 10/24/2008
From the article: According to Lising, the only words the doctor expressed to her upon seeing Lising’s pain was, “Oh shit,” not words Lising or any patient would be enthused to hear. Currently, Lising is awaiting a cornea transplant from an exact eye match donor.
Link to article.
Follow up article: Link. Related links: A Woman's Lasik Nightmare, Lasik 'Nightmare' Doctor in Trouble For Similar Blindness Cases
LASIK Class Action Lawsuit Filed: 10/21/2008
A class action lawsuit filed in the U.S. District Court in Southern California alleges a laser manufacturer, Nidek, and numerous defendant physicians engaged in a nationwide scheme and conspiracy to alter the laser software and hardware to enable it to perform non-FDA approved farsighted treatments, subjecting thousands of unsuspecting patients to substantial risk of serious injury.
Press Release: Non-Profit LASIK Surgery Watch Launched - LASIK Newswire 10/13/2008
LASIK Surgery Watch (LSW) was established to provide accurate, scientifically-based information to LASIK patients and the general public; to assist patients damaged by LASIK surgery with support and counseling; and to act as a public advocate on behalf of all LASIK patients...
Advanced Medical Optics [VISX, IntraLase] sinks on lower forecast - Associated Press 10/10/2008
Shares of Advanced Medical Optics Inc. tumbled to an all-time low Friday after the eye care products maker cut its 2008 estimates, reporting a decline in laser vision procedures and an unexpected decrease in eye care sales... Friday morning, Moody's Investors Service placed the company's long-term debt rating under review for a possible downgrade. Those ratings, including a "B2" corporate family rating, are already non-investment grade or "junk" status.
Eye surgery is risky - Toronto Sun 9/27/2008
From the article: We're all concerned about drunken drivers. But with millions of people having LASIK surgery, one wonders how many drive at night... Some post-operative patients have developed debilitating visual problems such as double vision, or have complained of glare halos... Others develop the dry eye syndrome. In these cases, the eye is unable to produce enough tears to keep the eye moist. This can cause not only discomfort, but also intermittent blurring and it can be a permanent problem requiring regular eye drops... And anyone who tells you there are no complications is either a liar or a fool.
LASIK business closes - KJRH.com 9/24/2008
From the article: A statement from Holley Vision said the economic downturn is to blame. It said Doctor Ronald Holley and his wife exhausted all their personal assets trying to keep the clinic open. Sales were down 75% in August from the year before.
Patients find laser vision correction doesn't last - Daily Mail 9/1/2008
From the article: So pleased was Jo with the treatment that she persuaded her mother, Maureen, then 49, who was long-sighted, to have the surgery. She, too, was delighted with the result. But earlier this year, Jo, now 33, noticed that her night vision was less distinct. 'My vision during the day was fine, but over a period of six months, while driving at night, I realised that car headlights and signs were becoming progressively blurred, and there was also a glare around headlights that was alarming,' she says. Her optician checked her vision and, to Jo's complete astonishment, said her night eyesight had deteriorated so rapidly she would need to have glasses to see at night once more... Shockingly, her mother's eyesight also deteriorated, and within seven years she again needed glasses for reading... 'My optician said the process had simply not worked, and that my eyes had reverted to how they had been before.'
Alcon Sued for Product Liability - LASIK Newswire 8/24/2008
From the press release: The LASIK industry generally, and defendants in particular, profess that the surgical laser systems used to perform the surgery are safe. However, on February 21, 2007, the United States Food and Drug Administration recalled defendants’ excimer surgical laser system, known as the LADAR6000 Excimer Laser (the LADAR6000) due to reports that the LADAR6000’s CustomCornea Myopia and CustomCornea Myopia with Astigmatism algorithm procedures were causing central islands in patients. Unfortunately for the plaintiff Jenna Reed, a 33 year old wife and mother of two, who resides in Longmont, Colorado, the FDA Recall came too late. She was one of approximately 20 patients who were injured by the defective LADAR6000, which was used by her LASIK surgeon at Insight LASIK, in Layfayette, Colorado.
Kenny Perry withdraws from PGA Championship due to post-LASIK eye infection - PGA.com 8/7/2008
From the article: "I have had Lasik surgery and have been wearing Lasik lenses which have a hard center and flatten out at the end," he said after withdrawing. "I had got some infection in there and my doctor said that I needed to let my eyes rest by keeping the contacts out. He gave me cortisone and steroids which were very painful and it was annoying and difficult to be to trying to fight a tough golf course and have my eye aggravating me at the same time."
TLC Vision reports second-quarter loss as Lasik demand slips - Reuters 8/5/2008
From the article: TLC Vision Corp said on Tuesday that it swung to a second-quarter loss, hurt by a decline in vision-correction procedures... The company said earnings were hurt by a 22.8 percent slump in demand for the corrective eye procedure during the quarter, compared with its rival firms, which together experienced a drop in demand of between 25 percent and 30 percent.
Advanced Medical Optics [VISX, IntraLase] profit disappoints, shares whipsaw - Reuters 8/4/2008
From the article: "Obviously, the LASIK market has gotten a lot worse than what we thought in January," said Jefferies & Co analyst Peter Bye... Still, Advanced Medical cut its forecast for full-year earnings to a range of $1.00 to $1.15 per share before special items, down from a prior forecast of $1.25 to $1.45 per share. It cited a lower outlook for U.S. vision-correction procedures, forecasting a 25 percent drop in its volume from year-ago levels and 30 percent decline for the total market.
Lasik patient receives $2.1M - Star-Ledger 7/8/2008
From the article: A Bedminster man who alleges he was left legally blind by Lasik surgery reached a $2.1 million settlement with the prominent eye surgeon who performed the procedure, his attorney said yesterday. James Dell'Ermo, 47, sought to rid himself of cumbersome eyeglasses and contact lenses he used for his nearsightedness, said his attorney, David Mazie of Mazie Slater Katz & Freeman in Roseland... Mazie said his client underwent Lasik surgery in the Bergenfield office of Joseph Dello Russo, an eye surgeon known in part for his advertising campaign and promotions.
Lasik surgeon settles suit with former patient Tuesday, BY KIBRET MARKOS
The Record online edition. NorthJersey.com 7/8/2008
From the article: The settlement ends one of numerous malpractice lawsuits against Dr. Joseph Dello Russo, who has been tangled in litigation for years while performing tens of thousands of Lasik surgeries from a well-advertised practice. The plaintiff in this case, James Dell'Ermo of Bedminister, is one of 16 former patients who filed malpractice claims against Dello Russo. Some of those plaintiffs have reached confidential settlements, while others are awaiting trial... The Dell'Ermo case is "further evidence as to the questionable safety of Lasik procedures and the physicians who perform those procedures," Mazie said... On his Web site, Dello Russo describes himself as a pioneer in Lasik surgery and points out that he has been crowned the "King" and the "Godfather" of Lasik by various media personalities. Mazie said the settlement is the only one so far that is not confidential. Dello Russo insisted on a confidential settlement, but Dell'Ermo would not agree, the lawyer said.
LCA-Vision (LasikPlus) expects 40 percent fall in volume - Reuters 6/25/2008
From the article: LCA-Vision Inc, a provider of laser vision correction services, expects a 40 percent fall in total procedure volume in the second quarter from a year ago, partly due to a panel recommending U.S. health regulators make clearer the risks of LASIK procedures.
Editor's note: In related news today, TradingMarkets.com reported internal problems for LCA-Vision. According to the article, the company's financial chief resigned, and its doctors are disgruntled over declining quality in patient care. Source
CNNMoney.com and Forbes.com also reported the resignation of the company's CFO.
Did the FDA and LASIK industry knowingly misrepresent LASIK problems? - Lasik Newswire 6/16/2008
From the article: Reports of LASIK complications to the FDA’s MedWatch program (MAUDE Database) for medical device adverse events have nearly doubled since the public announcement of the the April 25th, 2008 Special Hearing of the Ophthalmic Devices Panel, held to discuss post-LASIK quality of life, depression, and suicide... The recent, rapid growth of complaints in the MAUDE database is, presumably, particularly embarassing for the American Society of Cataract and Refractive Surgery (ASCRS)... Three other sources of information suggest collusion between ASCRS and FDA.
LASIK volumes take a hit in 2008 - Investors.com 6/13/2008
From the article: Laser eye surgery volume was down 15% to 20% in the first quarter, Vendetti says. He expects it to fall more than that later this year... Laser eye surgery stocks such as LCA-Vision (LCAV) also have taken a hit. Its procedures can run from $3,000 to $6,000, Vendetti says. That might be one reason sales grew only 1% last quarter and are expected to decline each of the next three quarters. Its stock currently trades at its lowest point in nearly five years.
International ophthalmologists support PRK over LASIK - OSN SuperSite Top Story 5/22/2008
From the article: After a discussion on the advantages and disadvantages of LASIK and PRK, the majority of international ophthalmologists in a session here changed their initial vote in favor of LASIK to favor PRK... Dr. Ambrosio questioned the safety of LASIK, showing a case in which a patient rubbed his eyes lightly on the first day postop and had complications. "The reduced comfort is a matter of 3 days, and it can be mitigated with medication," he said. He pointed out that in the long term, LASIK can cause a greater impact on the ocular surface and can lead to dry eye due to the reduction in the cornea's sensitivity caused by the cutting of nerves, unlike surface ablation.
An early adopter looks at her eyes - St. Petersburg Times 5/11/2008
From the article: For the past few years, I've known I was among the many Americans with painful dry eyes. But it wasn't until all the publicity about a recent federal hearing that I realized the dryness might stem from something other than age or heredity: Lasik eye surgery... In less than two months, the miracle turned out to be something less. It was hard to drive at night because every light had a brilliant halo. And the vision in my left eye began to slip, meaning anything more than few feet away looked fuzzy or blurry. I returned for an "enhancement'' of the left eye, in which the cornea was reshaped again. That restored perfect vision for a time. But within a year, my sight declined to the point I've had to wear glasses for driving ever since.
Pro golfer, Kenny Perry talks about failed LASIK - PGATOUR.com 5/8/2008
KENNY PERRY: That's just what I've been struggling with. You know, I've had two LASIK surgeries, I'm now wearing contacts. I wear glasses at night. So, I don't know, who knows. That might be one thing I'm having problems with I might need to look into; I don't know... It's probably been -- what do you think, Sandy, is it ten years since I've had it done? Ten years. And I had it done twice, I had it done once and then went back and had an enhancement done. Then I said I'm not doing that anymore.
Some Patients Say Life After LASIK Not Perfect - National Public Radio 05/01/2008
From the article: The FDA says it's not certain how many LASIK patients have problems with their vision weeks or months after their surgeries. But the agency is planning a new study, scheduled to begin next year, to get a better handle on the prevalence. Individual consumers can also report their LASIK complications directly to the FDA. (To report complications, click here or call 1-800-FDA-1088.) "We encourage as much information as possible here, because FDA does look at every voluntary report that comes in," says Mary Weick-Brady of the FDA's Center for Devices and Radiological Health. The agency uses patient reports to help determine if some new action is needed. "If it's a decrease in vision, if it's a halo, if it's a starburst, if it's a problem with night vision, these types of things would be considered adverse events to FDA, and we would want those reported because it has affected your vision," says Weick-Brady.
FDA Is Urged to Address Lasik-Surgery Risks - Wall Street Journal 4/26/2008
From the article: The panel also said an FDA Web site on Lasik treatments should include statistics on risks of the surgery, clearer and more coherent writing and further information on patients' need for reading glasses when they reach middle age. And it recommended that a system that reports adverse medical incidents associated with Lasik include not only incidents related to visual acuity but to quality of vision. The broader designation would encompass visual "glares," "starbursts" and "halos" commonly reported by patients with bad Lasik experiences.
Panel wants warnings for lasik users - The News & Observer 04/26/2008
From the article: "A published review of safety data for all FDA-approved ophthalmic lasers showed that six months after the surgery, 17.5 percent of patients reported halos in their vision, 19.3 percent had night-driving problems and 21 percent complained of eye dryness. The review didn't indicate how many had complications as severe as the patients who spoke before the panel. Some were legally blind. Others said they experience nausea or cannot sleep through the night because of eye pain. "We've heard your testimonies, and we are taking them seriously," said the FDA's Weiss, who wears glasses and admitted she won't undergo the surgery herself because she cannot tolerate any amount of risk."
Lasik patients complain to panel - The News & Observer 04/25/2008
From the article: "More than 200 people filled a conference room this morning to listen to report after report from patients suffering from complications of vision-correcting eye surgery. 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. "You have a serious problem on your hands," said Michael Patterson, a lasik patient from Atlanta... Matthew Kotsovolos, who experienced debilitating complications after lasik surgery, called the hearing a sham."
FDA advisers: Clearer LASIK warnings needed - CNN.com 04/25/2008
From the article: "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... Not everyone is a good candidate for LASIK surgery, and some suffer adverse side-effects... 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. But he said, "For the last two years I have suffered debilitating and unremitting eye pain. ... Patients do not want to continue to exist as helpless victims with no voice."...That's a big reason that Weiss, the 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."
Lasik Study Is Priority in U.S., Will Start by 2009 - Bloomberg.com 04/24/2008
From the article: "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." Advanced Medical, of Santa Ana, California, fell 11 cents to $20.05 in New York Stock Exchange composite trading at 4:15 p.m. Alcon, the Hunenberg, Switzerland-based company selling a majority stake to Novartis AG, gained $1.62, or 1.1 percent, to $154.99... 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".
FDA Examines Laser Eye Surgery Complaints - CBS Channel 4 Miami 4/24/2008
From the article: "Dean Kantis, who is scheduled to speak Friday, says his vision has suffered since his Lasik surgery in 1998. "My life is a blur," Kantis said. "When I look at a computer screen I see two pages; when I look up at the moon, I see three of them." Double vision, night-vision disturbances and dry eye are among the side effects outlined in literature given to Lasik patients, but Kantis and others say physicians often gloss over the risks."
LASIK industry braces for U.S. FDA meeting - Reuters 04/22/2008
From the article: "The laser eye surgery industry is steeling itself ahead of a Friday meeting expected to draw complaints from patients with blurred vision and other complications of a popular vision procedure. Millions of patients have hailed the LASIK procedure for freeing them from glasses or contact lenses, but others have have become a vocal bloc railing against the surgery, citing everything from dry eye to surgical gaffes that left scarring... The meeting "could become an overhang for LASIK companies such as EYE (Advanced Medical Optics) because of the uncertainty of the panel outcome and the potential for negative media coverage," Wachovia analyst Larry Biegelsen wrote in a research note last month."
A Blurry Outlook for LASIK? - ABC News 04/22/2008
From the article: "No one has received full informed consent for LASIK," Burch said. "If anyone knew what this procedure really does to their eyes, they wouldn't have it."... Nonetheless, after receiving reports of double vision, night blindness, dry eye and halos, the Food and Drug Administration is taking another look at LASIK. On April 25, experts will hear from patients and review what's known about the experiences of approximately 700,000 patients who undergo LASIK each year in the United States... But in Roger Davis' experiences, many people are unhappy due to complications from the surgery... "Anytime that you have a catastrophic physical injury, you're going to have a period of physical distress," Davis said. "I don't think catastrophic LASIK surgery is any different."
From the article: "The first public hearing on how complications from laser eye surgery affect a patient's quality of life will be held from 8:30 a.m. to 5 p.m. Friday, April 25, at the Gaithersburg Holiday Inn in Gaithersburg, Md., according to a notice published today in the Federal Register. Laser eye surgeons who are collaborating with the Food and Drug Administration to collect patient information hope to have three of their colleagues testify. Patients dealing with complications from lasik -- which stands for laser-assisted in situ keratomileuses -- have also requested to speak at the hearing. Patient petitions to more closely scrutinize lasik prompted the FDA two years ago to take another look at the medically unnecessary surgery, which is only loosely regulated. Testimony given at the public hearing may become part of a large, national study the FDA wants to conduct."
Lasik critics feel shunned by FDA - The News & Observer 3/20/2008
From the article: "As federal regulators prepare to hold their first hearing on how complications from laser eye surgery affect a patient's quality of life, patients are worried that they are being shut out. The Food and Drug Administration has said it will hold a public hearing on the issue this spring, but patients who have requested to speak at the event cannot get confirmation from the FDA on the date, time or location, said Michael Patterson, a lasik patient from Atlanta. However, at least one laser eye surgeon who is working with the FDA to collect patient information plans to report his findings at an FDA meeting April 24-25. And Dr. Richard Lindstrom, co-chairman of the group of surgeons collaborating with the FDA, said his group hopes to have three surgeons testify."
FDA panel to review laser eye surgery - Reuters 3/17/2008
From the article: "Dr. Daniel Schultz, director of FDA's Center for Devices and Radiological Health, said a number of concerns have been raised concerning patient satisfaction with the vision correction procedure, known as laser-assisted in situ keratomileusis, or LASIK... Known complications from the procedure can include dry eyes, glare, double vision, an increased risk of corneal inflammation or infection, and blindness. In July 2007, the FDA responded to petitions from an individual asking for a halt to the procedures and a withdrawal of their approval."
Lasik Surgery: When the Fine Print Applies to You - The New York Times 3/13/2008
From the article: "I asked about the risks, and they explained that some people come away with dry eye, double vision, decreased contrast sensitivity and decreased night vision. Some see halos around lights. I was assured these side effects were rare, and usually fleeting... True, I no longer wear glasses. But the 20/20 line on the eye chart is blurry. I can make it out only if I squint, and it takes about a minute to read. My doctor views this as proof of the surgery’s success... LOOKING back, I do not think my doctor and the other experts I consulted adequately represented the pitfalls..."
Patient responds to this article: LASIK surgery is a gamble
2/26/2008
From the article: "Physical problems such as vision loss, blurriness and impaired vision due to the surgery are well known – but the emotional impact of unsuccessful surgeries are rarely acknowledged, said Barbara Berney, the co-founder of the Vision Surgery Rehab Network, a online community for people who have had complications from eye surgeries. Berney calls herself a "LASIK disaster." She said depression leading to suicide is not uncommon."
U.S. FDA To Probe Links Between Laser Eye Surgery, Complications 2/25/2008
From the article: "Because of a large number of complaints it has received from patients who have undergone laser eye surgery, the U.S. Food and Drug Administration is planning to have a national study on the relationship between LASIK complications and life quality... Known complications include halos, double vision, loss of contrast sensitivity, glare, dry eyes, over or undercorrection, visual acuity fluctuation, light sensitivity and variations of flap damage. The FDA started to look into the link between LASIK complications and quality-of-life issues in 2006. For the new study, the FDA will convene a task force made up of representatives from the National Eye Institute and the National Institute of Health."
Some link depression, failed lasik: The News & Observer 2/3/2008
From the article: "A few researchers have already looked at whether changes in vision can affect the mind. Scientists at the Emory Eye Center in Atlanta reviewed suicides among organ donors who had had laser eye surgery. Preliminary results suggested the suicide rate might be four times as high among cornea donors who had had lasik as among cornea donors who had not. But the data were incomplete and the numbers could be significantly skewed, said Dr. Henry Edelhauser, the professor of ophthalmology who oversaw the Emory study. One of the participating eye banks failed to provide vital statistical data."
3/5/2008 Richard L. Lindstrom, LASIK Surgeon and President of ASCRS responds:
"One of the Emory researchers, R. Doyle Stulting, MD, offers the following context: 'It would be an error to conclude that poor results of LASIK are the cause of suicide. Controls for a valid study would have to include a population of patients who had other types of surgery (plastic elective procedures, for example), an age-matched control population that did not have LASIK, and even then it would be virtually impossible to conclude cause and effect.' " Source
4/25/2008 Diana Zuckerman, PhD, President, National Research Center for Women & Families wants more information about the Emory study of suicide rate among cornea donors (Go to 4:44).
Dr. Zuckerman: "The possibility of a higher suicide rate among [LASIK] patients has been raised and will be raised. More research and really good quality objective scientific research is needed. I tried to get that information. I contacted Emory University but was not able to get better information about that research which, it has not been published."
LASIK Risks: Today's TMJ4 Milwaukee: 1/30/2008
From the article: "Robert Scott is far-sighted, and has worn glasses since second grade. He says he was sick of his 4 eyes, and LASIK seemed like the answer... So now, instead of one pair of glasses...he's got a dozen! He has to switch them for different tasks...like reading, watching TV, and driving. What went wrong? A machine suctioning Richard's left eye didn't quite do the job. Optivision surgeon Gerald Clarke says that's not completely unheard of. In fact, it's one of the risks patients are warned about."
Warning issued on LASIK surgery: Hong Kong 1/15/2008
From the article: "Spectacle wearers may want to keep their glasses on. The Consumer Council warns LASIK surgery does not guarantee perfect vision or an end to the need for glasses, and urges people to weigh very carefully the pros and cons of such treatment. It recently surveyed 14 LASIK surgery service providers and found a varying level of detail on information covering potential risks or complications. The providers included four private hospitals and 10 eye-surgery clinics. Some provide comprehensive content on the potential risks, but a few only briefly note the possibility of complications and the need to consult doctors in advance..."
Pro golfer, Kevin Na, "Just slowly it got worse and worse... I can't see balls land": 1/11/2008
From the article: "I got it done from like the world's greatest doctor. He told me, 'It might take more than one surgery because your eyes are so bad, but we can probably get 20/20.' And I had it done, and the first week it was awesome. I was able to see very well. It wasn't like perfect, but it was very good. I was excited. Just slowly it got worse and worse. Right now it's not very good. I can't see balls land."
Update 2/14/2008: Kevin Na wearing contact lenses after LASIK
By Helen Ross, PGATOUR.com Chief of Correspondents
From the article: "Seeing on the golf ball, though, has been more problematic for Kevin Na since his LASIK surgery in December. After the procedure, his vision was still so bad -- 20/100, to be exact -- that Na couldn't even drive. His doctor gave him the go-ahead to try a pair of contacts last week, though, and the results were almost immediate."
Expert says LASIK is "waning in popularity" - OSN Supersite 11/11/2007
At the 2007 American Academy of Ophthalmology meeting, a LASIK industry expert reported that LASIK is falling out of favor with refractive surgeons. From the article: "LASIK is down to about 33% from a high of 53% back in 2001."
Eye surgery leaves many with problems: The News & Observer 9/30/07
From the article: "The American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery, estimates that only 2 percent to 3 percent of the more than 1 million LASIK surgeries each year are unsuccessful. But Food and Drug Administration records of clinical studies show that six months after the surgery, up to 28 percent of patients complained of eye dryness, up to 16 percent had blurry vision and up to 18 percent had difficulty driving at night."
End of Tiger Woods winning streak, he “didn’t see the ball mark”: 2/23/2007
By Helen Ross, PGATOUR.com Chief of Correspondents
From the article: “Standing over a 4-foot putt on the first extra hole to win his match with Nick O'Hern, Woods didn't see the ball mark in its path. Had he seen the blemish, which was ‘totally’ fixable, Woods said, and repaired it, the ball might not have veered right of the hole.”
Tiger Woods has surgery again, “My vision started slipping”: USA Today 5/15/2007
By Doug Ferguson, AP Golf Writer
From the article: “He had Lasik surgery in October 1999 after the Ryder Cup, won the Disney Classic in his first tournament back and has done fairly well since. He realized this spring it was time to do it again. ‘My vision started slipping,’ Woods said after The Players Championship. ‘I was getting headaches from squinting all the time.’ He said he had laser surgery for the second time the Monday after the Masters.
Surgeon Warns of Laser Eye Cure Risks: Expert Claims Dangers of Treatment not Made Clear 12/26/2004
From the article: "Unfortunately, it is marketed as being very simple and very safe, and I suspect that probably is just not true.... "A lot of companies say that 95% of patients have 20:20 vision after the treatment, but that doesn’t tell you that 10% of them might not be able to drive at night. "Apart from the major risks of infection, there are a significant number of people with dry eyes, double vision or who see halos around lights. In some cases, such as persistent haziness. The patient can be left with an impairment of vision that is permanent. Some people’s lives have been turned upside down by having LASIK because of complications that they felt they were not fully informed about."
Fears that grew over 'perfect' operation: Times Online, Britain 8/28/2004
From the Article: "When a number of doctors from across America began to question whether Alcon’s Ladarvision system, a machine using Nasa laser technology, was malfunctioning, the company had two choices. It could have gone public, and recalled the potentially defective model or, like the three wise monkeys, it could see no evil, hear no evil and speak no evil."
Original ArticleA Pain the Eye That's Forever: East Bay Express 4/23/2003
From the Article: "Ross is one of tens of thousands of patients whose lives have been turned upside down due to improper risk screening, malfunctioning machines, or shabby surgical techniques. Instead of the carefree new lifestyle these patients anticipated, they have received an involuntary lifetime admission ticket to their own personal laser light show. At best, they face glare, halos, starbursts, multiple images, or poor depth perception. At worst, they face chronic pain, corneal transplants -- even blindness in rare cases..."
"Happy LASIK patients are ecstatic, noted Dr. Arthur Epstein in the January 2002 issue of Review of Optometry. 'But unsuccessful patients exist in a permanently altered waking nightmare from which there is presently no escape,' he wrote. Epstein warned that LASIK is still experimental surgery, and in hindsight could ultimately prove to be a physician-induced health crisis. Despite voices of warning from Epstein and others, the money machine trudges onward."
Original Article$1.7M For Botched Laser-Eye Surgery Suggests New Mass Tort: Lawyers Weekly 12/10/2001
From the article: "Herren's client, plaintiff Tonya Oliver, had sought laser eye surgery to correct her astigmatism in 1998. A preliminary surgery conducted by the defendant, Dr. Thomas Abell, was a success. But the doctor, according to the plaintiff, encouraged her to return for a minor correction of her left eye - known in the industry as an enhancement. The plaintiff had the corrective procedure five months later. But, when the bandages were removed, the plaintiff's eye had gotten worse... On the advice of specialists, the plaintiff ultimately received a cornea transplant, which has resulted in several complications, said Herren."
10 Things Your Eye Doctor Won't Tell You: SmartMoney.com November, 2001
From the article: "'I use my eye chart as a crutch.' Managed care continues to put a dent in all doctors' profits, but eye doctors have become especially vulnerable. Falling reimbursements have flattened once-hefty profits on procedures such as cataract surgery, and HMO hassles make it tempting for many patients to blow off that annual eye exam."
Eyeball Hardball: Washington Post 9/4/2001
From the article: "But with some Lasik customers facing higher pressure to commit during consultation, it's more important than ever to know how to find unbiased, complete information about the procedure's risks and benefits. The process isn't easy or fast, but it's necessary if you intend to approach the procedure with your eyes wide open... Trust No One... Not Even Your Eye Doctor..."
LASIK Risks Understated: USA Today 06/28/2001
From the Article: "Laser eye surgery is being touted in advertisements as a quick, virtually risk-free procedure that can end patients' need for glasses. But with more than 1 million patients expected to undergo the procedure this year, thousands are learning what the ads don't say: The surgery can cause life-altering complications that sometimes can't be fixed. Problems include double or triple vision so severe patients can't watch TV or read, light distortions so blinding they can't drive at night and eyes so dry that goggles must be worn outside. Some patients have spent thousands of dollars trying to fix problems only to find the technology doesn't yet exist to provide a remedy. "
Read SourceOptions Limited When Lasik Doesn't Work: St. Petersburg Times 4/1/2001
From the article: "For 10 glorious days after her eye surgery, Wanda Barrit's world was crystal clear. Her vision was near perfect, her 20-year reliance on contact lenses seemingly over, her decision to have LASIK affirmed. Then her world appeared in threes. At first, her surgeon said the triple-vision was part of the healing process and would clear with time. But soon it became clear it wouldn't, and there was nothing he could do. Over the next two years, six other doctors would give her the same bad news."
Seeing LASIK's Risks Clearly: St. Petersburg Times 10/1/2000
From the article: "This is the one that got me," Cofer, 42, of Tampa, said recently, pulling a newspaper ad from a file by her desk. It offered a deep, deep discount rate of $499 per eye to the first 1,000 patients who visited a new LASIK center in Tampa, and promised "tens of thousands of satisfied customers worldwide." The ad quoted a nurse and a firefighter who were thrilled. And Cofer could afford the price. But that ad, like many for refractive eye surgery, made no mention of the risks. No mention of common side effects. No mention of the potential loss of contrast sensitivity, which makes it difficult to distinguish where one object stops and another starts."
LASIK in 20/20: Consumers should see the risks as well as the benefits 9/24/2000
From the Article: "LASIK centers are under enormous economic pressure because of high fixed costs. That means they need a steady flow of patients to ensure profitability, an increasingly difficult task as new entrants crowd the market."
Original Article'What Have I Done To My Eyes?': Washington Post 10/12/1999
From the article: "Before he had surgery last year, Mitch Ferro thought he knew everything he needed to about Lasik. His older brother, a physician, had the procedure in Baltimore and raved about how easy it was and how well he could see. "I figured surgery was a no-brainer," Ferro recalled. He figured wrong. Ferro now considers having laser eye surgery to be one of the worst mistakes he ever made. "Believe me, I've never felt regret like this. I'd give anything to have my old corneas back," he said."