FDA panel meeting pushes LASIK practices into the limelight

July 7th, 2008

Although the panel made no sweeping changes, it offered recommendations for updates to its patient labeling information and Web site.

GAITHERSBURG, Md. – Issues surrounding patient safety, patient satisfaction and even marketing practices associated with LASIK came under intense scrutiny since the U.S. Food and Drug Administration Ophthalmic Devices Panel heard public testimony in April in favor of and sometimes vehemently opposed to the surgery.

Based in part on the testimony and the passage of time since labeling information was last reviewed, the panel made recommendations for updating labeling information as well as its own patient information Web site.

Despite some dramatic testimony at the April 25 meeting, the panel was not a “referendum on LASIK,” according to Jayne S. Weiss, MD, who chairs the FDA Ophthalmic Devices Panel.

“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,” Dr. Weiss said.

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 after adverse complications, optometrists, ophthalmologists and attorneys representing those patients.

Much of the debate surrounded the proposed quality-of-life study to be conducted in 2009 by the National Eye Institute, the FDA, with support from the American Society of Cataract and Refractive Surgery, and the American Academy of Ophthalmology. The announcement of the survey comes on the heels of syndicated reports in recent months of depression and suicide of patients after LASIK.

Strong calls for change

Todd J. Krouner, JD, argued that the FDA quality-of-life study be carried out independent of the refractive surgery industry, which he sees as embodied in the ASCRS and AAO.

Mr. Krouner, a LASIK malpractice attorney based in Chappaqua, N.Y., said, “Given the self-interest of the LASIK industry and its surgeons, it is respectfully submitted that any review of LASIK safety, satisfaction or study of correlation between bad LASIK outcomes and suicide should not be delegated exclusively to those who have a vested interest in the conclusion.”

Matt Kotsovolos, former chief financial officer of Duke Eye Center in Durham, N.C., went even further, calling 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.

Mr. Kotsovolos argued that although the LASIK industry quotes complications rates of 1% to 3%, the real numbers are much closer to 20% to 30%, but these complications are disguised as side effects or symptoms.

“I have met plenty of people who are depressed and considering suicide because of complications that are currently buried in the device labeling and are classified as symptoms or side effects,” he said. “Patients do not want to continue to exist as helpless victims with no solutions and no voice. … I urge the FDA advisory panel to recommend placing a moratorium on LASIK until a proper comprehensive study of long-term LASIK complications and symptoms, including clinical depression, is completed.”

Malvina Eydelman, MD, senior medical adviser on ophthalmic devices to the FDA, defended the still-undefined survey at another point in the meeting, saying, “I can assure you that every precaution is being taken so there are no potential conflicts of interest and everything will be done consistent with FDA and NEI regulations.”

Painful stories from poor outcomes

Much of the public testimony given to the panel against LASIK concerned personal stories of depression, suicide or suicidal ideation and other psychological problems resulting from adverse LASIK outcomes.

Gerard Dorrian talked about his son Colin, who had LASIK as a law student at the University of Michigan. According to Mr. Dorrian, Colin had become intolerant of contact lenses due to dry eye. Mr. Dorrian said Colin suffered painful chronic dry eye after LASIK and committed suicide 6 years after the procedure. He read from a letter that his son wrote, which read, in part, “I cannot accept the fact I have to live like this. I am rotting from the inside out.”

“A patient satisfaction survey does not really give any information about how people are suffering. It doesn’t address issues faced by patients deformed by LASIK,” Mr. Dorrian said.

The panel also heard a presentation from Edward L. Boshnick, OD, who, according to the EyeFreedom.com Web site, specializes in “restoration of vision and comfort lost as a result of refractive eye surgery, keratoconus, pellucid marginal degeneration, extreme dry eye, corneal dystrophies, corneal trauma and Stevens-Johnson syndrome.”

Dr. Boshnick said he has cared for several hundred post-LASIK patients. Although he cautioned that because of the nature of his practice he does not see “happy post-LASIK” patients, he said he has seen the devastating effects of patients suffering from vision disturbances associated with LASIK.

“I would say that most of my patients are depressed, and many are on anti-depressant medication. From what I have seen and witnessed from many patients, I feel at the present time LASIK presents a significant public health crisis,” Dr. Boshnick said.

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  1. FDA Takes on LASIK Safety
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