Unhappy LASIK patients urge FDA to take action

By Susan Heavey
GAITHERSBURG, 28 april 2008- 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.
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.
Still, 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.
Several unhappy patients at the advisory meeting faulted their surgeon for not ruling them out as a poor candidates for LASIK, or for failing to stress the severity of possible side effects.
The FDA, which has said the surgery is safe and effective regulates LASIK devices but not the surgeons or clinics that offer the procedure.
Stock analysts have said the FDA focus on the procedure could further hurt LASIK companies, which have already seen the softening U.S. economy dampen demand for the elective surgery that is usually not covered by health insurance.
LASIK device makers include Advanced Medical Optics Inc, Alcon Inc and Bausch & Lomb, among others. TLC Vision Corp and LCA-Vision Inc run LASIK clinics.
Eric Donnenfeld, an ophthalmologist at New York University Medical Center, said the surgery aims to improve patients' lives.
"The reality is that, following LASIK, the great majority of our patients see as well or better than they ever saw with their glasses or contact lenses with which they were unhappy," he told the advisory panel.
Still, some patients said that while their vision had improved, dry-eye and other side effects were overwhelming.
The FDA is also planning to begin a study on LASIK patient satisfaction in 2009 along with the National Eye Institute and two industry groups: the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology.
Patient and consumer advocates at Friday's meeting objected to the groups' involvement with the study, citing conflicts of interest. Industry representatives said it would help them understand why some patients are unhappy with their LASIK results.