Patients that went through Lasik surgery informed the U.S. regulators at a meeting of their current side effects such as blurred vision, dry eyes, glare and double-vision, and even suffering of depression leading to suicides.
The patients urged the Food and Drug Administration at a panel to act more to avoid negative results from the surgery, which according to statistics is performed in 700,000 patients in the U.S. each year.
Too many Americans have been harmed by this procedure and it's about time this message was heard, says David Shell a patient who had LASIK in 1998 adding since LASIK, I am visually handicapped.
Lasik stands for laser-assisted-in-situ-keratomileusis and consists of a surgery that uses laser to reshape the eyes cornea and correct sight defects. The FDA received over a hundred reports of side effects and device malfunctions since 1998 to 2006. Now the agency plans to collect detailed information to have real results of how the ophthalmic services are performing, since it determined the existing data is insufficient and there is no way to know the quality of life of the patients who went through the surgery.
The American Society for Cataract and Refractive Surgery, which represents the doctors who make the procedures, revealed 95 percent of patients are satisfied with the results settling its basis in studies. Other representatives from industries have said depression has different causes and it hasn't been proved its direct related to LASIK.
The FDA has said the surgery is safe and effective. The agency regulates the LASIK devices but not the surgeons or clinics that make the procedure. Among the device makers are Advanced Medical Optics Inc, Alcon Inc and Bausch & Lomb while TLC Vision Corp and LCA-Vision Inc operate LASIK clinics.
Shares of Advanced Medical Optics closed 1.40 percent up to $20.33 in Friday's closing trading in the New York Stock Exchange.TLC Vision shares closed down 1.64 percent to $1.20 a share in Nasdaq on Friday. LCA-Vision shares closed 3.06 percent up at $12.47 in Nasdaq.