FDA Lasik Response to FDA Webview Challenged
Reprinted with permission from fdaweb.com
LASIK Surgery Watch says it disputes most of FDA’s response to FDA Webview in our publication of an interview with former FDA Division of Ophthalmic Devices Diagnostic and Surgical Devices Branch chief Morris Waxler, who said that FDA was mistaken in approving excimer lasers for LASIK during his tenure (see story).
In a 9/13 letter to CDRH acting director Jeffrey Shuren and other FDA and HHS officials and members of Congress, LASIK Surgery Watch says that FDA caveats that its guidance documents only provide guidance “in no way exonerate [it] for approving excimer laser devices for LASIK, a procedure with complications in excess of 20%.” The group also asserts that no number of subsequent meetings or revisions to the guidance could justify such damage to American eyes.
On the issue of LASIK re-treatments, LASIK Surgery Watch says that while it agrees with FDA that such re-treatments were never approved by the agency, they still are common and speak to the lack of efficacy of the initial LASIK procedure.
LASIK Surgery Watch also questions FDA’s comments on adverse event reporting in its database. The agency’s emphasis that most reports are not recent only demonstrates that damaged patients have no idea where to report adverse events, it says. It also says that FDA statements about adverse events reported in its own database are incorrect. It says the agency mis-reported the number of voluntary adverse event reports and asks why it is providing misleading data to the public on its own adverse event database.
The remainder of the letter reviews for Shuren all of LASIK Surgery Watch’s concerns about the procedure, including citation of a number of medical journal studies. “LASIK is a medically unnecessary surgery that carries with it permanent adverse effects and substantial risk of permanent visual impairment,” it says. “As evidenced, LASIK complications occur frequently. It is reasonable to conclude that LASIK eye surgery has become a leading cause of preventable visual impairment in the United States.”
The letter calls on Shuren to immediately withdraw FDA approval of LASIK devices.
Meanwhile, a Consumer Reports survey has found that 55% of Americans who had LASIK surgery continue to wear glasses or contact lenses at some time. And many of them say they were misled by advertising for the procedure that led them to expect they would not need other eye correction after surgery.
“Laser vision correction surgery is a largely unchecked industry, and consumers need to know the right questions to ask to be sure they’re protected and that they’re getting good quality care for their money,” says Consumer Reports Health Rating Center director John Santa. “Vision correction surgery is increasingly popular but there is a concerning lack of unbiased, concrete evidence about its safety and efficacy.”
Survey results showed that 53% of patients experienced at least one side effect within the first four weeks after surgery, and 22% experienced them six months after surgery, especially dry eyes and visual symptoms like halos, glare, and starbursts around lights.