Copyright Dickinson FDA Webview at www.fdaweb.com. Republished with permission.
03/31/2021
The leader of a Facebook group involving patients injured by LASIK eye correction procedures is urging FDA acting commissioner Janet Woodcock to crack down on false and misleading advertising by LASIK providers. Paula Cofer, who founded the 7,400-member LASIK Complications Facebook Group in 2014 to give a voice to people who have been allegedly harmed by corneal refractive surgeries, emailed Woodcock 3/30 asking for her to help rid the marketplace of the violative LASIK ads that she says have been rampant for 20 years.
The clearly frustrated Cofer notes in her email to Woodcock that over the years she has reported to FDA several violative LASIK ads, “but to my knowledge, no enforcement action has ever been taken. I basically gave up on the agency doing anything about false, deceptive LASIK ads. However, today when I saw an ad (masquerading as a press release) claiming ‘zero complications,’ I could not ignore it.” She also characterized LASIK in general as a “scandal,” which has caused at least 30 suicides and “left hundreds of thousands of unsuspecting citizens with chronic dry eyes, persistent corneal neuropathic pain, and debilitating visual symptoms, including blindness and loss of eyes.”
The recent “advertisement” that prompted Cofer to try again to get someone at FDA’s top to address her concerns is a press release posted on EIN Presswire for Park Avenue LASEK, which is described as “the only laser vision correction center in the U.S. that specializes exclusively in Advanced Surface Ablations (in other words we don’t cut, which means no LASIK and no flaps). We have the only glass operating room in the United States since we have zero complications.”
Cofer’s email urged Woodcock to use “whatever enforcement action necessary to remove this ad from the Internet and prevent future false claims… Please, also look at other LASIK ads and Web pages operated by LASIK surgeons. You’ll see that virtually none of them are in compliance with the statutes.”
The email, which was also copied to numerous other FDA officials, apparently garnered immediate agency attention because Woodcock 3/31 emailed Cofer to request that the original email be resent to her. Shortly thereafter, CDRH ombudsman Abiy Desta emailed Cofer that her complaint about the LASEK advertisement has been forwarded to the device center’s Allegations of Regulatory Misconduct Team. According to FDA’s Web site, an allegation of regulatory misconduct is a claim that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law.
Cofer’s email to Woodcock also pleaded for her to look at MedWatch reports filed by patients who have been harmed by LASIK procedures, adding: “When is the FDA going to do something about this needless epidemic of harm?” Additionally, she pointed out that CDRH director Jeffrey Shuren’s wife, Allison Shuren, is an attorney (Arnold & Porter) who defends LASIK surgeons and attends LASIK surgeon conventions. “How is this not a serious conflict of interest for Dr. Shuren?” Cofer asked. FDA Webview requested comments on the potential conflict-of-interest, and FDA and both Shurens did not respond at press time.