Reprinted with permission from www.fdaweb.com
03/30/2010
The organizers of two Internet-based LASIK patients’ protest groups wrote 14 Capitol Hill lawmakers 3/29 asking for a hearing on FDA’s “egregious” approval of the laser devices used in this booming eye-surgery retail industry. Stressing the elective, cosmetic nature of the procedure, Fort Lauderdale, FL-based Dean Kantis and Paula Cofer say in the letters that “FDA approved the LASIK indication for excimer lasers despite an approximate 20% incidence of adverse events such as dry eyes and night vision problems which persist beyond the endpoint of clinical trials.”
They quote former CDRH ophthalmic surgical devices branch chief Morris Waxler as publicly faulting the agency for not taking the side effects seriously enough under “enormous pressure from organized ophthalmology to approve LASIK.” Further, they say, CDRH used the “same since-discredited 510(k) expedited process” to clear the newest LASIK corneal flap-cutting devices as was used in the “now notorious Menaflex case” citing “inappropriate” devices for “new technology that is not similar or substantially equivalent to the named predicate device as required by the Food, Drug and Cosmetic Act.”
Kantis and Cofer tell the lawmakers that the agency has “refused to say what, if any follow-up action it is taking” after issuing more than 17 Warning Letters last year to surgical facilities that inspections had found were not complying with the Medical Device Reporting regulation. They allege that over 1,000 adverse events have been filed with FDA, “most of which were filed by injured patients. … We suspect that the number of Warning Letters issued [21] reflects the total number of facilities inspected — in other words, we believe that virtually 100% of LASIK clinics do not report adverse events,” they say.
They also cite an alleged lack of FDA enforcement action pursuant to a 5/09 “reminder letter” sent by CDRH compliance director Timothy Ulatowski to eye care professionals about requirements for LASIK advertising to the public — “The overwhelming majority of LASIK advertising continues to be misleading and unsubstantiated.”
Finally, Kantis and Cofer say that FDA has been unresponsive to patient groups’ complaints. Seven petitions since 2003 have “gone unanswered or have been denied,” they say, and “countless” emails and letters have not had responses. Cofer sent FDA Webview a list of seven letters to FDA since 10/09 that she said had been unanswered:
“10/10/2009 — Letter to CDRH director Jeffrey Shuren. requesting withdrawal of the approval of LASIK lasers.
“10/10/2009 — Letter to ODE director Donna-Bea Tillman, requesting recall of femtosecond keratomes cleared under 510(k) and require clinical trials.
“11/3/2009 — Letter to Jeffrey Shuren, requesting an “FDA News Release” to correct false information disseminated to the public that only 140 reports of LASIK dissatisfaction have been reported to the FDA.
“11/3/2009 — Letter to Jeffrey Shuren, requesting a public health advisory notifying LASIK patients that they need to obtain a copy of their LASIK medical file for future cataract surgery, and requesting a meeting with FDA officials to discuss this.
“Also, LSW sent 3 letters dated 10/30/2009 reporting advertising violators. The FDA did not acknowledge any of these letters.
“I would also like to add that the FDA ignored every single recommendation of the FDA patient rep (me) at the FDA panel meeting in April, 2008.”
Kantis told us he had sent 150 letters and emails to the agency in the past 16 months, and none of them had been answered.
CDRH’s inertia on this topic was excoriated in a recent letter to Ulatowski from Panama City former mayor Lauren DeGeorge, who says her eyesight was permanently damaged during intraocular lens implantations solicited by false and deceptive advertising: “I have written the FDA from early on with no response; so, I have no faith in you or anyone at FDA to do a thing about this huge cover-up in America. You are responsible for approving these procedures and should be held accountable. Shame on you for not removing them until further research is done — like I suggested in my first correspondence to you over two years ago!”
Asked for comment on these allegations, FDA press officer Peper Long sent a brief e-mail: “The FDA is aware of many requests made by many interested members of the public regarding LASIK. We keep the LASIK section of our Web site updated with recent, public information we think should be helpful. As far as enforcement actions we may be considering, they are often not subject to disclosure and we may not be able to discuss them.”