Reprinted with permission from fdaweb.com
Despite CDRH guidance limiting allowable medical device “complications” to 1%, it has approved lasers used in LASIK vision-correction surgery that exceeded a 20% complication rate in the clinical studies that supported their marketing applications. This is the basis of a 6/11 request by LASIK victim Lauranell H. Burch, who is molecular genetics core facility director at the National Institute of Environmental Health Sciences, that the devices’ approvals be revoked. She made the request in identical letters to the Government Accountability Office (GAO) and the HHS Inspector General.
Part of an escalating campaign to have FDA upgrade the devices’ labeling and enforce medical device reporting (MDR) requirements against ambulatory surgical facilities performing LASIK, Burch’s letters told the overseers that FDA “has been grossly negligent and has placed patients’ interests secondary to interests of medical device manufacturers.”
The letters follow by one day an appeal for presidential intervention from another activist and injured patient, and come less than two weeks before a scheduled 6/22 congressional presentation by injured patients and planned demonstration outside FDA headquarters.
Burch said about 700,000 people a year undergo LASIK, “largely as a result of aggressive and often-misleading advertising.” She did not mention CDRH compliance director Timothy A. Ulatowski’s cautionary message last month to eye professionals on marketing claims. Her letter linked CDRH’s other roles in the controversy to allegations by dissident Center scientists and physicians last October of corrupt scientific reviews.
Appending a bibliography of 19 footnoted medical literature citations, said adverse effects of LASIK are permanent and include:
- Reduced the biomechanical integrity of the cornea, which may lead to late onset corneal ectasia requiring corneal transplant.
- Corneal flap incisions that never completely heal and may be accidentally dislodged indefinitely.
- Life-long increased risk of corneal microorganisms.
- Corneal nerves which are severed and burned during LASIK and never fully regenerate normal densities and patterns, resulting in dry eye disease that can be permanent.
- LASIK-caused inaccurate intraocular lens power calculations for future cataract surgery.
- Inaccurate intraocular pressure measurement that exposes patients to risk of undiagnosed glaucoma and associated vision loss.
- Persistent and accelerated keratocyte (corneal cell) death. This means that corneas that have undergone LASIK may not last the patient’s lifetime.
- A reduction in quality of vision.
Burch called FDA’s 4/25/08 advisory committee meeting on injured patients’ complaints a “white-wash,” citing panel chairman and LASIK surgeon Jayne Weiss’ conclusion that “It appears to me from hearing what has been said today that this has really been a referendum on the performance of LASIK by some surgeons who should be doing a better job”. In the 14 months since then, Burch wrote, CDRH “has failed to respond to issues raised and requests for a moratorium on LASIK devices.”
Burch contended that LASIK-impaired vision, notwithstanding reported surveys showing high levels of patient satisfaction, are the cause of dangerous driving by people who have LASIK-induced loss of contrast sensitivity. “LASIK is a medically unnecessary surgery that carries with it substantial risk of permanent visual impairment,” she wrote. “As evidenced, LASIK complications occur frequently. With millions of LASIK procedures performed and high complication rates, it follows that LASIK eye surgery has become a leading cause of preventable visual impairment in the United States.
“I have submitted a Citizen’s Petition to the FDA to withdraw FDA approval of lasers for LASIK and have not received a response within 180 days as required by law. My petition is found at this link: https://www.regulations.gov/docket?D=FDA-2008-P-0319. Failure of the CDRH to ensure rigorous clinical trials and to respond to serious post-market safety and effectiveness concerns regarding LASIK in adherence to established regulatory requirements have resulted in irreparable harm to millions of Americans and is indeed a ‘silent danger’ to public health. For the reasons outlined here, I request an immediate withdrawal of FDA approval of LASIK devices.”