Reprinted with permission from fdaweb.com
11/06/2009
“The FDA’s mission is to serve and protect the public, not to serve industry,” says a 126-signatory letter to CDRH acting director Jeffrey M. Shuren, seeking a public health advisory on “the high incidence of adverse events and long-term consequences associated with LASIK surgery.” The five-page 11/2 letter, signed mainly by injured patients, says that when FDA approved the LASIK indication for several excimer lasers in 1998, “little was known about long-term safety and efficacy of the procedure.” It cites former CDRH ophthalmic surgical branch chief Morris Waxler as saying FDA was under enormous industry pressure to approve LASIK and the agency “failed to require proper scientific assessment of long-term safety and efficacy … in an apparent attempt to appease powerful ophthalmologists who lobbied for approval.”
The letter cites a 2007 published study of 12 Summaries of Safety and Effectiveness for laser approved between 1998 and 2004, which found that six months after LASIK, 17.5% of patients reported halos, 19.7% glare, 19.3% night-driving problems, 21% dry eyes worse than before surgery. FDA last year denied a citizen petition for a LASIK ban based on these data, contending that it contained no data and the agency was precluded by law from acceding to petitions seek enforcement action.
The letter contends that the body of literature on adverse LASIK events has been growing for the past 10 years, and that a “huge disconnect” exists between ophthalmologists who perform LASIK and the LASIK patient population regarding what constitutes a LASIK-related adverse event. “What a patient considers a bad outcome is often dismissed as an expected ‘side effect’ by the surgeon who performed the procedure,” the letter says, adding: “Risk of intractable dry eyes after LASIK is downplayed in the informed consent process.”
The letter says research published in 2005 and 2007 now demonstrates that in 100% of eyes treated, the corneal flap never fully heals, “exposing patients to life-long risk of traumatic flap dislocation and increased risk of eye infection.” In addition, a 2006 study demonstrated that “Biomechanical strength of the cornea is reduced after LASIK, which may lead to sight-threatening corneal ectasia months or years after surgery.”
Intraocular pressure measurements are falsely low after LASIK, according to a 2008 study, leading to possibility of vision loss from undiagnosed glaucoma. “LASIK causes error in calculation of lens power for cataract surgery, exposing patients to poor vision after cataract extraction,” the letter says, citing a 2007 study.
Citing widespread, heavy advertising of LASIK to the public, the letter says there “has been little, if any enforcement of regulations governing LASIK advertising. The overwhelming majority of LASIK advertising is misleading and unsubstantiated.”