Reprinted with permission from fdaweb.com
Sharfstein Investigates LASIK Patients’ Complaints
05/21/2009
FDA acting commissioner Joshua Sharfstein told FDA Webview 5/21 that he is looking into complaints of many LASIK (laser-assisted in situ keratomileusis) eye vision enhancement surgery patients that the agency has failed to honor its commitments to investigate their complaints since 2006 that the technique has unacceptable risks.
The primary issue in their complaints is that, with an adverse-reaction risk factor in excess of 5% (patient dissatisfaction) rate at six months, nobody is doing research on the procedure’s long-term quality-of-life. It involves either blade- or laser-cutting of flaps in the corneal surface layer that patients complain never heal. A post-operative trauma to the patient’s head at any time can forever open the flap and allow the entry of viruses and bacteria to the stromal layer beneath, with commensurate vision impairment and even blindness.
According to the injured patients, despite the procedure’s 95% success rate, the extent of failures exceeds FDA’s allowable 1% limit and the agency has failed for three years to address petitions submitted since 2006 that sought enforcement of mandatory adverse event reporting (MDR) requirements on facilities performing LASIK procedures. They allege an effective FDA conspiracy with for-profit LASIK surgery surgeons in concealing true adverse event rates.
In drug and device regulation, FDA is constantly monitoring long-term risk-benefit issues and addressing them through labeling revisions. Since LASIK surgery is primarily a practice-of-medicine technology regulated at state, not federal, level, who is doing the same thing for these lasers which routinely enter the market without clinical studies justifying their safety and effectiveness?
FDA’s reliance on its collaboration with the main eye surgeons’ organizations, which have a members’ income conflict-of-interest in objectively measuring and voluntarily reporting failure rates (only their physical facilities and the device manufacturers must report to FDA), is analogous to the outright operational dependency on plastics and chemical lobbyists that FDA’s Center for Food Safety and Applied Nutrition developed over many years in regulating the mutagenic and neurological toxic effects of bisphenol A in food containers, including baby bottles.
FDA commenters on our Web site are already asserting from this that industry’s infiltration and takeover of government agencies (not just FDA) has been an ongoing fact of life for many years, so we better get used to it.
Sharfstein’s investigation challenges this assumption.