Dr. Weeks’ Comment: I have known many people who regret their lasik surgery.

Man Who Led FDA Team to Approve LASIK Now Says It Was a Mistake

by Marcia Frellick

Morris Waxler, PhD, who led the US Food and Drug Administration (FDA) team that approved LASIK in 1999, has since said that decision was a mistake and is pushing for more transparent warnings on the risks of the procedures and the number of adverse events.

He’s been fighting this fight for more than 12 years with little to no response from the FDA, he told Medscape Medical News. In 2007, 7 years after he left the FDA, he said he began to meet people who had been hurt personally or had family members who had suffered after LASIK surgeries, and set out to convince the FDA to add warnings.

In his latest correspondence to the FDA on January 30, Waxler references Jessica Starr, a Fox 2 meteorologist in Detroit who died by suicide last December 12 at age 35. As the Detroit Free Press reports, a month before the suicide, she publicly shared in a video her struggle with her recovery during the 4 weeks she took off work after a LASIK-type procedure, SMILE, in October. The procedure’s role, if it is connected to the suicide, is unclear but it set off a wave of news reports on the potential risks of the procedure.

Waxler, who now has his own regulatory consulting business in Madison, Wisconsin, addressed the letter to Malvina Eydelman, director of FDA’s Division of Ophthalmic and Ear, Nose and Throat Devices, in the wake of the suicide, writing that the “FDA deceived the public about problems with SMILE. You deceptively say, ‘No AE (adverse events) occurred at a rate of 1% or greater per type of event.’

Your statement is true ONLY for your narrow definition of adverse events (AE) as loss of distance acuity greater than 20/40. In addition, your statement is limited to ‘per type of event,’ falsely assuming SMILE does NOT induce multiple eye problems simultaneously. You deceptively understate the risks by not cumulating complication rates for different types of events.”

FDA Clarifies Its Role

A spokesperson for the FDA told Medscape Medical News in a statement, “Whether or not to undergo LASIK is a decision made between a patient and a health care provider. The FDA’s role is to determine whether there is reasonable assurance of the safety and effectiveness of a device for a given use based on scientific data.

“Lasers used for LASIK are class III devices, meaning they potentially pose a high risk to patients. Class III devices are reviewed through the Pre-Market Approval (PMA) process, which is the most stringent and rigorous review process at the FDA’s Center for Devices and Radiological Health. The PMA process includes a scientific and regulatory review to evaluate the safety and effectiveness of class III medical devices. In addition, our review process includes a thorough review of the product labeling for both patients and providers.

“In our own continued assessment of the literature and medical device reports, the FDA continues to believe that based on all the available scientific evidence, there is a reasonable assurance of the safety and effectiveness of the approved devices used in LASIK procedures when used according to the FDA-approved instructions for use.

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