February 12, 2019
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.
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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.
"The FDA has extensive information for consumers and health care professionals on the benefits and risks of LASIK on its website, including patient labeling (information booklet), which discloses visual symptoms as potential risks of LASIK devices, and a summary of safety and effectiveness data for each LASIK device detailing information about the visual symptoms observed in the clinical studies. The FDA will continue to monitor postmarket data related to LASIK devices. We also encourage researchers to use robust questionnaires to elucidate the impact of visual symptoms on daily functioning," the spokesperson said.
ASCRS: 'LASIK Is Safe and Effective'
A spokesperson for the American Society of Cataract and Refractive Surgery (ASCRS) also said in a statement, "After 20 years and more than 19 million procedures in the U.S., we know LASIK is safe and effective. To be clear, there is a vast body of scientific evidence supporting laser vision correction as a both safe and effective option for vision correction.
"The results of the clinical trial conducted to support the FDA approval of the use of excimer lasers for LASIK surpassed the goals set by Dr. Waxler and his office. It is important to point out that the work on laser vision correction didn't stop upon LASIK's approval in the late 1990s or when Dr. Waxler left the FDA. Since the first studies were presented to the FDA, scientific investigation into laser vision correction has continued to both improve the procedure and to better understand and monitor postoperative complications. To date, laser vision correction technologies have received more than 50 FDA approvals."
As to why complication rates are not stated cumulatively, the ASCRS responds that "Cumulative complication rates are misleading and may overstate the proportion of patients who experienced symptoms because one patient may report experiencing several symptoms."
The ASCRS acknowledges that LASIK is not for everyone.
"It's important for patients to work with an experienced refractive surgeon and clearly understand the risks and benefits of any procedure so that they can make the decision that's right for them," the statement reads.
According to Market Scope estimates, surgical volume globally for refractive surgery is expected to increase from 4.3 million to 5.5 million procedures a year from 2018 to 2023.
Waxler is a former employee of the FDA. He has disclosed no other relevant financial relationships.
SOURCE: Medscape, February 12, 2019.