Medical Update: Lasik Surgery

Eye Openers: Why FDA Looks the Other Way on Safety & Severe Side Effects

Lasik eye surgery is widespread, but its popularity masks a darker side—severe side effects that can cause pain and loss of sight. Furthermore, critics say Food and Drug Administration downplays or ignores safety concerns.

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Age Fotostock

Brides-to-be who surfed the Internet in spring 2015 might have come across wedding suggestions from Christenbury Eye Center. Among the “beauty services” that the center suggested for June brides was Lasik eye surgery. The pitch: Lasik (laser-assisted in situ keratomileusis) enables brides to avoid the camera-flash glare that’s on eyeglasses in pictures and the possibility of losing a contact lens while snorkeling on a Caribbean honeymoon.

Touting an irreversible surgery on your eyes as a “beauty service” is an example of how surgeons have underplayed, ignored and even hidden intentionally from consumers and authorities the risks of Lasik, says critic and Food and Drug Administration whistleblower Morris Waxler. “It’s treated like having your hair coiffed or your eyebrows tweezed and as something that has essentially no risk at all. People are being sold a bill of goods,” says Waxler, who led FDA’s ophthalmological-devices unit in 1998 when FDA approved the first devices to perform Lasik.

In Lasik, an eye surgeon uses a laser to cut a flap in the cornea and reshape it to correct refractive errors, such as nearsightedness, farsightedness and astigmatism. Lasik averages $2,000 per eye and is elective surgery, which means that it typically isn’t covered by insurance, according to David Harmon of Market Scope, which is an ophthalmic market-research company.

When injured Lasik patients contacted Waxler after he retired, he looked back at the issue and decided that he made a mistake in ushering these devices to market. He says he was misled by Lasik surgeons and device-makers, who continue to enjoy the protection of FDA at the expense of patient health.

According to Cleveland Clinic’s Dr. Ronald Krueger, who is a leading Lasik surgeon, Lasik is the most common elective surgery in the country. In the United States, Lasik is performed on about 650,000 eyes annually, according to Harmon. Although studies appear to show that Lasik is safe and successful for the vast majority of consumers, interviews with Waxler, two other former FDA officials and 24 ophthalmologists, optometrists, injured patients and personal-injury lawyers tell a troubling tale of the darker side of an industry that generates about $1.3 billion in the United States each year.

Keeping an Eye on Lasik Business Practices

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Two former FDA employees say Lasik-device approvals were based on shoddy science and overlooked side effects that proved to be more severe than originally were represented. Interviews reveal that FDA subsequently failed to address its missteps in any significant way while surgeons misled consumers and failed to provide them with an accurate profile of the risks that they assume.

Consumers should know that when it comes to Lasik, the true rate of risk is unknown because of flaws in reporting adverse events and the paucity of long-term studies. What’s more, incomplete informed-consent processes and questionable business practices blur the line between practicing medicine and seeking profit.

EYES SHUT. Waxler’s petition that asked FDA to withdraw its approval of excimer lasers—the medical device that’s used to reshape corneas—to perform Lasik was denied by the agency in 2014. Waxler tells Consumers Digest that he offered FDA access to files that show that surgeons hid evidence of Lasik injuries. FDA told Waxler that it hasn’t found any evidence to indicate that the devices aren’t reasonably safe and effective. Waxler says no one from FDA contacted him about his files.

In May 2015, 1,073 injured Lasik patients and their advocates sent to FDA a letter that asked the agency to reconsider Waxler’s petition. The letter included stories of disability, derailed careers and even suicides that activists have presented to FDA for years. FDA, in response to our questions, tells us that it “takes adverse events concerning Lasik seriously. The FDA will continue to monitor postmarket data related to Lasik devices and the promotional claims made about these devices.” In other words, the agency promises nothing.

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