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LASIK eye surgery...Is it really safe?

Courtesy of Politics Daily

"Every year, nearly 2.5 million people go under the knife unnecessarily,
often with devastating consequences. Make sure you're not one of them."

"... in the months and years after LASIK became ubiquitous at 25-year class reunions, stories of eye damage and subsequent depression, even suicides, surfaced. The surgery can, it turns out, induce dry eyes, halos, light sensitivity, night blindness, ghost images, keratectasia (corneal thinning and bulging) and many other serious damaging effects.

In the nearly 10 years since he left the agency, Waxler, (now a regulatory consultant who has stayed involved in FDA product approvals) has come to particularly regret the LASIK decision. Unusual for a former regulator, particularly for someone with business before the agency, in 2010 Waxler went public with criticism about FDA's approval standards. A year ago he went on "Good Morning America" and told correspondent Lisa Stark, "I did the best we could ... but in hindsight it wasn't good enough." He heard more stories that suggested when people complained to their eye doctors, their adverse effects were not reported to the FDA.

The FDA issued a statement to ABC News that it considered "LASIK lasers to be reasonably safe and effective when used as intended," but has launched a two-year study to take a closer look at side effects.

Last May, Waxler became more persistent. He considered LASIK eye surgery complications "already a major public health problem" and he said so in a letter to the ophthalmic organization, American Society of Cataract and Refractive Surgeons.* He told the organization's president the group was presenting data for a safety study in an "unethical" manner. The association president responded in September that the former regulator's letter was "misinformed, unsupported by evidence, and lacking in balance and perspective."

Waxler again appeared on ABC News in September claiming "half of LASIK patients experience side effects." A committee of well-regarded LASIK experts (R. Doyle Stulting, M.D., Ph.D.; George O Waring III, M.D.; James J. Salz, M.D.; James McCulley, M.D.; Douglas Koch, M.D.; Jayne Weiss, M.D.; and Marian Macsai, M.D.,) responded to Waxler's claim: "We believe he has no reputable basis for such a claim since he did not produce the scientific evidence."

Finally last month, Waxler filed a formal citizen's petition to his former government employer requesting the FDA withdraw approval for all LASIK devices and to issue a public health advisory for recalling the equipment. The industry is working on newer models and newer methods so nearsighted consumers will still be able to get their vision remodeled (insurance companies still won't pay for it, probably). Since it was filed, the petition has been reposted on the Internet by numerous supporters.

In his petition, Waxler says manufacturers and also "clinics, refractive surgeons, and agents withheld and distorted safety and effectiveness data" and, he alleges, "in a classic example of the fox guarding the henhouse," the "collaborators" routinely hide reports of LASIK injuries from FDA by settling lawsuits out of court. He also claims that equipment makers have "cherry-picked, withheld, and hid data from FDA" that he believes show LASIK with "excessive adverse event" rates of 22 percent. Waxler also submitted "confidential information" on the matter to FDA's criminal investigation arm.

The FDA has not yet commented publicly about Waxler's petition but an FDA spokeswoman told Politics Daily "it is a citizen's petition and we will review it." The LASIK experts have not commented either. See complete article. --

See OpticianryReview.com.


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