Questions raised about LASIK surgery

Excerpts from an article at Politics Daily:

LASIK -- which is neither a trademark name nor a franchise, but the acronym of a surgical method, "laser-assisted in situ keratomileusis" -- seemed miraculously easy, even though it involved a scary-sounding and delicate procedure. (It entails slicing a thin, hinged flap on the front surface of the cornea, a surgeon lifts the tissue up and, using ultraviolet excimer laser beams, reshapes the eye before folding the flap back over the cornea). Well-heeled professionals then turning 40ish, (an age in which human sight weakens), were drawn to what seemed like a medical miracle of rejuvenation. Laser eye surgery, when done correctly on appropriate candidates, painlessly turned terrible vision to nearly perfect.

In 1995, the FDA approved the first laser-assisted system for refracted surgery... For the ophthalmic profession, LASIK correction surgery was like a gold rush. By 2008, 12 million patients had undergone the procedure in the United States at an average cost of $1,500 to $2,100 per eye. Over 700,000 people have the surgery every year...

But 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...

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... 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.

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