Sara E. Teller, Legal Reader: June 19, 2018
The Food and Drug Administration (FDA) first approved the use of lasers for vision correction the 1990s. By 2008, the administration began to hear patient complaints concerning little-known complications including impaired vision and chronic pain. These issues were so severe that, according to the patients and their families, they had led to disability, job loss, and depression. Some committed suicide. The families of those affected testified at an FDA meeting, but little was done back then.
These complaints directly contradict the common misperception that Lasik is not invasive, and therefore, virtually foolproof. However, truth be told, serious questions remain about both the short- and long-term risks and the complications of this common procedure even though the little-known side effects can be life-changing.
Researchers at Ohio State University (OSU) reported in 2007 that while most of the roughly 4,500 patients had achieved 20/20 or 20/40 vision six months after the procedure, twenty percent had dry eyes that were severe or worse than before surgery. And, a recent clinical trial performed by the FDA found nearly half of all participants who had healthy eyes before Lasik developed visual aberrations after the procedure and roughly one-third developed dry eyes for the first time.
The OSU researchers had written, “patients undergoing Lasik surgery should be adequately counseled about the possibility of developing new visual symptoms after surgery before undergoing this elective procedure.” Yet, not much was done.
Diana Zuckerman, president of the nonprofit National Center for Health Research said, “The FDA keeps promising to do a better job of post-market surveillance, but there is no evidence of real improvement,” she said. […]
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