EX-FDAer Waxler Says LASIK Effects Not Taken Seriously

"It's right there in the record. The agencies and the refractive surgeons, people knew these problems occur and there doesn't seem to be a plan to handle some of the more difficult problems that are created." Reported adverse effects, including cases in which the problems are permanent, include starbursts, halos, glare double-vision, and night blindness.
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After finding that Dr. Nicholas Caro had engaged in unprofessional conduct and gross negligence, the Illinois Department of Financial and Professional Regulation suspended his medical license for 30 days, placed him on probation for a minimum of 3 years and banned him from performing procedures aimed at changing the curvature of the cornea, which includes Lasik surgeries.
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On February 5, 2010, plaintiff, Laurie Shrieves, filed suit against Quentin Franklin, M.D., and LCA-Vision, Inc., d/b/a LASIKPlus, in the Virginia Circuit Court for the City of Chesapeake, for the negligent performance of LASIK surgery on Ms. Shrieves. On June 29, 2008, Ms. Shrieves came under the care and treatment of Dr. Franklin for the purpose of having LASIK surgery on both eyes at LCA-Vision, Inc., d/b/a LASIKPlus. The complaint alleges, among other things, that Dr. Franklin was negligent when he performed the LASIK surgery more than three millimeters off center of the pupil.
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Thomas plans to combat the decline in Lasik (Laser-Assisted In Situ Keratomileusis) procedures by adding new services such as in-depth eye exams, cosmetic eyelash enhancement and, potentially, cataract surgery... "These large Lasik mills have a lot at stake and great incentive to conceal side effects and problems," says Paula Cofer, a Florida woman who has spoken out against the surgery since hers went awry in 2000. "It's all about profit. It's not about treating a medical need. It's an unnecessary surgery."
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My life as a respected Police officer and my hobbies of fishing, scuba diving, surfing, working out at the gym, bicycling and living my life happily are now over and its been all Doom and Gloom for me and I have even considered suicide but a very close and loving friend has kept me from doing this. I would rather go blind and live in pain and anguish than to not see her again. At least that's what I feel today but I came very close a few different nights.
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LASIK results in permanent adverse effects

Happy LASIK patients may not realize or acknowledge the harm they suffered from LASIK for years; nonetheless, the damage is there. Medical research demonstrates (a) that the LASIK flap never heals and may be accidentally dislodged for the rest of a patient's lifetime...
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For Some, Lasik Brings More Problems Than Solutions

But there have been an increasing number of complaints from unhappy patients who say they have experienced significant problematic complications after Lasik. They've been reporting that problems like dry eye, glare, double vision and starbursts (blurring around objects) have impaired their ability to function day-to-day and significantly affected their quality of life, says Dr. Malvina Eydelman of the Food and Drug Administration. In response, the FDA has decided to investigate further...Paula Cofer of Tampa, Fla., has experienced many of these problems.
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Paula Cofer, FDA Patient Representative, served on the April 25, 2008 Ophthalmic Devices Panel in Gaithersburg, MD. The meeting was called to discuss issues concerning post-market experiences with LASIK. Ms. Cofer expressed several concerns about the safety and long-term consequences of LASIK, and asked for changes to the labeling of excimer lasers.
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The Truth Behind LASIK Satisfaction

Patient satisfaction after LASIK, as measured by unvalidated surveys or questionnaires, is neither scientific nor a reliable indicator of LASIK safety or efficacy. LASIK surgeons report high patient satisfaction even in cases with poor night vision and sight-threatening complications.
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Federal Register: FDA Extends LASIK Comment Period

The FDA has reopened a docket to continue to receive public comments regarding LASIK. Information and comments submitted to the docket will assist the FDA in identifying ways in which the agency can improve its public outreach efforts regarding the risks and long-term consequences of LASIK.
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