Amid bad publicity for the LASIK industry, a group of LASIK surgeons announced 'preliminary' findings from an 'unpublished' review of medical studies showing a "95.4% global LASIK satisfaction rate". Press releases issued by LASIK industry insiders appeared to link this literature review to the FDA with misleading statements such as, "The FDA reaffirms that LASIK is both safe and effective." When asked for clarification about the link between the study and the FDA, LASIK surgeon Kerry Solomon admitted that the study...
Read more...May 2008 Archives
Medical Research Scientist Submits Citizen Petition to the FDA Calling for a Ban on Lasers for LASIK
May 19, 2008 Dockets Management BranchFood and Drug AdministrationRoom 10615630 Fishers LaneRockville, MD 20852 Citizen PetitionThe undersigned submits this petition to:1) ban the use of all refractive surgery lasers for LASIK surgery due to substantial deception in the labeling and an unreasonable and substantial risk of injury, and2) acknowledge and enforce remedy for the misbranding of lasers used for LASIK (false and misleading labeling) due to failure to properly report adverse events and complications. The authority for the first...
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May 10, 2008 Daniel Schultz, M.D.Director, Center for Devices and Radiological HealthFood and Drug Administration9200 Corporate BoulevardRockville, MD 20850 Dear Dr. Schultz: I was initially encouraged to see the FDA take action by convening an advisory panel on April 25, 2008 to conduct a hearing on LASIK post-market issues including the impact on a patients' quality of life (QOL). However, I attended the hearing and found the lack of panel discussion regarding post-LASIK quality of life (QOL)...
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LASIK is a 2.5 billion dollar per year industry. LASIK is considered by some as the "gravy train" of ophthalmology. Recently many questions have been raised about the frequency and severity of complications, and now many are wondering if LASIK really lives up to the hype. In the past decade, several lasers have received FDA approval for use in LASIK surgery. A report of data from FDA clinical trials for LASIK, including current technology, reveals that approximately 20%...
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