As such incapacities provoke public criticism, FDA has answered by applying central control over the news media, lest lack of confidence in its mission be spread. As just one example, our questions since mid-March to find out who is conducting the joint FDA-Department of Defense study of LASIK post-surgical outcomes and the study's protocol have been routinely deflected by the FDA Press Office, the sole entry-point into the agency for the news media. Why? Nobody, not even principal deputy commissioner Joshua Sharfstein, who heads the agency's much-promoted Transparency Task Force, will answer. The hypothesis this presents is: Was the FDA-DoD LASIK outcomes study given to pro-LASIK Navy surgeons to achieve a biased result that would (a) vindicate CDRH's 1997 approval of the LASIK indication despite the chief approver's public recanting of that decision since, and (b) rescue an entire industry from liability lawsuits?
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"I am Morris Waxler, Ph.D., former Food and Drug Administration (FDA) official in charge of approving laser vision correction (LASIK) devices between 1996-2000 (resume attached). Thanks to pointed questioning by LASIK-injured patients, I have re-examined the data FDA used to approve LASIK devices as well as the data from subsequent scientific studies and now conclude that LASIK-induced risks of permanent loss of vision overwhelm the temporary benefit of visual acuity improvement."
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Former CDRH chief of ophthalmic devices Morris Waxler, who was in charge of evaluation LASIK devices approved between 1996 and 2000, told the American Society of Cataract and Refractive Surgeons (ASCRS) 5/7 its proposed Phase 2 keratectasia trial on LASIK effects is unethical and "I will do everything I can to block approval of such a study." Waxler, who has recently said the agency's approval of LASIK devices was a mistake, defined keratectasia as "a rare but serious complication of laser vision correction of any refractive errors."
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The organizers of two Internet-based LASIK patients' protest groups wrote 14 Capitol Hill lawmakers 3/29 asking for a hearing on FDA's "egregious" approval of the laser devices used in this booming eye-surgery retail industry. Stressing the elective, cosmetic nature of the procedure, Fort Lauderdale, FL-based Dean Kantis and Paula Cofer say in the letters that "FDA approved the LASIK indication for excimer lasers despite an approximate 20% incidence of adverse events such as dry eyes and night vision problems which persist beyond the endpoint of clinical trials."
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On 3/17, one of the nation's largest chains of refractive eye surgery facilities, TLC LASIK Centers, was sued 3/17 in South Carolina federal court by attorneys for 181 injured patients alleging breach of contract, conspiracy, Racketeer Influenced and Corrupt Organization (RICO) violations... Seeking a total $180 million in damages, the South Carolina class action complaint names as defendants 29 TLC LASIK surgical facilities in various states, 24 TLC clinical directors, 34 TLC LASIK surgeons and four corporate managers, including vice president for patient care John Potter. It alleges that they conspired to fraudulently extend post-operative, lifetime ocular health care until the injured patients' statute of limitations right to sue ran out -- usually two years.
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"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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