Thank you. My name is Matt Kotsovolos. I had LASIK surgery in 2006 using the current IntraLase Wavefront technology. At the time of my LASIK, I was the Chief Financial Officer at the Duke eye Center in Durham, North Carolina. My surgery was considered a success based on my uncorrected visual acuity now being 20/20. However, for the last two years I have suffered from debilitating and unremitting eye pain as a result of LASIK. The public hears LASIK complication rates quoted by the LASIK industry as ranging from between one to three percent. What the public doesn't know, because the LASIK industry markets this surgery in a most unethical way, is that the complication rate is likely in the 20 to 30 percent range.
Data from the FDA clinical trials for LASIK reveals that the FDA allows laser manufacturers to hide complications such as dry eyes and impaired night vision by reporting these as, quote, "symptoms." The overall percentage of patients reporting these complications in the FDA trials is approximately 20 percent. In April 2007, researchers from Ohio State University College of Optometry published results from a review of FDA clinical trials of the 12 lasers approved for LASIK between 1998 and 2004, including newer wavefront technology. They reported that six months after LASIK, roughly 20 percent of patients experienced worse or significantly worse dry eyes, and six months after LASIK roughly 15 percent experienced worse or significantly worse night vision disturbances.
Recently, the LASIK industry has hired a media consulting firm in its mass circulated results of a global LASIK patient satisfaction rate of 95.4 percent. The LASIK industry wants the public to believe that a high satisfaction rate indicates a low complication rate. However, being satisfied with one's visual outcome and being free of complications are two entirely different matters. Dr. Leo Maquire once wrote the following in an ophthalmology editorial: "The kerato-refractive literature contains disturbing examples of patients who have visual handicaps that place themselves and others at significant risk for nighttime driving accidents, and yet they are happy with their results." One of the most perplexing cases of patient satisfaction comes from a 2007 report of a patient who developed bilateral ectasia, a serious sight-threatening complication which may require corneal transplantation, who was reportedly satisfied with his surgery. As illustrated, patients can suffer significantly complications or "symptoms," and still claim to be satisfied patients. Patient satisfaction surveys in LASIK are guaranteed to lead to skewed results and significant false positive data.
In addition, there is enough evidence for the FDA to investigate that shows the effects of devastating and irreversible physical complications from bad LASIK outcomes often leads to clinical depression. Clinical depression can lead to suicidal ideation. The length between bad LASIK outcomes and suicidal ideation is real. The link is further evidenced by true stories of LASIK patients taking their own lives and leaving suicide notes behind that detail their struggles due to debilitating post-LASIK complications. I have met plenty of people who are depressed and considering suicide because of complications that are currently buried in the device labeling and classified as symptoms or side effects. How is it that patients want to commit suicide because of side effects? Can the Panel before us today explain this? Why was there no research into what constitutes a symptom, and what constitutes a complication? Was it so that the LASIK industry could obtain approval for medical devices that otherwise would never have seen the light of day? Patients do not want to continue to exist as helpless victims with no solutions and no voice.
The LASIK industry wants to use the upcoming quality of life study that will not commence until sometime in 2009 to stall for an extended period of time. The time for stalling is over. I urge the FDA Advisory Panel to recommend placing a moratorium on LASIK until a proper comprehensive study of long term LASIK patient complications and symptoms, including clinical depression, is completed. I ask the FDA to change the labeling for lasers for LASIK once this moratorium is lifted, to report dry eyes and night vision disturbances as complications and not symptoms. Both of these so called symptoms can last for a patient's entire post-LASIK lifetime. Those who are familiar with the phenomena of deep capture understand that over time regulatory agencies end up being controlled by the very industries they are supposed to regulate. The FDA is now controlled and works for the benefit of the LASIK surgeons and LASIK manufacturers. This is easily illustrated by an ASCRS press release on April 7, 2008, a full two weeks before today's hearing. In that press release, the FDA stated that LASIK is safe and effective. Clearly, the fix is in. ASCRS would not have issued such a -- CHAIRPERSON WEISS: Can you please start closing your remarks? MR. KOTSOVOLOS: Yes, thank you. Clearly, the fix is in. ASCRS would not have issued such a press release, had they not known in advance that the FDA was going to dismiss -- CHAIRPERSON WEISS: We are going on to our next speaker, please. Thank you. (Applause.)
Source from: http://www.lasikfda.com/index.php?option=com_content&view=article&id=44&Itemid=53
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