August 4, 2011
If you are considering LASIK surgery and are trying to find out the actual complication rate for surgeries, you may be dismayed at how difficult it is to get a straight answer
CHICAGO, IL, August 04, 2011 /24-7PressRelease/ — If you are considering LASIK surgery and are trying to find out the actual complication rate for surgeries, you may be dismayed at how difficult it is to get a straight answer. The reason why it’s so difficult is that nobody really knows the overall complication rate, and that the complication rate likely varies widely from surgeon to surgeon. However, here is some basic information about reported complication rates that can help you get a baseline of understanding.
Complication Rates Reported in Pre-Market Approval Studies
Traditionally, one of the more reliable places to look for complications associated with a medical device or drug is to look at the complication rates reported in the Pre-Market Approval (PMA) studies filed with the FDA prior to the device or drug being approved. For LASIK, though, some people have contended that the complication rates were understated (more on that below). The complication rates varied between the different lasers approved, but here is an average among a few of the more commonly-used lasers:
– Epithelial ingrowth (which can lead to blurry vision): 0.3-3.9%
– Feeling of something in the eye:0.3-1.2%
– Ghost images: 0.7-8.7%
– Persistent pain:0.6-1.4%
– Loss of BSCVA (the best vision you experience with glasses or contacts): 2.2-2.4%
Not all of these complications were seen for every laser. For example, the loss of BSCVA of 2 lines or more was seen for only two lasers.
Accusations that Laser Manufacturers Concealed Complications
In a recent citizen’s petition, a number of surgeons and other industry experts have accused laser manufacturers and LASIK surgeons of falsely reporting complication rates to the FDA in their PMA studies. One contention is that laser manufacturers and LASIK doctors pressured the FDA to reclassify certain complications from “adverse events” (used for serious complications) to “symptoms,” which allowed them to state that the adverse event rate for LASIK is less than 1%, when some of the now-called symptoms are experienced by as many as 48% or LASIK patients.
More serious, the petition’s authors contend that manufacturers withheld an average of 30% of the adverse event data from the FDA when reporting the results of their studies. In addition, labeling changes allow laser manufacturers to report that patients have a 95% chance of getting 20/40 vision or better (the minimum vision required to legally drive without glasses, instead of reporting that 43% of LASIK patients can still see significant vision improvement with glasses or contacts.
The Reality of LASIK Complication Rates
It is important to remember that the people making accusations about laser manufacturers and LASIK providers concealing complication rates also have a stake in the argument. Some of them are lawyers who are suing LASIK providers for malpractice and are impugning the character of the profession to improve their odds of success in their individual lawsuits.
But there does seem to be some truth to their concerns. For example, an independent study showed that the rate of epithelial ingrowth, a vision-threatening complication, ranged from 3% for initial treatment of myopia to 43% for enhancement of hyperopia treatment.
One more important thing to know about LASIK complication rates is that they vary widely between surgeons. Although the LASIK procedure proper is computer-controlled, the pre-care and after-care can have just as much impact on your risk of complications as the actual procedure, and these are highly variable.
If you are considering LASIK surgery, it is important to talk explicitly to your surgeon about his or her personal complication rates and how he or she works to keep them low. Gauge the answer carefully to determine the degree of honesty in their response. If you don’t feel comfortable with the answer, look for another surgeon.
If you live in Chicago and want to learn more about LASIK surgery safety, please visit the website of Doctors For Visual Freedom at www.doctorsforvisualfreedom.com.
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