LASIK Side Effects Not Taken Seriously, Former FDA Official Says
Date Published: Thursday, February 25th, 2010
Late last year we wrote about the potential impact on quality of life from LASIK surgery and a study launched by the Food & Drug Administration (FDA). According to an agency press release, the study was to be a collaborative effort between the National Eye Institute and the U.S. Department of Defense. Most recently, ABC News broke with a report about an FDA regulator who was involved in approving the procedure in the 1990s and who is now discussing his concerns over LASIK’s safety.
LASIK—laser-assisted in situ keratomileusis—surgery involves using a laser to cut a small flap in the eye’s cornea to allow for reshaping of the corneal tissue with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism. LASIK was approved a decade ago and an estimated six million Americans have undergone LASIK surgery with hundreds of thousands of Americans undergoing LASIK yearly. The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of LASIK remains unknown.
According to ABC, while most procedures appear to take place with no issue, there were adverse reactions about which the agency was aware, yet minimized, said Morris Waxler, former head of the FDA area that reviewed LASIK data, said ABC. Waxler, who retired from the agency a decade ago, recently discussed the matter in an interview with the news outlet.
“I wouldn’t say it was pooh-poohed so much it was just sort of shoved aside as the kind of, we, we don’t know what to do with that data,” he told ABC News. “It’s right there in the record. The agencies and the refractive surgeons, people know these problems occur and there doesn’t seem to be a plan to handle some of the more difficult problems that are created,” Waxler added, quoted ABC News.
ABC News explained, has resulted in some patients complained of both long- and short-term adverse reactions, and even permanent adverse effects that include “starbursts, halos, glare, double-vision, and night blindness.” Some adverse effects have created significant quality of life issues that have forced some people out of work or unable to drive or continue with other activities of living that were a normal part of their lives prior to LASIK.
Wexler told ABC News that the agency should have put in place stricter LASIK standards and feels the FDA should now mandate manufacturers and surgeons to discuss LASIK’s possible side effects with patients. “The agency actually has a lot of power,” Waxler said. “The agency could readily require that those manufacturers keep better tabs on what happens with their product,” he added, reported ABC News.
The FDA maintains that LASIK is safe when performed appropriately, but did respond to the issue of LASIK complaints and announced that it has, among other steps, established better reporting mechanisms, which should lead to better monitoring and improved safety and efficacy of the procedure, said ABC News. As we have previously written, the LASIK Quality of Life Collaboration Project will occur in three simultaneous phases; is expected to be completed in 2012; and will be a collaborative effort with the FDA, the Department of Defense, and the National Eye Institute.
This entry was posted
on Thursday, February 25th, 2010 at 8:35 am and is filed under Health Concerns.
Late last year we wrote about the potential impact on quality of life from LASIK surgery and a study launched by the Food & Drug Administration (FDA). According to an agency press release, the study was to be a collaborative effort between the National Eye Institute and the U.S. Department of Defense. Most recently, ABC News broke with a report about an FDA regulator who was involved in approving the procedure in the 1990s and who is now discussing his concerns over LASIK’s safety.
LASIK—laser-assisted in situ keratomileusis—surgery involves using a laser to cut a small flap in the eye’s cornea to allow for reshaping of the corneal tissue with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism. LASIK was approved a decade ago and an estimated six million Americans have undergone LASIK surgery with hundreds of thousands of Americans undergoing LASIK yearly. The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of LASIK remains unknown.
According to ABC, while most procedures appear to take place with no issue, there were adverse reactions about which the agency was aware, yet minimized, said Morris Waxler, former head of the FDA area that reviewed LASIK data, said ABC. Waxler, who retired from the agency a decade ago, recently discussed the matter in an interview with the news outlet.
“I wouldn’t say it was pooh-poohed so much it was just sort of shoved aside as the kind of, we, we don’t know what to do with that data,” he told ABC News. “It’s right there in the record. The agencies and the refractive surgeons, people know these problems occur and there doesn’t seem to be a plan to handle some of the more difficult problems that are created,” Waxler added, quoted ABC News.
ABC News explained, has resulted in some patients complained of both long- and short-term adverse reactions, and even permanent adverse effects that include “starbursts, halos, glare, double-vision, and night blindness.” Some adverse effects have created significant quality of life issues that have forced some people out of work or unable to drive or continue with other activities of living that were a normal part of their lives prior to LASIK.
Wexler told ABC News that the agency should have put in place stricter LASIK standards and feels the FDA should now mandate manufacturers and surgeons to discuss LASIK’s possible side effects with patients. “The agency actually has a lot of power,” Waxler said. “The agency could readily require that those manufacturers keep better tabs on what happens with their product,” he added, reported ABC News.
The FDA maintains that LASIK is safe when performed appropriately, but did respond to the issue of LASIK complaints and announced that it has, among other steps, established better reporting mechanisms, which should lead to better monitoring and improved safety and efficacy of the procedure, said ABC News. As we have previously written, the LASIK Quality of Life Collaboration Project will occur in three simultaneous phases; is expected to be completed in 2012; and will be a collaborative effort with the FDA, the Department of Defense, and the National Eye Institute.
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This entry was posted
on Thursday, February 25th, 2010 at 8:35 am and is filed under Health Concerns.
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