NYT HEALTH: Lasik Patients Should Be Warned of Complications, F.D.A. Draft Says
By Roni Caryn Rabin
Section: Health
Source: New York Times
Published Date: December 7, 2022 at 02:00AM
If put into effect, the agency’s warnings are likely to come as a surprise to many Americans, who view the procedure as safe and commonplace. Every year, more than half a million adults undergo Lasik surgery to correct poor vision.
The operation involves reshaping the cornea, the clear round dome that covers the front of the eye and focuses light on the retina at the back of the eye. The surgeon cuts a thin flap in the cornea and folds it back, and then uses the laser to sculpt the cornea. Afterward, the surgeon replaces the flap.
The operation normally takes less than 15 minutes per eye, and patients usually must pay thousands of dollars out of pocket, since the procedure is not covered by insurance and is considered cosmetic. Lasik surgeons, who point to surveys showing that 90% to 95% of customers are satisfied, often promote the procedure by offering free consultations and steep discounts.
The FDA document is not final. More than 600 individuals and professional groups have weighed in with comments since the draft of the guidance was made public in July, and the agency is now reviewing the input while preparing the final documents, officials said.
Organizations representing surgeons and medical device manufacturers have gone on the offensive, accusing the FDA of meddling in the practice of medicine and saying the information is one-sided and will needlessly frighten patients.
By Roni Caryn Rabin
Section: Health
Source: New York Times
Published Date: December 7, 2022 at 02:00AM
Draft recommendations by the agency describe dry eyes, visual disturbances and other side effects of the procedure. Surgeons say the benefits are being ignored.
Patients considering Lasik surgery should be warned that they may be left with double vision, dry eyes, difficulty driving at night and, in rare cases, persistent eye pain, according to draft guidance by the Food and Drug Administration. After surgery, patients might still need eyeglasses, the document warns.If put into effect, the agency’s warnings are likely to come as a surprise to many Americans, who view the procedure as safe and commonplace. Every year, more than half a million adults undergo Lasik surgery to correct poor vision.
The operation involves reshaping the cornea, the clear round dome that covers the front of the eye and focuses light on the retina at the back of the eye. The surgeon cuts a thin flap in the cornea and folds it back, and then uses the laser to sculpt the cornea. Afterward, the surgeon replaces the flap.
The operation normally takes less than 15 minutes per eye, and patients usually must pay thousands of dollars out of pocket, since the procedure is not covered by insurance and is considered cosmetic. Lasik surgeons, who point to surveys showing that 90% to 95% of customers are satisfied, often promote the procedure by offering free consultations and steep discounts.
The FDA document is not final. More than 600 individuals and professional groups have weighed in with comments since the draft of the guidance was made public in July, and the agency is now reviewing the input while preparing the final documents, officials said.
Organizations representing surgeons and medical device manufacturers have gone on the offensive, accusing the FDA of meddling in the practice of medicine and saying the information is one-sided and will needlessly frighten patients.
Many ophthalmologists say Lasik is the safest procedure done on the eye and that serious, long-lasting complications are rare.
But according to the FDA’s draft guidance, a few Lasik patients have become severely depressed, even considering suicide, after experiencing complications from the surgery. Certain chronic conditions, like diabetes, and some medications may put patients at risk for poor outcomes, the document says.
The FDA is proposing a patient “decision checklist” that describes Lasik surgery, noting that corneal tissue is “vaporized” and that corneal nerves “may not fully recover” from the incisions, “resulting in dry eyes and/or chronic pain.”
But according to the FDA’s draft guidance, a few Lasik patients have become severely depressed, even considering suicide, after experiencing complications from the surgery. Certain chronic conditions, like diabetes, and some medications may put patients at risk for poor outcomes, the document says.
The FDA is proposing a patient “decision checklist” that describes Lasik surgery, noting that corneal tissue is “vaporized” and that corneal nerves “may not fully recover” from the incisions, “resulting in dry eyes and/or chronic pain.”
Read more: https://www.nytimes.com/2022/12/07/health/lasik-injuries-fda.html
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