Patients considering Lasik surgery should be warned that they may end up with double vision, dry eyes, difficulty driving at night and, in rare cases, persistent eye pain, according to draft guidelines from the Food and Drug Administration. After surgery, patients may still need glasses, the document warns.
If put into effect, the agency’s warnings may come as a surprise to many Americans, who consider the procedure safe and commonplace. Each year, more than half a million adults undergo Lasik surgery to correct poor vision.
The operation involves reshaping the cornea, the transparent round dome that covers the front of the eye and helps focus light onto the retina at the back of the eye. The surgeon cuts a thin flap in the cornea and folds it over, then uses the laser to sculpt the cornea. Then the surgeon replaces the flap.
The operation normally takes less than 15 minutes per eye, and patients usually have to pay thousands of dollars out of pocket, as the procedure is not covered by insurance and is considered cosmetic. Lasik surgeons, who cite surveys showing that 90-95% of customers are satisfied, often promote the procedure by offering free consultations and steep discounts.
The FDA document is not definitive. More than 600 individuals and professional groups have provided comments since the draft guidelines were made public in July, and the agency is currently reviewing input as it prepares final documents, officials said.
Organizations representing surgeons and medical device makers have gone on the offensive, accusing the FDA of meddling in the practice of medicine and saying the information is one-sided and will scare patients unnecessarily.
Many ophthalmologists say that Lasik is the safest procedure performed on the eye and that serious and lasting complications are rare.
“All we’re asking for is balance,” said Dr. Vance Thompson, new vice president of the American Society of Cataract and Refractive Surgery. “This document mainly emphasizes the dangers and complications of Lasik, without mentioning the benefits, and the tone is negative enough to scare patients away.”
He noted that more than 90 percent of patients in the FDA’s own studies expressed satisfaction with the results because they “get good vision without glasses, which is the goal for most patients.”
But according to the FDA’s draft guidelines, a few Lasik patients have become severely depressed, even contemplating suicide, after experiencing complications from the surgery. Some chronic diseases, such as diabetes, and certain medications can put patients at risk for poor outcomes, the document says.
FDA guidelines have been in the works for more than a decade. The document briefly says the surgery is done to reduce reliance on glasses, but most of the 29-page interim guidelines focus on the risks.
While surgeons and device makers are calling for the project to be withdrawn entirely, critics of the procedure say the focus on risks is appropriate because the procedure is performed on healthy eyes, not to treat disease .
“I’ve been waiting 14 years for this to happen,” said Paula Cofer, a Florida woman who testified to the FDA in 2008 and 2018 that Lasik surgery ruined her eyesight and left her with chronic pain. .
The new warnings would provide essential information to consumers, she added: “Right now, even if patients search the internet and see warnings, they think it’s just one or two disgruntled people. Now they see it’s the FDA saying so.
The FDA offers a patient ‘decision checklist’ that describes Lasik surgery, noting that corneal tissue is ‘vaporized’ and corneal nerves ‘may not fully recover’ from the incisions, ‘resulting in dry eyes’. and/or chronic pain.
Even after healing, the project says, the cornea will never be as strong as before surgery.
In comments to the agency, some patients said they experienced life-changing complications and vision loss, while others were thrilled with their results.
The professional organization representing optometrists, who perform vision tests and prescribe eyeglasses and contact lenses, welcomed the project and recommended adding even more precautions regarding Lasik surgery for pregnant patients and those suffering from irregular astigmatism.
The Medical Device Manufacturers Association, meanwhile, accused the FDA of overstepping its authority and “unacceptably regulating the practice of medicine.”
In an emailed statement, agency officials dismissed the criticism, noting that the FDA routinely issues labeling guidelines to ensure providers and patients understand the benefits and risks of medical devices.
Last year, the FDA imposed a so-called black box warning and a new label on breast implants and said health care providers should discuss potential risks, such as cancer, with potential patients.
In 2018, the agency limited the sale of a permanent contraceptive implant called Essure to doctors who would review a list of safety issues with potential patients. (The device was taken off the market soon after.)
The agency’s project builds on findings from a 2017 study of patient outcomes with Lasik, a collaboration between the FDA and the National Eye Institute and the Department of Defense. He assessed visual symptoms before and after Lasik. The FDA also performed its own meta-analysis of peer-reviewed studies published between 2013 and 2018.
The first study found that three months after Lasik surgery, almost half of patients who had no visual symptoms before the procedure developed a new visual aberration for the first time, most often halos, which are forms of stars around the lights. Nearly a third said they had dry eyes at three months.
The study authors wrote that “Patients undergoing Lasik surgery should be properly informed of the possibility of developing new visual symptoms after surgery before undergoing this elective procedure.” However, more than 90% of patients said they were satisfied with the result.
The agency conducted its own analysis, finding that six months after surgery, 27% of patients suffered from dry eye and 2% had difficulties that prevented them from going about their usual daily activities.
Five years after the operation, according to the FDA, 17% of patients were still using eye drops, 2% continued to experience visual disturbances and 8% still had difficulty driving at night.
FDA officials said they don’t know when the guidelines will be finalized. Lasik critics worry that many patients don’t get to see the warnings because the agency doesn’t mandate a screening before surgery.
The advice and checklist “should be provided by the manufacturers and given to physicians and patients prior to a procedure” and used to “enhance” the physician-patient discussion of risks and benefits.
But reviewing the information with patients is only a recommendation, agency officials acknowledged. That’s problematic, said Diana Zuckerman, who directs the National Center for Health Research, a nonprofit think tank that analyzes research on medical and other consumer products.
“The question is, ‘Are they actually doing something that will make a meaningful difference for patients?’ “, she said. “And I don’t think they are.”
Dr. Zuckerman fears patients will see the checklist for the first time when they come in for their scheduled procedures, having already decided to have Lasik surgery “or having already put down a non-refundable deposit.”
“We think they should review the checklist before making a deposit, and at least a week before the scheduled procedure,” Dr. Zuckerman said.
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