LASIK patients should be warned of complications, FDA draft says

LASIK patients should be warned of complications, FDA draft says

Patients considering LASIK should be warned that they may experience double vision, dry eyes, difficulty driving at night and, in rare cases, persistent eye pain, according to draft guidelines from the FDA. The document warns that after surgery, patients may still need glasses.

If enacted, the agency's warning could 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 vision problems.

The surgery involves reshaping the cornea, the clear round dome that covers the front of the eye and focuses light onto the retina at the back of the eye. The surgeon cuts a thin flap of skin in the cornea and folds it back, then uses a laser to reshape the cornea. Afterwards, the surgeon replaces the valve.

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The procedure typically takes less than 15 minutes per eye and patients often pay thousands of dollars out of pocket because the procedure is not covered by insurance and is considered cosmetic surgery. With surveys showing 90 to 95 percent customer satisfaction, LASIK surgeons often promote the procedure by offering free consultations and deep discounts.

FDA documents are not final. More than 600 individuals and professionals have commented on the draft guidance since it was released in July, and the agency is now reviewing the submissions and preparing the final document, officials said.

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Groups representing surgeons and medical device makers have gone on the offensive, accusing the FDA of meddling in medical practice and saying the message is one-sided and causes unnecessary anxiety for patients.

Many eye doctors say LASIK is the safest eye surgery, with serious, long-term complications being rare.

"All we're asking for is balance," said Dr. Vance Thompson, the new vice president of the American Society of Cataract and Refractive Surgery. "The document primarily emphasizes the dangers and complications of LASIK surgery without mentioning the benefits, and the tone is negative enough to scare patients."

In the FDA's own study, more than 90 percent of patients were satisfied with the results, he noted, because they were "getting good vision without glasses, which is the goal for most patients."

But some LASIK patients become severely depressed and even contemplate suicide after experiencing complications from the procedure, according to the FDA's draft guidance. Certain chronic conditions, such as diabetes and certain medications, can put patients at risk of adverse outcomes, the document said.

FDA guidelines have been in the works for more than a decade. The document briefly states that surgery is being done to reduce reliance on glasses, but most of the 29-page draft guidance addresses the risks.

While surgeons and device makers have called for the draft 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 waited 14 years for this to happen,” said Paula Cofer, a Florida woman who testified before the FDA in 2008 and 2018 that LASIK ruined her vision and left her with chronic pain.

The new warning will provide important information to consumers, she added: "Even if patients are searching the Internet now and see the warning, they think it's just one or two unlucky people. Now they see that it's the FDA saying so."

The FDA proposed a "decision checklist" for patients describing LASIK surgery, noting that corneal tissue "evaporates" and that corneal nerves "may not fully recover from the incision," "resulting in dry eyes" and/or chronic pain".

Even after it has healed, the cornea will never be as strong as it was before surgery, according to the draft.

In comments to the agency, some patients said they had life-changing complications and vision loss, while others gushed about their results.

The professional group, which represents optometrists who perform vision tests and prescribe glasses and contact lenses, applauded the draft and suggested adding more precautions to LASIK procedures for pregnant women and patients with irregular astigmatism.

The Medical Device Manufacturers Association, on the other hand, accused the FDA of overreaching its powers and "improperly regulating the practice of medicine."

In an emailed statement, agency officials dismissed the criticism, noting that the FDA regularly issues labeling guidance to ensure both providers and patients understand the benefits and risks of medical devices.

Last year, the FDA implemented so-called black box warnings and new labels for breast implants, saying health care providers need to vet potential patients for potential risks, such as cancer.

In 2018, the agency restricted sales of a permanent contraceptive implant called Essure to doctors as they scrutinized a list of potential patients' safety concerns. (The device was withdrawn from the market shortly after.)

The agency's draft draws on findings from the 2017 LASIK Patient Outcomes Study, a collaboration between the FDA, the National Eye Institute and the Department of Defense. It evaluates visual symptoms before and after LASIK. The FDA also conducted its own meta-analysis of peer-reviewed studies published between 2013 and 2018.

Three months after LASIK surgery, nearly half of patients who had no visual symptoms before surgery first experienced new visual aberrations, most commonly halos, starburst shapes surrounding lights, the first study found. Nearly a third reported dry eyes after three months.

"Patients undergoing LASIK surgery should be fully aware of the possibility of new visual symptoms following surgery before undergoing this elective procedure," the study authors wrote. Still, more than 90 percent of patients gave up on the outcome. satisfy.

The agency conducted its own analysis and found that 27 percent of patients experienced dry eyes six months after surgery, and 2 percent experienced difficulty performing daily activities.

Five years after surgery, 17 percent of patients were still dependent on eye drops, 2 percent still had vision problems, and 8 percent still had problems driving at night, according to the FDA.

FDA officials said they did not know when the guidance would be finalized. Critics of LASIK worry that many patients will not have the opportunity to see the warnings because the agency does not mandate preoperative screening.

The guidelines and checklist "should be provided by the manufacturer and made available to physicians and patients prior to any procedure" and are used to "enhance" the physician-patient discussion of risks and benefits.

However, agency officials acknowledged that checking information with patients is only a suggestion. That's problematic, said Diana Zuckerman, director of the National Center for Health Research, a nonprofit think tank that analyzes research on medical and other consumer products.

"The question is, 'Are they really doing anything meaningful for patients?'" she said. "I don't think they are."

Zuckerman is concerned that patients will be the first to see the checklist when they go in for a scheduled procedure after they've already decided on LASIK "or already paid a non-refundable deposit."

"We think they should go through the checklist at least a week before scheduled surgery before paying any deposits," Zuckerman said.

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