Earlier this year, FDA issued draft guidance warning patients of potential risks associated with Lasik surgery, prompting praise from some, but backlash from surgeons who say the agency's "information is one-sided and will needlessly frighten patients," Roni Caryn Rabin writes for the New York Times.

FDA issues draft guidance on Lasikprocedures

Each year, over half a million adults undergo Lasik surgery to correct their vision. But, according to FDA's draft guidance, patients should be warned about potential risks associated with Lasik surgery before having the procedure.

FDA warns that, in some cases, patients may experience double vision, dry eyes, difficulty driving in the dark, and persistent eye pain. The agency also says some Lasik patients have developed severe depression after experiencing side effects from the procedure. In addition, some patients may still need corrective lenses after Lasik. According to FDA, certain chronic conditions and medications may increase a patient's risk of a poor outcome.

"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," Rabin writes.

In the draft guidance, FDA proposed a patient "decision checklist" that describes the procedure, explaining that corneal tissue is "vaporized" and that corneal nerves "may not fully recover" from the incisions, "resulting in dry eyes and/or chronic pain."

The guidance is based on findings from a 2017 study of patient outcomes after Lasik surgery, which was conducted by FDA, the National Eye Institute, and the Department of Defense. The study evaluated visual symptoms before and after the procedure.

In the study, researchers found that three months after Lasik surgery, almost half of all patients with no visual symptoms before the procedure developed a new visual symptom for the first time. Nearly one-third of patients also reported dry eyes at three months.

According to the study's authors, "patients undergoing Lasik surgery should be adequately counseled about the possibility of developing new visual symptoms after surgery before undergoing this elective procedure." However, over 90% of patients said they were satisfied with the outcome of the procedure.

FDA also conducted its own analysis, finding that six months after surgery, 27% of patients reported dry eyes and 2% reported symptoms that prevented them from participating in their typical daily activities.

Five years after Lasik, FDA found that 17% of patients still relied on eye drops, 2% still experienced visual disturbances, and 8% still had difficulty driving in the dark.

Experts weigh in on the draft guidance 

While FDA's guidance has not been finalized, over 600 individuals and professional groups have submitted comments since the draft was released in July. FDA is currently reviewing the comments while creating the final documents, according to agency officials.

Meanwhile, "[o]rganizations representing surgeons and medical device manufacturers have gone on the offensive, accusing the F.D.A. of meddling in the practice of medicine and saying the information is one-sided and will needlessly frighten patients," Rabin writes.

Many ophthalmologists have said that Lasik is the safest eye procedure, noting that serious, long-term complications are rare, Rabin adds.

"All we're asking for is balance," said Vance Thompson, incoming VP of the American Society of Cataract and Refractive Surgery. "This document mainly emphasizes the dangers and complications of Lasik, with no mention of the advantages, and the tone is negative enough that it will scare patients."

Thompson also noted that over 90% of patients in FDA's own studies were satisfied with the outcome of the procedure because they "are achieving good vision without spectacles, which is the goal of most patients."

"While surgeons and device manufacturers are calling for the draft to be withdrawn in its entirety, critics of the procedure say the focus on risks is appropriate, since the procedure is performed on healthy eyes, not to treat an illness," Rabin writes.

Paula Cofer, a Florida woman who testified before FDA in 2008 and 2018 that the procedure ruined her eyesight and left her with chronic pain, said the agency's new warnings would provide critical information for consumers.

"Right now, even if patients do research on the internet and see warnings, they think it's just one or two unhappy people. Now they see it's the F.D.A. saying this," Cofer said.

Separately, the professional organization that represents optometrists "praised the draft and recommended adding even more precautions about Lasik surgery for pregnant patients and those with irregular astigmatism," Rabin writes.

The Medical Device Manufacturers Association, accused FDA of overstepping its authority and "impermissibly regulating the practice of medicine."

In response, FDA officials dismissed the criticism, noting that the agency regularly issues labeling guidance to ensure that providers and patients understand the benefits and risks of medical devices, Rabin writes.

Currently, agency officials do not know when the guidance will be finalized. The agency noted that the guidance and checklist "should be provided by manufacturers and given to physicians and patients before a procedure" and used to "enhance" the discussion of risks and benefits.

But reviewing the information with patients is only a recommendation, which Diana Zuckerman, who heads the National Center for Health Research, says is problematic.

"The question is, 'Are they actually doing anything that will make a meaningful difference to patients?'" Zuckerman said. "And I don't think they are."

In addition, Zuckerman expressed concern that patients will see the checklist for the first time the day of their surgery "or after they've already put down a nonrefundable deposit."

"We think they should review the checklist before they give a deposit, and at least a week before the scheduled procedure," Zuckerman added. (Rabin, New York Times, 12/7)