Newest FDA Draft Guidance for LASIK Sparks Concern Among Doctors

Proposed guidelines would warn patients of harmful side effects, but physicians believe their input is being ignored.

The world of laser refractive surgery has been shaken this year by draft guidance from the FDA suggesting patients should be warned about the procedure’s drawbacks. Issued on July 28, 2022, the document outlines recommendations on labeling, including a proposed patient checklist to be completed by prospective patients pre-procedure.

The FDA’s motivations are clear. A string of high-profile cases from the early and mid-2000s involving compromised vision — and in some extreme cases, suicide linked to vision loss — have crescendoed to a fever pitch. Patient advocacy groups have long clamored for action. They see a LASIK landscape populated by unscrupulous doctors looking for fat paydays from a largely self-paid, elective procedure. The FDA’s draft guidance has been painted as a victory over the elite in a country with exorbitant healthcare costs and simmering tensions over wealth inequality.

Physicians are incensed. For them, LASIK has long been established as a safe and effective path to spectacle independence and greatly increased quality of life for patients worldwide. The global LASIK and laser vision surgery (LVS) market is worth $1.6 billion,¹ and is still underserved — mostly due to fear surrounding the procedure.

With a mere 800,000 surgeries performed in 2020 (out of a potential patient pool of 50 million)², many clinicians offering LVS feel hung out to dry by the potential for more fear in the marketplace. “We feel the draft guidance isn’t complete or reflective of the current clinical experience with LASIK,” said Dr. Vance Thompson, a leading refractive surgeon and rising vice president of the prestigious American Society of Cataract and Refractive Surgeons (ASCRS).

Framing the Debate

At issue is the nature of the checks that must be in place. The role of the FDA is to protect the patient, and the necessity of their existence is not under debate by even the fiercest critics of the policy. “We have a high amount of respect for the FDA and their scientific approach to novel technology,” explained Dr. Thompson. “Our FDA is the best in the world at providing the protection that our public deserves, so including them in the process makes a lot of sense.”

Doctors, on the other hand, are in more nebulous territory. In most cases, LASIK is not medically necessary, and is thus mainly performed in private clinics on self-payers. The private clinician’s dual role as salesperson and physician puts them in a precarious ethical position with both the power to influence patient decisions and profit from them. And with costs in the thousands of USD per eye, the temptation to perform surgery on borderline cases or worse can seem too great for some to resist.

Not (just) about the Benjamins?

But Dr. Thompson feels the physician perspective is being misrepresented. “We take an oath,” he stated. “When you choose to become a physician, the last thing you’re thinking about is the financial aspect of the procedure. The foundation of our discipline is to serve our patients and do no harm.” He believes that suspicions of unsavory behavior are overblown to mask the real issues underpinning physician malcontent.

One sore point for surgeons is what they perceive as a lack of balance in the process. For Dr. Thompson, it seems hardly fair for a patient to make an informed decision without presenting both sides of the story. “A good quality physician-patient discussion is a balance between their personal situation and what they should expect. A risk-benefit analysis versus an over-emphasis of the dangers … This document doesn’t talk about the safety and efficacy anywhere,” he explained.

Dr. Thompson doesn’t believe that the FDA shouldn’t have a seat at the table, but that the guidance and checklist in its current form is an overreach into the sacred doctor-patient relationship. Though the procedure isn’t medically necessary, it does have the potential to alter lives for the better, and he believes that patients shouldn’t be scared away from the procedure without the whole picture.

This echoes another gripe of many clinicians: The downsides stated in the FDA’s draft guidance are not entirely supported by the literature. “[The guidance] didn’t use relevant literature showing you what LASIK has evolved into since the time it was deemed safe and effective,” Dr. Thompson explained. Though the checklist has listed values for incidences of various side effects like dry eye, glare, halo and starburst, in Dr. Thompson’s view, these figures are given without context or citation of the proper literature.

The Error of Laser Surgery Terror

In the end though, for doctors like Dr. Thompson, the debate is less about a titanic clash between government regulation and private interest and more about inclusion and mutual respect. And the most bitter pill for the physician community to swallow is not the existence of additional FDA guidance and patient labeling.

“We don’t have a problem with the FDA’s desire to be involved in evolving patient education,” he explained. “But [we do want to] be allowed in as the societies and the physicians so that this final document has the proper tone and balance, is documented with the proper relevant literature, respects the physician patient relationship, and has evidence-based statements.”

Whatever the final score is, and regardless of the undercurrents of powerful private interest versus zealous government regulators, the precedent being set is perhaps the most critical. Refractive surgeons in private practice indeed do have a fiscal horse in the race, but they are also highly educated professionals whose daily experience with LASIK is critical.

Dr. Thompson, as an executive board member of ASCRS, believes ophthalmic societies are the perfect nexus to convene and make comprehensive, multilateral progress on patient protection issues. “Manufacturers, physicians and government come together in forums that lead to evolving procedures like LASIK so we can go all out and best serve the patients,” he said. “And so there’s no better place than the societies to bring these groups together that are going to best serve our public.”