When patient activist Paula Cofer of Tampa, Florida, learned that LASIK surgeries, laser eye surgery that corrects vision, were soaring during the pandemic, she was disappointed, but not surprised. "The LASIK industry depends heavily on advertising and their latest marketing gimmick has been targeting people frustrated with foggy eyeglasses while wearing a mask," she said.
Whether she likes it or not, the strategy seems to be working.
Recent data from the Refractive Surgery Council, an association of vision correction experts, said that while some ophthalmology subspecialties have struggled to attract patients to elective procedures during the pandemic, "refractive surgery has proven to be an exception." Indeed, the same report said the industry has "benefitted from a kick start during the COVID-19 era," with laser vision correction procedures such as LASIK and PRK "flourishing," and 2021 shaping up to be the industry's most profitable year since 2015.
While that may be good news for ophthalmologists who offer such services, for LASIK patients like Cofer who say they were damaged by the procedure, "it's devastating."
When vision correction surgery goes wrong
After undergoing the procedure two decades ago, Cofer said she's suffered from extremely dry eyes, a constant burning sensation, seeing "floaters" (spots or flecks in her vision) and has severely impaired night vision.
As bad as that sounds, Cofer's experience may not be unique. She operates a LASIK complications support group on Facebook that currently has over 7,600 members.
One of those members, Michelle Cooke from Derry, New Hampshire, had LASIK nearly four years ago. Since then, she said she's suffered from dry eyes, chronic inflammation, a drooping eyelid on one eye and ongoing pain.
"It's caused a lot of depression and anxiety," Cooke said, "not to mention loads of ongoing doctors' bills and daily medications that cost me more than $500 a month."
In 2018, The New York Times reported on many patients who have suffered similar symptoms and complications post-LASIK; and many former patients pleaded with the Food and Drug Administration at a public advisory panel the agency convened in 2008 to reverse their 1998 approval of LASIK devices.
Since then, the FDA says it's been listening to patients who have experienced post-LASIK complications, but still stands by its approval of LASIK devices today.
"The FDA considers LASIK lasers to be safe and effective when used as intended in accordance with the approved indications for use," an FDA official said in an email.
What those considering the procedure should know
Though the FDA backs the devices used in the procedure, it has expressed concerns about some of the eye care professionals caught misleading would-be patients.
The FDA issued a letter in May 2009, admonishing eye surgeons to "eliminat(e) deceptive or misleading health-related advertising claims" and a second letter in September 2011, said "eye care professionals’ advertising and promotion often failed to properly inform consumers of the indications, limitations, and risks of refractive procedures and the lasers used for those procedures."
The agency official said that even now the FDA, "continues to monitor adverse events associated with LASIK to better understand the safety and effectiveness associated with this procedure," and that it "takes adverse events concerning LASIK seriously."
Though such sentiments are appreciated by some, Dr. Morris Waxler, the former chief of the diagnostic and surgical devices branch in the FDA's division of ophthalmic devices who voted to approve LASIK in 1998, said he doesn't believe the agency is taking LASIK complications as seriously as it should.
"LASIK is neither safe nor effective," he said, adding that when he voted to approve LASIK devices, he trusted that manufacturers, clinics and surgeons "would provide accurate and specific information about bad outcomes from LASIK to customers," something he said hasn't happened enough in clinics or at the FDA. "I trusted my FDA colleagues to ensure customers got the truth about LASIK. I regret trusting them," he said.
Dr. Cynthia MacKay, a retired ophthalmologist who spent decades surgically helping patients suffering from eye diseases, echoes Waxler's concerns: "There are many lasers used in a variety of eye surgeries that I trust," she said, naming the argon laser, the YAG laser and the selective laser — lasers used to treat eye diseases like glaucoma and other retinal issues. "These lasers have saved the sight of millions around the world. The excimer laser used in LASIK does not save sight, it degrades it."
She explained that other lasers aren't used on the "delicate structure of the cornea," but that the excimer laser unique to LASIK "severs corneal nerves" and that the surface of the cornea heals unpredictably after that laser reshapes it. "This leads to under correction, over correction, scarring, warping, irregular astigmatism and, inevitably, decreased vision," she said.
Dr. Stephen Slade, a fellow of the American College of Surgeons and a refractive surgeon practicing in Houston, Texas, disagrees. He said the excimer laser "is as safe and effective as the LASIK procedure," and that it's an unique and important tool for refractive surgeons because "the excimer wavelength is specific for cornea tissue, other lasers would not ablate cornea tissue as well."
Another point of controversy surrounding the procedure is that there doesn't seem to be consensus on just how safe or effective LASIK really is in the long-term.
The procedure is commonly advertised by ophthalmologists as having a high satisfaction rate, but Dr. Edward Boshnick, an optometrist currently practicing in Miami, Florida, said such statistics misrepresent true outcomes because they only show how patients felt soon after receiving the procedure — when many complications don't manifest until months or years later.
He estimates that roughly 80% of the post-LASIK patients he's treated for complications initially felt satisfied after their surgery but developed problems sometime later. "Most of the patients I've seen developed complications three to six months after getting LASIK; others at a year or longer," he said. "No matter how long it's been, I can almost always trace the issue back to the procedure."
Indeed, the FDA has found a similar lag in LASIK complications that manifest months later. "To better understand LASIK’s safety profile, we undertook studies in partnership with the National Eye Institute and the Department of Defense and found that more than 95% of participants were satisfied with their vision following LASIK surgery. However, it’s important to note that almost half of participants who had no visual symptoms before surgery reported at least one visual symptom at three months after surgery," the FDA official said.
Such delayed complication symptoms have given rise to what Boshnick called "a whole new field in optometry that exists solely to treat post-LASIK patients who suffered complications."
And though Boshnick recognizes that he's making a living treating post-LASIK patients, he said he would put a complete stop to the industry if he had the power to do so. "It's a disastrous procedure affecting people in a real way," he said.
But other eye care professionals see the benefits of LASIK outweighing the risks and tout the positive outcomes. “We are literally giving people the gift of sight," said Slade.
"In giving the gift of sight, we not only improve vision, we significantly improve quality of life," said Dr. Eric Donnenfeld, a refractive surgeon practicing in Garden City, New York.
Dr. Roy Rubinfeld, a medical director and refractive surgeon practicing in Rockville, Maryland, said he trusts the procedure so much that, "I had laser vision correction in 1995, did LASIK on my wife in 1998, and just performed LASIK on our daughter."
He said that complications from LASIK were more common in the early years of the procedure and that devices and techniques have come a long way since then. "Modern LASIK has no more in common with early LASIK than your 2021 iPhone has in common with the brick phones from the 1990s," he said.
"LASIK has been overwhelmingly found to be safe and effective, perhaps the most studied procedure through the FDA," Slade said. He added that he and his colleagues "feel for the people who have had problems of any kind. We have been able to fix many, but not all, of them" and that many of the procedure's risks can be avoided by doctors more carefully screening out unqualified candidates.
"LASIK is a highly accurate, safe and efficacious surgery, but it is not for everyone," Slade said.
Indeed, the FDA has created a lengthy list of the type of candidate the procedure is not ideal for, and the FDA official said the agency keeps up a LASIK website that "describes the potential contradictions, warnings and precautions to consider prior to undergoing LASIK and the complications with the device."
What's more, the agency is in the process of creating a system to help ophthalmologists better explain the risks associated with the procedure to would-be patients. "As with all medical products, it is important that patients understand the potential risks. To that end, we are in the process of developing a LASIK patient labeling guidance to provide recommendations to industry about how to clearly communicate risks of LASIK to patients," the FDA official said, adding:
"Patients considering the LASIK procedure should thoroughly discuss the benefits and risks of the procedure with a health care professional."