FDA Meets with Patients Advocating LASIK Ban


September 7, 2018

Contact: Morris Waxler, PhD, 608-219-7947, morriswaxler@gmail.com

Mark your calendar for a news conference with a group advocating a ban on LASIK eye surgery. The news conference will take place on September 13, 2018 from 1:00 to 2:00 PM, in the Maple Room at the Sheraton Hotel, 8777 Georgia Ave., Silver Spring, Md. Prior to the news conference, the group will meet with FDA officials at the FDA’s White Oak facility in Silver Spring, Md.

A lover of golden retrievers, Eminem and red sports cars, Max Cronin, 27, of College Station, Texas, had only begun to check off his life’s goals. After serving in the Iraq War, he was studying for a degree in engineering. Before he left the Army, though, in 2011, he had LASIK eye surgery.

Cronin’s ophthalmologist convinced him that LASIK (laser in situ keratomileusis) was a low-risk way to correct his near-sightedness and ditch his glasses. The surgery triggered a four-year deterioration of his vision. In 2015, a second surgeon gave him an “enhancement” surgery to improve his vision. It left him visually-impaired and gave him excruciating, constant pain. Six months later, he committed suicide.

Now, Cronin’s mother, Dr. Nancy Burleson, will be one of five members of the LASIK Complications Facebook Group who will meet with representatives from the FDA’s (U.S. Food & Drug Administration) Division of Ophthalmic and Ear, Nose and Throat Devices on September 13 in Silver Spring, Md. The Division regulates devices for corneal refractive surgeries including LASIK, photorefractive keratectomy (PRK) and small incision lenticule extraction (SMILE).

Burleson is an obstetrician/gynecologist in Gonzales, Texas.

“This is the first time the FDA has agreed to meet with us,” said Paula Cofer of Tampa, Fla., who founded the 6,100-member LASIK Complications Facebook Group in 2014 to give voice to people who have been harmed, she said, by corneal refractive surgeries. “Our membership grows daily because doctors convince patients these are safe surgeries. In fact, they can cause intractable, severe pain; corneal ectasia [deformity], chronic dry eyes, night vision problems and vision loss.”

Cofer’s LASIK in 2000 resulted in painful dry eye, astigmatism and impaired night vision.

The group also includes people who have had their LASIK-damaged eyes removed and people like Burleson whose family members committed suicide after being unable to live with LASIK-induced pain and vision loss.

About 300,000 Americans have corneal refractive surgeries each year, according to Market Scope. In total, about 10 million Americans have had these surgeries to date. About 14,000 complaints about these surgeries have been filed since 2013 with the FDA’s online MedWatch. “Unfortunately, most people aren’t aware that bad outcomes from LASIK should be reported to the FDA, so most LASIK-injuries are never counted. But the larger problem is, the FDA ignores the thousands of reports that have been filed,” said Cofer.

In addition to Burleson and Cofer, those representing the LASIK Complications Facebook Group will include Dr. Cynthia MacKay, a New York, N.Y., ophthalmologist; Morris Waxler, PhD, a Madison, Wis., neuroscientist, and a patient who will tell her post-op story but wants her name withheld.

The patient agreed to be part of an FDA study to approve SMILE in 2013. She chose to have SMILE in one eye and LASIK in the other. The surgeon assured her that complications are rare. Immediately after surgery, she had pain, but the surgeon shrugged it off. “I was suicidal within weeks because I couldn’t get relief,” she said. “I finally found a medication that gives me partial pain relief, but my vision is poor and it can’t be corrected with glasses. I can no longer work and I’ve lost my independence.”

Waxler was the FDA official who approved the original LASIK device in the 1990s. “When I retired, I was shocked to see the widespread harm that LASIK had done,” he said. “I re-analyzed the FDA’s data and, in 2011, petitioned the FDA to issue public warnings about LASIK and rescind its approval of LASIK devices.” The FDA rejected his petition. Waxler now advocates for LASIK-impaired people.

MacKay is one of only a few ophthalmologists in the U.S. who speak to the media about the perils of LASIK, though they discuss it among their peers, according to her website. Before she retired this year, she treated post-LASIK patients and learned of 11 LASIK-related suicides.

“After years of inaction,” said Cofer, “we’re demanding the FDA move the focus from the interests of powerful ophthalmologists to real people’s suffering.”

Cofer and her colleagues will propose an Action Plan that includes these deadlines:

  1. Within 30 days, the FDA and doctors must quit deceiving potential patients with promises of zero side effects and, instead, warn the public about the true severity and prevalence of side effects, which is about 20 percent.
  2. Within six months, the FDA must convene a panel on care and compensation of LASIK-injured patients, many of whom have lost their jobs and can no longer pay their medical bills.
  3. Within six months, the FDA must ban these surgeries, before any more lives are destroyed.

The group will also ask the FDA to quiet the equipment manufacturers’ and doctors’ touting of the “new technology” as “better,” when the SMILE patient who will attend this summit is evidence that new isn’t necessarily better.

In 2008, the FDA heard a panel of corneal surgery patients tell their post-op stories and plead for the banning of these surgeries. But nothing happened.

“Look at all the people whose lives were destroyed since 2008,” said Cofer. “This time, we have to succeed. If only the FDA could meet with LASIK-injured patients at least as often as it meets with the doctors who profit from these procedures.”

Most important, Cofer plans to tell her FDA audience: “LASIK is inherently harmful. Before LASIK, our eyes are healthy. Yet, the Hippocratic oath says, ‘First, do no harm.’ This doesn’t make sense. The FDA can begin by acknowledging this.”

FDA will be represented by the following officials: Dr. Malvina Eydelman, CDRH/ODE Director, Division of Ophthalmic and Ear, Nose, and Throat Devices; Dr. William Maisel, CDRH Acting Director, Office Of Compliance, Director, Office of Device Evaluation and Chief Medical Officer; Dr. Jose Delgado Donayre, CDRH/OSB Associate Director for Post Market Surveillance and Ken Skodacek, CDRH Deputy Ombudsman.