‘There were just red flags’: Florida woman shares struggle following LASIK eye surgery

By Hayley Crombleholme

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    ORLANDO, Florida (WESH) — The Food and Drug Administration is considering updating the labeling, or patient information, related to LASIK surgery, saying they’ve gathered new information “pertaining to risks associated with LASIK” since the LASIK Advisory Committee Meeting in 2008. One Florida woman says people aren’t aware of the serious risks the surgery can pose. But a local surgeon says this update shouldn’t be viewed as a warning.

“I’m a shell of the person I would have been,” Paula Cofer told WESH 2. Cofer is the founder of the LASIK Complications Support Group, with nearly 8,000 members, and had LASIK surgery in the summer of 2000. She says pre-operation, things felt rushed.

“There were just red flags,” Cofer said. “If I had not already put a deposit down, I would have just walked out the door. But in hindsight, I should have.”

Post surgery, she says she knew something was wrong right away.

“The first time I was outside at night, I was blown away by what I was seeing at night,” Cofer said. “Massive, massive starbursts, halos, multiple images.”

She thought it would get better.

“That’s what the LASIK clinic was telling me. It’s temporary, temporary. Give it time, give it time,” Cofer said. “But it never got better.”

In the decades that followed, Cofer says she’s traveled across the country and even into Canada. Spending a lot of money to find a solution.

“There is no solution,” she said. “This is a one-way street. Having LASIK is a one-way street. There is no going back. And you only have one pair of eyes and once they’re messed up, that’s it.”

Cofer doesn’t believe patients are fully aware of the possible risks.

The FDA has issued draft guidance updating patient labeling, which is a patient information booklet unique to each laser approved for LASIK surgery. It includes benefits, risks, and results of clinical studies.

On the draft guidance from the FDA, it says, “FDA is issuing this guidance to help ensure that both physicians can share and patients can understand information on the benefits and risks of these devices. The recommendations are being made based on concerns that some patients are not receiving and/or understanding information regarding the benefits and risks of LASIK devices.”

“My reaction was, ‘what took you so long?'” Cofer said.

WESH2 reached out to the FDA about the draft guidance and received a statement in response. saying,

“Since the time of the LASIK Advisory Committee meeting in 2008, the FDA has continued to gather new information pertaining to risks associated with LASIK, including dry eye, pain and discomfort, and visual symptoms. Clinical and scientific knowledge about these events and symptoms has increased since the time of the last advisory committee meeting. The FDA has diligently collaborated with external partners, experts, and patient groups to better understand and characterize risks to ensure that the recommended labeling discussed in this guidance addresses the concerns uncovered in this collaboration and that risk information is communicated in an understandable format. For example, the FDA collaborated with the National Eye Institute and the Department of Defense to conduct research as part of the LASIK Quality of Life Collaboration Project to help better understand the potential risk of problems that can occur after LASIK. This project led to the development of the Patient-Reported Outcomes with LASIK PROWL Symptoms and Satisfaction (PROWL-SS), questionnaire, qualified through the FDA’s Medical Device Development Tools (MDDT) program.

Additionally, the FDA is aware that patients may not be receiving information in a format that allows them to make a well-informed decision about LASIK. The recommendations in this guidance are being made to help ensure that patients are informed of the significant risks associated with LASIK prior to choosing this type of surgery and are informed by the latest information about these devices.

To help ensure that both physicians and patients receive and have this information, patient labeling, including a patient decision checklist, should be provided by manufacturers and given to physicians and patients prior to a LASIK procedure, and should include considerations related to procedural information, candidate considerations, benefits/alternatives, contraindications, warnings and precautions, and specific health risk information.

The FDA is in the process of considering the nearly 700 public comments submitted on the draft guidance. When issued as final, the guidance will provide recommendations about the content and format for patient labeling information for laser-assisted in situ keratomileusis (LASIK) devices.”

But Dr. G. Brock Magruder Jr., CEO of Magruder Laser Vision, says this draft guidance shouldn’t be viewed as a warning.

“It’s a safe and effective procedure” Magruder said. “The FDA has confirmed that over multiple studies since the 90s. What we’re talking about is doing the best job that we can to inform patients so they can make the best choice for themselves.”

So how common are side effects?

“In terms of short-term complications with LASIK, they’re pretty common” Magruder said. “Lots of people are going to feel, maybe a third or a half, some foreign body sensation, some tearing, sensitivity to light.”

But he says that typically resolves within a few weeks. As far as longer term,

“Complications are much more rare. Under 1%,” he said.

When it comes to whether the reward of LASIK outweighs the risk, Magruder and Cofer don’t see eye to eye.

“For good candidates, yes,” Magruder said. “I mean, I had LASIK, I did LASIK on my wife, I did LASIK on my daughter-in-law, I did LASIK on my mom, I did LASIK on my brother– I believe in it.”

But for Cofer,

“Not at all. Not at all,” She said. “These are your eyes. You have one pair of eyes. If your eyes are messed up, you have to life with that forever.”

The FDA is now in the process of reviewing the hundreds of comments submitted on their draft guidance for LASIK labeling before issuing a final version.

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