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Should LASIK Eye Surgery Be Banned? Here’s Why Some People Say Yes

Discussion in 'Ophthalmology' started by Mahmoud Abudeif, Nov 23, 2019.

  1. Mahmoud Abudeif

    Mahmoud Abudeif Golden Member

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    In 2015, Max Cronin decided he wanted to ditch his glasses by getting LASIK surgery shortly after he served as a soldier in Iraq.

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    He felt the surgery would allow him to study easier as he took courses as a petroleum engineer student at Texas A&M University.

    His mother, Dr. Nancy Burleson, was so thrilled and supportive she paid for the elective surgery.

    However, after the surgery Cronin developed complications that led to blindness, severe eye pain, and eye dryness.

    He eventually dropped out of school and was unable to work.

    In 2016, Cronin was found dead of a single, self-inflicted bullet wound. He was 27 years old.

    In the suicide note he left on his body, he wrote that the aftereffects of LASIK surgery were one reason he had ended his life.

    Burleson, an OB-GYN who prides herself in understanding the medical world, told Healthline she’s not alone in her grief.

    Through support groups and social media, she’s connected with 23 others who have lost a family member to suicide after experiencing complications from LASIK.

    Burleson is also one of a number of people who have left comments on the website LasikSuicides.com.

    In addition, thousands of people have connected to a Facebook group created by Paula Cofer, who had LASIK surgery two decades ago.

    The members share stories of life after LASIK, the elective surgery they’d signed on to as a way to make life easier.

    Dump the glasses and contacts and still have good vision. That was their dream. The reality, they and others say, is that LASIK is a surgery fraught with long-term and difficult aftereffects.

    And while Food and Drug Administration (FDA) officials told Healthline that only 1 percent of people choosing LASIK experience long-term complications, others say the actual number may be much higher.

    Healthline contacted the offices of four medical professionals who provide LASIK surgery but received no response for comments on this story.

    Healthline also reached out to the American Academy of Optometry for comment but didn’t receive a response.

    The organization does have a page on its website that contains past research on LASIK surgery.

    A former FDA official speaks out

    Morris Waxler, PhD, served as a reviewer for the FDA until 2000 and was part of the approval process for LASIK.

    For years, he has been sounding an alarm on what he calls the serious dangers of LASIK eye surgery.

    Waxler started hearing from people when he was still at the FDA.

    “LASIK injured customers. They were calling me, complaining bitterly, and really in rather harsh terms, about what they were going through,” he told Healthline. “I was put off initially, but I started asking questions, as I always do. I went back and looked (at the FDA findings and comments on LASIK)… patients were not being told the truth.”

    What the FDA was telling consumers then is the same it’s telling them now: that less than 1 percent of people experience complications after LASIK.

    “In October 2009, the FDA, the National Eye Institute (NEI), and the Department of Defense (DoD) launched the LASIK Quality of Life Collaboration Project to help better understand the risk of problems that can occur after LASIK,” FDA officials told Healthline in an email statement.

    “The Patient-Reported Outcomes with LASIK (PROWL) study assessed visual symptoms before and after LASIK surgery to identify changes over time,” they wrote. “It showed that fewer than 1 percent of patients had symptoms that gave them a lot of difficulty with or prevented from doing their usual activities”

    Waxler says that’s wrong.

    In a submission he made earlier this year to the FDA, he says that “Manufacturers’ data submitted to FDA [Summaries of Safety and Effectiveness Data (SSED)] shows double-digit percentages of LASIK customers suffer late onset and/or persistent complications 6-12 months after surgery. FDA/industry buries these complication rates deep in the SSEDs, prepared jointly by agency and company managers.”

    In other words, he explained to Healthline, the FDA isn’t looking at the most common complications people experience:
    • dry eye
    • loss of night vision
    • constant eye pain
    He says 43 percent of people who’ve had LASIK surgery experience vision distortion such as halos, starburst, haziness, and loss of night vision. Some of these complications can be temporary.

    Surgery was ‘a disaster’

    Cofer, creator of that Facebook group, had LASIK about 20 years ago.

    She was looking forward to ending the hassle of glasses and contact lenses.

    “From day one, it was a disaster,” Cofer told Healthline.

    Today, she says she continues to suffer from poor night vision, chronic dry eye, and nearly crippling eye pain.

    “I was back in glasses in a month,” she said. And now, even those glasses don’t help her damaged vision much.

    “I felt tricked (by the LASIK industry),” she said. “They are very deceptive. People think glasses are a hassle? Wait until they have complications.”

    Her hope?

    “The FDA needs to pull the plug on the entire industry,” she said.

    Waxler doesn’t see that happening.

    “The agency is deeply embarrassed by the whole process,” he said. “There is a simple solution: they can just tell the truth. But they won’t. They want to save face. Institutions don’t like to say ‘I’m sorry.’”

    Spreading the word

    Burleson and Cofer both say they will continue to get their word out that LASIK comes with a high risk of complications.

    “They (LASIK providers) offered free services to [news] anchors and other media people to get the word out,” Cofer said. “Now, we are using the media to get this awareness out.”

    The story became personal at a television station in Detroit earlier this year.

    In February, Dan Rose, the husband of meteorologist Jessica Starr, told media outlets that a negative experience with LASIK led to his wife’s depression and her suicide.

    He said a type of LASIK surgery known as SMILE left his wife with dry eyes and vision problems.

    The FDA response

    For now, FDA officials say they have made information available on their website on the risks of LASIK.

    “The FDA is required to assure that the combination of regulatory controls applied to a device will provide reasonable assurance of the safety and effectiveness of the device. These controls include the kind of data or information required to be submitted in a Premarket Approval, or PMA, such as clinical data,” the FDA said in its statement to Healthline.

    “The FDA has reviewed clinical data from LASIK manufacturers, each of whom has to conduct clinical trials with their device to demonstrate its safety and effectiveness. These data shows that when LASIK is done properly, and on the right patient, the benefits of safety and effectiveness outweigh the risks.”

    Waxler says he cannot accept that conclusion, so he’ll continue his campaign.

    In the meantime, he hopes those considering LASIK will think carefully.

    “Lots of people are tempted,” Waxler said. “It’s a sad, sad story. Everyone (who has LASIK) is at risk. You can use glasses or contacts. There’s no reason to take on this risk.”

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