Is LASIK Surgery Safe? A Former FDA Adviser Raises Doubts—But Here's What Eye Docs Have to Say
Millions of Americans have had LASIK eye surgery to correct their vision, but a retired adviser who was on the FDA committee that approved the procedure in 1996 is calling for it to be banned.
According to Morris Waxler, PhD, LASIK has left many people with bad vision, and even driven some to suicide. “Essentially we ignored the data on vision distortions that persisted for years,” Waxler said on CBS This Morning. “I re-examined the documentation…and I said, ‘Wow this is not good.’”
The case of Jessica Star, 35, made headlines in 2018 when she died by suicide a couple of months after she had a SMILE surgery, which is similar to the LASIK procedure but uses a different type of laser. It was reported that the Michigan meteorologist took her life, leaving behind her husband and two young children, because she was struggling with a slow recovery and side effects after the operation.
What Exactly Is LASIK Eye Surgery?
LASIK, which stands for laser-assisted in situ keratomileusis, is a quick, minimally-invasive refractive surgery that reshapes the cornea to correct near-sightedness, far-sightedness or astigmatism (a defect in the eye resulting in distorted vision).
“This is done by making a flap in the top layer of the cornea and reshaping the middle layers with a laser,” optometrist Neil Satija, OD, from Green Eye Care in Harlem, New York, tells Health. “The flap is then placed back and the patient can see clearly––sometimes as soon as immediately.”
What’s Waxler’s Issue With It?
Waxler says that when he carried out his own analysis of industry data, he discovered LASIK complication rates of between 10% and 30% percent. In 2011, he petitioned the FDA to issue a voluntary recall of LASIK. In 2014, his request was denied, and this week the FDA told CBS News that it “has not found any new safety concerns associated with LASIK devices.”
“Morris Waxler is wrong,” Stephen Slade, MD, an ophthalmologist at Slade & Baker Vision, in Houston, tells Health. “His inappropriate use of science (i.e. combining data from different studies and not disclosing his data sources) is designed to scare people––which is incredibly irresponsible given the huge amount of research backing LASIK.”
Dr. Slade, who was the first surgeon in the US to perform LASIK and is a member of the American Refractive Surgery Council, points to the FDA’s PROWL (Patient-Reported Outcomes with LASIK) studies, which were published online in JAMA Ophthalmology and reported a patient satisfaction rate of 96% among LASIK patients.
Dr. Satija, who performs both pre-op and post-op assessments for LASIK patients, says common LASIK symptoms include dry eyes, visual distortions, and light sensitivity. “Severe eye pain has been attributed to about 1 out of 10,000 surgeries and needs to be considered by the patient before undergoing LASIK,” he says. In relation to the media reports that this pain has led to suicide in some patients, Dr. Satija points out that suicide is a complex mental health issue and suggests that more studies need to be done to verify these claims.
How Dangerous Is LASIK, Really?
According to Dr. Slade, LASIK is not dangerous. “It is surgery, so there are risks and benefits, just like any other surgery,” he says. “After 20 years, 20 million procedures, and more than 7,000 clinical studies, we know that LASIK is a terrific vision correction option.”
According to the American Refractive Surgery Council, absolute contraindications (aka, reasons not to use a medication or procedure) to LASIK include cataracts, diabetes, and autoimmune diseases like lupus or rheumatoid arthritis. Plus, some medications, such as corticosteroids and acne medications can affect the healing process—as can pregnancy.
LASIK isn’t right for everyone, Dr. Satija admits, but he stresses that it can be a great low-risk surgery for many patients. “As with any surgery, there is always a risk for complications, and patients should make an educated decision with the proper expectations,” he says.
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