Posted on Nov 15, 2019, 4 p.m.
LASIK eye surgery procedures were designed to improve eyesight, some doctors are alarmed at how many patients report vision impairment post surgery, and one former FDA advisor who voted to approve laser eye surgery now views the procedure very differently.
LASIK is a minimally invasive surgery that aims to correct vision within minutes by using lasers rather than blades to make incisions that can reshape a small portion of the cornea; and since being approved by the FDA over 20 years ago an estimated 20 million hopeful Americans have undergone the eye corrective surgery.
Morris Waxler an expert who once consulted about the procedure and voted to okay it, is now retracting that decision due to what is now known about the potential of long term health effects from the surgery, he even believes the procedure should be absolutely taken off the medical market completely.
“Essentially we ignored the data on vision distortions that persisted for years,” Waxler told CBS News, calling his vote a mistake. “I re-examined the documentation … and I said, ‘Wow this is not good.’” “There’s nothing wrong with a person’s eyes who goes to get LASIK,” Waxler said. “They have healthy eyes. They could go and get a pair of glasses.”
Waxler has analyzed data independently since the vote and has recently observed a vision complication rate as much as 30%, which prompted him to petition for a LASIK recall to correct what he calls a mistake which the FDA has denied because it “has not found any new safety concerns associated with LASIK devices.”
Common side effects of laser eye surgery include dry eyes and temporary vision disturbances, with some patients being affected by under or over corrections, astigmatisms, and even potential loss of eyesight, according to the Mayo Clinic.
LASIK surgery was first performed in American in 1991, and the procedure gained FDA approval in 1996, according to the Eye Doctor Network which is led by private practicing optometrists who recommend that LASIK patients schedule follow up appointments at one day, one week, one month, three months, and one year after the procedure to track any changes to vision whether they be positive or negative.
It is suggested that up to 95% of LASIK patients report being satisfied with their results which typically costs on average $2,200 per eye, but others report suffering, painful, and disruptive complications.
“For the patients who have pain, it’s absolutely a condition that requires treatment and attention,” Dr. John Vukich, chair of the Refractive Surgery Clinical Committee for the American Society of Cataract and Refractive Surgery, previously told PEOPLE. “But the risk of winding up with chronic pain is very low.”
The FDA recommends consulting with your doctor about whether LASIK is right for you who can help you to assess the potential risks, and anyone who is considering the procedure should have their eyes examined for corneal conditions that may lead to problems post operation.
“There are patients who are turned away — as many as 10 to 20 percent of patients may have some corneal finding or some other condition that would make them a less-than-ideal candidate, but most patients are counseled and redirected to some other way to correct their vision,” Vukich said.
LASIK complaints were once the focus of an FDA appeal in 2008 and a survey in 2017 of 574 patients who described their vision before and at 3/6 months after LASIK; although visual symptoms were common few reported functionally important limitations: 4% reported dissatisfaction with vision, 2% reported dissatisfaction with surgery, and 2% reported complications.
“We know that for most individuals who have dry eye and other conditions, it almost always gets better within three to six months,” Vukich said. “… There are going to be very rare cases of individuals who may have difficulty that can be attributed to the surgery, but I think that’s true of any kind of procedure.”
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