The similarities are striking. New technology, imprecise estimates (“large majority”), barely involved FDA, lawsuits, more “informed consent” information the proposed solution.
I did not have to dig through the internet to find this. It’s a front page article on the theguardian.com web site.
Unfortunately, the article itself uses imprecise wording at times to hype up the story. But the former FDA advisor’s comments seem significant.
https://www.theguardian.com/us-news/2023/apr/18/lasik-laser-eye-surgery
“…
But patient advocates and some experts say that is not the full picture. Dr Morris Waxler, a retired FDA adviser who voted to approve Lasik in the 1990s, is now one of its biggest critics. He says he regrets his role in bringing the procedure to the public.
According to his own analysis of industry data, the complication rate of Lasik falls between 10% and 30%. One investigation of an FDA database by the reporter Jace Larson found more than 700 complaints of severe pain, described as “worse than childbirth” or as if “their eyeballs would stick to their eyelids almost every night”.
Last year, the FDA released draft guidance telling doctors that prospective patients should be warned they might be left with double vision, dry eyes, difficulty driving at night, and persistent eye pain.
…”
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