Lasik surgery: a study in medical risks, complications, lack of official followup

lasik-199x300Caveat emptor, federal officials are reminding patients anew about an eye surgery that tens of millions of Americans already have undergone and all too many may believe ── wrongly ── is all but risk-free.

In fact, significant numbers of the 9.5 million Americans who had laser-assisted operations, the so-called Lasik procedure, may show vision improvements, but they also may be under-reporting problems connected with their surgeries, the New York Times reported.

The federal Food and Drug Administration approved Lasik in the 1990s, but the agency only recently has supported the gold-standard of medical research, a randomized clinical trial, to check in on long-running complaints about the surgery.

The FDA trial, involving several hundred patients, may not have shed as much light as it might have, and it mostly provided a good way for eye specialists to get better information from patients about Lasik’s effectiveness and complications, experts say. Still, for those who have warned about Lasik’s downsides for some time, the FDA trial raised more alarms, showing, as the New York Times reported:

Nearly half of all people who had healthy eyes before Lasik developed visual aberrations for the first time after the procedure, the trial found. Nearly one-third developed dry eyes, a complication that can cause serious discomfort, for the first time. The authors wrote that ‘patients undergoing Lasik surgery should be adequately counseled about the possibility of developing new visual symptoms after surgery before undergoing this elective procedure.’

The newspaper delves at some detail into these problems with laser-assisted in situ keratomileusis, a procedure that typically isn’t covered by health insurance and costs on average more than $4,000 per eye. Patients, for example, emphasize that what ophthalmologists may term in simple fashion as “dry eyes,” fails to describe what they experience as searing, sustained pain ── which many complain can’t be treated and resolved easily, quickly, or at all. Glare, halos, and double vision also vex Lasik patients, including in night driving and if they must do heavy work on computers. In many cases, these “vision aberrations” diminish over time, and ophthalmologists insist it typically is so.

But patients disagree. The FDA study raises the worry that, in fact, declines in visual performance may pop up later post-operatively than specialists count on. And, the agency’s researchers found another concern in its study: Patients’ unwillingness to discuss negatives or “adverse outcomes” about this or any other surgery, notably because they don’t want to offend, worry, or cause troubles for caregivers.

In my practice, I see the harms that patients suffer while seeking medical services, including and especially when they undergo procedures deemed elective or cosmetic. Patients may have myriad reasons for wanting to lose their glasses, and some may wonder, “Haven’t all the worries about Lasik gotten aired after all these years?” Let’s put this matter in clearer focus, because Lasik illustrates critical concerns in medicine.

First, as the New York Times underscores, the persistent and worrisome issues surrounding Lasik ought to force lawmakers and regulators to keep questioning the process in which medical devices and procedures they’re used in win federal approval, before and after the fact. As the newspaper reported:

Lack of precise information about complications is a problem that plagues many medical devices, which are tested by manufacturers and often gain FDA approval before long-term outcomes are known, said Diana Zuckerman, president of the nonprofit National Center for Health Research in Washington. ‘The F.D.A. keeps promising to do a better job of post-market surveillance, but there is no evidence of real improvement,’ she said.

Second, researchers in the FDA’s Lasik clinical trial hit another troubling issue with medical devices and their associated surgeries ── whether doctors give patients, especially over time and when procedures become routine and comfortable to the public ── the robust, appropriate counsel about not only what will but also what might happen to them. Are doctors patiently, fully, and appropriately discussing with the hundreds of thousands who undergo them the Lasik surgeries’ risks and benefits?

This is what the law calls informed consent, and it is one of your fundamental and critical rights. It’s the duty of every health care provider to ensure that you know fully your treatment options and that you decide what path to take, without strong-arming or scare tactics from the person in the white coat.

In an argument filled with more than its share of illogic, doctors point to Lasik’s popularity as proof of its safety and effectiveness: If it wasn’t sound, why would almost 700,000 patients in 2017 have the procedure, up from 629,000 or so the year before, the New York Times reported?

Well, the paper also noted that Lasik can impede detection of the serious condition of glaucoma. It can lead to a vision-threatening condition called corneal ectasia. Besides chronic and severe pain, it can lead to vision loss and blindness.

Experts say studies show that severe complications like these occur in “just” 2 percent of cases. But do that math ── it amounts to 14,000 patients in 2017 alone and 190,000 over the time since the surgery won FDA approval. Is that acceptable? Would you choose to be one of these harmed patients? Caveat emptor isn’t enough. We need to demand more from our doctors, lawmakers, and taxpayer-supported regulators.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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