A long article in The New Yorker at the beginning of July told of men hideously maimed by “the secretive world of penile enlargement.” A couple of weeks later, a page one piece in The New York Times detailed a tsunami of shocking amputations caused by risky artery surgery. Which body part will be next?
The answer is likely to be connected to the Food and Drug Administration (FDA) rule known as 510 (k). That’s not a retirement account option, but a rule saying that a medical device “substantially equivalent” to one already on the market can be marketed without having to prove to the agency that it’s safe and effective.
The streamlined requirement, noted the Times, has meant a “low bar” for approval of atherectomy devices used to clear arterial blockages. Surgeons have flocked to use them for highly profitable procedures despite “rigorous medical research” showing that “patients with peripheral artery disease who undergo the procedures are more likely to have amputations than those who do not,” the newspaper wrote.
And it’s meant that an implant into the sensitive tissue of the penis could be cleared by the FDA as “substantially equivalent” to other “soft tissue” implants without the application even mentioning the word “penis,” according to The New Yorker, clearing the way for a lucrative procedure that reportedly left many men permanently disfigured and in pain.
If you think that two high-profile publications exposing horrific examples of a red tape-slashing rule gone wrong will prompt significant change, think again. As the years roll by, the names of the scandals change, but the root cause goes unaddressed.
Five years ago, a Netflix documentary by two Academy Award-nominated filmmakers investigated what even a former FDA commissioner called the 510 (k) “loophole.” The Bleeding Edge, noted a Time magazine review of the 2018 film, featured patients “personally harmed by an array of devices – including cobalt-based hip replacements, vaginal mesh and robotic surgery devices.”
The Netflix horror stories might have been surprising in light of a report seven years earlier by the prestigious Institute of Medicine that called for completely scrapping the 510 (k) pathway. That 2011 report resulted from scandals such as metal-on-metal hip replacements that crippled thousands of individuals. According to the Times, the Institute (now the National Academy of Medicine) warned that the rule was never intended to screen out dangerous or ineffective products.
In turn, the Institute of Medicine recommendation might have seemed unnecessary, considering that 28 years before that a report from a Congressional oversight committee accused the FDA of “exposing the public to unnecessary risks from medical devices” due to lax regulation, according to an article in the Chicago Tribune.
That 1983 Tribune article was one I wrote way back in my journalism days. The committee report cited another article I’d written, exposing how a Chicago company submitted a 510 (k) application calling its device “substantially equivalent” to one on the market and including a photo that was actually a photo of a competitor’s device with a different label. (The Justice Department declined to prosecute for a false submission, noting that the photograph wasn’t the sole reason for the approval.)
Congress should urgently direct the FDA to close this loophole, but don’t hold your breath. “Innovation by the Private Sector” is an American tribal god, and among the zealous protectors is the powerful trade group for medical device makers. If, say, the member of a member of Congress had been mutilated, or a formidable political fundraiser had forfeited a foot, perhaps the Institute’s policy recommendation for a new category of device approval that reduces risk would get fresh consideration. That does not appear to have happened.
Nor is it very encouraging to examine how the public finds out when physician autonomy crosses the line from helping patients to harming them. Investigative journalism, muckraking documentaries and critical policy reports typically occur only after years of abuses have spawned formal complaints and a long trail of victims.
We know another body part will be the next to suffer avoidable abuse. We just don’t yet know which one.
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