A man holds a small cucumber in his hand. Patient harm from penis enlargement surgery and artery … [+]
A long article in The New Yorker told in early July about men horribly maimed by ‘the mysterious world of penis enlargement’. A few weeks later, a page a piece in it The New York Times detailed a tsunami of shocking amputations caused by risky artery surgery. Which body part is next?
The answer is likely related to the Food and Drug Administration (FDA) rule known as 510(k). That’s not a retirement account option, but a rule that says a medical device that is “substantially equivalent” to one already on the market can be marketed without the agency having to prove it’s safe and effective.
The streamlined requirement, the Time, marked a “low bar” for the 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 paper wrote.
And it means that an implant in the sensitive tissue of the penis can be FDA-approved as “substantially equivalent” to other “soft tissue” implants without the application even mentioning the word “penis,” according to The New Yorkerswhich paved the way for a lucrative procedure that reportedly left many men permanently disfigured and tormented.
If you think that two high-profile publications revealing horrific examples of a red tape-cutting rule gone wrong will lead to significant changes, think again. As the years go by, the names of the scandals change, but the root cause remains unaddressed.
Five years ago, a Netflix documentary by two Academy Award-nominated filmmakers explored what even a former FDA commissioner called the 510(k) “loophole.” The Bleeding Edgenoticed one Magazine review of the 2018 film, patients were “personally harmed by a range of devices – including cobalt-based hip replacements, vaginal meshes, and robotic surgery devices.”
The Netflix horror stories may have been surprising in light of a report seven years earlier from the prestigious Institute of Medicine calling for the complete scrapping of the 510(k) path. That 2011 report was a result of scandals such as metal-on-metal hip replacements that crippled thousands of people. According to the Timewarned the Institute (now the National Academy of Medicine) that the rule was never intended to exclude dangerous or ineffective products.
In turn, the Institute of Medicine’s recommendation may have seemed superfluous, given that 28 years earlier a congressional oversight committee report accused the FDA of “exposing the public to unnecessary risks from medical devices” as a result of lax regulations, according to an article in the Chicago grandstand.
That 1983 Stand article was one I wrote way back in my journalism days. The commission’s report cited another article I wrote that revealed how a Chicago company filed a 510(k) calling its device “substantially equivalent” to a device on the market and attached a photo which was actually a photo of a competitor’s device with a different label. (The Justice Department declined to prosecute for a bogus entry, noting that the photo was not the only reason for the approval.)
Congress needs to 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 its zealous protectors is the powerful medical device manufacturing trade group. For example, if a member of Congress was mutilated, or a formidable political fundraiser forfeited a foot, perhaps the Institute’s policy recommendation for a new category of device approval that reduces risk would be reconsidered. That appears not 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. Investigative journalism, sordid documentaries and critical policy reports usually emerge only after years of abuse have led to formal complaints and a long trail of victims.
We know that another body part will be next to undergo avoidable abuse. We just don’t know which one yet.