We pay a high price for unregulated medical devices

When we talk about misbehaving medical companies, we often go straight to big bad Pharma. But we shouldn’t overlook the ongoing issues with approval and regulation of medical devices, which have led to serious harm for countless Americans. Fortunately, new investigations and research are raising awareness about the lack of oversight of medical devices and the consequences this has engendered.

Hip, hip, no way!

It sounds crazy that a hip implant that poisoned thousands of patients by leaking toxic chemicals would continue to be sold for over a decade. But that’s exactly what happened with Johnson & Johnson’s metal-on-metal hip implants, Jeanne Lenzer, journalist and author of The Danger Within Us: America’s Untested, Unregulated Medical Device Industry, explains in a recent New York Times article. From 2000 to 2013, about 150,000 patients received these implants, not knowing that the implants had never been tested on humans in a clinical trial, or that the ions in the metal could leak into their body. 

“Most high-risk devices on the market have undergone no clinical testing at all.”

This is far from the only medical device that the FDA has approved with little to no evidence of effectiveness or safety. While “many people assume that the Food and Drug Administration requires rigorous testing of medical devices before they are approved,” writes Lenzer, “In fact, most high-risk devices on the market have undergone no clinical testing at all.” 

Even when early trials reveal safety concerns about a medical device, the FDA often approves them nevertheless, allowing companies to market their device widely on the condition that they conduct subsequent studies showing the device is safe. The standard for post-approval research is low, writes Lenzer. Cyberonics, the maker of a vagus nerve stimulator, submitted five studies “proving” the device was safe, none of which included data on how many patients died. And a recent study on the Pinnacle hip implant found that Johnson & Johnson’s post-approval study was “poorly designed and implemented,” including manipulated data and false claims about the study’s rigor. 

The device snowball effect

The low threshold for approval of medical devices has another disturbing consequence – the proliferation of unsafe devices piggybacking on the approval of one unsafe device. For example, transvaginal mesh for pelvic organ prolapse was originally approved by the FDA nearly 20 years ago, and has since been linked to severe pain in some patients due to mesh exposure and erosion. However, since the approval of the original device, 61 other transvaginal mesh products were approved, with no clinical trial evidence, according to a 2017 study in The BMJ.

Why is the approval and regulation of medical devices so lax? Lenzer explains the history of how this “device snowball effect” got started, in a WBUR interview

“Once devices came under FDA regulation, they said, ‘OK, all you guys that are already out on the market, you can stay on the market… With the high-risk devices, companies were able to keep putting new versions on the market simply by tweaking them and saying, ‘Well, there’s already a device on the market like this. So we’re just gonna add a supplement.’ Well, the original device was never put through clinical trials in the first place.”

Unsure about Essure

The pattern of devices being hastily approved and marketed before ensuring safety is especially noticeable in gynecological devices. Besides the problems with transvaginal mesh products, power morcellators and sterilization devices have also been found to cause severe complications.

Power morcellators were meant to facilitate less invasive hysterectomies, but it was later discovered that they could spread undetected cancers throughout the body. Despite hearing about the potential risks as early as 2006, Johnson & Johnson kept marketing the device for years, denying that any events were reported. If it wasn’t for activists like the late Dr. Amy Reed and her husband, the FDA might never have issued a warning against using this device. 

The latest in this disturbing trend was a sterilization device called Essure, meant to be a safer alternative to surgery that would avoid complications. However, tens of thousands of patients who received the device experienced distressing side effects due to the device migrating or puncturing an organ, or an allergic reaction to the nickel in the device, The Washington Post reported last year. The FDA finally issued a “black box” warning about Essure…14 years after the device first went on the market.

These examples of hasty approval, lack of evidence, and patient harm are not aberrations, as Lenzer writes in her new book. They are widespread problems caused by an outdated and broken medical device approval and regulation process. We have to fix the problem at its source by demanding evidence before approval, restrictions on marketing, and a more robust reporting system for medical devices (and drugs too, while we’re at it!)