There's no doubt that surgically implanted devices improve lives — drug pumps, nerve stimulators, spinal rods. But the devices can also do serious damage, like they have to Mechel Keel.
"It ruined my life, yes it did. I'm sitting here with tears," the 59-year-old grandmother says.
To stop bladder leakage, a doctor in Columbia recommended stitching a flexible mesh strap inside her pelvis. She agreed to the procedure but says the mesh never felt right. And it hardened and started cutting her insides — a scenario that's played out a thousand times over around the world.
The pain kept her from returning to her job as a hairdresser. A decade later, living in mid-Michigan, removing all the bits and pieces from the scar tissue has required multiple surgeries and resulted in chronic infections. Keel can see why her doctor in Tennessee thought the high-tech mesh would help. But she also now feels like she was "a guinea pig."
"We were the testers," she says. "There was no animal testing done. We were the animals."
More and more ailments are being treated these days with implants. And most of these medical devices, unlike pills in a medicine cabinet, don't go through human testing before being offered to patients. But many devices have been breaking down in people’s bodies, and reports about sometimes debilitating injuries are forcing the Food and Drug Administration to revamp the approval process, which is green lighting an average of a dozen new devices a day.
For devices in which failure is obviously life threatening, regulators have required some sort of human testing as part of the most stringent path — known as Pre-Market Approval. But most medical devices enter through a side door. And the FDA now acknowledges that even some seemingly harmless, inert devices have caused major problems.
"We have things like metal-on-metal hips," says medical author Jeanne Lenzer. "Outside the body, seem to function just fine. They put them in little machines, rack them back and forth, they don't break. [But] put them inside people, and something very different happens."
For example, little shards of cobalt from the joint have leached into the bloodstream of some patients and caused dementia-like symptoms, forcing a massive recall. Lenzer just wrote a scathing book titled "The Danger Within Us" about the device industry and says she was "dumbfounded" to find out how many devices never went through human testing like drugs do.
That's in part due to an expedited approval process known as 510(k). It allows manufacturers to bypass many requirements by showing their product has "substantial equivalence" to a "predicate device" already approved for use.
"You just say your device is like an old device, and the old device was never tested nor was your device," Lenzer says.
In practice, sometimes the basis for a whole family tree of devices turns out to be defective. Pelvic mesh is a good example, with much of what's on the market being based on mesh that was around prior to FDA regulations for medical devices. One study found that 16 percent of mesh on the market was based on products that had been pulled from the market over safety concerns.
The FDA has paid special attention to problems with mesh and even started requiring human testing for some products in recent years. The agency will hold an advisory committee meeting next week to discuss the safety and effectiveness of mesh.
Manufacturers have pushed back against calls to bring regulation of medical devices in line with medication. Scott Whitaker, CEO of AdvaMed, speaks for industry giants like Stryker, Johnson & Johnson and Medtronic, dismissing the idea that devices — which range from a tongue depressor to surgical robots — should all go through human trials.
"Testing should be as complete and as thorough and as ethical and as appropriate as possible," Whitaker tells WPLN. "But it doesn't all fit the same and can't all fit the same standard. Not every surgery to treat the same condition goes exactly the same way every time."
The FDA declined a request for an interview but has released some written justification for the regulatory revamp.
"We believe firmly in the merits of the 510(k) process," FDA commissioner Scott Gottlieb said in a November statement, noting that applications have doubled in size to an average of 1,100 pages. "But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices."
In the same statement, the agency confronted some specific shortcomings and charted plans to make changes to the process over the next few months:
- Pushing back on manufacturers that base any new device on one that's more than 10 years old
- More actively watching how devices perform once they're on the market rather than relying on patients to report problems
- Scrapping the 510(k) name for the something more descriptive, the "Safety and Performance Based Pathway"
Michael Matheny, a professor who tracks medical devices at Vanderbilt University, approves of the FDA’s incremental approach, and calls it thoughtful. He says he wouldn’t want changes to spark hysteria over high-profile device failures.
"It would really be unfortunate if patients wouldn't consider any medical devices at all to be used in their bodies," Matheny says. "But I do think being aware that there's nothing without risk is also important."
Matheny notes, though, that in some ways the risks are more profound than with medication. If the FDA recalls pills, a patient can at least stop taking them immediately. With devices, they're sort of stuck with it, at least for a while — and that's if a surgeon can even safely remove it.