Reports of problems with transvaginal mesh implanted to treat pelvic floor disorders and incontinence in women have led the Food and Drug Administration to scrutinize the product more carefully. Ted S. Warren/AP hide caption
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Ted S. Warren/AP
Ted S. Warren/AP
There’s no doubt that surgically implanted medical devices can improve lives.
Hip and knee replacements can help people regain their mobility. Drug pumps can deliver doses of pain-relieving medicine on demand. And metal rods can stabilize spines and broken bones.
But implanted devices can also do serious damage, as happened to Mechel Keel, who lives in Owosso, Mich.
To fix her leaky bladder, an OB-GYN stitched a flexible mesh strap inside her pelvis in 2004. But within months the mesh hardened and started cutting her insides.
The pain kept her from returning to her job as a hairdresser. The injuries and scar tissue that developed required multiple surgeries to correct and also resulted in chronic infections.
Keel says she understands 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.”
Thousands of cases of complications from surgical mesh have been reported to the Food and Drug Administration. More and more ailments are being treated these days with medical devices, including implants. And most of these medical devices, unlike pills in a medicine cabinet, don’t go through human testing before being offered to patients.
Enlarge this imageAfter she experienced bladder problems, Mechel Keel of Owosso, Mich., had flexible mesh implanted. But the mesh hardened inside her, causing pain and infections. In this 2015 photo, she is awaiting surgery to remove parts of the failed mesh. Courtesy of Mechel Keel hide caption
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Courtesy of Mechel Keel
Courtesy of Mechel Keel
But some devices break down or malfunction in people’s bodies, and reports about sometimes debilitating injuries have led the FDA to rethink how it assesses medical devices before allowing them to be sold.
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 premarket approval. But most medical devices enter the market after manufacturers provide technical information and show that the devices are similar to others that have been legally sold previously.
The FDA has acknowledged that some seemingly safe devices have caused major problems, and the agency has elevated the risk level of those products following reports of injuries, as it did with urogynecologic surgical mesh for some uses in 2016. “Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market,” the agency said in a recent statement.
“We have things like metal-on-metal hips,” says health journalist Jeanne Lenzer about a kind of orthopedic implant. “Outside the body, [they] 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.”
There have been massive recalls of hip implants, for example, due to devices causing swelling and pain. And there have been problems with weakened bones in patients who received hip implants that contained plastic.
Lenzer 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 the way drugs do.
Medical Treatments
Are Implanted Medical Devices Creating A ‘Danger Within Us’?
Are Implanted Medical Devices Creating A ‘Danger Within Us’?
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