Patients Question How FDA Approves Medical Devices

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.