Artificial hip parts aren’t tested for safety
It sounds almost too crazy to believe. The Food and Drug Administration (FDA) puts new drugs through rigorous clinical trials before approving them, but when it comes to new medical devices, ones implanted inside the body through invasive surgery, the standards are far more lax. Implants, such as artificial hips, can be sold without first going through trials. In fact, device makers can bundle components from an unapproved implant into an existing one and sell a device with very little testing, leaving unsuspecting patients to serve as guinea pigs.
“You are basically testing these devices in an uncontrolled way on a large number of people,” Dr. Sidney M. Wolfe, director of the watchdog group Public Citizen told the New York Times.
It’s a notion that is quickly dismissed by DePuy Orthopaedics, the world’s largest maker of artificial hips. The company recalled two different hip replacement system parts in August 2010 because of because an unusually high number of hip implants were failing, many after five years or less of use. Most hip implants can last up to 35 years before needing replacement.
An estimated 93,000 people are affected by the recall. The exact number is not known as DePuy does not track the devices once they have been implanted.
Should new or improved implants go through the same rigorous testing as new drugs? Victims of the recalled hip implant say they should. For now they are left with constant pain, disability, and the hardship of having a second hip replacement surgery.