Consumer Reports recently investigated the medical device industry and found that many medical devices - such as metal hip replacements, lap bands and transvaginal mesh - are rarely tested for effectiveness and safety, leaving millions of Americans at risk for injury.
The probe included interviews with doctors and patients as well as an analysis of medical research and a device-safety database maintained by the U.S. Food and Drug Administration (FDA). Consumer Reports found that for most implants and high-risk medical devices brought into the market, manufacturers are only required to file paperwork and pay the FDA a user fee of about $4,000 before they can begin selling a medical device.
Frequently, problems with safety are only found when patients experience severe adverse reactions to the devices. This leads to events like the 2010 worldwide recall of all 93,000 DePuy’s ASR XL hip replacements after patients experienced high failure rates.
For the smaller number of high-risk medical devices, the government allows manufacturers to sell their products based on studies that are less rigorous than for prescription drugs.