Investigation: Most Medical Devices Implanted in Patients Without Testing


Some popular medical devices, including hip replacements, lap-bands and defibrillators may not be as safe as the people implanted with them may think, according to a new eye-opening investigation.

According to Consumer Reports, the majority of medical implants are not tested to make sure they are safe. In fact, much of what medical implant or high-risk device manufacturers have to do to get their product sold is file some paperwork and pay the Food and Drug Administration (FDA) a fee of about $4,000 with minimal testing.

“Standards for devices exist, they just don’t make sense,” industry critic Dr. Diana Zuckerman, president of the National Research Center for Women & Families, said in a Consumer Reports release.

Consumer Reports’ investigation determined that medical devices are often tested on unsuspecting members of the public instead of before implantation. The problem is that there’s no system for the government, researchers or patients to learn of potential problems with devices without a serial number on the device or a company that catalogs problem.

“A coffeemaker or toaster oven has a unique serial number so if a problem is found, the company can contact you to warn you. Your artificial hip or heart valve doesn’t,” Zuckerman says. If no changes are implemented, these problems will persist.

Read the original article here.