April 11, 2012
Dangerous Medical Devices: Most medical implants have never been tested
A recent article by Consumer Reports addresses the potential risks associated with medical devices such as artificial joints and pelvic mesh. Although millions live each day with artificial medical devices in their bodies, the article reports that "Often, the only safety ?testing' that occurs is in the bodies of unsuspecting patients."
According to National Research Center for Women and Families President Diana Zuckerman, who spoke with Consumer Reports, "Standards for devices exist, they just don't make sense."
Many medical devices, including pelvic mesh and DePuy® hip implants, were tested through the 510 (k) clearing process. This process clears products to be used in patients without clinical testing if the manufacturers can show that the devices are "substantially equivalent" to an implant already on the market. Rather than recognizing that this system fails to protect patients from potentially dangerous products and working to develop a new regulatory system, Congress is now debating a proposed law that would move products to the market even faster.
In addition to sharing the stories of three people hurt by various medical devices, Consumer Reports explores the problems with the current medical device regulation system, offers tips about what consumers can do to protect themselves and gives recommendations about how the system could be improved.
Read the full Consumer Reports article on medical devices and safety.
Motley Rice represents patients allegedly harmed by pelvic mesh and DePuy hip implants. Learn more about how our medical lawyers fight for people hurt by pharmaceutical drugs and medical devices and work to hold accountable those responsible for negligent medical care, corporate wrongdoing, and inadequate warning, research and testing.