Written by Mary Anne Meyers

KANSAS CITY, Mo. – People might be surprised to learn that the medical devices surgically implanted in their bodies are subject to almost no government regulation, testing or monitoring. The Consumers Union is one group looking to change that and, along with other patient safety advocates, is asking Congress to step up the regulation of such medical devices as hip replacements and heart stents.

Lisa McGiffert, who directs the Consumers Union “Safe Patient Project,” says seniors are especially at risk, since surgical complications can be more serious later in life.

“Having to do any surgery when you’re older is a dangerous endeavor, but having to do it over again if something goes wrong can really cause a lot of harm.”

In addition to medical device testing, another concern is the use of surgical mesh, which has been known to cause problems after surgery. McGiffert says the mesh is being used more often to replace sutures.

“It’s placed internally so that, if it goes awry, it’s very, very difficult to remove the mesh and can cause pain for the rest of someone’s life.”

She adds more than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective before being cleared by the Food and Drug Administration (FDA) for distribution or sale. And according to the General Accounting Office, more than 700 medical devices are recalled each year.

McGiffert says Congress needs to reauthorize the Medical Device User Fee Act (MDUFA) this year in order to maintain at least some medical device monitoring. The law requires manufacturers to submit their own clinical data to support their claims, and also that they report incidents in which a medical device contributed to a death or serious injury. Such groups as the Consumers Union are pushing for even tougher oversight, including more testing and safety monitoring.