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.


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.

Patient safety advocates are asking Congress to step up the regulation of such medical devices as hip replacements and heart stents. Seniors are especially at risk, since surgical complications can be more serious later in life, warns Lisa McGiffert, who directs the Consumers Union "Safe Patient Project."

"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 the need for testing medical devices, surgical mesh is another concern. It has been known to cause problems after surgery. The mesh is often used instead of sutures, McGiffert explains.

"It's placed internally. So if the mesh goes awry, it's very, very difficult to remove and can cause pain for the rest of someone's life."

She adds that 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. 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 this year in order to maintain at least some medical device monitoring. This law requires manufacturers to submit their own clinical data supporting their claims and also to report incidents in which a medical device contributed to a death or serious injury. Watchdog groups such as the Consumers Union are pushing for tougher oversight, more testing and safety monitoring.

Congress is taking up the issue of medical device regulation. This year, the Medical Device User Fee Act (MDUFA) must be reauthorized in order to maintain some oversight into the use of such devices as stents and artificial joints. Watchdog groups, including the Consumers Union, are demanding stricter regulation, pointing out that there is no current requirement that the Food and Drug Administration (FDA) test, monitor or track these devices. Comments from Lisa McGiffert, director of the group's Safe Patient Project.

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. Patient safety advocates are 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."

She says Congress needs to reauthorize the Medical Device User Fee Act 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. Groups such as the Consumers Union are pushing for tougher oversight, more testing and safety-monitoring.

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 people's, 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 F-D-A for distribution or sale. And according to the General Accounting Office, more than 700 medical devices are recalled each year.

This year, Congress is taking up the issue of medical device regulation. Kathleen Ryan reports on what some call the surprising lack of government oversight for such devices as artificial hips and stents.

Ryan reporting.

Reach McGiffert at 512-415-5405.