Product News and Recalls

Consumer Reports says tracking for implants needed

According to Consumer Reports, a major problem with medical devices in the United States is a lack of any systematic way to keep track of them.

The May issue of the magazine contains an investigation titled “Dangerous Medical Devices,” which examines the flawed federal approval process that allows potentially hazardous devices to go onto the market.

Some of those problematic devices are surgically implanted in patients’ bodies. They include metal-on-metal joint replacements for hips, and transvaginal mesh implants to treat patients suffering from urinary incontinence and pelvic organ prolapse.

The investigation highlights a principle called “substantial equivalence,” under which the FDA will approve a device because it’s similar to one that’s already been approved even if it’s never been safety tested in humans.

But Consumer Reports also calls for the creation of a “unique identifier system,” or IDs for implants, so that patients can be quickly notified about recalls and safety problems.

The article quotes Diana Zuckerman, Ph.D., president of the National Research Center for Women & Families, as saying: “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. Your doctor is supposed to notify you of a problem but may not be able to if he has retired or passed away.”

The article also notes that regulators in Australia, England and Wales were identifying serious problems with the faulty hip implants years before their counterparts in the U.S.
That’s because their countries have national joint registries — lists of every joint implanted—and the ability to track how patients fare with various models.

The U.S. has no such registry – only a voluntary system from the FDA in which doctors, manufacturers, and patients can report problems with medical devices. From 2009 through 2011, the FDA received 20,518 reports of injuries from metal-on-metal total hip replacements, including 15,137 involving a DePuy model recalled in 2010. Even that likely represents only a small fraction of the actual problems with the devices, the report says.

See the report here: http://www.consumerreports.org/cro/consumer-reports-magazine/May-2012/medical-devices.htm