• 18
  • April
    2011

In an attempt to prevent government intrusion - and to make the process easier for medical device manufacturers who want their product on the market - the Food and Drug Administration has an exemption for medical implants that are similar to ones that are already approved and available. However, when looking at those medical devices included in the exemption there seems to be a disproportionate number of recalls.

According to sources, part of the problem with the exemption is that it allows medical devices that have only gone through rather minor testing to be put inside of human beings. In fact, out of the 113 medical devices that were recalled between 2005 and 2009, 80 of those had been approved through the FDA's exemption.

One recent example of this is the Depuy hip implants that were approved by the FDA in 2005. Those devices were part of the 501(k) exemption, and have since been recalled. A nationwide lawsuit has also been filed.

The problem with the hip implants is that the replacement joints and cup that the joints are matched up with are both made of metal. Over time as the metal-on-metal joints start to wear down, chromium and cobalt are released into a person's body.

Normally with hip implants the replacement joints are metal or ceramic, but the cup is actually made of plastic.

Now it's estimated 12 to 13 percent of the 93,000 that have received DePuy hip implants actually need to go back in and have the rather serious replacement surgery redone.

However, even though it's known that many with the medical implants need to go back in for the second surgery, the problem is that there is no national registry to be able to identify, locate and inform all of the people who have DePuy hip implants, which means people may be walking around with deteriorating devices but not even know it.

Source: The Virginia-Pilot, "Faulty implants argue for database," 11 April 2011