Pharmaceutical

Consumer group lobbies for stricter oversight of medical devices

Consumers Union (CU) is joining the fight to urge lawmakers to require stricter oversight of medical devices, especially since it says the current practice puts consumers, especially senior citizens, at risk for ongoing complications. CU is a nonprofit consumer watchdog that also publishes Consumer Reports magazine and ConsumerReports.org.

The Food and Drug Administration (FDA) is charged with protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; and human and veterinary drugs, vaccines and other biological products and medical devices intended for human use are safe and effective. Foods are regularly checked, and drugs must go through rigorous testing before they are approved for sale. But, the vast majority of medical devices are an exception. Up to 90 percent of devices such as artificial hips and surgical mesh are approved without clinical testing under an accelerated process if the devices are similar to ones already on the market.

This process bodes well for medical device manufacturers, who say this puts much-needed devices on the market faster and speeds medical technology. Yet, more and more evidence suggests this practice is dangerous. As many as 5,000 deaths have been associated with defective medical devices in the past few years.

The FDA’s accelerated approval process for medical devices only recently became an issue when the FDA began receiving reports of problems with a new type of artificial hip. Traditional hip implants are made with ceramic or plastic parts, but newer versions featuring a metal-on-metal design were introduced within the past decade. Because they were similar to devices already on the market, most sped through the approval process.

It didn’t take long for surgeons to realize the devices were flawed. They were failing at a faster than expected rate – even faster than traditional hip implants. But why? Doctors soon discovered that the materials used to make the artificial hips could actually be toxic. As the metal parts rubbed together, bits of metal debris could drop into the joint space, potentially causing inflammation that may speed up the devices’ failure. Not only that, but the bits of metal may be seeping into the patients’ bloodstream, possibly causing type of blood poisoning known as metallosis.

The reports of problems with all-metal hip implants began mounting, and the FDA had little choice but to address the issue. Last year, the agency ordered the more than 20 manufacturers of metal-on-metal hip implants to conduct safety studies on their devices and to note in particular cases of heavy metals in the blood.

Perhaps the most troubling problem with these metal-on-metal hips is that many recipients of them must undergo revision surgery to remove and replace defective implants. Revision surgeries are often more invasive and dangerous than the original surgery, and can require much longer recovery periods. This is a particular concern for senior citizens, many of whom are recipients of these defective hips.

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

Source: Fowler Tribune