FDA Calls for Better Hip Implant Safety Studies

A report by the Food and Drug Administration (FDA) suggests more research is needed to determine the safety risks of metal-on-metal hip implants.

The FDA is meeting this week to review the safety of metal-on-metal hip devices.

The agency’s report said that studies of metal-on-metal hip replacements and their revision rates do not sufficiently review risks such as localized response by patients’ immune systems, dislocation, and dangerous increase in levels of metals in patients’ bloodstreams, according to Law360 (subscription required).

The revision rate refers to when a hip implant fails and must be surgically removed or replaced. The FDA report said the rate for metal-on-metal devices “is likely not lower” than other systems, according to Law360. Data on metal hips indicates they are more prone to failure than other types of hip replacements.

Thousands of Americans have been implanted with metal-on-metal hips. In 2010, Johnson & Johnson's DePuy Orthopedics recalled its metal-on-metal ASR hip system after it was linked to high failure rate. J&J faces thousands of lawsuits due to problems with the devices, as do other manufacturers.

If you or a loved one has been harmed by a metal on metal hip implant, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you. For legal help, call (800) 581-6358.

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