Product News and Recalls

FDA unveils new rules for metal hip implants

Consumer Reports describes new U.S. Food and Drug Administration rules for “metal-on-metal” hip implants, which feature both a ball and a socket coated in a combination of cobalt and chromium.

The new regulations will give manufacturers 90 days in which to file applications including the results of clinical trials and other “valid scientific evidence” showing that the devices are safe and effective. Manufacturers who fail to produce this evidence will be prohibited from selling the implants in the United States.

The all-metal hip implants have generated thousands of reports concerning patients who were injured after the devices broke down and needed replacement after only a few years. They’re also prone to shedding toxic metal debris in patients’ bodies.

In the first of about 11,000 lawsuits pertaining to the DePuy Orthopaedics implant alone, a jury awarded one of the implant recipients $8.3 million.

Consumer Reports says the stricter regulations are sorely needed.

“Incredibly, for the past decade manufacturers have been aggressively marketing the devices as being better than conventional varieties without that evidence, to the great harm of patients,” the piece says.

The FDA says that if you have an all-metal hip implant, you should watch out for the following symptoms:

  • Swelling, numbness, noise (such as a popping, grinding, clicking or squeaking of the hip implant), and/or a change in ability to walk.
  • Skin rash.
  • Deterioration in hearing or eyesight.
  • Mental changes such as depression or cognitive impairment.
  • Kidney problems
  • Thyroid dysfunction, including neck discomfort, fatigue, weight gain or feeling cold.

You should consult with a doctor if you have any ongoing symptoms or health concerns from a DePuy hip implant. If you have significant injuries, you should also consult with a DePuy hip lawyer to discuss your legal rights.

See the story here:

http://news.consumerreports.org/health/2013/01/fda-cracks-down-on-all-metal-hip-replacements.html