FDA Examines Metal-on-Metal Hip Replacement Complications

CBS News reports that the U.S. Food and Drug Administration has ordered 21 prosthesis manufacturers to conduct research to determine if metal-on-metal replacements are making people sick or are otherwise defective.

It’s possible that any implant can cause damage, instead of easing the pain of people whose own bodies are worn down. Defective medical products can leave the manufacturer open to product liability lawsuits. If you have been adversely affected by hip replacement or other consumer products that have caused you harm, our Defective Medical Product Lawyers are here to help.

It wasn’t that long ago that DePuy Orthopedics Inc., a division of Johnson and Johnson, had hip replacement products recalled. DePuy recalled the ASR XL Acetabular System and the ASR Hip Resurfacing System because of a high failure rate within five years of surgery.

The ASR hip replacement is a metal-on-metal device that has been shown to cause patience to require hip revision surgery because of a design flaw. Now, it appears the FDA is looking into whether these metal-on-metal devices cause metallic particles to get into a person’s bloodstream and cause severe pain, shortness of breath, numbness, weakness, damaged organs and other medical complications.

According to CBS News, about one-third of the 250,000 hip replacement surgeries in the United States each year used a metal-on-metal device. The FDA gives a more detailed description of the problem, saying that the metal ball and metal cup in the devices slide against each other during walking or running, which causes metal particles to wear off and enter the bloodstream.

The FDA offers some symptoms:

• Pain in the groin, hip or leg
• Swelling at or near the hip joint
• A limp or change in walking ability

It’s possible that those symptoms have nothing to do with a defective product, a thorough evaluation by an orthopedic surgeon may be necessary to determine whether a subsequent surgery is necessary. Patients with these devices are encouraged to pay close attention to changes in their health or new symptoms, related to their:

• Heart (chest pain, shortness of breath)
• Nerves (numbness, weakness, change in vision or hearing)
• Thyroid (fatigue, feeling cold, weight gain)
• Kidney (change in urination habits)

Previous Blog Entries:

Generic Lipitor Saga Involves Company Accused of Peddling Potentially Dangerous or Defective Drugs: May 5, 2011