The U.S. Food & Drug Administration (FDA) issued an updated safety communication regarding metal-on-metal hip implants on January 17, 2013. The safety communication reports how metal-on-metal hip replacement systems by design have early and high failure rates.
Furthermore, as a result of the hip replacement components making contact with one another during movement like walking or running, metal particles are released into the patient’s body and bloodstream, which may result in what the FDA calls adverse local tissue reactions (ALTR).
As detailed in the FDA’s safety alert, some patients are more likely than others to experience an accelerated degree of hip implant degradation and adverse local tissue reactions. High failure rates in metal-on-metal hip implants and adverse reactions could be the result of an active lifestyle, patients with kidney problems, poor immune system, and a number of other factors.
Though the FDA is not clear on the exact level of metal ions in the bloodstream that cause health complications, they have established frequent adverse reactions to metal ions of cobalt, chromium, and molybdenum. These reactions include:
It is important to meet with an orthopedic surgeon immediately if you begin to experience any of these adverse reactions after receiving a metal-on-metal hip implant. In addition to the health complications outlined above, further adverse reactions include:
The FDA released this new safety communication after analyzing information gathered at the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee, which was held in June 2012. This Advisory Committee was assembled by the FDA in order to draw information from experts on metal-on-metal hip replacement systems.
With the new safety announcement, the FDA has since brought forth a new measure that orders manufacturers of metal-on-metal hip replacements, such as Johnson & Johnson’s DePuy, to turn in premarket approval (PMA) applications to the FDA.
Lawyers at Carey Danis & Lowe are currently evaluating DePuy ASR Hip Replacement lawsuits and other metal-on-metal hip replacement claims. If you or someone you love has experienced health complications arising from a defective hip implant, you and your love one may be entitled to receive compensation for your medical expenses, lost wages, and pain and suffering.Defective Medical Device litigation, Hip/Knee Replacement