According to latest news from the FDA, it has issued a “Safety Notification” over the use of metal-on-metal hip implant devices. In the notification issued on January 17, 2013 it was stated that all metal-on-metal implants could be risky and could jeopardize the health and well-being of consumers. The notification was based on the recent evaluation conducted by the agency to judge the potential risks of metal-on-metal implants that they pose to patients and consumers.

The news could be unsettling for those companies that are actively engaged in the manufacturing and distribution of metal-on-metal implants as it could increase the number of lawsuits brought in by consumers against them. It is imperative to underline here that most of the metal-on-metal implants are facing lawsuits in various Multi District Litigation Courts across the United States and many are yet to be heard and tried.

According to the safety notification published by the FDA all the metal implant devices that have a ball and cup joint combination composed of metals  on both the sides pose serious risks as when these metals rub together they release metal particles that can easily make their way into the blood stream and other major parts of the body like bone and soft tissues. The agency has also warned that the potential risks of Metallosis with these implants have also not reduced and that health care professionals should take precautionary measures while implanting such devices.

About Metallosis

Metallosis is a condition that occurs when body tissues and cells get contaminated with unwanted metal debris. In fact most of the metal-on-metal implant devices are made up of metallic coils and components that tend to friction and rubbing. The continuous rubbing and friction of the metal components causes release of metallic particles from the device to the adjacent tissue and vascular system. The accumulation of metal debris and components leads to tissue swelling and pain. Putting it simply Metallosis is a condition that is caused by the buildup of metallic debris in the soft tissue of the body.

Side Effects that people experience with metal-on-metal implants are:

  • High failure rate of the implants
  • Pain in the region around implans
  • Squeaking noises
  • Bone fractures
  • Metal poisoning or metallosis
  • Mortality
  • Dislocation
  • Heterotopic Ossification
  • Infection
  • Avascular Necrosis (Osteonecrosis)
  • Component Loosening