Johnson and Johnson Predicted Forty Percent Failure of Metal-on-Metal Hip Implants
According to an article in The New York Times published on January 22, 2013, Johnson & Johnson estimated in 2011 that nearly 40 percent of its all-metal hip replacement devices would fail within five years of implantation. The company never released these findings to the public and was actually playing down similar findings about the device provided by a British implant registry. Very soon the Johnson & Johnson internal analysis and hundreds of other company documents will likely become public when the first of an anticipated 10,000 patient lawsuits get underway in court later this month. The situation represents one of the largest medical device failures seen in recent decades.
How Do Metal-on-Metal Hip Implants Work?
Metal-on-metal hip implants rely on a metal ball and metal cup, which slide around each other as a patient walks or runs. During these activities, metal from other parts of the implant can be released into locations where two implant components connect. As tiny metal particles wear off, they can cause damage to the patient's bone and/or soft tissue. This can result in pain, a loosening implant, device failure, and ultimately the need for revision surgery. In addition, a portion of the released metal ions will enter the patient's bloodstream and can potentially reach other areas of the body, resulting in unpleasant symptoms and/or illness.
While Johnson & Johnson recalled one of its troubled hip implant devices in 2011 the FDA currently does not have sufficient scientific data to determine how great the concentration of metal ions must be in a patient's body or blood in order to produce adverse systemic effects. At present, reactions seem to vary among patients.
Recently, the FDA notified healthcare professionals that very soon it would be providing updated safety recommendations regarding the use of metal-on-metal hip implants. The new recommendations and safety information are a result of the FDA's current assessment of the metal-on-metal hip implants based on the evaluation of published literature and results of the June 2012 Orthopedic and Rehabilitation Devices Advisory Panel meeting.
Physicians are encouraged to review safety communications prior to undertaking a metal-on-metal hip replacement with their patients. They should pay special attention to recommendations regarding pre-surgery, patient follow-up, imaging the implant, and monitoring and assessing metal ion levels and considerations for device revision. Patient recommendations also are provided for those considering hip implants and those who already have a metal-on-metal hip implant.
If you or someone in your family has been harmed by a metal-on-metal hip implant, we encourage you to contact the attorneys at Bachus & Schanker, LLC to discuss your situation and how we can help you receive the compensation you deserve for your suffering. You can also call us at 866-748-4773.
For more information on the failure of metal-on-metal hip implants, read the New York Times article about hip implant failures.