A recent New York Times article highlighted the growing problems with Metal on Metal implants, such as the DePuy ASR and Zimmer Durom Cup, and what is being done to identify each of the implants that are defective. According to the article,
"All metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007. About 7,700 complaints have been filed in connection with that recall"
It is estimated approximately 1/3 of hip implants performed each year are metal on metal, and 500,000 patients have been implanted with a metal on metal replacement at some point in their lives.
The DePuy ASR, which was recalled in August 2010 accounted for 75% of the complaints that were reviewed by the NYT. Under the 510k approval process nearly all of the metal on metal devices were sold without testing in patients and without a requirement that the manufacturers track adverse events and their failure rates. Many patients with the MoM implants have reported having tissue damage caused by metallic particles in the surrounding soft tissue and also in the patient's blood stream. It's possible these harmful side effects could have been avoided had the MoM implants undergone clinical testing prior to their approval.
If you have a metal on metal hip implant device contact the attorneys at Rheingold, Giuffra, Ruffo & Plotkin LLP for a free consultation.
Since the ASR recall and the withdrawal of the Zimmer Durom Cup from the market, the use of metal on metal implants has plummeted to about 5% of the hip implant market share. One doctor likened the use of a MoM product as, "playing Russian roulette."
The FDA has ordered all manufacturers to investigate the failure rates and adverse events in their MoM products, but it could take years before there are results from those investigations. Many of the companies don't even know how to begin investigating such a wide ranging problem. While the world waits, patients will continue to be implanted with metal on metal implant devices and will continue to suffer from the side effects. Revision rates for the ASR were first reported at around 12-13% in the first three years after implantation, but now at least one study has moved that figure to 50% within the first 5 years.
If you have a MoM hip implant device contact the attorneys at Rheingold, Giuffra, Ruffo & Plotkin LLP for a free consultation. Our firm has handled thousands of medical device product liability litigations and are deeply involved in the MoM implant litigations.