FORT LAUDERDALE, Fla.
- May 23, 2013
-- After years of controversy, Johnson & Johnson’s orthopedic unit, DePuy Orthopaedics, announced it was ceasing production of all-metal hip implants because of “high early failure rates,” according to a recent New York Times article. This move reflects an industry-wide trend to abandon the once widely used devices due to high failure causing necessary revision surgery as well as significant health problems associated with the all-metal hips. In 2010, DePuy recalled the Articular Surface Replacement model or ASR because it was failing within 5 years of implant, well short of the 15- year average life of an artificial hip.
However, after the 2010 recall, DePuy continued to sell a similar model, the Pinnacle, insisting that this particular model was safe and as effective as other hip replacement systems. According to DePuy, its decision to cease production of the metal hip devices is not a response to the dangers the devices pose to patients, but rather guided by business economics. DePuy representatives stated that its decision was made due to sharply declining surgeon demand for all-metal devices and a recent ruling by the Food and Drug Administration (FDA) which will require clinical studies to test the product. The FDA recently determined that companies which marketed all-metal hip devices that were allowed to go to market without proof of prior clinical testing, would now be required to run those clinical studies to keep their products on the market. DePuy has decided not to pursue such studies, but will simply cease production of the all-metal devices. This begs the question whether even DePuy believes its products are safe and would withstand clinical testing.
Depuy also noted that it would be discontinuing sales of a metal component that can be used with a ceramic hip implant called the Complete. Sales of the metal components used in both the Pinnacle and the Complete will end in August. Although DePuy is now ending production of the metal-on-metal hip devices, there are thousands of patients who have suffered with these implants. There are currently over 10,000 lawsuits that have been filed over the ASR and thousands others based on the Pinnacle. Additional hip implant failures are still occurring daily, so this number is expected to increase.
Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who received any metal-on-metal hip device including the DePuy Pinnacle, DePuy ASR, Stryker Rejuvenate, ABGII and Accolade, Wright Conserve and Profemur and Biomet M2A Magnum by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.