FDA Edges Closer Towards Action on Metal Hip Implants
Previously we have chronicled some of the problems surrounding the De Puy ASR metal on metal hips that have required revisions by countless people in the USA and elsewhere.
Depuy ASR Hip Replacement Linked To Metal Toxicity and Additional Surgery
In April 2010, the United Kingdom’s (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert that included specific follow-up recommendations for patients implanted with metal on metal hip replacements. The recommendations included blood tests and imaging for patients with painful metal on metal (MoM) hip implants. In 2009, citing “declining sales, Johnson and & Johnson stopped marketing the De Puy ASR. On August 26, 2010 the De Puy ASR was effectively recalled.” (DePuy Orthopaedics, Inc. is a Johnson & Johnson company.)
In May 2011 the FDA ordered manufacturers of metal on metal implants to collect more safety data on the devices. Covered by the order are DePuy ASR, and devices by Zimmer and Stryker.
In February 2012 the New York Times reported that Johnson & Johnson continued to market an artificial hip in Europe and elsewhere after the 2009 rejection by the FDA of its sale in the USA.
In February 2012, MHRA published a medical device alert with updated advice on the management and monitoring of patients implanted with MoM hip systems recommending that people with metal on metal hip implants undergo annual examinations to make sure they are not suffering tissue damage or other problems.
On March 29, 2012, The FDA announced an Advisory panel hearing set for June 27-28 to gather information that will help decide if new requirements are needed before a device can be sold in the USA.
About 270,000 hip replacements are performed each year in the United States, accounting for nearly 40 percent of all joint replacements, according to the British Medical Journal. Failure rates on the nearly 500,000 people in the USA who have received metal on metal implants is unclear, but data from orthopedic registries in Australia and England has shown that all-metal hips are failing prematurely at two to three times the rate of those made from metal and plastic. Studies have indicated that the use of the larger ball component increases the amount of torque and motion at the points where that ball and cup or the ball and stem are joined, generating debris.
This office is currently representing numerous people injured by De Puy ASR and other metal on metal hip implants. If you would like more information contact the Brandi Law Firm at (800) 481-1615 or click here to learn more about the Brandi Law Firm DePuy Attorneys.