Wednesday, March 14, 2012

3rd MDL Approved For Metal On Metal Hip Implant Lawsuits

From Drugwatch

Another manufacturer of defective metal-on-metal hip-replacement implants is facing Multi district Litigation (MDL) . Wright Medical Technology’s Conserve Plus implants are under fire for causing injuries similar to those produced by the DePuy Pinnacle hip system.

This is the third MDL organized to consolidate pre-trial proceedings for plaintiffs suing over dangerous hip implants. Four lawsuits are effected by the MDL and 16 more are expected to be added. The Wright Conserve MDL will be heard by Judge William S. Duffey, Jr., in the U.S. District Court for the Northern District of Georgia.

More than 3,500 lawsuits have been filed over DePuy ASR hip replacement systems in the United States, and they have been consolidated in the U.S. District Court for the Northern District of Ohio. An MDL has been established in the U.S. District Court for the Northern District of Texas for more than 900 patients filing suits over the DePuy Pinnacle hip replacement systems.

Patients suing Wright Medical say they were not warned about the real risk of early failure of the medical devices. Furthermore, they have suffered from metallosis, high levels of chromium and colbalt as a result of metal shavings produced when the metal ball and metal socket of the hip implant grind against each other. The metal fragments also damaged tissue, which one study found increases the risk of cancer.

Published in the United Kingdom’s The Telegraph, the study was conducted by researchers at the University of Bristol and involved 72 patients. Of the subjects, 17 were found to have genetic damage to the bladder and three already had cancer. The Telegraph also reported that because of the soft-tissue damage resulting from metallosis, revision surgery for patients whose metal-on-metal hip implants have failed can be complicated.

The National Joint Registry for England and Wales released its Eighth Annual Report in September 2011 and found that Wright Conserve’s revision rates were second only to the ASR devices manufactured by DePuy, which have been recalled. This means about one in 12 Wright Conserve patients will need a revision surgery five years after receiving the device.

The Wright Conserve hip-replacement system includes the Conserve Femoral Surface Replacement, the Conserve Plus Total Resurfacing Hip System, the Conserve Total A-Class Advanced Metal and the Conserve Total Hip System. The system was approved by the U.S. Food and Drug Administration (FDA) through its 510(k) process, which allows products similar to ones already on the market to skip patient testing. More than 200 adverse events involving the Wright Conserve have been reported to the FDA since the device was approved.

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