Studies to Assess Safety of Biomet Hip Replacement Underway in U.S., Japan
The manufacturer facing a growing number of Biomet hip replacement lawsuits is in the midst of collecting data for two studies assessing the safety of its M2a Magnum Hip Replacement System and other metal implants.
According to a notice posted on clinicaltrials.gov on November 6, 2012, patients who received metal-on-metal hip devices marketed by Biomet Inc. are being enrolled in an observational study examining adverse local tissue reactions that may have manifested in the months following the hip’s initial implantation. This study has been conducted in cooperation with a 2011 surveillance order by the U.S. Food & Drug Administration (FDA) that required all metal-on-metal hip manufacturers to conduct safety testing on their products. It is expected that this study will be completed in December 2014.
This is not Biomet’s only safety study regarding its metal-on-metal hips, however. According to an update published March 6, 2013 on clinicaltrials.gov, the British manufacturer of artificial hips is no longer recruiting participants for a study involving the metal ion release and renal function of M2Magum hip recipients it has been conducting in Japan since 2009. Researchers will collect final data in December 2013, and the study is expected to be completed in December 2021.
Biomet Hip Lawsuit Claims Allege Early Failure
Meanwhile, dozens of plaintiffs in Biomet hip lawsuit claims have alleged side effects stemming from the M2a Magnum hip device, which include but are not limited to pain, swelling, metallosis (metal ion poisoning) and other adverse tissue reactions. These cases allege the implant was defectively designed by Biomet in that its metal components may break off, shedding debris into the patient’s blood stream.
Many of these cases are now pending in a multidistrict litigation (MDL) in the U.S. District Court, Northern District of Indiana. (In re: Biomet M2a Magnum Hip Implant Products Liability Litigation – MDL No. 2391)
Given the rising concerns over metal-on-metal hip replacements, the FDA has vowed to investigate the safety of these implants. In January, the agency proposed new regulations that would require all manufacturers of this class of devices to submit all products for pre-market approval, thus making them ineligible to receive clearance through the 510(k) process. The agency also recommended that doctors conduct metal ion testing for all recipients in the event that they are experiencing pain, swelling, loosening of the implant and other symptoms associated with early hip failure.
How Do I File a Biomet Hip Replacement Lawsuit? Contact the Firm Today.
For those who received the Biomet M2a Magnum hip replacement and suffered a myriad of painful complications afterward, there is no time to waste in filing a lawsuit against the manufacturer. Contact the lawyers at Bernstein Liebhard LLP to learn about your legal rights at (877) 779-1414.