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Wright Medical Tried to Block Approval of Rival’s Birmingham Metal-On-Metal Hip Implant | cialis online

Wright Medical Tried to Block Approval of Rival’s Birmingham Metal-On-Metal Hip Implant

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Device maker, Wright Medical, worked to block approval of its rival, Birmingham’s, metal-on-metal hip implant device from reaching United States implant patients, according to U.S. Food & Drug Administration (FDA) filings. At the same time that the agency was reviewing a pre-market approval (PMA) application for the Smith & Nephew’s device—the first metal-on-metal implant—Wright filed a citizen’s petition that claimed the study behind the PMA application was not sufficient to prove the device’s safety and efficacy, said MassDevice The FDA granted two PMAs to Smith & Nephew for the device—May 2006 and October 2006 (for additional sizes)—while Wright Medical had at least two PMAs in the

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same class (metal-on-metal) for its Conserve and Lineage implants devices, according to MassDevice. According to

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Wright, the clinical data supporting Birmingham’s PMA was flawed as it only covered one surgeon’s cases, Dr. Derek McMinn, the metal-on-metal implant inventor, MassDevice explained. “The PMA for the BHR—which rests on a retrospective, uncontrolled case series at a single center by a single physician without any protocol and with incomplete follow-up—is not scientifically valid and does not satisfy the agency’s standards for safety and effectiveness,” according to an FDA filing. “Smith & Nephew tries to create the impression that this was a multi-center trial. Yet, at the [FDA advisory] panel meeting, the acting panel chairperson stated that the data was ‘an unusual PMA based on a retrospective study designed by a single surgeon based on a British data set,” it added, according to MassDevice. The implants, introduced in 1997, were created by McMinn in what MassDevice described as a “back-yard shed.” According to McMinn, metal ion shedding risks could be minimized with a construction that kept metal surfaces from touching each other. Midland Medical Technologies’ (MMT) Birmingham Hip Resurfacing device was marketed to younger, active patients needing a hip that would be much longer lasting than then-current models. In a carefully controlled release, MMT touted good technique and identified “good patient candidates” with its team of “hand-picked surgeons,” said Mass Device. In 2004, Smith & Nephew acquired MMT for $117 million. McMinn’s device spurred an all-metal hip boom as Smith & Nephew’s competition released their own versions: Zimmer’s Durom and Johnson & Johnson’s Pinnacle and DePuy ASR models. The DePuy ASR was recalled globally in August 2010, prompting numerous class action and multidistrict lawsuits (MDLs), increased agency scrutiny, and public outcry, said MassDevice. In fact, an MDL involving more than 1,100 personal injury DePuy Pinnacle implant lawsuits is in progress in the U.S. District Court for the Northern District of Texas. The first of the ASR implant lawsuits is expected to begin jury trials this year.

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