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ASR Manufacturer Avoided Initiating a Recall for Implants

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http://www.depuyhipreplacementlawsuit.com/ Hip replacement surgery is a common procedure with 250,000 surgeries occurring annually in the United States. Only 1-3 percent of those procedures will require corrective surgery. This small population should be manageable for regulators to quickly identify and track defective hip replacements. It is unfortunate that the U.S. does not have any type of national artificial joint registration implemented. This lack of a regulatory system along with the prolonged amount of time it takes for a hip replacement to malfunction has allowed DePuy to sell 93,000 hip replacements worldwide unregulated. Consequently, the DePuy hip recall has caused deleterious effects to thousands of recipients. In addition to that, DePuy is also under fire because of the alleged ‘kickback scandal’ reporting of the company paying consultants to make them use its products exclusively.

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ASR Manufacturer Avoided Initiating a Recall for Implants

  1. 1. As Published on the DePuy Hip Replacement Recall Website
  2. 2. Hip replacement surgery is a common procedure with250,000 surgeries occurring annually in the United States.Only 1-3 percent of those procedures will requirecorrective surgery. This small population should bemanageable for regulators to quickly identify and trackdefective hip replacements. It is unfortunate that the U.S.does not have any type of national artificial jointregistration implemented. This lack of a regulatory systemalong with the prolonged amount of time it takes for a hipreplacement to malfunction has allowed DePuy to sell93,000 hip replacements worldwide unregulated.Consequently, the DePuy hip recall has caused deleteriouseffects to thousands of recipients. In addition to that,DePuy is also under fire because of the alleged ‘kickbackscandal’ reporting of the company paying consultants tomake them use its products exclusively.
  3. 3. Australia and the United Kingdom were able to immediatelydetect the presence of defective hip implants because theywere fortunate enough to have artificial joint registries inplace. As early as 2007, the National Joint ReplacementRegistry in Australia reported higher than normal failurerates of the DePuy hip replacements. By 2009, DePuyvoluntarily withdrew its products from the market. In asimilar situation, the National Joint Registry of England andWales was also prompt in discovering defective hipreplacements. A study performed by English researchers atOxford University showed that 3.4 percent of patients outof 660 who received DePuy metal hip implants experiencedsigns and symptoms associated with metallosis.Comparatively, the studies also showed that 155 patientswho received a competing manufacturer’s hip implantswere examined and did not exhibit any similar side effects.
  4. 4. Around the same time, the U.S. Food and DrugAdministration received several hundreds ofcomplaints regarding metal-on-metal implants, buttook no action due to the lack of a regulatory nationalregistry. Although many surgeons have steppedforward, claiming that they immediately alerted DePuyabout complications from their defective hip implants,their claims were met with little to no response. Thepublic was not aware about the seriousness of thisissue until the media began reporting about DePuy’shigher than normal failure rates in 2010. Public outcryin 2010 from media reports about the high failurerates of the DePuy implants along with pressure fromthe FDA finally forced DePuy to initiate a recall inAugust of 2010.
  5. 5. The orthopedic manufacturer knewof its defective products andavoided initiating a DePuy hipreplacement recall .It has shown ablatant disregard for the health andsafety of its consumers.

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