Pete Kaufman Reviews The FDA’s Approval Process And Offers a Brief Case Study of The DePuy ASR Hip Implant
The DePuy ASR metal-on-metal hip implant has brought pain to people all across the world who have been victimized by the failure of this device. In August 2010, Johnson & Johnson finally announced the recall of this defective product, which had a shocking failure rate of around 49% after six years of use, according to… read more
SOUND to Prevent Medical Devices Based Off Recalled Designs
An act being considered by the Senate and the House of Representatives takes aim at medical devices whose design was based off of previously recalled products. The Safety of Untested and New Devices Act, known as SOUND, was brought about largely because of complications with a transvaginal mesh implant that had numerous complications. The issue… read more
DePuy Sold Remaining Hip Implant Inventory Before Issuing Recall
More information continues to come out regarding the DePuy ASR hip implant and the problems associated with the device that led to a recall. It was reported that, in 2009, the Food and Drug Administration sent DePuy a letter denying approval of one version of the hip implant device that was currently available in other… read more
FDA Tells Spinal Implant Maker Synthes to Fix Plant Problems
First came the recalls that were initiated against hip implants and infant Tylenol made by subsidiaries of Johnson & Johnson. These were owing to serious safety concerns with the products. Now, another potential Johnson & Johnson company is being warned of its product’s deficiencies by the Food and Drug Administration. The FDA fired off a… read more
ASR HIP PATIENTS WHO HAVE NOT YET SUFFERED SYMPTOMS
IMPORTANT INFORMATION FOR ASR HIP PATIENTS WHO HAVE NOT YET SUFFERED SYMPTOMS from Pete Kaufman of Panish | Shea | Ravipudi LLP: The recall of the DePuy ASR hip replacement system has been described as one of the biggest disasters in orthopedic history. Thousands of ASR hips have already failed, resulting in significant pain and… read more