Metal Baseball Embellishments
Author: Baseball Bob
DA On Course With Comprehensive Review Of Metal-On-Metal Hip Replacements
The U.S. Food and Drug Administration is seeking independent action as a result of the DePuy hip replacement recall fiasco This is a highly anticipated development in conjunction with the multiple lawsuits facing the company. According to the internal website created by the FDA, a comprehensive review will be made of all hip replacements similar to those involved in the DePuy recall. As stated on the website, “The FDA is actively working in several areas to further assess the safety and effectiveness of metal-on-metal hip implants.”
The timing of this review is not only warmly welcomed, but is also speaks volumes as to the futility and inefficiency of the 510(k) approval process that DePuy and other manufacturers utilize in order to clear their defective hip replacements for marketing and distribution.Companies use the 510(k) approval process as a loophole in order to avoid subjecting their new products to clinical trials and getting FDA approval for distribution by claiming that they are fundamentally similar to ones already approved and on the market. This loophole has proven to be deleterious to those thousands that have received DePuy’s ASR XL Acetabular System and Resurfacing System hip replacements.
In a press release given by the American Academy of Orthopaedic Surgeons (AAOS), they claim that the FDA has their utmost support.However, in an effort to maintain some diplomacy, AAOS President John Callaghan stated, “We believe that a significant majority of metal-on-metal hip replacement implants have successfully relieved pain and improved function without any problems for the patients who have received them but there have been some concerning exceptions.”
These “concerning exceptions” will ultimately be tantamount to thousands of hip replacement lawsuits. If you have been a victim of the DePuy recall and are seeking punitive damages, speaking with a hip replacement lawyer should be top priority. If you wish to read more on the FDA’s review of DePuy’s hip devices , go to the hip replacement recall center.
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