Asr Manufacturer Avoided Initiating A Recall For Implants
Annually, about 250,000 hip replacement procedures are commonly performed in the United States
. Out of that frequency, only about 1-3 percent of recipients require corrective surgery of the original implant. A small percentage like this should facilitate the identification and tracking of defective hip replacements by regulators. Unfortunately, the U.S. does not have a national artificial joint registration system. Without a registration system in place, in addition to the lag in time it takes for a hip replacement to malfunction, companies like DePuy were able to sell 93,000 hip replacements worldwide undetected. DePuy was able to sell 93,000 hip replacements undetected worldwide due to the fact that there is no regulatory system in place and it takes a long time for hip implants to malfunction. As a result, the current DePuy recall has affected thousands of patients. Additionally, the company faces more scrutiny over the
kickback scandal which says that DePuy pays consultants for them to use its products.
Australia and the United Kingdom are two countries that do have artificial joint registries in effect and were able to detect the defective implants immediately.As early as 2007, the National Joint Replacement Registry in Australia reported higher than normal failure rates of the DePuy hip replacements. DePuy then voluntarily withdrew its products from their market by 2009. Parallel to this, the National Joint Registry of England and Wales quickly detected the defective hip replacements as well. Published studies by researchers at Oxford University presented statistically that 3.4 percent of patients out of 660 who received DePuy metal-on-metal hip implants suffered from signs and symptoms of metallosis. Comparatively, the studies also showed that 155 patients who received a competing manufacturers hip implants were examined and did not exhibit any similar side effects.
Around the same time, the U.S. Food and Drug Administration received several hundreds of complaints regarding metal-on-metal implants, but took no action due to the lack of a regulatory national registry. Although many surgeons have stepped forward, claiming that they immediately alerted DePuy about complications from their defective hip implants, their claims were met with little to no response.Finally in 2010, the media began creating public awareness as to the dangers of DePuys defective hip replacements. Public outcry in 2010 from media reports about the high failure rates of the DePuy implants along with pressure from the FDA finally forced DePuy to initiate a recall in August of 2010.
The company was aware of its defective products and was negligent in initiating a DePuy hip replacement recall. It has shown a blatant disregard for the health and safety of its consumers.
by: Katherine Russel
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