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FDA’s Role In The DePuy Hip Replacement Recall

12th December, 2010 - Posted by health news - No Comments

There is a belief that whatever medical product available for the public to use would be safe. This is the job description of the Food and Drug Administration. Making the product go through necessary tests will be part of DePuy’s duty. On the other hand, people should be reminded that the manufacturer will be the one to test their own product. The FDA will be there to determine if the risk does not exceed the advantages of the product.

There are times that a product needs not go through certain tests for it to be available in the market . The premarket notification also known as 510(k) makes this possible because the product’s quality is determined by the products already approved by the FDA that came through the same employer. The manufacturer will have a lot of benefits upon gaining a premarket notification. The manufacturer will only have to wait six months and spend less. If this is quite advantageous for the manufacturer, it does not work the same way for the people who will be using the product. There is a chance that the product will fail. Making the product go through necessary tests will be the only way to assure quality.

A premarket notification clearance has made to DePuy’s ASR XL Acetabular System and the ASR Hip Resurfacing System to be available in the market which happens to be defective products. These products claimed to be at par with the previous products DePuy has created. The public can suffer from this if the product happens to be defective.

Suffering should not have happened on the individuals affected by the recall. These suffering have made these individuals to file a DePuy lawsuit. As an individual suffering from this situation, you need to see a lawyer to discuss your case. We can hate the FDA for this situation.