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DePuy Hip Replacement Recall Could Have Been Restrained By More Stringent FDA Supervision

Posted on | January 8, 2011 | No Comments

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The safety of drugs and medical devices for public use is determined by the United States Food and Drugs Administration. To be able to sell their products on the market, manufacturers need to acquire approval from the FDA. But there is no definite assurance that once a product is approved, it is absolutely safe. It is merely an indication that the FDA finds the benefits of the product outweigh the disadvantages.

Approvals will be given by the Administration depending on the outcome of these clinical trials. But the FDA is not the one who handles the research procedure. The integrity of the data found in the clinical trials will be checked by the FDA but they are usually performed by the same company who intends to sell the product on the market. Testing could take years and cost hundreds of thousands of dollars to complete.

When a product submitted for testing is deemed “substantially equivalent” with previously approved products, it could receive a premarket notification or what is called a 510(k) clearance. When the product gets a 510(k) clearance, it can be sold to the public. As opposed to clinical trials, 510(k) only takes about six months and cost a few thousand. One out of ten 510(k) submissions is asked by the FDA to undergo clinical testing.

Clearly, a premarket notification would prove most favorable to manufacturers. Though not all 510(k) rulings backfire, there have been cases where consumers of certain products have suffered the dangers of products that have not gone through clinical trials.

Similarly, this was what occurred in DePuy’s products known as ASR XL Acetabular and ASR Hip Resurfacing System. These devices received a 510(k) as they claimed that they were “substantially equivalent” to three more products that have been previously manufactured and were FDA approved. They were subsequently recalled from the market due to a design flaw that generated health complications to their recipients.

This would lead people to think that the DePuy hip replacement recall should not have happened if the FDA had performed clinical testing on the ASRs. As of now, in eight hip recipients, one would need revision surgery. Consulting with legal experts are one of the top priorities of hip recall recipients to obtain compensation. At the DePuy Hip Lawsuit Site, recipients of the defective ASRs can find out more about the DePuy lawsuit. The losses you have had to go through would be best addressed by seeking legal counsel.

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