Streamlining of Medical Device Approval Proposed by Legislators

Lawmakers among US Democrats have reached accord to block medical products with safety issues, Bloomberg reports. They talked about untoward results brought about by medical products of Johnson & Johnson. Because of the numerous complaints against the DePuy hip system, the British Hip Society has pushed for an informal metal-on-metal hip replacement ban. There are around 93,000 recipients of the ASR XL Acetabular System and the ASR Hip Resurfacing System worldwide. After the release of data presenting defectiveness in one out of eight patients to whom they were implanted, the two devices were pulled back.

Problems with the design of metal-on-metal hip devices, specifically DePuys, may lead to the rubbing of metal components against each other and casting microscopic metal bits into the body. The metal particles shed from metal-on-metal hip replacement implants may increase the amount of some metals in the blood, such as chromium and cobalt. This condition may result in genetic damage (genotoxicity) and blood poisoning (metallosis). {Chromium and cobalt have also been linked to cancer, and might lead to the development of tumors.

A bill introduced this week before the lower house of Congress would close a loophole that allowed devices to win approval even when these are similar to a product already pulled out from the market, says Representative Edward Markey of Massachusetts in a statement issued to reporters. If an automobile is recalled for a major safety problem, we wouldnt allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies, adds Markey. Similarly, three U.S. senators intended a new bill last year regarding the strengthening of medical device regulations. This was published last December 14, 2011 on the New York Times. Theproponents were Herb Kohl (D-WI), Richard Blumenthal (D-CT), and Charles E. Grassley (R-IA). According to Senator Blumenthal, there is clearly a need for scrutiny once products are implanted or used on patients. According to the Times, these lawmakers have proposed a wave of medical device industry-friendly bills that would further streamline FDA regulations, allowing more product clearances. This coordinated effort from a significant and different group of legislators displays that the government are listening to the public about their concerns onr the probable negative consequences from a lenient medical device regulation. According to legal observers, this move also demonstrates that the policymakers are acknowledging the significance of improving health care for the citizens. There are many other pharmaceutical companies, not only DePuy, which will be affected by these forthcoming law. The Food and Drug Administration (FDA) have taken notice of about 400 negative feedbacks from DePuy clients between 2008 and the time of its recall announcement. Many of these clients need a second hip replacement surgery. Presently, numerous clients have pursued legal complaints against DePuy Orthopaedics Inc. and its mother company, Johnson & Johnson.These lawsuits claim that the company was deferring the implementation of DePuy hip recall although it is aware of the problems of the devices. To facilitate medical attention for men and women who had bought the devices from it, DePuy should provide wide-ranging information dissemination on the flawed hip replacement symptoms.