Policymakers Driven to Restructure Approval Process of Medical Products
As Published on the DePuy Hip Replacement Website
Lawmakers among US Democrats have reached accord to block medical products with safety issues, Bloomberg reports. They mentioned injuries from flawed medical products like those manufactured and distributed by Johnson & Johnson.
After information saying that the devices have defects in one out of eight clients, the ASR XL Acetabular System and the ASR Hip Resurfacing System were withdrawn. There are about 93,000 recipients of these products worldwide.
Problems with the design of metal-on-metal hip devices, specifically DePuy’s, 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 may cause metallosis (blood poisoning) and genotoxicity (genetic damage).
“ 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 wouldn’t allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies,” explains Markey.
Additionally, on December 14, 2011, the New York Times published an article saying that three U.S. senators proposed a bill reinforcing medical device regulations. The authors of the bill were Richard Blumenthal (D-CT), Herb Kohl (D-WI), and Charles E. Grassley (R-IA). “ There is clearly a need for scrutiny once products are implanted or used on patients,” stated Senator Blumenthal.
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 effort from a group of lawmakers demonstrates that policymakers are listening to patients, companies, and consumers about their concerns for potential negative consequences from a stricter medical device regulatory regime, legal observers say. It also shows that senators are recognizing the important role industry plays in improving health care and outcomes for patients. Aside from DePuy , there are several other manufacturers who will be affected by these impending bill.