Legislators Seek to Stop the Manufacture of Unsafe Products

Senators among US Democrats have proposed a bill to hinder approval of medical devices with safety issues, as reported by Bloomberg.  They mentioned injuries from flawed medical products like those manufactured and distributed by Johnson & Johnson. Because of the booming complaints against the DePuy hip system, the British Hip Society has proposed 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.
 
Transporting of microscopic metal parts into the body due to metal components rubbing against each other is one effect of design problems with  metal-on-metal hip implant devices, like the DePuy. The amount of certain metals in the blood, like chromium and cobalt, may be augmented by the metal bits transported from the implant device. Furthermore, tumors and cancer may also arise because of cobalt and chromium in the patient’s blood.

In a statement disclosed publicly, Representative Edward Markey of Massachusetts explains that “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.”

 “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,” adds 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…

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