Commentary and insight about the complex legal, medical and social issues surrounding pharmaceutical litigation.

U.S. Regulators Want FDA More Involved with Hip Replacements, Transvaginal Mesh and Other Faulty Medical Devices

March 26, 2012

Bloomberg reports that four Democratic lawmakers, led by Edward Markey of Massachusetts, have issued a bill that would give the FDA the ability to block medical devices based on a past history of safety concerns. This authority would also be valid to block a medical device that is similar to one previously pulled.

According to Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, the agency needs this power to block unsafe products from the market and prevent repeats of faulty medical devices, such as hip replacement and transvaginal mesh implants that sparked patient lawsuits.

This is because the current lack of authority creates a “loophole” that has challenged the credibility of some device approvals, said Shuren. This loophole is created when companies voluntarily recall a device before it is ordered off the market. As a result, the devices can continue to serve as a basis for future products. 

While the article noted that Shuren doesn’t endorse the bill, it does say that the FDA would support a legislative fix. 

Shuren added: “It’s good for patients, and it’s good for companies, and it assures that if there’s a problem with the new device, it gets addressed before it goes to market.” 

Meanwhile, a Washington D.C. trade group, Advanced Medical Technology, cites issues with the Democratic proposal saying that manufacturers have to deal with enough FDA regulation. 

In response, Shuren said the bill could actually make things easier by reducing the amount of negotiations when there is cause for concern with a medical device design. 

For the sake of everyone’s safety, let's hope for a positive change.

This article can be read in detail at: http://www.bloomberg.com/news/2012-02-28/fda-device-chief-says-approval-loophole-needs-closing.html

 

Comments (1)

Posted by transvaginal mesh lawsuits on July 27, 2012, 1:53 pm

There is no doubt about the serious risks involving the Transvaginal mesh patch. Many doctors failed to inform their patients about the possible risks and only after developing serious complications women experienced the problems on themselves.

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