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Rottenstein Law Group Pleased by FDA Device Chief’s Recommendation to Close Dangerous Loophole in Agency’s Medical Device Approval Process


(New York, NY , March 6, 2012) The Rottenstein Law Group, which represents clients with claims stemming from the dangerous side effects of medical devices like vaginal mesh, commends Jeffrey Shuren, director of the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, for stating that the FDA needs more power to block unsafe products like vaginal mesh that initiated thousands of patient lawsuits.
Shuren made these statements when he was interviewed for a Bloomberg article which ran on February 28, 2012. The “loophole” the article’s title refers to is the fact that the FDA often lacks the authority to reject medical devices that have designs that are based on past products that have been voluntarily recalled by their manufacturers for safety flaws.
“By law, the FDA has to approve devices that cite an eligible predicate unless the older device has been ordered off the market by the agency or a court order,” the article quotes Shuren as saying.
Since, quite often, the FDA-approved devices that prove dangerous are voluntarily taken off the market by their manufacturers before the FDA or the courts have a chance to act, dangerous medical devices can serve as the basis for new product applications that the FDA is obliged to approve, the article explains.
The changes Shuren supports, namely, giving the FDA more power to reject medical devices, requiring manufacturers to submit information about recalls of predicates used in an application, and requiring the FDA to review previously cleared products to see if they have any safety issues in their “device lineage,” are laid out in legislation that was introduced on February 1, by four Democrats lead by Representative Edward Markey of Massachusetts (HR3847). A representative from the FDA told Bloomberg that the agency currently has no position on Markey’s bill, but “would be glad to work with [Rep. Markey] to provide technical help. “
Anyone seeking more information about vaginal mesh can visit the Rottenstein Law Group’s Vaginal Mesh Lawsuit Information Center. The site has vital information about the dangers of this medical device, along with easy-to-use social media features that allow for easy sharing on sites like Facebook and Twitter. Visitors are also encouraged to link to their own Web sites and blogs in order to spread the word about defective medical products and dangerous drugs.
About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site, or call (888) 9-ROT-LAW.


 vaginal mesh
 medical devices
 medical implants
 bladder prolapse
 pelvic organ prolapse

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