Rottenstein Law Group Supports FDA Letters Ordering Vaginal Mesh Manufacturers to Study Safety and
New York, NY, January 17, 2012) The Rottenstein Law Group, which represents clients with claims stemming from the dangerous side effects of vaginal mesh, supports the letters sent to vaginal mesh manufacturers by the U.S. Food and Drug Administration (FDA) requiring all 31 companies to conduct three-year studies of the productsí safety and effectiveness.
The FDAís mandate was reported in a January 10 article that appeared on the Web site of Bloomberg Businessweek. The letters require the companies, which include C.R. Bard, Johnson & Johnson, and Boston Scientific to study rates of organ damage and other complications linked to vaginal mesh used in transvaginal procedures. Those procedures involve mesh products implanted through incisions in womenís vaginas as treatment for a common condition known as pelvic organ prolapse. The companies have 30 days to respond.
Despite the FDAís mandate for more studies, vaginal mesh products are still widely used, with more than 300,000 devices implanted in women in 2010 alone. The devices received clearance for use under the FDAís 510(k) approval process, which states they are safe for use based on their similarity to other devices currently on the market. This approval process bypasses many of the stringent testing requirements necessary to bring new medical devices to market. To date, there have been 650 lawsuits filed by patients alleging that they have been significantly injured as a result of having a vaginal mesh product implanted in their bodies.
The Rottenstein Law Group hopes the publicity surrounding the letters sent by the FDA will serve as a warning to women who are considering having a vaginal mesh procedure, and that the number of women harmed by this device will eventually decline.
Anyone seeking more information about vaginal mesh can visit the Rottenstein Law Groupís 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.
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