Rottenstein Law Group Very Upset, But Not Surprised, by News That Johnson & Johnson Marketed Vaginal Mesh Without FDA Approval
(New York, NY, March 22, 2012) The Rottenstein Law Group, which represents clients with claims stemming from the serious side effects of vaginal mesh, is disheartened by a recent news story reporting that Johnson & Johnson sold a vaginal mesh implant for three years before the U.S. Food and Drug Administration (FDA) approved the device, which is now the subject of more than 550 lawsuits brought by women who claim it injured them.
Bloomberg broke the news in an article by David Voreacos and Alex Nussbaum. According to the piece, Johnson & Johnson marketed the Gynecare Prolift vaginal mesh device in March 2005, touting its benefits in an annual report. “The U.S. Food and Drug Administration said it learned of the Prolift in 2007,” the Bloomberg article goes on to explain, “when J&J sought approval for a related product. The FDA cleared both devices in May 2008.”
Johnson & Johnson argues that marketing the Prolift without FDA approval was appropriate because it was similar to an approved device, the Gynecare Gynemesh, but the FDA doesn’t agree, according to the Bloomberg article. The agency has therefore concluded that Johnson & Johnson began marketing the Gynecare Prolift “without appropriate [clearance].”
This latest development in the vaginal mesh implant injury saga once again highlights the problems with allowing certain medical devices, including vaginal mesh products, to get FDA approval without the benefit of clinical trials on humans but rather based solely on the new devices’ similarity to formerly approved devices. The Rottenstein Law Group has created and published an infographic which clearly illustrates how several vaginal mesh products, manufactured by different companies but all the subject of hundreds of pending lawsuits, attained FDA approval based on their similarity to a recalled device.
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.
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