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Rottenstein Law Group Incensed–But Not Surprised–by News That Johnson & Johnson Marketed Vaginal Mesh Implant Without FDA Approval.

Rottenstein Law Group Incensed–But Not Surprised–by News That Johnson & Johnson Marketed Vaginal Mesh Implant Without FDA Approval

Bloomberg broke the news on March 21, 2012, in an articleby David Voreacos and Alex Nussbaum. According to the piece, J&J marketed the vaginal mesh device at issue–the Gynecare Prolift–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.”

J&J 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 J&J began marketing the 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–viewable at http://www.vaginalmeshlawsuit.com/vaginal-mesh-infographic/–which clearly and succinctly 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.

The Rottenstein Law Group urges anyone who has suffered adverse side effects from a vaginal mesh implant to speak to a qualified personal injury lawyer as soon as possible. The Rottenstein Law Group maintains a Vaginal Mesh Lawsuit Information Center at http://www.vaginalmeshlawsuit.com. The site has features that allow for easy sharing, including links for automatic posting on Facebook and Twitter, specifically to enable visitors to spread the word about the dangers of surgical mesh.


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, who has more than two decades of experience as a lawyer, to represent clients in consumer product injury, mass tort, and class action lawsuits in a compassionate manner. http://www.rotlaw.com


The Rottenstein Law Group, LLP

Rochelle Rottenstein, Esq.

1259 Veeder Drive

Hewlett NY 11557

(212) 933-9500 (office phone)

(212) 933-9980 (facsimile)