Gynecare Prolift Implanted Surgical Mesh Was Sold For Years Without FDA Approval

A report yesterday in Bloomberg News revealed publicly one of the facts learned in the vaginal mesh litigation: Ethicon, a subsidiary of Johnson & Johnson, illegally marketed the Gynecare Prolift implanted vaginal mesh from March 2005 through May 2008.

Under the so-called 510(k) process, a medical device manufacturer does not have to obtain FDA approval before selling a new medical device to doctors and hospitals if the new medical device is the “substantial equivalent” of an old, previously-approved device. As Bloomberg News reported, Ethicon didn’t even tell the FDA that it had begun selling the Prolift, because, the company now claims, it believed the Gynecare Prolift was so similar to the Gynecare Gynemesh that additional approval was not needed. The FDA only learned about the Prolift in 2007, when it was cited by Johnson & Johnson in their application for 510(k) approval of the Prolift+M vaginal mesh surgical implant.

This situation reveals yet another problem with the 510(k) process, which the Institute of Medicine has recommended be eliminated, and which played a large role in why the DePuy metal hip implants were never properly tested.

Our lawyers are actively involved in the pelvic mesh lawsuits, including those against Johnson & Johnson for the Ethicon mesh implants like Gynecare. Recent research has demonstrated that use of the mesh exposes patients to a wide variety of additional serious complications. Most pelvic mesh is made the same way as abdominal hernia mesh, but the muscles around the the vaginal wall are not nearly as strong as the muscles in the abdomen, and so the same mesh is more prone to failure in the pelvic floor than in the abdomen. Further, most meshes are made of polypropylene, which can interact with tissues, leading to chronic inflammation in the area where the mesh was implanted.

For over fifty years, the product liability lawyers at The Beasley Firm have successfully represented injury victims, including victims of defective medical devices, recovering over $1 billion for our clients. We are currently active in the vaginal mesh litigation. If you had surgery that involved transvaginal mesh, like surgery to treat pelvic organ prolapse or stress urinary incontinence, and then needed another surgery to repair or to replace the mesh, or if you had continuing complications like inflammation, repeated infections, exposure of the mesh, or painful intercourse, contact our legal medical team for a free, confidential consultation.