Gynecare Vaginal Mesh Withdrawn

Gynecare and other transvaginal mesh systems are surgically inserted into the vagina to treat conditions including pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP occurs when the structures that hold the pelvic organs become so weak or stretched that the organs move from their original position and prolapse into the vagina. The mesh has been known to experience problems such as shrinking, causing serious adverse physical effects. The complications due to the contraction of the mesh are varied, including:

• Vaginal shortening
• Bleeding
• Scarring
• Discomfort during sex
• Infection
• Erosion
• Perforation
• Tightening
• Significant pain

In addition to over 1,500 consumer reports to the FDA and hundreds of lawsuits, the FDA announced last summer that vaginal mesh implants have not been proven any more effective than alternative non-mesh procedures. In January, the FDA ordered Johnson & Johnson and 30 other manufacturers to study closely safety effectiveness of the mesh products.

In March, the FDA released a statement saying that J&J distributed its Gynecare Prolift mesh for three years without agency approval. The agency allegedly did not even know the product existed until 2007, two years after it was released, when the company looked to gain approval for a related product. J&J reportedly claimed that the Prolift did not need approval to be marketed, because it was similar to the already-approved Gynemesh.

If you or someone you love has been hurt by a defective or harmful medical product, our attorneys may be able to help you take part in a class action lawsuit.