GYNECARE VAGINAL MESH WITHDRAWN
Gynecare Vaginal Mesh
Johnson & Johnson and its subsidiary Ethicon have announced that they will move to take four vaginal mesh implant devices off the market. J&J has pledged to stop marketing and manufacturing the Gynecare Prolift Pelvic Floor Repair System, Prolift MTM, TVT Secur, and Prosima vaginal mesh systems, but asked the FDA to continue sales of one mesh product, the Gyencare Gynemesh, with a label update. The company has faced a mounting number of reports of serious side effects associated with the devices, as well as legal action on behalf of women experiencing mesh erosion and other complications.
Complications of Gynecare, Pelvic Meshes
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
- Discomfort during sex
- Significant pain
The FDA and Vaginal Mesh Systems
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.