Consumer Alerts

Gynecare Vaginal Mesh Withdrawn

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. In light of these claims, our attorneys are investigating potential claims on behalf of women implanted with the Gynecare mesh systems to determine if they have legal recourse to recover compensation.

Have you experienced adverse complications due to a Gynecare mesh system? Fill out our free, no-obligation case review form today to learn more about your eligibility to file a claim seeking financial compensation for medical bills, lost wages, and pain and suffering.

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
• Bleeding
• Scarring
• Discomfort during sex
• Infection
• Erosion
• Perforation
• Tightening
• 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. 

Are You Eligible for Compensation?

The adverse effects linked to vaginal mesh implants can lead to significant pain, hospitalization, revision surgeries and permanent injuries. If you or a loved one has experienced complications due to vaginal mesh products, you may be able to seek compensation through a Gynecare vaginal mesh lawsuit for medical bills, lost wages, rehabilitation costs, and pain and suffering. Receive a consultation from an experienced vaginal mesh lawyer by filling out our free, no-obligation form.