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Transvaginal Mesh: From Approval and Complications to Lawsuits and Settlements FAQ

Transvaginal mesh and transvaginal sling are medical devices used to treat Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI). They are surgically implanted to strengthen the internal organs and prevent POP and/or SUI.

What is the issue with transvaginal meshes?

Lawsuits filed against the companies that make transvaginal meshes allege the meshes were defectively designed, resulting in problems such as erosion of the mesh, organ damage and chronic pain. In some cases, women have had to have the meshes removed.

Complications can include: Mesh erosion into the vagina, bladder, intestines and/or uterus; infection; bleeding; pelvic pain, urinary problems; vaginal scarring; and bowel, bladder or blood vessel perforation during insertion.

According to the FDA, the agency received more than 4,000 injury reports linked to transvaginal meshes between 2005 and 2010.

How do I know if I’ve been injured by transvaginal mesh?

Side effects include persistent vaginal bleeding or discharge, pelvic or groin pain, pain during intercourse, or a recurrence of POP or SUI.

Who makes transvaginal meshes?

There are a variety of companies that make transvaginal meshes. They include Johnson & Johnson’s Ethicon Division, CR Bard, American Medical Systems and Boston Scientific.

Where does litigation with transvaginal meshes stand?

Litigation depends on the company involved in the lawsuit, but so far thousands of lawsuits have been filed against some of the companies that make transvaginal meshes. Many bellwether trials involving allegations about transvaginal meshes were scheduled for early 2014. If you have been injured by a transvaginal mesh, you may still have time to file a lawsuit against the maker of the device implanted in you.

What does the FDA say about transvaginal meshes?

The FDA has warned about the risk associated with transvaginal meshes used for POP and/or SUI. On October 20, 2008, the FDA issued a Public Health Notification warning about the number of adverse events reported to the FDA that were linked to surgical mesh devices. At the time, the FDA noted the possible complications linked to the use of surgical mesh and warned that the use of surgical mesh to treat POP introduced risks that were not seen in traditional non-mesh surgery to treat POP.

On July 13, 2011, the FDA issued a safety communication update, warning that the risks of complications linked to transvaginal mesh were not rare.
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Last updated on May-21-14

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