Transvaginal Mesh Recalls and Litigation

Transvaginal mesh products are marketed under a variety of names and are produced by several manufacturers. At Emerson Straw, PL, we constantly monitor the state of the law in this evolving area. Since the late 1990s, these medical implants have been used to repair pelvic organ prolapse and stress urinary incontinence issues in millions of women. Unfortunately, these medical implants have resulted in ongoing and devastating health complications for many of the people who turned to them for help. The very first transvaginal mesh product, Boston Scientific’s ProtoGen, was voluntarily pulled from the market just three years after its launch after serious safety issues arose.

What Are These Products?

Transvaginal mesh products are medical and surgical implants used to treat pelvic organ prolapse and stress urinary incontinence. The mesh is also sometimes referred to as a sling, tape, or pelvic sling. In recent years, some manufacturers have rebranded their products for use in the abdominal cavity only.

These medical devices are produced by many different companies, including the following:

• Boston Scientific’s ProtoGen (pulled from the market in 1999)
• Boston Scientific’s Pinnacle, Obtryx, Advantage Sling, Perfyx
• American Medical System’s Spar, Miniarc, Apogee, Elevate, Perigee, Monarc
• Mentor Corporation’s ObTape Vaginal Sling
• Johnson & Johnson’s Ethicon Division’s Gynecare transvaginal mesh (no longer sold as of June 2012)
• Johnson & Johnson (Ethicon) Gynemesh
• C.R. Bard’s Pelvicol, Pelvisoft
• C.R. Bard’s Avaulta Plus (no longer sold as of July 2012 after a $5.5 million jury award)

Through its Ethicon unit, Johnson & Johnson sold a variety of Gynecare products, including the Gynecare Prolift Kit, the Gynecare TVT Secur, the Gynecare Prolift + M Kit, and the Gynecare Prosima Pelvic Floor Repair System Kit.

Has the FDA Recalled These Products?

As of 2014, the FDA has not recalled any transvaginal mesh product made by any manufacturer. Because several transvaginal mesh makers have been sued, however, a number of manufacturers have voluntarily pulled their products from the market.

In 2011, the FDA issued a safety communication warning consumers that the complications associated with these products are “not rare” and that serious side effects have been known to result.

What Are the Health Concerns Associated with Transvaginal Mesh Products?

According to the FDA and numerous studies, thousands of woman have experienced serious, debilitating health concerns after receiving transvaginal mesh implants. The plaintiff in a 2012 lawsuit against C.R. Bard, Inc. received $5.5 million after undergoing eight surgeries to repair damage caused by the mesh cutting through her colon and invading her internal organs. Known side effects include:

• Excessive bleeding
• Infection
• Severe pain
• Painful sexual intercourse
• Abdominal pain
• Protrusion of the mesh outside the body
• Organ perforation
• Vaginal mesh erosion
• Urinary incontinence
• Vaginal scarring

If you have experienced health problems after receiving a transvaginal mesh or sling implant, you might be entitled to compensation for your injuries. Contact our office today at 727-821-1500 to speak to an attorney about your case.