Transvaginal Mesh Litigation

A Bakersfield, California Couple was Awarded $5.5 Million against C.R. Bard Medical, the Maker of a Vaginal Mesh Implant Called Avaulta Mesh

With hundreds of lawsuits involving vaginal mesh pending across the country, this is the first jury win for a woman who has suffered severe complications after undergoing vaginal mesh implant surgery.

In July 2011 the Food and Drug Administration (FDA) warned that it is unclear that transvaginal mesh products are any more effective than non-mesh repairs for Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI). More importantly, serious complications are not rare for transvaginal mesh products for POP and can result in mesh exposure into the vagina or mesh erosion into the bladder or rectum. Even without mesh erosion, women can experience severe medical problems:

• Pelvic pain
• Infection
• Dyspareunia (pain during intercourse)
• Vaginal scarring
• Urinary problems
• Neuro-muscular problems

As many as 40% of American women will cope at some point with Stress Urinary Incontinence (SUI), a medical condition in which control of the bladder is reduced due to stress on the bladder, sometimes from childbirth. Pelvic Organ Prolapse (POP) is also very common and can result in serious medical issues that lead women to seek solutions. The medical products industry responded with surgical polypropylene mesh, or transvaginal mesh, products that address these issues that affect so many women. However, transvaginal mesh products like SUI slings and POP kits often induce a chronic foreign body inflammatory response that frequently leads to significant alteration or even destruction of pelvic tissue and nerves.

If you have had a procedure to correct POP or SUI any time since 2002 and have experienced any of the above symptoms, contact Magaña, Cathcart & McCarthy at 310-553-6630, or fill out the form below.

POP Kits with Mesh Criticized For Poor Design, Lax Safety Testing

POP kits include the surgical mesh and the tools doctors use to implant the transvaginal mesh repair, are larger, and are anchored with arms. This is a poor design that is very difficult if not impossible to remove, and can leave women crippled or subject to several painful surgeries to repair POP kit damage.

In addition to the poor design of POP kits, the material used to make surgical mesh was cleared using the 510(k) process which essentially “piggybacks” off a previous product, leaving many polypropylene products virtually untested for safety and efficacy.

There are several manufacturers of transvaginal mesh products, and some manufacture several separate models for SUI or various subtypes of POP, but there are 4 major manufacturers:

• C.R. Bard
• Johnson and Johnson (and its subsidiaries)
• American Medical Solutions
• Boston Scientific

In addition to the 4 major manufacturers, there are also numerous smaller manufacturers of transvaginal mesh products:

• Tyco/IVS
• Mentor
• Cook Medical
• Caldera Medical
• Coloplast

Many women who have had a transvaginal mesh procedure for Pelvic Organ Prolapse are unsure of the manufacturer of their implant.  If you have any questions, please call Carter Spohn at 310-553-6630.  It is important that you contact Magaña, Cathcart & McCarthy right away to determine your specific case’s eligibility for compensation.