Vaginal Mesh – Bard Avaulta Surgical Mesh

Many women suffer the unfortunate daily side effects from stress urinary incontinence (SUI) and pelvic organ prolapse (POP) due to the effects of child birth and menopause.  Some women undergo transvaginal placement of surgical mesh devices to correct and restore weakened vaginal muscles.  During the past few years, thousands of complaints have been linked to these products.  In October of 2008, the FDA issued a Public Health Notice warning the public about the unacceptably high number of complications with more than nine different vaginal surgical mesh  products.  The Avaulta™ BioSynthetic Support System, manufactured by New Jersey company C.R. Bard, Inc., is one of the mesh products included in the FDA's notice. This product is currently on the market.

The Avaulta Support System is a permanent implant that provides long-lasting organ stabilization of fascial structures of the pelvic floor.  The device has knit "arms" to provide tension-free fixation of the implant. The Avaulta product is made of synthetic polypropylene mesh and is designed to allow vaginal tissue infiltration (or ingrowth), which can make removal of eroded or infected Avaulta mesh extremely difficult and can lead to disfigurement, scarring of pelvic tissue, and necessitate multiple additional surgeries.  Many women have suffered devastating mental and physical pain and suffering due to defective vaginal mesh products.  Some women must undergo multiple surgical procedures to remove the device and/or repair vaginal scarring.   

Serious Complications Associated with Surgical Mesh Products Include:

• Infection
• Extreme Pain and Urinary Problems
• Mesh Erosion into the Vaginal Tissue
• Vaginal Scarring
• Hardening of Vaginal Mesh
• Recurrence of POP and/or Incontinence
• Bowel, bladder and blood vessel perforation during insertion
• Painful Sexual Intercourse

Background on Vaginal Mesh Products

Mesh products first came on the market in the 1950s for use in hernia repairs. In the 1970s, surgeons began using the mesh "off label" for abdominal procedures, and for vaginal procedures in the mid-1990s. Under the FDA's controversial 510(k) approval process, the agency granted approval for using the mesh in vaginal procedures in 2002 without requiring new studies demonstrating their safety or effectiveness since mesh products were already in widespread use and were "substantially equivalent" to mesh products already on the market.

Tampa Vaginal Mesh Attorneys

Women all across the country have filed lawsuits for serious injuries associated with vaginal surgical mesh products including the Bard Avaulta mesh.  Alley, Clark & Greiwe has been involved in litigation involving vaginal surgical mesh products over the past several years.  If you or a loved one have been implanted with a Bard Avaulta mesh device and suffered any serious complications or have undergone additional surgery, please contact the Tampa vaginal mesh attorneys at Alley, Clark & Greiwe for a free consultation regarding your legal rights.

Consumer Information on Vaginal Mesh Claims

Surgical Mesh Update from FDA (1/4/12)

FDA Public Health Notice (7/13/11)