Bard Avaulta Transvaginal Surgical Mesh

On October 20, 2008, the FDA issued a Public Health Notification about serious complications associated with transvaginal placement of surgical mesh to repair pelvic organ prolapse and stress urinary incontinence.

For the past three years, the FDA received over 1,000 reports from nine surgical mesh manufacturers regarding complications of these devices, including Bard. The mesh devices are placed transvaginally with tools that are considered minimally invasive.

The FDA's list of frequent complications from the use of this mesh includes the following:

• Erosion through vaginal epithelium
• Infection and pain
• Urinary problems
• Recurrence of prolapse and/or incontinence
• Bowel, bladder and blood vessel perforation during insertion
• In some instances, vaginal scarring and mesh erosion that led to severe discomfort and pain, including dyspareunia (severely painful sexual intercourse).

Treatment of the above complications involve surgical procedures (some to remove the mesh), IV therapy, blood transfusions and drainage of hematomas or abscesses.

According to the FDA's notification, "Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status."

Unfortunately, complications from the implantation of a Bard Avaulta or other mesh can lead to a serious decline in the patient's quality of life. At Heygood, Orr, Reyes, Pearson & Bartolomei, we have worked with many individuals and families who have been injured by dangerous products such as the Bard Avaulta Mesh. If you or a loved one has suffered injury as a result of the implantation of this device, please fill out our questionnaire to the right of this page for a free consultation.

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