Bard Avaulta FDA Advisory
On October 20, 2008, the U.S. Food and Drug Administration (FDA) issued an FDA advisory regarding serious complications associated with transvaginal placement of surgical mesh, including Bard Avaulta surgical mesh. The Bard Avaulta FDA advisory stated that, over the last three years, it has received more than 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair Pelvic Organ Prolapse and Stress Urinary Incontinence. Among the surgical mesh products associated with complications are the Avaulta Biosynthetic Support System and Avaulta Plus Biosynthetic Support System, both of which are manufactured by Bard.
Bard Avaulta Surgical Mesh Side Effects
If you were treated for Stress Urinary Incontinence or Pelvic Organ Prolapse with surgery that involved the placement of surgical mesh through an incision in the vaginal wall, you may be at risk for developing serious medical complications. According to the Bard Avaulta FDA advisory, one of the most common Bard Avaulta transvaginal mesh side effects is surgical mesh infection. Other possible Bard Avaulta side effects include:
- erosion through vaginal epithelium
- urinary problems
- recurrence of prolapse and/or incontinence
- bowel, bladder, and blood vessel perforation
The Bard Avaulta FDA advisory stated that the FDA has not yet determined whether specific characteristics put some patients at an increased risk for transvaginal surgical mesh complications. Contributing factors may include the patient’s overall health, the transvaginal surgical mesh material, the size and shape of the surgical mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
Treatment of Bard Avaulta Complications
Treatment of the various types of complications associated with transvaginal placement of surgical mesh may require additional surgical procedures (some of them to remove the transvaginal mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
Transvaginal Mesh Lawyer
If you or a loved one has experienced any of the painful complications associated with transvaginal placement of surgical mesh, you may be entitled to compensation for your injuries. Contact an experienced transvaginal mesh lawyer for a free and confidential case evaluation regarding your potential Bard Avaulta lawsuit.