Over the past three years, the FDA has received more than 1,000 reports from nine different surgical mesh manufacturers of complications with their devices. These devices, used to repair Pelvic Organ Prolapse and Stress Urinary Incontinence, were introduced on the market to alleviate the pain and discomfort experienced by the women suffering from these conditions, however the FDA reports suggest otherwise.
Surgical mesh functions by supporting the bladder, and reinforcing the muscles that control the flow of urine from the body for treatment of Stress Urinary Incontinence. For proliferation, the mesh acts as a barrier to hold the pelvic organs in place, preventing any painful slipping from their normal place in the pelvis. The mesh is inserted through the vagina for both of these procedures, using minimally invasive techniques.
What is proving to not be minimally invasive are the serious side effects being reported by patients who have had this surgery performed. Complications being reported include eration of vaginal tissue, pain, and additional urinary problems. The most common complication reported to the FDA is serious infection.
Infections from transvaginal placement of surgical mesh can occur in one of two ways. First, an infection may be caused by bowel, bladder, or blood vessel perforation, which occurs during insertion of the surgical mesh. Second, the mesh design may inhibit surrounding tissue from receiving nutrients and oxygen, causing impaired healing that can lead to an infection.
A surgical mesh recall has not yet been issued for Bard Avaulta or other surgical mesh devices, as the FDA has not yet determined whether specific characteristics put some patients at an increased risk for transvaginal surgical mesh infection. Some contributing factors to complications 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 (eg hysterectomy), and possibly estrogen status.
As reports on Bard Avaulta side effects continue to increase, attorneys are working with Bard Avaulta victims who may be entitled to compensation.