Federal regulators are warning that transvaginal placement of surgical mesh, a common procedure used to treat Stress Urinary Incontinence and Pelvic Organ Prolapse in woman, has been linked to serious complications.  In 2006, one type of surgical mesh used in this procedure, the Mentor ObTape Vaginal Sling, was removed from the market because of its high complication rate.  Now, the Food & Drug Administration (FDA) is warning that other surgical mesh products are causing similar problems when used in this procedure.

According to the FDA, during the last 3 years, 9 surgical mesh manufacturers have submitted more than 1000 reports of complications that have included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.  The FDA said that bowel, bladder, and blood vessel perforations have also been reported. In some cases, vaginal scarring and mesh erosion have led to significant discomfort and pain, significantly decreasing the patient’s quality of life.According to the FDA, specific characteristics of patients at increased risk for such complications have not been determined. The agency said that 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.

The agency warned  treatment of complications associated with the procedure can be painful and require further surgery (some for mesh removal), intravenous therapy, blood transfusion, or hematoma/abscess drainage.  The FDA has advised that clinicians should receive specialized training for the transvaginal placement of mesh products and be vigilant for adverse events.  Physicians should also:

• Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
• Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
• Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

Problems with this treatment have been reported before.  In 2006, the Journal of Urology published a study that examined an unusually high number of complications caused by one type of surgical mesh, the Mentor ObTape Vaginal Sling. The study looked at  67 women who had been implanted with the Mentor ObTape Vaginal Sling, and found that more than 13 percent developed vaginal extrusions. Another eight developed a chronic vaginal discharge, and one patient developed an abscess of the left thigh that tracked to the incision site.

The poor design of the Mentor ObTape did not allow surrounding tissue to receive nutrients and oxygen, which impaired healing.  As a result, between 17 and 18 percent of the women who were implanted with a Mentor ObTape Vaginal Sling suffered from complications, with many forced to undergo a difficult surgical procedure to have the device removed. The problems associated with the Mentor ObTape Vaginal Sling were so severe and widespread that finally, in 2006 Mentor Inc. pulled it from the market.