FDA Warns of Complications with Surgical MeshJan 9, 2009 | Parker Waichman LLP
The Food & Drug Administration (FDA) recently warned that surgical mesh used in gynecologic surgery to treat pelvic organ prolapse and stress urinary incontinence had been linked to serious complications. As we've reported previously, one such type of surgical mesh, the Mentor ObTape Vaginal Sling, was withdrawn from the market in 2006 because of a high rate of serious complications.
According to the FDA, in the past three years, it has received over a thousand reports of complications. The most frequent included erosion of the mesh through the vaginal epithelium, infection, pain, urinary problems, and recurrence of the prolapse or the incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in quality of life due to discomfort and pain, including dyspareunia. Treatment of the complications included IV therapy, blood transfusions, drainage of hematomas or abscesses, and additional surgical procedures, in some cases to remove the mesh.
These types of complications are already all-too familiar to victims of the Mentor ObTape Vaginal Sling. In 2006, the Journal of Urology published a study that examined an unusually high number of complications caused by Mentor ObTape. 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.
The FDA has warned that clinicians using mesh for treatment of pelvic organ prolapse and stress urinary incontinence should:
- Obtain specialized training for each mesh placement technique, and be aware of its risks.
- Be vigilant for potential adverse events from the mesh, especially erosion and infection, and also from the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
- Inform patients about the potential for serious complications and their effect on quality of life, including scarring and pain during sexual intercourse. Patients should also be informed that implantation of surgical mesh is permanent, and that some complications associated with the mesh may require additional surgery that may or may not correct the problem.
- Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if it is available.