Download FDA Update on the Serious Complications Associated with TVM. Transvaginal placement of surgical mesh has caused serious complications, the Food & Drug Administration (FDA) warned yesterday. According to the agency, treatment of these complications 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.
The transvaginal placement of surgical mesh is used to treat Stress Urinary Incontinence (SUI), an embarrassing loss of bladder control that afflicts 13 million people.
The disorder occurs mostly in women, and is caused by weak muscle tone that can result from child birth, old age and other conditions.
when the pelvic floor muscles become weak or damaged and can no longer support the pelvic organs
This procedure is also used to treat Pelvic Organ Prolapse (POP), a condition that occurs in women when the pelvic floor muscles become weak or damaged and can no longer support the pelvic organs.
While POP is not considered a life threatening condition it may cause a great deal of discomfort and distress.
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.
Transvaginal placement of other surgical mesh products has caused similar problems, FDA warns
Now the FDA is warning that the transvaginal placement of other surgical mesh products has caused similar problems.
According to the agency, 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.
To lessen the chances that the transvaginal placement of surgical mesh will result in complications, the FDA said physicians 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.
- Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
- 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.