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U.S. Department of Health and Human Services

Medical Devices

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Looking Into Problems With Transvaginal Surgical Mesh

By Nasrin Mirsaidi, RN, CNOR, MSN

(Article reprinted from July Nursing2009, Volume 39, Issue 7)

A PATIENT, 67, had a transvaginal repair with synthetic mesh for pelvic organ prolapse. Four weeks later, she reported spotting, discomfort, and vaginal irritation. The surgeon found that the surgical mesh had eroded into her vagina and prescribed estrogen cream for a month, but it wasn’t effective. The patient needed more surgery for resection of the exposed mesh and closure of eroded tissue.

Pelvic organ prolapse and stress urinary incontinence are pelvic disorders affecting millions of women in the United States.1 They occur when pelvic floor muscles lose strength, allowing pelvic organs, including the bladder and uterus, to descend from their normal location and bulge through the vaginal wall (pelvic organ prolapse), or diminishing bladder control (stress urinary incontinence).1,2

Treatment options for pelvic organ prolapse or stress urinary incontinence include several surgical and nonsurgical approaches. Transvaginal placement of mesh has become increasingly popular in recent years.3

What’s the problem?

In the last 3 years, the FDA has received over 1,000 adverse event reports about mesh used in transvaginal surgical repair of pelvic organ prolapse and stress urinary incontinence. These reports include problems such as pain, infection, mesh erosion (into vagina, bowel, and bladder), and recurrence of prolapse or incontinence. Some reports involved rare but serious intraoperative injuries such as bowel, bladder, or blood vessel perforation. Most patients described in the adverse event reports needed medical or surgical intervention, and some required hospitalization.4

Although the exact cause of these adverse events hasn’t been identified, they’re likely to be the result of multiple factors. Further investigation is needed.

What precautions can you take?

Although treatment with mesh may have helped many women, in others it’s caused complications affecting quality of life.3,4 A literature review demonstrates conflicting information on success rates for transvaginal mesh placement, but everyone agrees on the need for controlled trials.5 If you care for a patient undergoing a transvaginal mesh placement procedure, consider this advice:

  • Become familiar with the types of mesh and procedures used for the repair of pelvic organ prolapse and treatment of stress urinary incontinence.
  • Ensure that your patient has given her informed consent. Make sure she’s received appropriate information about her choice of treatment, the type of procedure she’s undergoing, and possible adverse events.
  • During preoperative teaching sessions, tell your patient about possible adverse reactions, the signs and symptoms of infection, and when to notify her healthcare provider.
  • If you’re an OR nurse, follow your facility’s policies and procedures for recording information about implanted materials. Record the name of the mesh used and its catalog number, lot number, and size in the patient’s medical record.
  • Provide your patient with a written copy of the patient labeling from the surgical mesh manufacturer, if it’s available.
  • If your patient has surgery to remove mesh, follow your facility’s policies and procedures for properly handling the explanted mesh. Additionally, follow your facility’s policies and procedures for reporting adverse events.
  • For further information, refer your patient to this FDA Web site.

REFERENCES

1. Weber AM, Richter HE. Pelvic organ prolapse. Obstet Gynecol. 2005;106(3):615-634.

2. Fultz NH, Burgio K, Diokno AC, Kinchen KS, Obenchain R, Bump RC. Burden of stress urinary incontinence for community-dwelling women. Obstet Gynecol. 2003;189(5):1275-1282.

3. Mistrangelo E, Mancuso S, Nadalini C, Lijoi D, Costantini S. Rising use of synthetic mesh in transvaginal pelvic reconstructive surgery: a review of the risk of vaginal erosion. J Minim Invasive Gynecol. 2007;14(5):564-569.

4. FDA Public Health Notification: Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. October 20, 2008.

5. Slack A, Jackson S. Advances in the surgical management of prolapse. Menopause Int. 2007;13(1): 38-43.


Although you need to support your healthcare facility’s adverse event—reporting policy, you may voluntarily report a medical device that doesn’t perform as intended by contacting MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178) or online.

Diane Dwyer, RN, BSN, who coordinates Device Safety, is a nurse consultant at the Center for Devices and Radiological Health at the FDA in Rockville, Md.

Nasrin Mirsaidi is a nurse consultant for general and plastic surgery devices at the Center for Devices and Radiological Health.