FDA Issues Vaginal Mesh Safety Alert In October 2008
Dear Healthcare Provider:
This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.
Nature of the Problem
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.
The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or 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 patient quality of life due to discomfort and pain, including dyspareunia.
Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
Specific characteristics of patients at increased risk for complications have not been determined. 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.
- 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.
- Additional patient information can be found on the following FDA Consumer website at http://www.fda.gov/cdrh/consumer/surgicalmesh-popsui.html.
Reporting Adverse Events to FDA
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of surgical mesh, you should follow the reporting procedure established by your facility.
We also encourage you to report adverse events related to surgical mesh that do not meet the requirements for mandatory reporting. You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm, by phone at 1-800-FDA-1088, or obtain the fillable form online at www.fda.gov/MedWatch/getforms.htm, print it out and fax to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
Getting More Information
If you have questions about this notification, please contact the Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 240-276-3356, or by e-mail at email@example.com. You may also leave a voice mail message at 240-276-3357 and we will return your call as soon as possible.
FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through e-mail each time a new Public Health Notification is added to our web page. To subscribe to this service, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39 .
Daniel G. Schultz, MD Director Center for Devices and Radiological Health Food and Drug Administration
CALL US: 1-800-810-3457[hr]
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.
- Weber AM, Richter HE. Pelvic organ prolapse. Obstet Gynecol. 2005;106(3):615-634.
- 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.
- 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.
- 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.
- 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 eventÃ¢â‚¬â€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.