WARNING ABOUT SURGICAL MESH DEVICES USED IN WOMEN UNDERGOING SURGERY FOR PELVIC ORGAN PROLAPSE OR STRESS URINARY INCONTINENCE

July 15, 2011

Here’s an important health alert for women who are considering or have had surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI) that involves transvaginal placement (surgery done through a vaginal incision) of surgical mesh. While Public Citizen usually does not cover safety issues related to medical devices in Worst Pills, Best Pills News, we are making an exception because of the serious complications commonly associated with this widely used device.

Do not undergo surgery for POP if it involves transvaginal placement of surgical mesh because it commonly results in many serious and potentially life-threatening complications. If you have had surgery with implantation of surgical mesh for POP or SUI, you should monitor yourself for symptoms of these serious complications, as discussed below.

On July 13, 2011, the Food and Drug Administration (FDA) issued a safety announcement to health-care providers who use surgical mesh to repair POP or SUI, health-care providers who care for patients undergoing surgical repair of POP or SUI and patients who are considering or have undergone such surgical procedures. The FDA in particular noted that serious complications associated with transvaginal repair of POP are not rare. Furthermore, the FDA stated that it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP, and it may expose patients to greater risk.

POP, SUI and Surgical Mesh

Surgical mesh is a medical device that is used for a wide variety of surgical procedures to repair weakened or damaged tissue. It is made from porous absorbable or nonabsorbable synthetic material or absorbable biologic material. In many patients undergoing surgery for POP or SUI, surgical mesh is permanently implanted to reinforce the weakened vaginal wall or to support the urethra, respectively. The most common types of mesh used for these surgeries are made of nonabsorbable synthetic material (e.g., polypropylene or polyester).

POP occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to 50 percent of women may experience POP in their lifetime. When POP happens, organs bulge (prolapse) into the vagina, sometimes past the vaginal opening. Organs that can prolapse in POP include the bladder, uterus, rectum, top of the vagina and the bowel.

SUI is leakage of urine during moments of physical activity, such as coughing, sneezing, laughing or exercise.

Complications From Use of Surgical Mesh

The FDA alert reported that from Jan. 1, 2005, to Dec. 31, 2010, the agency received approximately 4,000 reports of adverse events associated with surgical mesh devices used to repair POP and SUI. The most frequently reported complications from having surgical mesh devices for POP repair include erosion of the mesh through the vaginal wall (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during intercourse (dyspareunia), organ perforation and urinary problems. Other reported complications include recurrent prolapse, neuromuscular injury, vaginal scarring/shrinkage, emotional problems and death. Many of these complications require additional treatment, including medical and surgical treatments and hospitalization. Over the past three years, the FDA also received more than 1,300 reports of similar complications associated with surgical mesh used for SUI repairs.

Vaginal mesh erosion is the most common mesh-related complication in women undergoing transvaginal POP repair, occurring in approximately 10 percent of patients within 12 months of surgery. Treatment of this complication (and others) can require multiple surgeries and may result in permanent debilitating pain and other symptoms, even after the mesh is removed.

Furthermore, the FDA’s review of the medical literature showed that transvaginal POP repair with surgical mesh does not improve symptomatic results or quality of life over traditional non-mesh surgical repair. In contrast, mesh used in transvaginal POP repair introduces risks that are not seen in traditional non-mesh surgery for POP repair.

Read the full FDA safety announcement.

What You Should Do

If you are considering surgery for repair of POP, you should choose to undergo surgery without mesh or consider nonsurgical options, such as pelvic-floor muscle exercises or vaginal inserts, called pessaries, to support the prolapsing tissue.

If you have undergone repair of POP or SUI with surgical mesh, you should do the following:

• Continue with your annual and other routine checkups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.
• Notify your health-care provider promptly if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain during sex.
• Let your health-care provider know you have surgical mesh implanted, especially if you plan to have another surgery or other medical procedures.
• Talk to your health-care provider about any questions you may have.

Report any adverse effects related to urogynecologic surgical mesh to the FDA’s MedWatch program.