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What is considered Vaginal Mesh Extrusion?

On July 13, 2011, the FDA warned of the risk of serious transvaginal mesh complications in women who have undergone or are considering surgical repair with mesh for conditions like pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Vaginal mesh extrusion, the most common of the transvaginal mesh complications, describes a condition in which the mesh used during surgical repair erodes through the skin and tissues and becomes exposed through the vaginal skin. Other transvaginal mesh complications include pain, infections, bleeding, urinary incontinence, recurrence of prolapse, and pain during sexual intercourse.

 

Vaginal mesh extrusion reported as a common complication


According to the FDA’s July 2011 warning, vaginal mesh extrusion (also called vaginal mesh erosion, exposure and protrusion) is the most common of all the transvaginal mesh complications, with about 10 percent of women reportedly experiencing it within a year of surgery.

Repair of vaginal mesh extrusion often requires additional surgeries that attempt to remove the visible mesh. Sometimes the surgeries are successful, but sometimes they aren’t, leaving women with transvaginal mesh complications like pain, bleeding, pain during sex, and perhaps even an inability to engage in sexual intercourse. Extruding mesh can also be painful for men during sexual intercourse, if the penis rubs against the mesh material.

According to an FDA review of the scientific literature, more than half of the women who experienced vaginal mesh extrusion required surgical excision in the operating room, with some women requiring two to three additional surgeries.

 

Surgery with mesh increases risk of vaginal mesh extrusion


Surgical mesh has long been used to repair abdominal hernias, but in the 1990s gynecologists began using it to repair stress urinary incontinence (SUI) and pelvic organ prolapse POP.

Many women experience POP as they age. Childbirth, menopause, surgeries, and other life events can gradually cause the pelvic muscles and tissues to stretch and weaken, making them less able to support pelvic organs like the bladder, uterus, rectum and bowel. As a result, one or more of these organs may fall or bulge into the vaginal wall. Some women experience few symptoms, but others may experience pain, pressure, painful sexual intercourse, or stress urinary incontinence.

Traditional repair of POP involved stitching the muscles and tissues back together to hold the prolapsed organ in place. Some studies seemed to indicate, however, that surgery with vaginal mesh provided a superior hold and more longer-lasting POP and SUI repair. The risk of transvaginal mesh complications, however, were noted to be higher.

 

Transvaginal mesh complications may depend on the product


In response to surgical demand, medical device companies began making surgical mesh kits in the later 1990s for use specifically in POP or SUI repair. In 1996, the FDA approved the first product for use in SUI, and in 2002, the first one for use in POP.

Each of these surgical mesh products may be made of different materials or designed in different ways, though most surgical mesh devices for POP and SUI procedures are made of non-absorbable synthetic polypropylene. In lawsuits brought against the manufacturers, the design of these mesh products is often blamed for the high risk of transvaginal mesh complications like vaginal mesh extrusion.
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