Problems Associated with Transvaginal Surgical Mesh Patches

The following, from the July 2009 issue of Nursing and now available on the website of the U.S. Food and Drug Administration (FDA), focuses on a case study of a patient who experienced serious post-surgical complications caused by transvaginal mesh patch surgery.

If you have experienced complications with a Gynecare surgical mesh implant—or that of another manufacturer—we urge you to complete the form below for important lawsuit information.

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. 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).

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.

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.

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. 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:

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see also:

2012 FDA Scrutiny Pelvic Mesh Subject of Additional FDA Scrutiny
Pelvic Mesh Subject of Additional FDA Scrutiny

Medical opinions on pelvic mesh dangers Medical opinions on pelvic mesh dangers


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