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FDA Updates Warning Against Transvaginal Mesh

July 2011 — In October 2008, The FDA issued a Public Health Notification to notify patients and doctors about the adverse side effects associated with transvaginal mesh implantation to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Almost three years later, the FDA has recently published an update to its 2008 findings. The report amends its 2008 notification by stating that serious adverse events are not rare, as the FDA previously believed. Additionally, vaginal mesh does not appear to provide any medical benefit over traditional surgeries without mesh, and may add an additional risk to patients.

POP occurs when the tissue around the pelvic organs weakens, often occurring after serious injury, pregnancy or childbirth. As a result, the pelvic organs begin to bulge into the vaginal walls, sometimes even bulging past the vaginal opening. More than one organ can prolapse at the same time. The most common organs that prolapse include the bladder, the uterus, the rectum, the top of the vagina or the bowel.

SUI affects anywhere from 20-40 percent of women. Meanwhile, 30-50 percent of women are affected by POP. Most women will never develop symptoms of POP; others will develop mild symptoms that may be easily treated by exercises or vaginal inserts called pessaries. However, for some women, POP causes so much discomfort — even interfering with sex, urination and defecation — that it negatively impacts their quality of life. Surgery is an option for patients with these severe symptoms.

Transvaginal mesh has been used by surgeons to treat POP and SUI since the 1990s. Surgeons cut a piece of mesh to the desired shape, matching the prolapsed organ, and place it through an incision in the vagina to reinforce the vaginal wall. In 1996, the FDI approved the first surgical mesh product for use in SUI, and in 2002, the FDA approved the first surgical mesh product for POP repair. Mesh materials can be divided into four different categories: non absorbable synthetic, absorbable synthetic, biologic and composite.

The majority of vaginal mesh used in surgeries is non-absorbable synthetic polypropylene.

On October 20, 2008, the FDA issued a Public Health Notification that transvaginal placement of surgical mesh for POP and SUI was associated with serious complications. The alert advised doctors and patients that the complications were rare, but serious.

Through 2008, the FDA received over 1,000 reports of complications from mesh manufacturers. The most frequently reported complication was erosion of the mesh through the vagina (also called exposure, extrusion or protrusion), causing infection, pain, urinary problems, bowel perforation, vaginal scarring and recurrence of prolapse or incontinence.

Due to the various complications, patients required additional surgery (sometimes to remove the mesh), IV therapy, blood transfusions and drainage of hematomas or abscesses.

Since the 2008 report, the FDA has received 2,874 additional medical device reports, including notifications of injury, death and malfunction. 1,503 of the reports were associated with POP repairs — 1,371 with SUI repairs. The number of adverse event reports concerning POP treatment with vaginal mesh was 5 times higher than the number of reports received between 2005 and 2008 — an increase the FDA finds as “a cause for concern.”

To date, there have been 3,979 total reports of complications.

As a result of the exponential increase in complication reports, the FDA issued an update to its 2008 Public Health Notification.

The updated report determined that serious adverse events are not rare, as previously reported. Based on data from 110 studies of 11,785 women, approximately 10 percent of women who received vaginal mesh during POP repair experienced mesh erosion within 12 months of surgery. Half of the women who experienced mesh erosion required an additional excision surgery; some patients required two or three. Furthermore, POP repairs using transvaginal mesh do not provide any improved surgical outcomes over traditional non-mesh repair. In fact, it my subject patients to mesh-related complications, not experienced by patients undergoing traditional surgery without mesh. Additionally, while erosion was still the most frequently reported complication, there were also reports of vaginal shrinkage, shortening or tightening — a complication not reported in the 2008 alert.

There were three reported deaths, directly associated with POP mesh placement repair.

Based upon these findings, the FDA is considering regulatory changes, including changing the risk classification of transvaginally used mesh from a Class II to Class III, requiring manufacturers to submit premarket approval applications, which would include clinical data. Other changes may include more clinical studies or expanding post-market monitoring of the device’s performance.

The FDA is also planning to convene an advisory board meeting of outside experts on September 8-9, 2011. The board will discuss the studies and findings reported by the FDA in order to better assess the safety and effectiveness of mesh use in POP and SUI repair.

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