FDA News Release — The FDA issued an updated safety communication on July 13, 2011 warning doctors and patients that surgical vaginal mesh repair of pelvic organ prolapse (POP) may expose patients to greater risks than other repair procedures.
After reviewing scientific data published between 1996 and 2010 comparing vaginal mesh surgeries to other forms of POP repair, the FDA concluded procedures using vaginal mesh may place patients at a heightened risk of complications. Furthermore, there is no evidence that vaginal mesh POP repair has any added clinical benefits — such as improved quality of life — over other forms of surgery.
William Maisel, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health, advises surgeons to consider all other treatment types before operating transvaginally. Maisel states:
“There are clear risks associated with the transvaginal placement of mesh to treat POP.”
POP occurs when the tissue supporting the pelvic organs weaken or stretch. Because of the weakened structure, the organs drop from their usual position and bulge (or prolapse) into the vaginal wall. Pelvic organs include the bladder, uterus and bowel. POP is not life-threatening, although patients may experience symptoms of discomfort and a disruption of their sexual, urinary and defecatory functions, which may reduce the quality of life.
One way to treat POP is through surgical repair, which can be conducted abdominally or transvaginally using stitches or surgical mesh.
When POP repair surgery is done transvaginally, stitches and vaginal mesh are permanently inserted through the vagina, in order to reinforce the bulging organ and correct anatomy. The FDA estimates that there were approximately 100,000 POP repair surgeries conducted in 2010. Of those, 75,000 used transvaginal mesh.
Despite these numbers, there has been evidence for at least two years that transvaginal mesh procedures are dangerous to patients.
Previously, in 2008, the FDA issued a warning about the danger of vaginal mesh implants, due to an alarming number of adverse event reports made regarding complications.
Since 2008, however, that number has only risen. Between 2008 and 2010, the FDA received 1503 reports of complications occurring in patients who received mesh during POP repair.
Most frequently, complications included erosion, when mesh becomes exposed or protrudes out of the vaginal tissue. Other side effects of pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems occurred. Some of these side effects required additional surgeries, sometimes to remove the mesh. However, as Maisel states:
“Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”
As a result, the FDA is recommending surgeons carefully consider all other treatment options before suggesting vaginal mesh surgical procedures. The FDA noted that mesh placed abdominally for POP — an alternative to transvaginal mesh implants — may result in lower rates of mesh complications. Surgeons should also make sure that their patients are fully informed about the risk of complications.
As part of the news release, the FDA also announced a panel of experts will meet on September 8-9, 2011 to discuss the safety and effectiveness of vaginal mesh procedures used to treat POP and SUI. Topics will include the risks of repairs, the need for additional clinical studies, and the FDA’s interim recommendations for patients and doctors.
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