FDA Warns of Serious Complications From Vaginal Mesh Implants

July 15, 2011 — On Wednesday, FDA released a warning that transvaginal placement of surgical mesh implants used to treat pelvic organ prolapse carry more risks and fewer benefits than other surgical options, Medpage Today reports (Fiore, Medpage Today, 7/13). Pelvic organ prolapse -- which can occur when women's vaginal tissue is weakened, especially after childbirth -- can cause a woman's uterus, bladder or rectum to slip out of place. The mesh can be implanted abdominally or vaginally to support the vaginal tissue (Mai Duc, Los Angeles Times, 7/13).

In its review of literature from 1996 to 2010, FDA found that women who have transvaginal pelvic organ prolapse repair with mesh implants are at greater risk of bleeding, pain and infection, and might require additional surgeries or hospitalization, compared with those who have repair with only stiches. FDA officials said that the current warning does not apply to abdominal placement of mesh or to mesh used for treatment of urinary incontinence. The agency has received reports of adverse events including erosion through the vaginal tissue, pain, infection, bleeding, pain during intercourse, organ perforation from surgical tools and urinary problems. FDA called for an advisory panel to convene in September to discuss future recommendations (Medpage Today, 7/13).

William Maisel, FDA deputy director of the center for devices, cited academic literature and a recent increase in adverse event reports that found the "added benefit of using mesh is not evident," but "there certainly appears to be an added risk." FDA first cautioned physicians about serious but "rare" side effects in 2008 after receiving 1,000 reports of complications between 2005 and 2007 (Los Angeles Times, 7/13). Between 2008 and 2010, FDA received 1,500 adverse reports (Perrone, AP/Boston Herald 7/13). Maisel noted that once implanted, the mesh cannot be completely removed in all cases (Medpage Today, 7/13).

Despite the risks, Maisel said FDA will not withdraw mesh from the market because certain patients, such as those who require mesh implants for incontinence, are not at greater risk for complications because the surgery requires less mesh. "Rather than remove mesh from the market and not have an important product available to these patients, what we'd like to do is make sure it's used in the proper patients," Maisel said.

For patients with past mesh-related complications, doctors should attempt to remove the product except in dire cases. According to the AP/Boston Herald, in 2010, 75,000 women had prolapse surgery with surgical mesh inserted vaginally and more than 200,000 women had the procedure for incontinence (AP/Boston Herald, 7/13).