FDA Issues Warning About Vaginal Mesh

The Food and Drug Administration has issued a warning to surgeons and prospective female patients about a vaginal mesh that’s been used in surgeries to correct a condition known as pelvic organ prolapse. The directive called on surgeons to consider other options to the mesh until the FDA can convene an advisory committee to explore more thoroughly the problems with the vaginal mesh.
Use of the mesh is widespread with approximately 100,000 women having the mesh surgery each year. According to the FDA, mesh-related symptoms include painful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding, usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it.
According to the Boston Globe, “In 2008, the FDA announced that “rare’’ problems could be associated with transvaginal placement of the mesh, which is used along with surgical stitches to support sagging pelvic organs such as the bladder, uterus, and bowel after they have been lifted back out of the vagina, where they descended.
From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for pelvic organ prolapse repair, five times as many as the agency received from 2005 to 2007. It also received three reports of deaths that were related to the mesh placement procedure.
Recent studies indicate that about 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half require additional surgeries to remove the mesh. Less commonly, the mesh becomes so intertwined with scar tissue that it cannot be removed.”