The public advocacy group Public Citizen urged the U.S. Food and Drug Administration (FDA) on Aug. 25, 2011 to ban all non-absorbable transvaginal surgical mesh products used to repair pelvic organ prolapse (POP).
POP occurs in 30 to 50 percent of women after the stress of childbirth weakens the muscles and connective tissue supporting organs such as the bladder, uterus, rectum, bowel, and top of the vagina. The organ or organs bulge or prolapse into the vagina or past the vaginal opening.
Public Citizen petitioned FDA officials to ban all surgical mesh products designed specifically for transvaginal repair of POP because it claims that using these products is no more beneficial than doing surgical repair without them.
The consumer advocacy group also alleges that the devices have a high rate of complications. Many of the complications require additional surgery or surgeries, which may not work and can permanently affect the woman’s quality of life, the group claims.
In the petition, the group also urged the FDA to require that any future transvaginal surgical mesh products be reclassified as class III devices, requiring them to go through prospective clinical (human) trials proving them safe and effective.
The mesh products, which are classified as Class II, were approved by testing in the laboratory and on animals. They did not go through clinical trials.
Public Citizen said it based its decision to petition for the ban and recall of the surgical mesh on evidence that shows that using the transvaginal pelvic mesh in surgical repair proved to be no better than using native tissues.
The group says it is also petitioning for a ban because surgically implanted surgical mesh for POP repair often results in serious complications, including mesh erosion (sometimes called exposure or extrusion), severe vaginal pain worsened by movement, infection, urinary problems, bleeding, organ perforation, vaginal tightness, vaginal shortening and pain during sexual intercourse.
Public Citizen pointed to the FDA’s own conclusions that serious complications with transvaginal mesh repair were “NOT RARE” and that the “overall increase in the number of serious adverse event reports is cause for concern.”
If you’ve experienced problems with transvaginal mesh, you should speak with an experienced lawyer about your rights. To schedule a free review of your case, contact Flood Law Group, LLP today.