On July 13, 2011, the U.S. Food and Drug Administration (“FDA”) issued an updated safety communication, warning patients and doctors to carefully consider the risks associated with transvaginal mesh implants when deciding on a course of treatment for Pelvic Organic Prolapse (“POP”).  POP occurs when a woman’s uterus, bladder or rectum changes position after childbirth and pregnancy.  One option to treat POP involves the surgical placement of transvaginal mesh into the vaginal wall.  Although an estimated 75,000 women underwent vaginal mesh surgery last year, research suggests that women who receive transvaginal mesh implants face the possibility of mesh erosion, as well as other complications that require additional surgery to remove the mesh.  Because of these risks, the FDA has advised that patients and doctors consider alternatives to transvaginal mesh.  Additionally, the FDA announced that it will assemble a panel of experts to convene in September to determine whether transvaginal mesh should be removed from the market.  This is not the first time the FDA has reviewed the safety of transvaginal mesh.  A previous FDA safety communication was issued in 2008, advising consumers of the dangers associated with transvaginal mesh.  However, the number of adverse events has continued to climb.  Between 2008 and 2010, the FDA received over 1,500 adverse event reports related to transvaginal mesh implants used in the treatment of POP – five times as many as the agency received between 2005 and 2007.  In addition to serious injuries, three fatalities have also been reported.  In response to this spike, the FDA was prompted to take further action.  In stressing the dangerous risks associated with transvaginal mesh, the FDA stated that “with the exposure to greater risk comes no evidence of greater clinical benefit such as improved quality of life.”  We hope that health care providers and patients who are considering available treatment options make informed decisions.  Given that there is no evidence to support any benefit that would outweigh grave risks that needlessly expose women to potentially life-threatening danger, choosing a safe and effective alternative is clearly the best bet.

To view the FDA’s press announcement, click here.

Published July 15, 2011 by