Safety Communication Background
Transvaginal mesh is a common treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In 2010, more than 550,000 women had surgery for POP and SUI, many receiving transvaginal mesh implants.
A number of adverse event reports detailing often serious medical complications have been associated with the use of transvaginal mesh. According to a
2008 FDA Public Health Notification, the administration received over 1,000 reports of complications over the course of a three year period between 2005 and 2007. Additional reports, as well as numerous transvaginal mesh lawsuits, followed.
July 13, 2011 Food and Drug Administration Safety Communication
The purpose of the 2011 FDA safety communication was to provide an updated report on the potential for serious medical complications arising from transvaginal mesh surgery. The FDA stated that "serious complications associated with surgical mesh for transvaginal repair of POP are not rare." Additionally, the FDA noted that their review of transvaginal mesh showed that the product did “not improve symptomatic results or quality of life over traditional non-mesh repair.”
In the 2011 safety update the FDA stated that it had received an additional 2,874 reports of
transvaginal mesh complications between 2008 and 2010, in addition to the over 1,000 reports that it received between 2005 and 2007. These reports included incidents of
mesh erosion and
mesh contraction, both of which "may lead to severe pelvic pain, [and] painful sexual intercourse." In many instances additional surgeries were required to remove or repair the transvaginal mesh implant. The FDA established a committee to evaluate the risks and benefits of transvaginal mesh in light of these findings.
No Evidence of Greater Clinical Benefit
The FDA news release that accompanied the July 13, 2011 Safety Communication made it clear that "with the exposure to greater risk comes no evidence of greater clinical benefit such as improved quality of life." The new release cited an increasing number of adverse event reports associated with the mesh, "five times as many as the agency received from 2005 to 2007" related to the use of transvaginal mesh to treat POP.
Injured by transvaginal mesh or sling?
The transvaginal mesh lawyers at Girard Gibbs investigate cases of women across the country who have experienced health complications after receiving a transvaginal mesh implant. If you or a loved one suffered transvaginal mesh injuries, you may have a legal right to pursue financial compensation for your injuries or other damages. Fill out the form to the right or call (866) 981-4800 for a free and confidential consultation concerning your possible transvaginal mesh lawsuit.
Why Girard Gibbs?
Girard Gibbs is a national litigation firm representing consumers, investors, employees, and small businesses in cases involving consumer protection, personal injury, securities, antitrust, and employment laws. The firm’s senior partners, Daniel Girard and Eric Gibbs, have been selected for inclusion in The Best Lawyers in America® 2012 and Northern California Super Lawyers, and have earned AV-Preeminent ratings from Martindale-Hubbell, recognizing them in the highest class of attorneys for professional ethics and legal skills.
