2008 FDA Transvaginal Mesh Public Health Notification
On October 20th, 2008 the Food and Drug Administration issued a Public Health Notification regarding reports of serious complications associated with transvaginal mesh, a popular treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
The notification stated that "over the past three years, FDA has received over 1,000 reports… of complications that were associated with surgical mesh devices.” It also mentions that that “although rare, these complications can have serious consequences.” The most common complications included erosion through the vaginal tissue, infection, pain, urinary problems, and recurrence of POP or SUI.
July 13, 2011 Update
In July 2011 the FDA issued an update to the 2008 Public Health Notification. This update alerted patients and healthcare practitioners that "complications associated with surgical mesh for transvaginal repair of POP are not rare." The FDA said that it had received 2,874 reports of complications from transvaginal mesh between 2008 and 2010, in addition to the over 1,000 reports it received from 2005-2007 that prompted the initial notification.
According to the July 2011 FDA update, the most common complications reported to the FDA included "mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems." The FDA also stated that there is insufficient evidence to show that transvaginal mesh provides any benefit to patients when compared to traditional non-mesh procedures to treat POP and SUI. In September 2011 the FDA convened a panel to assess the risks and benefits of transvaginal mesh in light of these findings.
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.
