New Transvaginal Mesh Warning: FDA Recommends Patients Consider Alternative Treatment Options
On July 13, 2011, the U.S. Food and Drug Administration (“FDA”) issued a safety communication advising doctors and patients to consider alternative treatments to transvaginal mesh, also known as pelvic mesh. Additionally, the FDA announced that a panel will convene in September to determine whether transvaginal mesh should be removed from the market. Transvaginal mesh implants are used to treat Pelvic Organ Prolapse (“POP”), a common condition in which a woman’s uterus, bladder, or rectum changes position due to pregnancy or childbirth. To treat POP, transvaginal mesh is surgically implanted into the vaginal wall; however it exposes women to an increased risk of serious and fatal injuries. The FDA’s transvaginal mesh warning stated that “with the exposure to greater risk comes no evidence of greater clinical benefit such as improved quality of life.”?
FDA’s Transvaginal Mesh Warning Prompted by an Increase in Adverse Event Reports
In 2008, the FDA issued its first transvaginal mesh safety communication after receiving numerous adverse event reports. However, in its 2008 notice, the Agency indicated such events were rare. Since 2008, the number of adverse event reports has continued to climb. Since the FDA’s first transvaginal mesh notice, an additional 1,500 adverse events associated with the mesh used for POP repair have been reported. Three fatalities have also been linked to transvaginal mesh implants. Further, in 2010, an estimated 75,000 women underwent vaginal mesh surgery to repair POP. Hopefully, the latest FDA transvaginal mesh warning will encourage patients and health care providers to consider alternative treatments as the FDA continues its ongoing safety review of the mesh implants.
Transvaginal Mesh Lawsuits
If you or a loved experienced complications as a result of being implanted with transvaginal mesh, you may be able to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more. Contact one of our transvaginal mesh lawyers today for a free and confidential lawsuit evaluation. The lawyers at Bernstein Liebhard LLP have extensive litigation experience and have recovered billions of dollars for their clients. In addition to being staunch advocates for your claim, our transvaginal mesh lawyers also provide personal attention to guide you through the complex litigation process.