NEW YORK, Jan. 9, 2016 /PRNewswire/ -- Seeger Weiss LLP is reporting that the U.S. Food and Drug Administration has increased regulations on vaginal mesh medical devices. These devices are used to treat female urinary incontinence and pelvic organ prolapse. The FDA has reclassified vaginal mesh as a Class III device in treating pelvic organ prolapse and will now require manufacturers to submit premarket approval applications.
These requirements are to "help address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health. This change is due to the significant increase in the number of reported adverse events associated with the use of vaginal mesh in cases of pelvic organ prolapse.
Patients experience pelvic organ prolapse when the pelvic floor is damaged and can no longer support organs such as the bladder, bowel and uterus, causing them to drop and prolapse into the vagina. Surgery may be performed when symptoms are severe. Vaginal mesh may be used to reinforce the pelvic floor muscles and treat pelvic organ prolapse.
Over the years, the FDA has received an increasing number of reports on issues with the vaginal mesh. In 2008, the FDA issued safety warnings about transvaginal mesh kits and in 2012 it required manufacturers to conduct post-marketing safety surveillance. The most common issues are "severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues."
These new requirements do not apply to other types of surgical mesh.
In 2014, there were nearly 60,000 pending transvaginal mesh lawsuits, many of them involving mesh products used to treat pelvic organ prolapse. The lawsuits claim that treating pelvic organ prolapse with surgically implanted mesh results in damaging side effects. The FDA's new regulations will require manufacturers to submit an application that demonstrates that their surgical meshes are safe and effective when treating pelvic organ prolapse.
Seeger Weiss LLP Partner Jeff Grand serves as Co-Liaison Counsel in two coordinated litigations in New Jersey state court and is a member of the Plaintiffs' Steering Committee for the seven federal MDLs involving transvaginal mesh products.
Seeger Weiss LLP is one of the nation's leading trial law firms handling complex individual, mass and class action litigation on behalf of consumers, investors, injured persons and whistleblowers. The firm, with offices in New York, Philadelphia and New Jersey, represents plaintiffs throughout litigation and as trial counsel in a variety of practice areas, including financial, securities and investment fraud, pharmaceutical injury, consumer protection, qui tam (whistleblower cases), environmental and asbestos exposures, personal injury and medical malpractice, product defect, antitrust, and commercial disputes. For more information, go to www.seegerweiss.com.
SOURCE Seeger Weiss LLP