Vaginal Mesh a High-Risk Device
Written by Faith Anderson on January 5, 2016
FDA Issues High-Risk Warning for Transvaginal Mesh Devices
The U.S. Food and Drug Administration (FDA) has finally responded to calls for stronger warnings on the use of transvaginal mesh, reclassifying mesh devices marketed for the transvaginal repair of pelvic organ prolapse (POP) as class III high-risk devices. According to its new warning, issued on January 4, 2016, the FDA is also requiring mesh manufacturers to submit a premarket approval application before their vaginal mesh devices can be approved for marketing. If you believe you have been adversely affected by side effects of vaginal mesh, our consumer advocates at the Consumer Justice Foundation can help. We are committed to protecting the rights of consumers harmed by allegedly defective products, and can help put you in touch with an attorney who has experience handling surgical mesh claims.
Potential Side Effects of Transvaginal Mesh
Surgical mesh was first introduced in the 1950s, as a treatment for abdominal hernias, but it wasn’t long before mesh began being used for the abdominal repair of pelvic organ prolapse, in the 1970s, and for the transvaginal repair of POP, in the 1990s. It wasn’t until 2002 that the first synthetic mesh device was approved for the transvaginal repair of POP as a class II moderate-risk device, and there are currently five manufacturing companies marketing their mesh devices for this particular indication. Now though, transvaginal mesh has been reclassified by the FDA as a class III medical device, which typically includes high-risk devices, due to the potential for surgical mesh to cause serious and potentially life-threatening complications in women.
In the years since synthetic mesh began being used for the transvaginal repair of pelvic organ prolapse and stress urinary incontinence (SUI), the product has been associated with an increasing number of adverse event reports detailing serious complications like mesh erosion, mesh infection, pain during intercourse, recurrence of POP or SUI, and the need for additional surgeries to remove the mesh. In an effort to better evaluate the benefit-risk profile of transvaginal mesh, the FDA conducted a review of research published between 1996 and 2011, and in a 2011 safety announcement, warned that “transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair.”
What is Pelvic Organ Prolapse?
Pelvic organ prolapse is a condition in which the pelvic muscles and tissues become stretched, torn or weakened due to injury or childbirth, and are no longer able to adequately support pelvic organs, which begin to prolapse into the vagina. Transvaginal mesh is a net-like implant inserted through the vagina to reinforce the weakened vaginal wall in women with POP. However, over the past several years, the FDA has received thousands of reports of bleeding, urinary problems and organ perforation associated with the use of transvaginal mesh for POP repair, and many affected women have required revision surgery to remove the mesh, which isn’t always successful. Despite these risks, the FDA has refrained from issuing a transvaginal mesh recall, although the agency has taken action to warn doctors and patients about the possible risks of surgical mesh for POP repair.
Vaginal Mesh Warnings from the FDA
In October 2008, the FDA issued a public health advisory alerting consumers and medical professionals about the risk of complications associated with transvaginal mesh. The warning stated that, “although rare, these complications can have serious consequences,” and at that time, the FDA had received more than 1,000 reports of side effects associated with vaginal mesh devices used to repair POP and SUI. In July 2011, the FDA updated its warning, indicating that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” The FDA also noted that “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
In its most recent transvaginal mesh warning, the FDA indicates that the reclassification of mesh as a high-risk device, along with the premarket approval application constraint, will force mesh manufacturers to address surgical mesh safety concerns, including pelvic pain and organ perforation. “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” says William Maisel, M.D. M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
An Experienced Surgical Mesh Attorney Can Help
Mesh manufacturers Boston Scientific, C.R. Bard and Johnson & Johnson’s Ethicon subsidiary are among a handful of companies that are together facing an estimated 100,000 product liability lawsuits over side effects from transvaginal mesh. All of the lawsuits involve similar allegations that poor design and substandard materials can cause serious vaginal mesh side effects like infection, bleeding and permanent nerve damage. If you received a transvaginal mesh implant in the past, and you have since suffered devastating complications like bleeding, mesh erosion, mesh infection or nerve damage, consult a knowledgeable vaginal mesh attorney for legal help. You may have grounds to file a transvaginal mesh lawsuit against the manufacturing company, in order to pursue financial compensation for your injuries and medical expenses.