Once hailed as a revolutionary solution to pelvic organ prolapse (POP) and stress urinary incontinence (SUI), transvaginal mesh implants have caused serious complications, including organ perforation and mesh erosion, in thousands of women, compelling consumer advocates and health care professionals to push for a transvaginal mesh recall. Some are also demanding stricter product testing and legislation to prevent further damages.
If you or someone you know has been surgically implanted with a transvaginal mesh product and experienced severe side effects, you may be entitled to compensation. Contact Ward Black law: (336) 333-2244 or toll-free at 800-531-9191; our transvaginal mesh recall lawyers can explain your legal rights, provide a free, no-obligation case review, and advocate for you. Call today!
Introduced to the market in the 1990s, transvaginal mesh was touted as a breakthrough in the treatment of two common conditions that plague women after childbirth, hysterectomies and menopause: pelvic organ prolapse (when the pelvic organs sag, or prolapse, into the vagina) and stress urinary incontinence. A square of synthetic mesh is surgically implanted through the vagina to support the pelvic organs that have slipped. To treat stress urinary incontinence, medical practitioners use a smaller piece of mesh, or a bladder sling.
But the mesh was not everything health officials had hoped for. Within months of implantation, some woman began experiencing critical post-surgery complications. In many cases, the mesh had cut through the vaginal wall and eroded or perforated nearby organs. Other side effects included everything from erosion of vaginal tissue to infection, and recurrence of POP and SUI. For some women, the treatment has resulted in chronic vaginal drainage and bleeding, unbearable pain during sexual intercourse, profound scarring and even death.
Often, multiple revision surgeries were required- a costly and painful process. Doctors must painstakingly trim or extricate the mesh from capillaries and tissue that have grown through the porous material.
As complaints of serious side effects from transvaginal mesh implants rise, public concern has increased significantly. In 2008, the U.S. Food and Drug Administration (FDA) issued a safety alert that acknowledged the problems with transvaginal mesh devices, but said complications were “rare.”
A follow-up alert was announced in July 2011, reporting that complications were no longer considered “rare.” It stated that between 2008 and 2010, transvaginal mesh failures caused thousands of injuries and resulted in seven deaths.
The agency did not issue a recall, but instituted more stringent protocols for pre-market testing to ensure the safety and efficacy of future devices.
While the FDA has not issued a transvaginal mesh recall, a number of manufacturers have voluntarily withdrawn their products from the market. Boston Scientific’s ProteGen, the first transvaginal mesh implant approved to treat POP, was released in 1997 and withdrawn from the market in 1999. The manufacturer recalled 20,000 devices, citing the mesh’s link to discomfort, painful sex and erosion of vaginal and surrounding tissue.
But by that point, several other manufacturers were already producing and receiving 510(k) FDA approval for similar mesh devices. 510(k) is a fast-track clearance system which allows products to be approved without human testing if they are “substantially similar” to a product already on the market.
Since ProteGen, other manufacturers have discontinued their products due to consumer pressure and lawsuits. Mentor withdrew its ObTape sling from the market in 2006 after hundreds of claims of adverse health events.
In June 2012, Johnson & Johnson agreed to stop selling most of its transvaginal mesh products, distributed by its Ethicon division, including the following:
The manufacturing giant maintained that it was not a product recall.
On July 1, 2012, C.R. Bard Inc. stopped selling its Avaulta Plus mesh product. On July 20, a lawsuit against C.R. Bard was settled for $5.5 million.
More than 700 lawsuits have been filed against the four major mesh manufacturers, American Medical Systems, Boston Scientific Corp., Johnson & Johnson’s Ethicon and C.R. Bard, and have been consolidated into a multidistrict litigation (MDL).
Moreover, a bill was introduced to Congress in February 2012 that would close the loopholes created by the 510(k) approval process. This legislation would allow U.S. regulators to block medical devices based on past safety concerns.
If you or a loved one has been surgically implanted with a transvaginal mesh device, you may have legal options. Contact the NC transvaginal mesh recall lawyers of Ward Black Law today to discuss your potential case. You can reach us by phone: (336) 333-2244 or toll-free at 800-531-9191 or via email.