Transvaginal Mesh Products
Originally touted as a simpler way of treating women with pelvic organ prolapse (POP) and stress urinary incontinence in the early 2000s, transvaginal mesh products are now being named in a rising number of lawsuits that allege mesh erosion, pain, infection, and other transvaginal mesh complications caused by the implants.
Thousands of claims involving transvaginal mesh brands sold by Johnson & Johnson’s Ethicon unit, C.R. Bard Inc., Boston Scientific and American Medical Systems are now pending in courts throughout the U.S.
Johnson & Johnson/Ethicon Inc.
Many transvaginal mesh products manufactured by the Johnson & Johnson subsidiary, Ethicon, received U.S. Food & Drug Administration (FDA) clearance though the agency’s 510(k) process, which allows a product to enter the market if the company can prove it is equivalent to one already approved. This process has already been scrutinized by plaintiffs in lawsuits involving metal-on-metal hip replacement devices, which were also approved through this method and are now associated with widespread patient injuries caused by early failure complications.
Johnson & Johnson’s Ethicon was one of the first to start creating transvaginal mesh products, and were also one of the first to stop selling them.
In June 2012, the company announced it would stop selling the following vaginal mesh implants:
- Gynecare Prolift Kit
- Gynecare TVT Secur
- Gynecare TVT Abbrevo
- Gynecare Prosima Pelvic Floor Repair System
- Gynecare Prolift + M Kit
Transvaginal mesh products manufactured by Johnson & Johnson are not the only ones that received approval by the FDA’s 510(k) program, however.
C.R. Bard Inc.
Lawsuits filed against C.R. Bard Inc. allege erosion, organ perforation, nerve damage, infection and other injuries from these widely-used products, which also entered the market after being approved through the 510(k) program:
- Avaulta Solo Anterior and Posterior (prolapse repair)
- Avaulta Plus Anterior and Posterior (prolapse repair)
- Pelvilace Trans-Obturator BIoUrethral Support System (bladder sling)
- Uretex Trans-Obturator Urethral Support System (bladder sling)
Many of the claims that involve C.R. Bard’s products are pending in a federal multidistrict litigation (MDL) underway in the U.S. District Court for the Southern District of West Virginia. In state court, suits against Ethicon and C.R. Bard have also been filed in two consolidated proceedings in Atlantic County Superior Court in New Jersey (In re: Pelvic Mesh Litigation/Bard, No. L-6339-10, and In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10).
The cost of defending itself in transvaginal mesh lawsuits may be starting to weigh on this transvaginal mesh brand, a recent report from MassDevice.com indicated. According to an article dated April 24th, 2013, C.R. Bard’s first quarter earnings for 2013 were influenced by a $26 million charge related to transvaginal mesh lawsuits, totaling $90.7 million.
C.R. Bard’s first fiscal quarter for 2013 ended on March 31.
Endo Pharmaceuticals/American Medical Systems
American Medical Systems, a subsidiary of Endo Pharmaceuticals is facing mounting litigation over the following devices:
- Apogee (prolapse repair)
- Perigee (prolapse repair)
- IntePro (prolapse repair)
- Elevate Anterior and Posterior Repair (prolapse repair)
- MiniArc Precise Sling (bladder sling)
- MiniArc Single-Incision Sling (bladder sling)
Filing a Lawsuit over a Transvaginal Mesh Product
If you saw the transvaginal mesh product you received listed above, consider contacting an attorney at Bernstein Liebhard LLP. You may be eligible to take legal action in filing a transvaginal mesh lawsuit. Call the Firm to find out more at .
