Johnson & Johnson was the first medical device manufacturing company to follow Boston Medical’s example and introduce a second transvaginal mesh device aimed at treating pelvic organ prolapse. Although surgical mesh was originally designed for hernia repair procedures, over the years, companies like Johnson & Johnson have sold hundreds of thousands of surgical mesh devices implanted transvaginally to support prolapsed organs. Under the subsidiary Ethicon, Inc., Johnson & Johnson manufactured and sold several vaginal mesh devices including:
- Gynecare TVT
- Gynecare Secur
- Gynecare Prosima
- Gynecare Prolift
- Gynecare Prolift +M
Surgical Mesh Surgery vs. Non-Mesh Surgery
Implanting a surgical mesh in a pelvic organ prolapse or stress urinary incontinence procedure was believed to have better results as the vaginal sling could function as a support system. But following a thorough review of the available medical literature on mesh use in urogynecological operations, the FDA stated that there was no evidence to suggest that a mesh implant surgery are better than non-mesh procedures. Traditional non-mesh surgeries does not pose the risk of mesh-related complications that occur in 10 to 20 percent of transvaginal mesh sling surgeries, while providing the same symptomatic results.
Vaginal Mesh Implant Failure
A significant number of the adverse events reported to the FDA regarding pelvic mesh implants are due to mesh erosion or contraction. Mesh erosion through the vaginal tissue can cause pain, bleeding and infection. In addition, most surgical mesh are made of polypropylene, a material that can shrink after being implanted, causing serious side effects and the POP or SUI condition to return. Symptoms of vaginal sling failure include:
- Urinary incontinence
- Abdominal pain
- Pelvic pain
- Pain during sexual intercourse
FDA Warning and Manufacturer Liability
Due to the findings in the medical literature review, the FDA cautioned patients and healthcare provider against using vaginal mesh devices to treat POP and SUI. In the event of either a mesh contraction or erosion, it is frequently necessary to conduct revision surgeries to remove the device from the pelvic region, but even with multiple surgeries, the device may not always be completely removed. While the FDA may have granted Johnson & Johnson clearance to sell the Gynecare devices the manufacturing company is still responsible to ensure the safety and effectiveness for their products. Women who have been a victim of Johnson & Johnson mesh failure may be capable of recovering damages related to their injuries and permanent disfigurement.
Johnson & Johnson Vaginal Mesh Lawsuits
In the face of dozens of lawsuits filed by women who have suffered complications related to Ethicon’s vaginal sling devices, Johnson & Johnson announced it would withdraw many of its Gynecare products from the market. Gynecare Gynemesh PS is the only remaining product Ethicon will continue to market, but with restricted use limited to abdominal sacrolpopexy procedures for treating POP. For more information concerning the Johnson & Johnson Gynecare devices or the pending lawsuits, please contact our Johnson & Johnson vaginal mesh injury lawyers for a free case evaluation.