On July 1, 2012, Johnson & Johnson subsidiary, Ethicon, announced it would cease the sale and manufacture of four transvaginal mesh products, including:
- Gynecare TVT Secur system
- Gynecare Prosima Pelvic Floor Repair System
- Gynecare Prolift Pelvic Floor Repair System
- Gynecare Prolift+M Pelvic Floor Repair System
Ethicon’s Gynecare line of products were just one of dozens of transvaginal implants available on the market until recently. With over 3,500 reports of adverse events filed with the FDA linking the vaginal mesh implants with serious complications, Ethicon is one of many medical device manufacturers facing hundreds of lawsuits from injured patients.
Lawsuits Against Ethicon
With over 450 cases filed against Ethicon and its parent company, Johnson & Johnson, the medical device manufacture is being held liable for the hundreds of preventable injuries and complications endured by women who paid to have the defectively designed Gynecare mesh implanted in their bodies. Although marketed as a better and more permanent surgical solution to traditional non-mesh surgeries, the FDA found the mesh implants were no more effective in preventing recurrent pelvic organ prolapse (POP) than non-mesh surgeries. Women and families who have filed lawsuits against Ethicon are seeking to recover damages related to:
- Past and future medical fees
- Lost wages
- Pain and suffering
- Permanent damage to vagina
- Emotional trauma
Gynecare Mesh Complications
Unfortunately, the introduction of the foreign material (surgical mesh) in the pelvic region presents health risks unique to the implant. The FDA has found that the mesh can cause a variety of complications including:
- Mesh erosion/extrusion
- Internal bleeding
- Return of underlying condition
- Vaginal scarring/shrinkage
- Chronic pain
- Neuro-muscular problems
FDA Alerts Warn Patients
In July 13, 2011, the FDA released a public alert warning patients and healthcare providers that serious complications associated with transvaginal mesh implants are not rare. That same year, the New England Journal of Medicine published research demonstrating the increased risk of complications for transvaginal mesh implants when compared to colporrhaphy, the non-implant surgery traditionally used to treat POP. Since then, the FDA has required all transvaginal mesh manufacturers for more clinical evidence supporting the continued use of the clearly dangerous implants.
How Product Liability Laws Work
When a product is sold in the United States, the manufacturer, retailer, or any third-party connected to the production or sale of said product may be held liable for the damages incurred as a result of the product’s defects. And while product liability laws differ from state to state, the general principles remain the same, allowing hundreds of injured consumers to file class action lawsuits or multi-district lawsuits against the businesses at-fault. UInder such laws, transvaginal mesh victims may also be entitled to receive financial compensation for all or part of the damages incurred.
Protecting Your Legal Rights
The best way to ensure your rightful compensation will not be compromised is to consult a skilled product liability lawyer as soon as possible. If you have any questions regarding a potential transvaginal lawsuit, be sure to speak with a trusted attorney for a free case evaluation.