Ethicon Mesh Recall Lawsuit
As reports of injuries continue to skyrocket after the Ethicon mesh recall, Johnson & Johnson’s Ethicon unit is preparing to defend more than 1,400 Ethicon lawsuits. The Ethicon lawsuits have been filed by women who suffered mesh erosion, bleeding and scarring as well as a range of other severe complications as a result of being implanted with the company’s transvaginal mesh devices. Ethicon transvaginal mesh is a surgical material used to treat such conditions as Pelvic Organ Prolapse (“POP”) and Stress Urinary Incontinence. (“SUI”)
If you sustained one of the following injuries after the Ethicon mesh recall, you too may be eligible to file an Ethicon lawsuit:
- Erosion through the vaginal epithelium;
- Painful sexual intercourse;
- Urinary problems; infection;
- Recurrence of POP and/or incontinence;
- Chronic pain; and
- Vaginal scarring.
Before the Ethicon Recall: Transvaginal Mesh Devices Manufactured by the J&J Subsidiary
Johnson & Johnson subsidiary, Ethicon, is the manufacturer of such transvaginal mesh products as the Gynecare TVT Secur System, Gynecare Prosima Pelvic Floor Repair System, Gynecare Prolift Pelvic Floor Repair System; and Gynecare Prolift+M Pelvic Floor Repair System.
On June 5, 2012, Ethicon announced it would stop selling these four products in three to six months, after asking the U.S. Food and Drug Administration (“FDA”) for 120 days to notify its customers around the world. Additionally, Ethicon notified the FDA that it would be changing the indication for Gynemesh, notifying surgeons that the product should no longer be placed transvaginally. Rather, it should only be implanted through abdominal incisions.
Ethicon Mesh Devices Subject of Mounting Controversy
The manufacturer’s decision to cease sales of four of its Ethicon mesh devices in June 2012 came just a few months after the FDA ordered 30 transvaginal mesh companies to conduct a safety and effectiveness analysis of their mesh products.
Earlier this year, it was reported that in 2005, J&J’s Ethicon started selling its Gynecare Prolift mesh without notifying the FDA it was placing the product on the market. Two years later, when the agency discovered the device was being sold, it required Ethicon to submit an application so that it could legally market the Prolift. In review of Ethicon’s application, the FDA found numerous deficiencies in the device’s labeling and product brochures. The agency also expressed concern of the “potential high risk for organ perforation” that might be associated with Ethicon mesh. Although the Ethicon Gynecare Prolift mesh was cleared by the FDA in 2008, questions remained whether the product was safe for use.
Concerns Over Transvaginal Mesh Rise In Recent Years
In October 2008, the FDA took its first step in addressing the dangers of transvaginal mesh by issuing a public health notification identifying the risks associated with the devices. The announcement was prompted by hundreds of adverse event reports by women who suffered mesh erosion, infection, pain, scarring and other complications as a result of being implanted with the material.
Then in July 2011, the FDA issued a revised health notification, which categorized the potential for serious complications stemming from the devices as ‘not rare.’ The agency also vowed to further evaluate the serious side effects of transvaginal mesh. Following the news of this heightened concern, the FDA’s Obstetrics & Gynecology Devices Advisory Committee then met to review the health issue in September 2011, where they agreed to institute more rigorous testing of mesh devices, and suggested reclassifying transvaginal mesh pelvic floor repair products as Class III devices. This would have required premarket approval for all future products.
How to File an Ethicon Lawsuit
If you suffered one of the severe side effects associated with the pelvic mesh implants manufactured by Johnson & Johnson’s Ethicon, you may be eligible to pursue an Ethicon lawsuit. By filing an Ethicon lawsuit, you may be able to obtain compensation for any medical expenses, lost wages and pain and suffering this unfortunate situation has caused you. Call the lawyers at Bernstein Liebhard LLP at (877) 779-1414. We will be happy to answer any questions you may have regarding the legal process.