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Gynecare Gynemesh Archives - Carey Danis & Lowe

Ethicon Gynecare Prolift History & Lawsuit Background

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

ethicon johson johnsonTransvaginal mesh is used to treat patients with pelvic organ prolapse (POP) and stress urinary incontinence (SUI). As a national law firm representing individuals who believe their injuries (stem) from transvaginal mesh implants, Carey Danis & Lowe is invested in providing out clients and those who would like to learn more about transvaginal mesh with a comprehensive background of this product.

The following review of Ethicon’s Gynecare Prolift transvaginal mesh device contextualizes the mounting lawsuits targeted at this medical device manufacturer.

In March 2005, Ethicon, a unit of Johnson & Johnson, ushered the Gynecare Prolift transvaginal mesh device onto the medical device market. In marketing the mesh, Ethicon promoted it as an state-of-the-art device with successful outcomes.

According to Bloomberg, Ethicon sold the Gynecare Prolift for three years without approval from the U.S. Food and Drug Administration (FDA). Ethicon reasoned that the Prolift model was similar enough to an existing FDA approved product, the Gynecare Gynemesh device, that requesting FDA approval was unnecessary.

However, after learning about the Prolift model in 2007, the FDA deemed the unsanctioned release of the Prolift as unacceptable.

Even so, the FDA granted approval of Ethicon’s Gynecare Prolift in May 2008.

In 2011, three years after the Prolift’s approval, the FDA received strong recommendations from an advisory body to categorize transvaginal mesh as causing significant harm. They also advised that more research was necessary in order to determine the safety of transvaginal mesh, and that this research should involve human subjects.

In January 2012, the FDA ordered makers of transvaginal mesh to conduct studies of mesh related injuries, among them damage to organs. This order was directed at Ethicon and thirty other mesh manufacturers.

Later in 2012, Ethicon initiated a Gynecare Prolift recall. They also removed three other transvaginal mesh products off of the market, the Prolift+ M, TVT Secur, and Prosima.

In justifying its recall, Ethicon claimed the action was not influenced by mounting lawsuits or reported health complications, but instead with market viability.

Also in 2012, transvaginal mesh lawsuits were consolidated into a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of West Virginia before U.S. District Judge Joseph R. Goodwin. The litigation is In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation MDL No. 2327.

As of early October 2013, there are currently 10,400 vaginal mesh lawsuits targeted at Ethicon and their transvaginal mesh products in the West Virginia MDL.

These lawsuits claim that Ethicon’s transvaginal mesh products, including the Gynecare Prolift, caused serious injuries. More specifically, women have faulted the mesh for bleeding, pelvic area pain, infection, and painful intercourse. Furthermore, the FDA has cited mesh erosion and mesh contraction as the two transvaginal mesh injuries reported with the most frequency.

The St. Louis class action attorneys at Carey Danis & Lowe are currently accepting transvaginal mesh cases, and are providing free legal evaluations. In addition, individuals who have questions about transvaginal mesh and health complications can pose those questions to our on-staff medical experts. Our team is here to support you with expert legal and medical advice.

 

Share you transvaginal mesh story with Carey Danis & Lowe by calling 800.721.2519, or by completing a confidential personal injury claim form.