FDA Bares Warning Over Gynecare Prolift Vaginal Mesh

The U.S. Food and Drug Administration (FDA) in January 2012 asked Johnson & Johnson (J&J), and 32 other manufacturers to look into the rates of organ damage and complications linked to vaginal mesh implants. In 2010, doctors implanted more than 70,000 such devices in U.S. women to shore up pelvic muscles.

Johnson &Johnson’s Gynecare Prolift vaginal mesh implants have been a negative product for the company. Gynecare vaginal mesh lawsuit started to pile up after it ran into negative publicity.

The company introduced the Gynecare Prolift vaginal mesh device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles. The FDA learned of the Gynecare Prolift after J & J cited it in July 2007 as a predicate for a follow-on device, the Prolift+M. 

However, in August 2007, the FDA warned Johnson & Johnson to stop marketing the Gynecare Prolift after the agency became aware that the product was being sold without FDA clearance. The FDA further required J&J to submit a so-called 510(k) application to review the Gynecare Prolift vaginal mesh. Even with the warning, J&J continued to market Gynecare Prolift for nine months while engaged in talks with the FDA.

Reports say that J&J faced no sanctions for failing to gain FDA approval and continuing to sell Gynecare Prolift after the agency ordered a stop.

J&J’s unauthorized marketing of the device might cost the company more to resolve Gynecare prolift vaginal mesh lawsuit over the product. Several reports have it that J&J already has endured recalls of artificial hip implants and over-the-counter drugs.

According to the FDA, manufacturing companies that sell devices without mandatory approval are subject to compliance actions like warning letters, seizure of illegally marketed devices, and injunctions or financial penalties against the companies and their managers.

The FDA has documented a number of instances of “organ perforation” or punctured vaginas upon using the product. When this occurs, most women must have an additional surgery to repair, replace, or remove their defective vaginal mesh. Unfortunately, medical experts cannot completely treat all types of vaginal mesh complications. For instance, severe vaginal scarring or nerve damage may permanently restrain a woman’s capability to engage into sexual intercourse without pain. With this, her quality of life may be severely damaged.

References:

• bloomberg.com/news/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval.html
• businessweek.com/news/2013-02-25/j-and-j-failed-to-warn-of-vaginal-mesh-risks-n-dot-j-dot-jury-rules
• online.wsj.com/article/SB10001424052702303506404577448422586204212.html