J&J Sold Vaginal Mesh Implant After FDA Ordered Halted Sales

By Sarah Mirando | June 29, 2012

Category: Pharmaceuticals

By Mike Holter

Johnson & Johnson continued to sell a vaginal mesh implant for nine months after U.S. regulators told the company to stop marketing the device, according to court documents released this week.

The unsealed documents reveal the U.S. Food and Drug Administration (FDA) told J&J in August 2007 to stop selling Gynecare Prolift vaginal mesh implant until the agency could decide whether the device was “substantially equivalent” to other vaginal mesh products on the market. The FDA cited the “potentially high risk for organ perforation” when surgeons insert the mesh vaginally to support weakened pelvic tissue. Despite the FDA warning, Gynecare Prolift vaginal mesh product remained on the market for nine months, before it was eventually cleared by the FDA. J&J began selling the Gynecare Prolift transvaginal mesh without seeking FDA approval in 2005, reasoning that it was substantially equivalent to Gynemesh, another type of transvaginal mesh also manufactured by J&J and approved by the FDA.

J&J’s Ethicon unit faces more than 1,400 vaginal mesh lawsuits by women who claim the mesh caused organ perforation, pain, scarring and nerve damage. The FDA received 123 complaints about the Prolift from 2005 to May 15, 2008, when the device won clearance. Vaginal mesh lawyers say the device’s approval history could increase J&J’s cost to resolve the litigation, which is part of an ongoing and growing multidistrict litigation (MDL) case taking place in the U.S. District Court for the Southern District of West Virginia against numerous vaginal mesh manufacturers.

Hundreds of women who have suffered vaginal mesh complications have filed lawsuits against the manufacturers, many of which have been consolidated into a single MDL proceeding. The vaginal mesh lawsuit MDL allows hundreds of transvaginal mesh victims to file lawsuits under the jurisdiction of one judge, but still allows each vaginal mesh Plaintiff to retain her own attorney and receive an individual award if the case is won or settled. The award they would receive is typically much larger than any individual award expected in a vaginal mesh class action lawsuit. In a transvaginal mesh class action lawsuit, hundreds of thousands of vaginal mesh patients are joined together. Once, or if, a vaginal mesh class action settlement is reached, the class members would typically share the award, which could be in the range of thousands of dollars per claimant, rather than tens of thousands, hundreds of thousands, or even millions of dollars in some cases for individual transvaginal mesh lawsuits. On the other hand, if the MDL settles, everyone who joined the transvaginal lawsuit MDL would receive any financial award individually, unlike in a class action lawsuit. The vaginal mesh lawsuit MDL lawyers will determine exactly what each Plaintiff will receive depending on the injury suffered. This may mean that those who suffered more serious vaginal mesh complications such as organ injuries will receive more than those who suffered less serious complications, such as pain during sex. The transvaginal mesh law firms litigating the MDL will determine this as the case progresses.

Anyone who has a transvaginal mesh device, vaginal sling, or bladder sling needs to know the side effects so they can be caught and hopefully treated without further serious complications. Common transvaginal mesh side effects alleged in lawsuits include pain during sex; urinary problems; pelvic organ prolapse; vaginal scarring; perforated bladder, perforated bowl or perforated blood vessels; mesh erosion into the vagina; infection and organ injuries. If you are experiencing these vaginal mesh side effects, you should see a doctor immediately for treatment. If you are experiencing these symptoms, or experienced some or all of these symptoms in the past, you should also speak with a transvaginal mesh specialist to see if you are a good fit to file a vaginal mesh class action lawsuit or an individual transvaginal mesh lawsuit.

If you would like more information about filing a transvaginal mesh class action lawsuit or would like to file an individual transvaginal mesh lawsuit or join the vaginal mesh lawsuit MDL, just go to the Transvaginal Mesh Class Action Lawsuit Investigation page. You can submit your information, or your loved one’s, to vaginal mesh attorneys who are actively investigating all claims regarding urinary problems, vaginal scarring, mesh erosion, organ injuries and other complications related to vaginal mesh devices. Transvaginal mesh attorneys are waiting to talk to you now and the consultation is free. These lawyers don’t get paid unless you win or settle.

Updated June 29th, 2012

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