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Ethicon Ordered to Disclose Transvaginal Mesh Communications with FDA

Transvaginal mesh lawsuits included in the consolidated Gynecare litigation have been subjected to an order in which Johnson & Johnson subsidiary Ethicon was required to produce all communications it had with the U.S. Food & Drug Administration.

Transvaginal mesh lawsuits included in the consolidated Gynecare litigation have been subjected to an order in which Johnson & Johnson subsidiary Ethicon was required to produce all communications it had with the U.S. Food & Drug Administration (FDA). In pursuant with the case management order, Ethicon must turn over all related correspondences with the FDA to plaintiffs in the Gynecare transvaginal mesh litigation. Like many other brands of vaginal mesh, the Gynecare Prolift Pelvic Floor System has recently been linked to a large number of severe side effects including infections, erosion of the mesh into the vagina, injury to nearby organs, and a recurrence of the urinary problems the devices were implanted to treat in the first place.

Free Transvaginal Mesh Lawsuit Evaluation: If you or a loved one has been injured by a transvaginal mesh device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the transvaginal mesh and we can help.

What’s the problem?

On August 8, 2012, Judge Carol E. Higbee, who is presiding over all of the transvaginal mesh lawsuits filed in New Jersey state court, issued an order requiring Ethicon to produce all communications and correspondences between the company and the FDA related to section 522 Orders. Specifically, a Section 522 Order requires a medical device manufacturer to conduct post-surveillance studies of a product that has the potential to cause adverse side effects when implanted in patients.

Earlier this year, the FDA ordered more than 30 vaginal mesh manufacturers to conduct up to three year’s worth of research on the safety and effectiveness of their products. As of January 2012, the companies had one month to comply with the administration’s mandate.

On June 4, 2012, Ethicon issued a press release stating that it was planning to halt sales of its Gynecare line of transvaginal mesh implants. Ethicon requested four months from the FDA to completely stop commercialization of the products. Additionally, the company requested that the administration delay their requirement to conduct post-surveillance studies on the devices. But regardless of Ethicon’s decision to halt sales of the Gynecare transvaginal mesh, the company must still divulge all correspondences and communications to plaintiffs in pursuant with this month’s Case Management Order.

In February, a panel of federal judges consolidated the American Medical Systems (AMS), Boston Scientific and Ethicon transvaginal mesh lawsuits as part of three separate multidistrict litigations (MDLs) under Judge Joseph R. Goodwin for pretrial proceedings in the U.S. District Court for the Western District of West Virginia. A fourth MDL, involving C.R. Bard vaginal mesh lawsuits, was previously centralized under Goodwin in October 2010.

According to a 2008 FDA Public Health Notification regarding vaginal mesh side effects, the administration had received over 1000 reports of pain, recurrence of prolapse, urinary problems, and perforation of organs during insertion:

“The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.”

Then in July 2011, the FDA issued an update to the 2008 notification about the growing number of injuries reportedly suffered by women treated with vaginal mesh and bladder slings. Specifically, the FDA stated:

“Complications related to transvaginal mesh surgery are NOT rare; (ii) There is no evidence that transvaginal mesh repair is more effective than traditional non mesh repair; and (iii) Transvaginal mesh surgery exposes patients to greater risk than traditional non mesh repair.”

Do I Have a Transvaginal Mesh Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in transvaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.

Free Transvaginal Mesh Lawsuit Evaluation: If you or a loved one suffered a serious injury after being implanted with a transvaginal mesh device, you should contact our law firm immediately. You may be entitled to compensation by filing a transvaginal mesh injury suit and we can help.

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