Johnson & Johnson Violated FDA Order to Halt Sales of Transvaginal Mesh

Ennis & Ennis, P.A. Explains J&J Continued to Market Gynecare Prolift Mesh Device Despite FDA Order

- Ennis & Ennis, P.A.

06/27/2012 - In complete disregard of an order by the U.S. Food and Drug Administration (FDA) to stop marketing the Gynecare Prolift vaginal mesh implant, Johnson and Johnson (J&J) continued to sell the product for nine additional months.  According to court records, in a letter dated August 24, 2007, the FDA advised J&J to halt the sales of the Gynecare Prolift vaginal mesh until such time the agency determined whether the device was the “substantially equivalent” to other mesh products on the market. [1]. The letter clearly stated that, “you may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval.  “If you market the device without conforming to these requirements, you will be in violation of the Federal Food Drug and Cosmetic Act.”  Despite this warning, J&J continued to sell the mesh product until the FDA cleared the device in May 2008 after months of negotiations with J&J. [2]

J&J initially began selling the Prolift in 2005. It failed to apply for application and approval from the FDA because it unilaterally determined its product was substantially similar to the Gynemesh product already approved by the FDA. The FDA disagreed and required a new application be submitted. The company’s failure to initially heed FDA orders could prove costly.  Currently there are more than 1,400 lawsuits pending against J&J by women injured by the mesh device, which has caused scarring, perforation of other organs, nerve damage and intense pain. “Women suffering injuries from the defective device should be outraged at both J&J and the FDA for their respective failures in ensuring that safe products are on the market,” says attorney Holly Ennis from Ennis & Ennis, P.A., a firm representing women nationwide injured by transvaginal mesh devices.

On June 5, 2012, J&J announced it would stop selling four vaginal mesh implants including the Prolift. [3]. The company is quick to note that this is not a recall but a “planned discontinuation” of the mesh products over the next several months.  However, the FDA has concerns over the safety of these devices due to the number of complications relating to the devices. Such problems include infection, abscess and organ perforation, most of which required additional surgery.  

Lawsuits are currently pending in state court in Atlantic City, New Jersey and in Federal Court in the U.S. District Court, Southern District of West Virginia (Charleston).

For women who have suffered as a result of a vaginal mesh implant, it is not too late to file a claim.  Contact Ennis & Ennis, P.A. for a FREE nationwide confidential consultation by calling toll free 1-800-856-6405 or by completing an online case evaluation form at www.ennislaw.com.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies and medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving Accutane, Actos, Avandia, Fosamax, Pradaxa, Plavix, Paxil/Birth Defect, Zoloft/Birth Defect, Prozac/Birth Defect, Depuy Hip Recall, Zimmer Hip Recall, Wright Conserve Hip, Wright Profemur Hip, all Metal-on-Metal Hips, Tekturna, Reglan, Medtronic Infuse Bone Graft, Yaz, Yasmin and Ocella Birth Control Pills.

Remember the law limits the time in which a claim can be filed, so don't wait.  Call today toll free 1-800-856-6405 or visit www.ennislaw.com.

[1] http://www.judiciary.state.nj.us/atlantic/pelvicmesh/orders_decisions_gynecare.htm
[2] http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071512.pdf
[3] http://freepdfhosting.com/012ad47703.pdf

Vaginal Mesh Implant Lawsuit

If you or a loved one have suffered or been injured from a defective transvaginal mesh sling you may be entitled to compensation. Contact the vaginal mesh sling attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding your transvaginal mesh sling injury, a possible class action lawsuit, or any other type of vaginal mesh litigation. Call us toll-free at: 1.800.856.6405 or fill out the free case evaluation form on this page. Ennis & Ennis, P.A. Ft. Lauderdale vaginal mesh attorney and Miami vaginal mesh attorney.

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