Vaginal Mesh Device Sold in the US Without FDA Approval

April 12, 2012 - PRLog -- Bloomberg News reported that Johnson & Johnson marketed the Gynecare Prolift mesh device in March 2005, touting it as an “innovative and effective surgical option” for weakened pelvic muscles. (http://www.bloomberg.com/news/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval.html).  However, the U.S. Food and Drug Administration (FDA) did not clear the Gynecare Prolift mesh until May 2008, after Johnson and Johnson sought approval for a related product.  (http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071512.pdf).  Now more than 550 lawsuits have been filed over these mesh devices. (http://www.ennislaw.com/vaginal-mesh-implant-lawsuit-lawyer.html).  “The first problem is the process in which these devices are cleared or approved by the FDA,” commented attorney Holly Ennis of Ennis & Ennis, P.A.

The mesh devices used for transvaginal pelvic organ prolapse repair were classified under Class II, which allows the devices to be cleared for market under the FDA’s controversial 510(k) approval process, as long as they are “substantially equivalent” to existing products.  (http://www.fda.gov/MedicalDevices/ProductsandMedicalProce...). Therefore these devices were never studied in women to determine their safety and effectiveness before they were put on the market.

In 2007, the FDA required Johnson & Johnson to submit a so-called 510(k) application to review the Prolift, said Morgan Liscinsky, an FDA spokeswoman. The FDA had learned of the Prolift after Johnson & Johnson cited it in July 2007 as a predicate for a follow-on device, the Prolift+M, she said.

The lead FDA reviewer determined that Johnson & Johnson began marketing the Gynecare Prolift without appropriate clearance, reports Bloomberg.  However, Johnson and Johnson argues that the marketing of the device without FDA approval was appropriate because it was similar to an approved device already on the market, the Gynecare Gynemesh.  

“This is the very problem with the FDA’s 510(k) approval process.  It subjected our clients to unnecessary pain and suffering because the manufacturers of the mesh devices unilaterally decided to put these devices on the market,” commented Ennis.  

Transvaginal mesh lawsuits, where plaintiffs allege that mesh devices manufactured by Johnson & Johnson caused serious injuries, are pending in New Jersey state court before Judge Carol Higbee.

Last month more than 150 federal lawsuits against transvaginal mesh device manufacturers were consolidated before U. S District Judge Joseph Goodwin in West Virginia.

If you or a loved one has suffered from any of these injuries caused by a transvaginal mesh device, 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, representing 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, Paxil/Birth Defects, Zoloft/Birth Defects, Prozac/Birth Defects, Depuy Hip Recall, Wright Conserve Hips, Wright Profemur Hips, all metal hips, Plavix, Pradaxa, Depakote, Reglan/SJS, 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.