Breaking News! Johnson & Johnson’s Ethicon Plans to Pull Plug on Four Transvaginal Meshes!

Jun 4th, 2012 | By | Category: Legal News

June 4, 2012 ~ Breaking news!  Bloomberg is reporting (here) that Johnson & Johnson (J&J) has requested the paperwork to stop selling four different types of transvaginal mesh in the face of hundreds of lawsuits.

The Ethicon unit of J & J told a federal judge in West Virginia that it has requested the official form from the U.S. Food and Drug Administration (FDA) to stop selling or “commercializing” the devices. That information was contained in a letter filed today with U.S. District Judge Joseph Goodwin in Charleston, West Virginia, the federal judge overseeing the consolidated product liability lawsuits against four makers of synthetic transvaginal mesh.

MDND reported last August (here) that a trial study of Prolift mesh, one among those to be pulled, was stopped before its conclusion in August of 2009 when 15.6% of participants experienced mesh erosion, or a wound breakdown from infected mesh.

You’ll recall in January 2012, the FDA ordered about 30 makers of synthetic mesh, along with J & J, to do post- market studies on women implanted to determine the amount of organ damage, infection, mesh migration and other complications. There are no pre-market comparable studies on safety and efficacy as they are not required before marketing transvaginal mesh.

Sold Without Approval

This news marks more trouble for J & J, whose Ethicon division makes the Gynecare Prolift. Earlier this year it was reported that the company began selling Prolift in 2005 bypassing any regulatory approval by the FDA.

What was the defense? The company said it didn’t think it needed to file a new 510(k) submission under FDA rules, which is customary for Class II medical devices to be approved for sale.  The Prolift was similar enough to another mesh it sold, the Gynemesh PS, which was marketed beginning in 2002, according to the company.

In response, the FDA did not press for any sanctions and instead approved both the Prolift and a new mesh, the Prolift +M in May 2008.

Prolift Lawsuits

State lawsuits over Prolift are also pending in Atlantic City, New Jersey and have generated more than 2.3 million pages of documents with lawyers seeking to interview company officials including Gary Pruden and Sheri S. McCoy who headed the pharma and consumer products divisions. J & J is fighting the deposition of the executives even thought McCoy left  J & J to head Avon after she was bypassed to be CEO by Alex Gorsky last month.

Matthew Johnson, a spokesman for Ethicon did not return calls to Bloomberg. He has never returned a call to MDND.  Part of the J & J, Ethicon, Gynecare creed states:

“We hold ourselves accountable to the highest standards to ensure that our interactions with health care professionals, institutions and non-profit organizations are conducted in an appropriate manner. To that end, we regularly review and improve our practices as part of an ongoing commitment to ensure ethical and transparent interactions with medical professionals.”

Learn More:

Ethicon Gynecare products
http://www.ethicon360.com/products/ethicon-womens-health-urology

MDND, March 21, J&J Sold Vaginal Mesh Implant Without FDA Approval
http://meshmedicaldevicenewsdesk.com/media-reports/breaking-news-j-j-sold-vaginal-mesh-implant-without-fda-approval/

MDND, August 21, 2011, Study Halted Due to Mesh Complications
http://meshmedicaldevicenewsdesk.com/featured-articles/study-halted-due-to-mesh-complications/

 

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Tags: , , , , , , , , ,

10 Comments to “Breaking News! Johnson & Johnson’s Ethicon Plans to Pull Plug on Four Transvaginal Meshes!”

  1. Amy G says:

    Incredibly good news!

  2. Nonie Wideman says:

    I am thrilled, only wish it had happened sooner, but better late than never!!!!

  3. Patty says:

    Im happy for the victims, only that they are but pioneers in what may very well set a new standard! Im happy that they were able to get someone to LISTEN! True life warriors and heros for others. Im saddened by what they have lost, for their families as well. I know what it is to be the spouse of a victim. We dont give up!! No matter what, we keep fighting and will continue to fight until change comes about.
    Thank you meshmedicaldevicenewsdesk, for being a super highway of help, information, links and thoughtful press for the victims of medical devices.

  4. Diane says:

    I am so happy to see that there is something being done, finally…

  5. Diane says:

    Can you tell me if Gynecare Johnson & Johnson is putting a halt on the selling of the TVT-O sling as well???
    I would think the fact that this product is also made from polypropylene, it should also be pulled.
    Would love for someone from the J&J company to report on this.
    Thank you!!!

  6. Bruce Rosenberg says:

    Hernia Mesh is next!! Don’t forget to report your adverse event to the FDA, documentation is key to proving this problem exists.

  7. [...] mean time, women continued to suffer and die. It is only recently, after hundreds of lawsuits, that J&J applied to recall Prolift and other vaginal mesh products. According to a J&J [...]

  8. Barbara Dykes says:

    wow, here I am after an implant in October 2008…explant December2011(had to drive total of 1200 miles for explant…had to use estrogen for 6 mo to “toughen my vaginal tissue”. This was closest MD credentialed to do this. Total “erosion” and he tells me under sedation “Had to leave some mesh in”. Reluctant to discuss why. 6 years wasting my life. Tried to go back to work as a Hospice Nurse but that did not work out for long because driving long distances/needing bathroom breaks. so many lives ruined so J&J could make money. All my implant MD said was “it doesn’t always work” as she showed me a roll of soft mesh. Quickly sheduled my surgery. I have worked for so many GREAT Doctors but some will just chase the money. A 30 minute surgery that cost thousands in dollars and stole my spirit.

    • Jane Akre says:

      Barbara- While I understand many must go to the closest doctor I do not know what credentialed means? So few can actually do a complete removal and leaving portions behind can be dangerous according to experts. If you can travel to someone who has a history of doing full removals might be the best option. You are right about money…. Let’s not forget medicine is a business as well and for some that is the primary driving force it appears.

Leave a Comment

We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.