J&J Continued to Sell Vaginal Mesh Implant After FDA Ordered Halt

Jun 26th, 2012 | By | Category: Media Reports

Gynecare Prolift, Medtechmarket.ru

June 26, 2012 ~ Johnson & Johnson, the global healthcare company, has once again found itself in the spotlight for failing to follow the rules.

J & J was ordered to stop selling a controversial vaginal mesh product, the Gynecare Prolift,  but kept selling it even after being warned by the U.S. Food and Drug Administration in an August 24, 2007 letter. The letter said that the Prolift mesh had the “potential high risk for organ perforation” when it was inserted vaginally to support prolapsed tissues and organs in women.

The letter was recently released among a number of documents that had been under seal in Atlantic City, NJ state court and made public by attorney, Adam Slater, who is representing about 150 vaginal mesh victims, reports Bloomberg.

“You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval, the agency told the New Jersey-based company. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”

What happened? Nothing. All was forgiven in May 2008 when the FDA failed to apply any sanctions and approved the Prolift for market.

You’ll recall the Prolift was put on the market by J & J’s Ethicon division in 2005 without undergoing any FDA scrutiny. In its defense when the lapse was discovered, the company claimed the Prolift was the substantial equivalent of the Gynemesh, already on the market. The FDA had ordered Prolift sales stop in the August 2007 letter while it determined whether Prolift was the same as Gynemesh.

However an FDA spokeswoman recently told Bloomberg that there could yet be sanctions for selling an unapproved product which could include a fine, an injunction against a company or its managers and/or the seizure of the illegally marketed device.

A lead attorney in the mesh lawsuits, Henry G. Garrard III told Bloomberg that the inability or unwillingness of the FDA to follow its own rules and impose sanctions raises questions about the agency’s credibility and its power to protect Americans.

“Companies know the FDA has little enforcement ability and scarce resources,” Garrard, of Blasingame, Burch, Garrard & Ashley PC of Athens, Georgia told Bloomberg in a telephone interview. “Every woman in America who has been implanted with these devices absolutely should be outraged,” he said. “They should be mad at the company because the company knew they could get away with it.”

No recall has been issued on the Prolift. Instead on June 5, J & J announced it would stop selling four vaginal meshes, the Prolift among them.  Refraining from the word “recall” the company’s Ethicon division says it has plans to “discontinue” the product over the next three to nine months.

“Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics,” said spokesman Matthew Johnson to Bloomberg.

Mass Device reports  J & J is calling the news about unsealed FDA letters misleading and says that it acted in good faith.

“Ethicon remains committed to vigorously defending all product liability lawsuits concerning the use of our pelvic mesh products,” Johnson told us. “Numerous clinical studies suggest that when combined with proper surgical technique, surgical mesh can improve patient outcomes, and Ethicon’s devices are among the most studied devices on the market for this condition.”


J & J
is facing more than 1,000 lawsuits in Atlantic City state court and in a federal multidistrict litigation in District Court in Charleston West Virginia where women allege the defective vaginal mesh, used to correct incontinence and prolapse, instead caused traumatic and life-altering injuries. #

Learn More:

Bloomberg, June 26, J&J Sold Vaginal Mesh Implant After Sales Halt Ordered
http://www.bloomberg.com/news/2012-06-26/j-j-sold-vaginal-mesh-implant-after-sales-halt-ordered.html

Mass Device, June 26, J&J says unsealed FDA letters on vaginal mesh sales taken “out of context”
http://www.massdevice.com/news/jj-says-unsealed-fda-letters-vaginal-mesh-sales-taken-out-context

MDND, June 5, Four J & J Vaginal Meshes Named, Will be Removed from the Market
http://meshmedicaldevicenewsdesk.com/featured-articles/four-jj-vaginal-meshes-named-will-be-removed-from-market/


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4 Comments to “J&J Continued to Sell Vaginal Mesh Implant After FDA Ordered Halt”

  1. Amy G says:

    Why isn’t this a surprise?

  2. EH says:

    The bottom line is greed. NOT ETHICS. We need more and more laws and regulations because the motives of the companies that produce the products have nothing to do with “helping women”, instead it is about the stock holder and those in power gaining profits. When regulation is brought up, they (the pharmaceutical companies) pull the “move jobs overseas” card. Which, to me, is basically saying, if we can’t hurt American women, then we’ll take it elsewhere where people are not valued and a commodity, where we won’t be hindered by ethics. THIS IS INSANE!! And I agree with Amy – why am I not surprised?

    • Linda Dodson says:

      In my opinion, I TOTALLY BLAME THE FDA for allowing these companies to continue to market these products. The FDA has the law behind them to regulate and enforce their OWN POLICIES!!!!! Why they are NOT doing it is anyone’s guess. IF the FDA is in need of more money then one way of getting it is to start issuing FINES to these manufacturer’s when they are found to be in violation of the FDA’s rules and regulations.

      As recent as two weeks ago, I was in communication with the FDA, asking why were they not issuing RECALLS on these products, and also asked why hasn’t the FDA enforced their own policies and WHY can’t I find a WARNING LETTER on the FDA’s website? RESPONSE: “You can request it through the FOIA.” Warning Letters are public records and their are thousands on the FDA’s web site. However, for these particular products……THER IS NOT ONE WARNING LETTER. WHY NOT???

  3. MarieAnn says:

    The FDA is a joke, I don’t know how these people can sleep at night. Mesh is the true War on Women!! If this was a device ruining men’s ability to use their Viagra body part, believe me mesh would have been history years ago!
    As a woman of the 70′s, this sets us back years, as far as women’s rights. We have no right to life, liberty and the pursuit of happiness. I have not been a day without pain in almost 3 yrs! I’ve missed part of my last child’s childhood!. No amount of money can give me back the precious moments I ve not been able to be a part of. I went from a healthy, athletic woman in the prime of my life, a registered nurse, wife, who could have a loving sexual relationship with my husband of many yrs, an involved mother in my son’s school to a near cripple. I had to hide my cath bag many times when my sweet son had his friends over. At times he would just hold me as I saw him off to school in the mornings while dragging my catheter bag to the door. Also, I did change gyns here locally and now the creep that placed this crap in me has become a partner with that Gyn group! I can’t practice nursing, probably ever again, due to the continued issues from my damage from my POP mesh. I can’t lift more than 10# s for life. How am I gonna explain that to my future grandchildren when they lift their arms and say ” grandmama, can you please hold me?”. This is criminal what has been done to all of us. I feel as I’ve been part of a Nazi experiment by Dr Mengela and the FDA is the SS, I have had complete removal, but the trauma was so great, that I will be limited to what I can do for life. I am thankful to be alive as I almost bled to death with the removal. six surgeries in 2 yrs has taken a toll on my petite body for sure. I will Never be able to run or even walk far as of now. Will see as time goes by since my last surgery. I always am in the recovery stage. The mesh was bigger than my entire pelvis, which I found out after the fact!! I could go on and on. I do try to count my blessings as I am a Christian. The FDA needs to be disbanded if this is the best they can do! I have NO confidence in them or in healthcare in general. Pharm reps and device reps should be banned from doctors offices and from surgery. Unbelievable that men of science, Drs, are taught by pharm/device reps on how to implant these devices in patients. How did medicine come to this point? They are apparently are owned by Big Companies and the FDA turns a blind eye! The Reps are practicing medicine without a license! I just had to say my peace. May God be with us all.

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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.