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Endo Will Stop Making Pelvic Mesh and Close Women’s Health Division

Endo logoMarch 2, 2016 ~ Facing billions in defective product lawsuits, Endo International will shut down its pelvic organ mesh unit, Astora Women’s Health, after a search for a buyer was unsuccessful.

Based in Eden Prarie, Minnesota, Astora will close March 31 to “reduce the potential for product liability related to future mesh implants.” the company says. Endo is based in Dublin, Ireland where it enjoys a lower tax-base than it had in Pennsylvania, reports the Wall Street Journal.endo logo  two

ENDO/ AMS 

Endo Health Solutions acquired women’s urology products when it took over American Medical Systems (AMS) in 2011 for $2.9 billion. In doing so, it also acquired more than 22,000 lawsuits that claimed the polypropylene mesh was defective and doctors were not adequately warned about the complications associated with the mesh. Last year Endo sold the men’s  health division to Boston Scientific for $1.6 billion, reports Fierce Medical Devices here.

By closing Astora, the company will limit its exposure to expensive lawsuits filed by women who were implanted with the AMS meshes.

brochureAMS makes the Perigee, Elevate and Apogee transvaginal mesh (TVM) used to treat pelvic organ prolapse (POP), a common condition in women following pregnancy, due to weak collagen or as a result of aging. Apogee and Perigee are  no longer for sale in the U.S. according to the AMS website.

AMS also makes the Sparc and Monarc slings to treat urinary incontinence, using a narrow strip or sling to support the urethra. 

According to the company’s website the Apogee Vaginal Vault Prolapse Repair System and the Perigee Transobturator Anterior Prolapse Repair System are “not available for sale in the U.S.”

The company won the CE approval in Europe for a fecal incontinence mesh implant which recently won approval by an FDA expert panel.

In the company’s Securities and Exchange Commission filing in 2013, AMS said it plans to “vigorously defend themselves in the remaining mesh product liability cases and in any new cases that may arise.”

The FDA recently announced that it would tighten regulations and required more stringent proof of safety and efficacy before mesh for pelvic organ prolapse could enter the market. The FDA gave mesh makers 30 months before it imposed the more stringent premarket approval or PMA, which is required of drugs.  Currently mesh is classified as a moderate risk or class II device.  The change will reclassify them as class III or higher risk.

 

Was On The Settlement Track

In June 2013, Endo Health Solutions Inc. agreed to pay $54.5 million to settle some outstanding lawsuits that have been filed by women who were implanted with the Perigee, Apogee and Elevate transvaginal mesh implants. See the Master Settlement here.

In March of the same year, the company announced it had put aside $520 million to cover the cost of litigation or settlement.  Endo also recorded a pretax charge off about $316 million at the end of 2013 which brought its product liability fund to about $520 million.

In its SEC filing, Endo Health Solutions Inc. said that an estimated 500 million women worldwide may suffer from urinary or fecal incontinence and around 400,000 surgeries are performed around the world annually to correct some form of pelvic organ floor prolapse.

 

Endo Under Investigation by AG Office

Also in March 2013, in the Endo annual report released by the Securities and Exchange Commission, Endo admitted it had received subpoenas from several states investigating the overpayment for its pelvic mesh products. The California Attorney General’s office is one of those states which issued a subpoena to Endo.

 

Post-Approval Monitoring Ordered

In January 2012, the U.S. Food and Drug Administration ordered pelvic mesh makers of mesh for pelvic organ prolapse, to conduct post-approval monitoring on the rates of organ damage and complications among the women implanted with its transvaginal meshes used for pelvic organ prolapse.

AMS received 19 orders but had honed that down to sixteen “for various commercial reasons” it said in an SEC filing. The company then took its Apogee and Perigee pelvic organ transvaginal mesh (TVM) off the market and in doing so it relieved the company of the post-market monitoring.   Ethicon, a division of Johnson & Johnson removed four meshes from the market in 2012 as well to obtain relief from the 522 orders as they are known within the FDA.    #

 

 

Learn More:

Philadelphia Business Journal February 29, 2016 Endo shutting down its women’s health division, here

Moody’s Investors Service Feb 29, 2016 here

Mesh News Desk, March 2014, Endo Under Investigation, See background story here.

Mesh News Desk, Endo Offers $830 Million to Settle 20k AMS Pelvic Mesh Lawsuits, here

Reuters, Endo Agrees to $830 million to Settle Vaginal Mesh Cases, April 30, 2014 here 

Mesh News Desk– Endo/ AMS set aside $520 Million to Settle, February 2014 here

Master Settlement, SEC filing, $54.5 Million, Freese & Goss, Matthews & Associates and AMS here

Mesh News Desk, June 21, 2013,  Endo Agrees to Settle Some AMS Vaginal Mesh cases for $55 Million here

 

13 Comments

  1. Dorothy says:

    Thank you Jane for all your help in getting us to this point. I’m sure our packets will be coming soon and one can only hope that the money amounts will be enough for a fresh start for all of us. I’m going to suggest that everyone send you a small gift of money for you to enjoy. Again thank you for all your hard work.

  2. meshie says:

    More in the article ”

    “Astora also makes mesh implants to treat stress urinary incontinence, which are not the subject of the increased regulation or safety concerns. And the company’s CE-marked mesh implant for fecal incontinence recently won the backing of an FDA advisory panel, making U.S. approval likely”

    They are still going to make it and put in bodies….when will this madness stop!

    Oh lord the FDA needs to really step up before more and more people are hurt…..

  3. Debi says:

    Wow!!!!! I love my morning coffee and mesh news desk read. Thank you so much Jane for all your hard work and endless research you do for us.

    Ever day starts with feeding the dogs, brushing my teeth, make coffee, grab the Ipad and read your site. I love opening it up and seeing something new has been added.

    Thank you, and may God bless all of us today and bring us happiness, joy and a day without pain. Amen

  4. stopmeshimplants says:

    Finally some positive news that more women may not be harmed by this mesh.

    Grateful for this news. Thank you, Jane.

  5. Lisa CT says:

    I’m confused??? They are shutting down that division so there products can’t hurt other women.. What about there outstanding lawsuits to help other women get needed surgeries and such. Are they not going to help them? There are a lot of hurting women still out there.. Where does this go now?

    • Jane Akre says:

      I believe it is safe to say the risk outweighs the benefit for them…. don’t think it has so much to do with altruistic reasons.

  6. Mary Pat says:

    This is a victory for the mesh injured. We ARE making a difference. Thank you Jane for all that you do. Endo doesn’t want to claim liability yet they don’t want to risk further liability. They are only fooling themselves. We, and the entire world, can see the truth. Our Lord brings truth to light. God is working on our behalf. Keep praying, everyone. God bless you all, especially you, Jane.

  7. anna says:

    Will J@J eventually admit their error, or will they continue to gain from our pain.

  8. kitty says:

    it’s interesting when I think back of how many of us some years ago had this put in us and then we were left to fend for herself never required to go to therapy physical therapy or watch out how we bend or lift or not given hormones are even suggesting things that ss prescribes she must be a nurse practitioner but there we were left to fend for herself

  9. Toni says:

    With J N J it was no error and the other companies either. It has been proven over and over that they knew what they were doing. They chose profit over our health. They were aware and warned by their own internal researchers of the dangers. That is not an error it’s criminal.

  10. Dixie says:

    Has anyone heard anything about Boston Scientific? What is going on with them?

    • Jane Akre says:

      Boston Scientific is worried about its mesh from China…..

      • Dixie says:

        I heard about their problems with mesh from China. And they said their mesh product’s cause to problems. Cheap made mesh from China. Makes me sick to think Boston said their mesh is safe and cases no problems. I say BS. I have had problems with the Obtryx Mesh from day one and gets worse all the time. Of course doctors say it’s not the mesh causing problems, it’s all in your head !! Tell my disfigured body that. Before I had this mesh, I was active, did not have to depend on anyone. I was independent, did what I wanted to do, go where I wanted to go, enjoyed time with my grandchildren. Since the mesh horror I can’t be the grandmother like I used to be. Besides the severe pain, my body has become totally different… swelling in my abdomen, feet and legs, severe constipation with blood, also still have incontinence. So what good did the mesh do? It was supposed to stop the incontinence not make matters worse. Walking is awful, can’t walk without assistance. Wearing adult diapers is the pits. Gives you a terrible rash even though I change them several times a day and night. I can’t sit in a chair without a cushion. Have to have something soft to sit on or sharp pains will shoot up through my lower extrimities. Never been through anything like this before. Been 5 yrs. 5 yrs of pure mesh hell. I hope Boston Scientific makers can sleep well at night cause I can’t..

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