AMS Exec Wants Incontinence Devices Back on the Market

//AMS Exec Wants Incontinence Devices Back on the Market

AMS Exec Wants Incontinence Devices Back on the Market

Mesh Medical Device News Desk, June 18, 2018 ~ Product liability lawsuits were filed against American Medical Systems in Multidistrict litigation (MDL)  as early as 2012 when the MDL was created in Charleston, West Virginia. 

To date, there are 21,178 cases naming AMS filed there listing 19,524 as closed. 

That’s because AMS was the first company to begin settling with mesh-injured plaintiffs. Judge Joseph Goodwin hailed AMS as an example the other mesh makers should follow.  As a result there were no trials naming AMS, now owned by Endo International.

Image: John Nealon, LinkedIn

But that not-to-distant memory is not stopping some principals of the company from trying again to enter the lucrative medical device arena with a newly branded type of pelvic/ transvaginal mesh.

AMS EXEC WANTS INCONTINENCE DEVICES BACK ON THE MARKET 

John Nealon, who in the past headed the AMS Women’s Health Division that made transvaginal mesh, is launching a new company to reintroduce two incontinence devices back onto the market.

Nealon heads UroCure, a privately held medical device company based in Minneapolis, Minnesota, that is developing slings to treat female incontinence.  Opened one year ago, Nealon is the President and CEO. He left AMS in 2013 after five years as Senior Vice President and General Manager of Women’s Health Business.

UroCure raised $2.5 million to fund creating of the urethral slings. It has goals of raising upward of $3.5 million. The slings will rely on the same patented technology used to create the AMS slings such as Sparc and Monarc to treat stress urinary incontinence.

Nealon says the new company plans to “build on the long-standing market leadership position,” said Nealon.

How will the new mesh be different from the old mesh that landed AMS in court facing at least 22,000 lawsuits in the U.S, MND asked John Nealon.

“We’re not sharing that at this time. It’s not public. Until we launch we are keeping things private,” he said to MND.  

The new products are expected to launch sometime after the first quarter of next year.

An SEC filing from March (here).

UroCure
701 North Third Street,
Minneapolis MN 55401
612-850-6814

Other principals of the company are listed as Dave Staskin, Executive Officer,  and Doug Kohns, Executive officer.

 

COMPANY STATEMENT

A Company statement from gust.com says:

“Re-commercialize slings for female incontinence with IP re-acquired from AMS. We will design, develop and commercialize the products and re-submit for FDA clearance according to previously established 510(k) pathway. Slings are gold standard and are reimbursed in all geographies. During product development phase, the company will use an experienced team of contractors with in-depth knowledge of space, sling design/manufacturing and physicians.”

IP is intellectual property.  There is no word here whether or not the slings will be made of polypropylene (PP), a cheap polymer used in most hernia and pelvic meshes.

 

BACKGROUND – A BAD DEAL

In 2011, Endo International, based in Dublin, Ireland, purchased American Medical Systems Women’s Healh Division for $2.9 billion even though at the time it was valued at $2 billion. In doing so, Endo acquired more than 22,000 product liability defective transvaginal mesh lawsuits.

The men’s health urology division was then sold to Boston Scientific for $1.65 billion.

The women’s health division was relaunched and with a new name, Astora Women’s Health.

Astora Women’s Health closed its doors in March 2016 due to the cost of litigation.  At that time, Astora announced it suspended commercial activity concerning women’s health products.

On September 30, 2014, American Medical Systems announced a master settlement of $1.6 billion designed to resolve substantially all of its remaining US vaginal mesh lawsuits.

In August, 2017, Endo International agreed to settle 22,000 unresolved pelvic mesh product liability lawsuits. The company set aside $775 million to do so.  Totaling that with its previous settlement dollars, the company pledged more than $3.58 billion to resolve its pelvic mesh litigation and vowed it would pay no more settlements to mesh-injured women.

By being one of the first companies in the multidistrict litigation (MDL) to settle, AMS/ENDO did not face multi-million dollar plaintiff awards in court as other defendants in multidistrict litigation have faced.

At this writing, no AMS mesh case has gone to trial, though some are being prepared for trial.

At one time AMS made the Elevate, Apogee/ Perigee and Monarc,Sparc  and Mini-Arc meshes for both pelvic organ prolapse and stress urinary incontinence.  POP meshes were removed from the market when in 2012, the Food and Drug Administration ordered they go through a more stringent review before being sold.  Most companies did not want to put millions of dollars into research & development of a technology that was proving problematic in implanted women.

Mesh News Desk has regular contact with AMS-implanted mesh women who have not had their cases resolved.

AMS has also been one of the most aggressive to pursue legally those involved in alleged “schemes” to profit from encouraging women to undergo additional mesh removal surgeries to increase the value of their case.  See MND story here.

Endo is also facing financial difficulties after one of its opioid medications, Opana ER, was withdrawn from the market, cutting sharply into revenues. Its stock price today is $9.17 from a high of over $12.30 in 2018.

In April 2015, Endo enjoyed a stock price over $94 a share.   ###

LEARN MORE:

Mesh News Desk,  How Cases are Dismissed, Adams v. AMS, August 28, 2017 Here

Mesh News Desk, Endo American Medical Systems Under Investigation for Transvaginal Mesh March 5, 2017 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

 

By | 2018-07-17T14:12:27+00:00 July 11th, 2018|Medical News|10 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

10 Comments

  1. Still Standing June 18, 2018 at 2:23 pm - Reply

    That is unbelievable. I assume it will have to go through clinical testing on women, but how can that be if they are bringing it to market so quickly? A pharmacy tech at the pharmacy where I got my medication who literlly saw me fade away had a mesh repair four months ago and went in last week to have it removed. She thought everything was ok since she went to a university medical center to have it placed and it was not “”my kind of mesh.” She wasnt evaluated for pelvic floor dysfunction and referred to PT before the mesh, which can contribute to higher complications. She also had a previous chronic pain disorder, another complication risk. Im just amazed that women we tell and warn are led to believe that their mesh will be ok. Some will be, but there are enough wounded women littering the path to dspute that.

    • Jane Akre June 18, 2018 at 3:46 pm - Reply

      The power of a doctor’s advice…… I would guess many readers of MND will never again believe everything they are told by medical professionals.

  2. anonymous June 19, 2018 at 10:45 am - Reply

    I will never ever have anything put into my body again. Nothing. After what I have been through and have had taken from me by a medical device I will never again allow a doctor to put anything in me that is not human. It is just not worth the pain and misery that I have to live with after for the rest of my life.

    • Jane Akre June 19, 2018 at 10:56 am - Reply

      Anonymous, what would you say to this executive if you had a chance?

      • Anonymous September 7, 2018 at 9:00 am - Reply

        I would say ” I had a sling placed eleven years ago”. Yesterday, pee rolled down my leg without warning! They don’t work !!! Don’t continue to harm woman !
        I also have mesh in my vagina!
        I have this plastic inside me and it doesn’t work. We can argue the health issues all day long but if we still pee our pants it’s for what ?

        • Jane Akre September 7, 2018 at 1:26 pm - Reply

          I wish that man would listen to you before he launches again, his products.

  3. daniees S June 19, 2018 at 3:07 pm - Reply

    putting plastic in people is not the gold standard

    • Still Standing June 20, 2018 at 2:39 am - Reply

      Dainees, poastics have been used in medicine for over 50 years. They are used in vein grafts, heart valves pacemakers, stents, cochlear implants and lens implants for cataract. They are used as suture material for many types of wounds and in joint replacements. There are perhaps millions of people alive today because of the medical,use of plastics. Yes, polypropylene transvaginal mesh has caused many to suffer needlessly, but to say plastics dont belong in the human body would put medical advances back in the dark age. We should not nthrow the baby out with the bath water here. Instead, we should campaign for the proper oversight of the development of medical devices that use plastic, including rigorous pre and post market analysis of reported complications.

  4. Danie S June 20, 2018 at 10:23 am - Reply

    Than you still….I actually was referring to the use of a device made of plastic ( as you know plastic actually melts and deteriorates in our bodies) blindly placed in an area so sencitive full of nerves and vains.

    The whole concept of plastic in our bodies is wrong….plastic does not stay inert.
    The use of mesh in the vagina IS NOT THE GOLD STANDARD.

  5. daniees S July 5, 2018 at 5:50 pm - Reply

    Mr. Nealon perhaps you will be willing to try on this devises in your scrotum I could’t think of a better way to taste this product …. do you agree with me?

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