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Teresa Stevens Speaks Out About How She Got Involved in Boston Scientific Lawsuit Over Counterfeit Transvaginal Mesh

Woman statue resizedMesh Medical Device News Desk, June 6, 2016 ~ 

On October 27, 2014, Teresa Stevens was preparing for a scheduled hysterectomy when, at the suggestion of her doctor, she agreed to have a Boston Scientific Obtryx Halo vaginal mesh implanted into her body, like thousands of American women do each year. The problems started immediately.

“When I came out of surgery, my bladder wasn’t completely evacuating and I told my doctor I couldn’t feel my bladder,” the 46-year-old West Virginian said. “In almost two years since my surgery, I’ve regained no sensation.”

Today Stevens says she cries a lot. Stevens says her symptoms worsened—including frequent urinary tract infections, shooting pains in her abdomen and painful sex—she started growing more despondent by the day until, just a few months after her surgery, she decided to do something about it.

“I was at home one day and a commercial came on about problems caused by vaginal mesh, so I called the listed number for the law firm. They let me know about the problems surrounding the mesh, explaining that certain providers may have used a counterfeit product to create the medical device,” Stevens said. “I had a UTI at the time and I was hurting. I started crying when I found out that counterfeit mesh is possibly inside me.”

For Stevens, that one call revealed a wealth of knowledge about vaginal mesh and led her to file a lawsuit against Boston Scientific, the company that made her mesh implant.

The Mostyns

The Mostyns

Thousands of lawsuits have been filed against the company, but Stevens and her attorneys—Steve and Amber Mostyn of Mostyn Law and Harry Bell of Harry F. Bell Law in Charleston—allege that after losing their main mesh supplier, Boston Scientific panicked and decided to go outside the U.S. to China to source then smuggle into the U.S. thousands of pounds of potentially counterfeit mesh from China, that has been untested and non-FDA approved.

The discovery potentially could upset the company’s $120 million a year pelvic mesh revenue stream.

Obtryx Halo patent

Obtryx Halo patent

It really upsets me thinking about what’s actually in me, because I don’t know if it came from China, if it’s counterfeit and what kind of chemicals are in there,” Stevens said. “I have no idea what’s going on in my body and I don’t know where these pains and infections are coming from.”

Harry Bell Law, Charleston, WV

Harry Bell Law, Charleston, WV

As for having the mesh removed, pelvic mesh is intended to be a permanent implant. Finding one of the few who specialize in mesh complications is another obstacle. First of all is it safe or will an explant procedure potentially do more harm.

Then there is the question of insurance, even if she can find a specialist. “Who even knows if my insurance will pay for it?”

Boston Scientific uses its Advantage mesh made of its proprietary Marlex polypropylene mesh.  It claims to have implanted 500,000 women and to this day claims the mesh is biocompatible.

advantage mesh promises detanged over 500,000 placedBilled as a minimally invasive procedure, there are 93,000 lawsuits consolidated in Charleston, WV naming seven mesh makers, Boston Scientific among them, in product liability lawsuits. Stevens has filed an action that alleges racketeering in bringing the mesh to the U.S. and fraud in its marketing. Here is her RICO action. 

Obtryx halo introducer

Obtryx halo introducer

Since Steven’s class action lawsuit was filed earlier this year, progress has been made: A grand jury has convened in Charleston, W.Va, and sent out subpoenas for documents regarding Boston Scientific’s purchase of the materials.

Mostyn Law has also called on the FDA to further investigate the potentially counterfeit material from China to see if it’s equivalent to FDA-approved Marlex, or a specific type of polypropylene that is cleared by the FDA for use under its abbreviated 510(k) approval process.

The firm also asserts that even if the mesh is compliant with FDA standards, Boston Scientific has still violated counterfeiting laws by smuggling in the Chinese mesh.

bs logoStevens hopes that by bringing her case to the forefront of the conversation she’ll be able to protect other women from enduring a similar fate. Boston Scientific mesh allegedly made from the counterfeit raw material from China is still being used and implanted in women suffering from prolapse and incontinence.

“So many women with vaginal mesh have this uncertainty of ‘what’s in me.’ ” Honestly, I don’t think that doctors should put mesh in anybody, but especially not counterfeit mesh,” she said. “Would these doctors recommend vaginal mesh to their own mother or sister without knowing what’s exactly in it? I don’t think they would.” #

LEARN MORE

 WV State Journal coverage
http://www.statejournal.com/story/31141261/we-dont-know-whats-in-itlincoln-county-wv-woman-concerned-resin-in-mesh-implant-is-making-a-bad-situation-worse

WV Gazette-Mail
http://www.wvgazettemail.com/news/20160116/mesh-lawsuit-filed-on-behalf-of-lincoln-county-woman

 

 

 

8 Comments

  1. Lordhelpus says:

    I still have what my dr. calls the “hooks” that holds the mesh in place inside of me, which he says he could not remove because it was too dangerous to, so I still have the same pain I had before, nothing’s changed. I had mesh erosion. He removed the mesh in two pieces which were eroded beyond recognition with pieces of my bladder were stuck to them, it was gross. The betrayal I felt, after all those years of having gone to so many Drs. about the horrible pain I was going through day and night with it (mesh) cutting and stabbing me 24/7, then having them lie to me boldface was remarkable. Shame on ALL of them. Right now this pain is so bad, it’s beyond words at this point. But to add insult to injury, in the name of GREED they continue to market this poison AND continue to find more victims so the crime goes on, and why not?…they’re no being stopped… But what gets me most is, if someone kills another by poisoning, they go to jail, right? WRONG again…not if you’re involved in the mesh industry you don’t…! It is a “TRAVESTY” pure and simple from the greatest to the smallest, there’s no getting around it….

    • Jane Akre says:

      This is a good example of why its so important to go to a doc who can do the most complete job possible….. perhaps this person was and your case was just terribly difficult, but readers should go to the docs who’ve had the most success. Remember these implants were made to be permanent with no plans on how they should be removed even though mesh makers understood that might be possible due to complications.

    • jan says:

      Yes it was Greed from these manufacturers.
      I also had the Orybtrx in 2006..I will be going into my 4th surgery next week. . I could lose my bladder do they care NO they have all there parts.. and I believe deep in my heart they will never care about what they have done to us. This is so so sad
      And we will never see any settlements that we should because of our medical issue’s for the rest if our lives. . I have not heard anything I filed in 09 still hanging with bad health because of this manufacturer

  2. Jack Podolski says:

    We need a restitution plan which must include
    Development and study
    Of how to rectify the mesh problem and technology developen technology for safe mesh removal and remidial after steps.
    Companies and hospitals involved should as part of their restitution pay and develop this under proper supervision.

    • Still Standing says:

      Well, Jack. The problem lies in that they did not develop a plan prior to implanting mesh for safe mesh removal. You cant go back if mesh was put in to be permanent and retroactively make it safe to remove. Are younthinking restitution instead of legal settlements?

  3. Rebecca says:

    I too had my first surgery in June if 2013. It soon became apparent it had failed. In April of 2014 I had it removed and it took the dr hours to get it out because it had imbedd into my bladder so bad it cause permanent damage to my already bad bladder. So in April of 2015 I had yet another surgery to put in a completely new device and so far so good, the only thing is that I will need another surgery within 5 years to replace the new device. Thank gooddness I joined the lawsuits, hopefully it will compensate for a small amount of the horrible pain I’ve had to endure and will have to endure in the future

  4. Patricia says:

    “Jesus! Why can’t someone help us??? I feel I am in the era of contemp for the Jews and am in a Holocaust situation…….screaming out for. HELP!…and…no one is listening. I have faith in the morals built in the United States….yet…”they are far too many obvious
    and unanswered questions!!!!

    Faith in my country, my public health providers and the good will of all mankind

  5. Tanisha says:

    Omg !!! I’m so lost of what to do i been dealing with this problem for 6 years now last year i went to surgery to have my sling removed and the surgery went well but i was told i still had large amount of mesh still there that couldn’t be removed do to the places it was located … I have been to the doctor a million times i keep hurting, i keep a bladder infection and bacterial infections … I’m tired my life isn’t my life anymore i don’t know what to do anymore

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