The Mess of AMS Mesh

On the night of 4th July I was about to go to bed when I thought I would check the comments on this blog. One caught my eye and although I was too tired to reply, I kept thinking about her. She said that she was told this was a relatively new product on the market. When I read that I was taken back to the time when I realized I was in trouble a few weeks after my own surgery back in March 2010. I had no clue where to turn when my own doctor said that the symptoms I was having were not due to my surgery. I wanted to believe it at first because to not believe it was to except betrayal and I was nowhere near ready for that at that time.

This is what she wrote:

“I had TVT surgery done April 10th along with A&P repair. The type of sling used on me was American Medical Systems retroarch. This is relatively new to the market but from what I’ve read, no testing was done before it was used. After surgery, I had more pain on the right side than I did on the left. It hurt to walk but I figured it was just because the surgery just took place. When my doctor removed the catheter I was unable to go, wound up having terrible bladder spasms and wound up having the catheter in for a week before I was able to go on my own. My doctor told me by 2 weeks I’d be fine. Needless to say, I wasn’t. I still had the stabbing pain, not all the time, just when I moved a certain way or stood for too long. At 4 weeks I went back to work and just sitting all day made the pain excruciating. I needed quite a bit of pain meds at the end of my day to take the edge off. I called my doctor and he was less than sympathetic. Told me he had never had anyone ever have this much pain at the 4 week mark. He had no explanation for it other than, he told me my body was just taking longer to heal. He put me out of work for an additional 2 weeks. It was better when I went back but the fatigue sidelined me, all I could do was work and sleep, occasionally I would get that sharp pain that would shoot down my inner thigh. It doesn’t last long but enough to make me aware. I cannot touch the spot where the incision was, it’s too painful. Sometimes, sitting and having my clothes brush up against it makes it ache, kinda like a deep bruise. When I went back for my 8 week check up again, doctor was less than sympathetic. He told me there was nothing but time that would help me. He told me there was no way the fatigue was from the surgery, that I should just take vitamins and go for more walks. He also told me the pain was probably from scar tissue and he could inject it and that would immediately take the pain away. I opted not to have the shot, just seemed barbaric to me. I was already having enough pain, I didn’t need to add to it. So that leaves me wondering, is this a mesh complication or just recovery that’s taking a little longer than usual?

I am sure this woman has seen the adverts on TV and more than likely questioned her doctor about them. I am also sure if she did she would heard “We no longer use THAT mesh”. I want her to understand that she is NOT stupid because she took her doctors word. She is part of a giant marketing machine that ONLY mesh injured women can change. We have all fallen into that snake pit and many of us are still trying to get ourselves out of it and we know where she was coming from. We trusted our doctors!

I knew of course she definitely has mesh complications but I wanted to give her more information, so the morning of the 5th July I went to work. The first link was the AMS product information written by the company. I will give you the link at the bottom of this blog, but the second I asked for patent information another link caught my eye and it was a shocker. Ladies of the UK I want you to take note because this product is in YOUR area as well as here and other countries.

I took this off the RetroArc introduction page and the purple parts are by me wanting to know things that are not answered here. If you are a mesh injured woman with time on your hands then please start digging to see if you can find the answers. Then I will post them. Leave a comment and only I will see it and I will remove it once I have called up the link. You can be part of the campaign to STOP MESH by helping.

pagedivider

RetroArc™ available in UK from Nov 8 2013!

The latest launch product following the successful roll out of Elevate™ PC and MiniArc™ PRO is RetroArc™ from American Medical Systems. A retropubic incontinence sling that mimics the technique of well established and documented retropubic bottom up slings on the market.

The mesh is the same mesh as in Sparc and Monarc, and features the AMS patented tensioning suture (established and documented benefits from Monarc™) and blue sheath markings to ease detection during implantation.

What data exists on RetroArc? Where are the documents pertaining to the advers effects of the Monarc?

The mesh has 17 year data and is well documented from Sparc and Monarc. Ongoing clinical projects for RetroArc include CAPTURE (13 sites in EMEA), and a multicenter RCT lead by Professor Ralf Tunn in Germany.

Who are the experts leading the RetroArc roll out of this new product? I found that answer by clicking on the link below. British women, you may want to contact the woman who is in charge, Prof Linda Cardozo and ask her is they put this sling in her? Her email address is there.

The introduction of this new product is done with the most experienced surgeons in the UK. The RetroArc Premier User Group is highly skilled, very experienced and have all long experience with implants to treat stress urinary incontinence.

Where can I get trained on RetroArc?

For hands on training and training courses, please click here: Training

Training resources: (send us an email to request information)

Product overview (ppt presentation
Procedure overview Step-By-Step (ppt presentation)
Product and procedure (animation)
IFU (pdf)
Product sheet (pdf)

What is the order number?

RetroArc™ has order number 9000262

Can I use RetroArc in the MUS vs adjustable SIMS study starting next year?

Yes, according to the leading PI: as long as RetroArc is your standard MUS and you have done more than 20 procedures.

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The information above was taken from here (page has now been removed)

Now as you read this you may wonder about training. I definitely did so I clicked and this is the outline of the course. Please note the 17 year data comment. WHERE IS THAT DATA? I know so many women who have been injured by both the Sparc and the Monarc made by AMS I have lost count! IS THAT ON THE SAME DATA?

This is what doctors get when they are trained in the U.K.:

pagedivider

Soft Preserve Tissue sample hands on training

Venue: St George’s Hospital, University of London, London UK

As part of our commitment to your training, you will also receive a one to one proctoring session
in your own hospital NOTE ONE SESSION

Course Objectives:

This course has been designed for clinicians and surgeons who would like to advance their knowledge and surgical skills on female pelvic anatomy as well as the surgical treatment of female stress urinary incontinence and mesh augmented pelvic organ prolapse repair. The workshop will achieve these goals with:

  1. Didactic Lectures

An evidence based review and discussion on the different surgical procedures for stress urinary incontinence using midurethral transvaginal slings (retropubic, transobturator and mini-slings) and mesh augmented urogenital prolapse repair

  1. Video demonstrations
  2. Simulators/pelvic models
  3. Case presentation on avoiding & managing complications and point/counterpoint discussions or controversial surgical topics
  4. Hands on soft preserved cadavers

COURSE OUTLINE:

The didactic sessions will cover the following topics:

  1. The anatomy of the female pelvis in the cadaver lab
  2. The FDA warning on the use of transvaginal mesh repair of pelvic organ prolapse
  3. The published reported scientific evidence on the safety, short and long term efficacy of the mesh augmented prolapse repair and different surgical treatment for SUI
  4. How to avoid complications
  5. The management of intra and postoperative complications

Video presentations of different techniques for midurethral slings and mesh augmented prolapse repair and cadaveric prosections will be used. This session will utilize illustrations, video clips and cadaveric prosections to review important anatomic landmarks as they relate to sling procedures and specific pelvic reconstructive procedures.

The practical session will include “hands on” silicone pelvis mannequins/simulators covering the surgical techniques as well as technical tricks for various anti-incontinence and reconstructive surgical procedures using mesh augmented prolapse repair. Delegates will be instructed and guided through the surgical steps how to perform all the midurethral sling approaches (retropubic top-bottom, bottom-top; transobturator approaches; mini-sling) and how to perform the mesh augmented prolapse repair (anterior, posterior and apical compartment).

pagedivider

So how did I feel when I read the outline course? ANGER and I wanted to scream! The reason being you cannot practice on DEAD WOMEN and know the true results of mesh complications. We are REAL LIVE WOMEN with REAL lives they take away from us.

So now what can this woman do? Sadly I have no clue. This just happened to her less than three months ago and now she will have the betrayal, expenses, fears and grief we all have had when we realized we had mesh complications. THAT IS WHY WE MUST SWITCH TO, NO MORE MESH! I am giving her and any other woman who just had this put into them and have leg pain, the heads up so they know they definitely have mesh complications. But they deserve the truth that makes it really bad for new women who just realize they have a problem. AMS already settled a group of cases last summer and are now working to settle more. Can she join the lawsuit? Well that is a question she has to ask lawyers who may say yes, but then put her claim into a new file for the next round of complainants. Then she may have to wait as many as ten years for enough cases to warrant a new round of suits that will make it profitable for lawyers. Please read this document to understand that some cases have ALREADY been settled and more are about to be. WITHOUT YOUR CONSENT I am sure.

Sounds like a lot of money doesn’t it, but go to an online calculator and see how little it is for each woman and that is BEFORE 50% goes to lawyers.

If you are part of an AMS lawsuit you may want to contact your lawyer and demand notice of where your case stands.

I am the one who now has to break this news to her that removal of any sling is difficult and dangerous if in the hands of the wrong doctor. I hope she takes this serious piece of advice and goes out to UCLA to Dr. Raz. She can now read a blog that will have her horrified, but once over it, she will understand why I am giving her this advice. This is the blog

Facts. Corporations hold some patents for themselves but they also have PEOPLE who work for them who hold many patents in THEIR names. Everything they use in pelvic surgeries are patented separately. Mesh, slings, tools, anchors etc. Even a tool to stretch the mesh. I knew you’d love that one. In fact the man who holds the patent for mine holds 36 patents in his name and he works for Boston Scientific.

Top holder, A.M.S under two names. AMS and AMS research.

They began in 2003 and received patents for 8 items. From then on this is how many they received each year.

2004, 3
2005, 3
2006, 5
2007, 4
2008, 6
2009, 3
2010, 3
2011, 9
2012, 6
2013, 5

And 2014 to this date 4 already and we are half way through.

This is the direct marketing link for AMS and this particular sling I want you to take note that Dr. Ostergard wrote a well-known article about mesh and although he wrote it in a way that made it look like he was against mesh for several reasons, he actually wrote it FOR American Medical Systems to PROMOTE THEIR products.

This is for those women who have been giving me hell on the Medical Mesh News Desk support group. If you spent a fraction of the time I have helping women then you would know why I do it. I myself are disabled because of mesh. I will never drive again because of mesh. I still have more issues, but my blog is not about talking about me all the time, it is about getting and giving the facts.

Did you know that in the past other companies have settled mesh injury cases and one settled for twenty thousand dollars per woman BEFORE the 50% went to their lawyers? All these companies are at fault which is why I am trying to inform new women like the one above what is going on BEFORE they get in the mess we are. Why don’t you have the courage to begin something like this blog and give YOUR life to it instead of blasting me? THEN and only then will you make a difference in women’s lives.

2 Comments

  1. a meshed-up nurse

    Dear Linda, Thank you for finding and posting this.

    Women need to know that the plan is to pay out a pittance to injured women and then continue on with another product line that will harm even more women. It’s built into the cost of doing business. Apparently if a doctor learns to use this mesh and has done over twenty of them, then that doctor can participate in the “MUS vs adjustable SIMS study” which will take place next year. So living women will still be used as guinea pigs- I wonder how well informed they will be? Will they know they are in a study using an untested sling that is similar to others involved in thousands of law suits due to the serious injuries and complications they have caused?
    The FDA has not even completed it’s review of TVMs (that had no trials required ahead of time because of the FDA’s antiquated and faulty 510(k) “clearance,” NOT “approval” process, yet more TVMs are being allowed access to the market. This is morally and ethically wrong, unacceptable, and is an ABUSE OF WOMEN.

    Reply
    1. lavalinda

      Thank you Messed up nurse. We need more nurses on board learning the truth because so many are affected by this. We are on that to see how we get the word out and I will work harder to inform.

      Reply

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