While they applaud Mesh

Almost every day I check my blog to answer women’s comments when they realize they have mesh complications. The hardest thing for me to do is break the truth to them to confirm I also believe they do according to the symptoms they describe. They are varied from retention and infections to erosion, leg pain and then onto more serious complications that force them to retire to their bed. And yet when they go to doctors to find out why they are ill, none will confirm mesh is the culprit. The reason is simple. If you remove mesh off the market, most of these doctors would be put out of business.

Although we may not realize it, doctors have known the truth for many years and discuss our situations as if it is all so simple and not detrimental to our wellbeing. However, loss of partnerships, finances and lifestyle and living in pain is NOT simple and we deserve to be listened to and something has to be done about this situation. I am not sure how many of these procedures are done daily around the world, but although some women like me will have complications immediately and still not believed they are in pain, other women won’t feel the effects of it until 3, 5, 7, or 10 years later and often when they are extremely ill and close to dying.

I wish I could change what is happening but even getting women to realize they are at the first stages of mesh complications is difficult because it is extremely hard to face. I get it believe me. Who would ever believe they will need to travel far and wide and perhaps have several surgeries according to the damage the mesh has done. But not facing it can mean the difference from life and death.

This is why women need to realize this did not happen overnight and the cover-up has gone on for many, many years. I am including a conversation between some prominent doctors who know full well what is happening to us and yet they don’t shout to the world and stop it. They are at fault, even if they are on the right side, saying it is doing damage to our bodies, because without change thousands of women will go down on a regular basis and do not know where the pain is coming from.

I am sure like me, while these men argue over how to classify our mesh complications, when you read this you will want to scream to let them know we were once useful and productive women and mesh screwed up our lives. Now we struggle every day while they congratulate and applaud each other and discuss things they know nothing about and that is how it feels to have mesh complications. Just because they THINK they know it all, they know nothing as they are not in the mess we are. The following link was sent to me by another mesh injured woman and I believe all of us need to know what these non-compassionate idiots think. I applaud none of them because they have done nothing but talk! I will give you the actual link at the bottom of this conversation, but wanted to make sure you all read it before it disappeared.

This discussion took place two months after mesh was put into my body in March of 2010 and I was struggling every day while this was going on. How many of you have been injured since that time? I would say a few thousand. I hope you will read it and get as angry as I did.

ICS / IUGA Joint Terminology and Classification Report of the complications related directly to the insertion of prostheses (meshes, implants, tapes) & grafts in female pelvic floor surgery (Draft) (All Versions)

IUGA IUGA  Urogynaecologist, United States
15:46:09 GMT, Wednesday 5th May 2010

I think the following aspects need consideration:
1. Development of contra-lateral compartment prolpase/dysfunction following mesh placement in one compartment.[eg: development of stress incontinence following mesh correction of cystocele.
2.Obstruction and Pain after a mid urethral sling sometimes require sling lysis. there is no mention of this in category.
3.Can we classify ‘failure of a procedure’ as complication? (eg: recurrence of stress incontinence after TVT)
4.Sacral periosteitis following mesh sacrocolpopexy – how to classify.
Dr Kiran Ashok

IUGA IUGA  Urogynaecologist, United States
16:03:17 GMT, Wednesday 5th May 2010

I applaude the committee for taking the time to develop such a comprehensive system for standardizing complications encountered with grafted pelvic reconstruction. This will allow much better tracking with in institutions and much more applicable research. I fear this system is too complex for use on an everyday basis outside a research protocol and will need to be significantly simplified to achieve wide spread acceptance. That is acknowledged in the paper. This is a great first step. Just to comment on above response. A recurrence of prolapse or incontinence is not a complication. There is no claim that any procedure is 100% effective. Complications refer to untoward outcomes not directly related to the purpose of the surgery.
Nathan Guerette, MD, FACOG
Associate Clinical Professor
Medical College of Virginia
Director, The Female Pelvic Medicine Institute of Virginia

IUGA IUGA  Urogynaecologist, United States
21:51:05 GMT, Wednesday 5th May 2010

I appreciate undetaking such a difficult task as to classify mesh complications. I agreee that the system is necessarilly complex but that this will limit its widespread clinical use. I have a few suggestions. First, I would adjust the definition of a sling. There are many on the market now that use barbs, or other attachements devices which could lead people to question if they were just a thin strip of mesh. I also might add an early post-operative timepoint. I would dvide the 48hrs to 6 months block again, with an intervening 6 week time as many perofrm post-op checks at this timepoint and could better classify the timing of the occurence of the compliaction. The charts are good, but if you can condense this down to pocket-card size I think you will find more people using it which is the goal so that we can get a better description of mesh complications.

Peter Petros  Urogynaecologist, Australia
01:46:45 GMT, Thursday 6th May 2010

The review haswide ranging descriptions. Commend reference to Hippocratic tenet”First do no harm”. Unfortunately the review does not address the basic science of implants. Comments below are based on experimental animal work, in 1986-88, at Royal Perth Hospital, a prelude to the”tension-free vaginal tape”operation developed with Ulf Ulmsten.
) Petros PE & Ulmsten U And Papadimitriou J, The Autogenic Neoligament procedure: A technique for
planned formation of an artificial neo-ligament. Acta Obstetricia et Gynecologica Scandinavica,
Supplement 153, Vol 69, (1990), 43-51.
Petros PE & Ulmsten U. The combined intravaginal sling and tuck operation. An ambulatory procedure for stress and urge incontinence.idem 53-59.
The prosthesis and tissue reaction: We demonstrated (Hernia,(2005) 9: 75-78), that the amount of tissue reaction is proportional to the volume of the implant, and that macrophages penetrate even 5 micron spaces.
Individual hypersensitivity: A wide range of tissue reactions was seen in both the animals and the humans (ACTA Scand 1990). At 6 weeks, there was total assimilation of the graft by the tissues. In others, a sinus occurred which discharged sterile pus. Some patients tolerate the implant more than others.
Foreign body reaction: 2 types of inflammation: infection(bacterial)& foreign body (prostheses). Lack of space limits further discussion. Detailed discussion &refs in “The Female Pelvic Floor”Petros Springer Heidelberg 2nd edition pp95-110.

Peter Petros  Urogynaecologist, Australia
09:51:18 GMT, Thursday 6th May 2010

More on foreign body reactions (FBR). These vary widely. It is the varying FBR which causes the problem initially a wound-type reaction for 48 hours, then granulation tissue, then collagen III deposition, and in 3 months, change to collagen 1. Collagen shrinks and hardens with time. It is not wise to exclude injectables from the classification. I have seen some severe concrete like reactions where the injectable has to be actually dug out- not an easy task. The majority of mesh reactions are FBR, not infection. Both are inflammations, with exudate of white cells, pnls for infection, macrophages & lymphocytes often in addition to pnls with FBRs. FBRs are quite benign. We found very little reaction with radioactive Gallium studies in the animal studies. If there is swelling, there maybe pain. However, like a splinter (an exact analogy), the pus is sterile, and the pain disappears on removal. Infection is a different potentially severe problem, with necrotizing fasciitis (described with TVT ops) an extreme manifestation.

Donald Ostergard  Urogynaecologist, United States
15:11:54 GMT, Thursday 6th May 2010

Hi Bernie and Dirk,
You and your co-authors have done a great job withthis project. Congratulations!!
Here are my comments on the mesh draft:
On page 8, first paragraph, perhaps you should include low surface area of the mesh, since this is also known to be important for bacterial attachment. The larger the surface area the more space is available for bacteria to attach and, also, the more inflammatory reaction that is elicited. In addition, you might want to mention that the use of an inert mesh is important—since polypropylene degrades in the human body, and polyester does not the search for the best mesh must continue.
In the next paragraph, you mention “rejection”. Unless you have evidence that there is an immunological reaction to the mesh, you might want to just say “erosion”. I think rejection should be reserved for a true immunological reaction. True rejection may be occurring secondary to the release of polypropylene degradation products. However, I don’t know of any scientific evidence as yet that this is occurring. I think “rejection” is used elsewhere in this draft.
In the next paragraph, you say the mesh materials will not be covered. Please give consideration to mentioning the ObTape and the IVS tape, which have caused so many problems, even death, and encourage readers to not use these. As mentioned below, it would also be helpful to know which meshes are causing which problems to determine if some meshes have an excess of complications.

Donald Ostergard  Urogynaecologist, United States
15:13:08 GMT, Thursday 6th May 2010

On page 15, there are several other complications that you might want to consider adding:
1. chronic pelvic pain—it is known that introduction of mesh arms disrupt nerve fibers and neuromas have been found on extirpated specimens. Pain may also occur from entrapment of nerve fibers in the contracting scar tissue stimulated by the mesh. I’m seeing patients who cannot sit down because of pain.
2. pain from major nerve involvement, e.g., pudendal or sciatic. Placement of mesh arms produce the same type of nerve problems as from sacrospinous fixation by involving these nerves, either primarily and directly related to the surgical process of mesh insertion or secondarily as scarification occurs over time.
3. peripheral neuropathy is also appearing, with various levels of involvement of the nerves to the lower extremities.
4. fecal incontinence—mesh arms erode into the anal sphincter causing permanent damage due either to the scarification from the presence of the mesh or the surgical procedures which are necessary for its removal.
5. vaginal shortening and narrowing is probably covered in what you have, but what about the vagina after multiple procedures to remove the grafts resulting in a totally destroyed vagina requiring a neovagina?
In Table 1- the tape (sling) category -since this is also a mesh, should this be indicated?
In Table 4 – would you consider adding something to indicate the degree of vaginal compromise, such as, vaginal length and/or diameter?

Donald Ostergard  Urogynaecologist, United States
15:13:33 GMT, Thursday 6th May 2010

I know you might want to avoid this topic due to relations with industry, but, in the interests of scientific purpose, it would be very helpful to know which meshes are involved in the various complications, otherwise, what can be done to discourage the use of meshes like ObTape and IVS? There are other meshes in current use that seem to be associated with more complications than others. The early knowledge of the association of these meshes with such excess complications would be very important information to have. Please consider adding mesh types by brand name.

Peter Petros  Urogynaecologist, Australia
05:53:04 GMT, Friday 7th May 2010

We should all thank Donald Ostergard for emphasizing what are really far more serious problems than erosions, chronic pain, fistulae, dyspareunia, urinary and fecal incontinence. Large mesh insertions cause formation of large concrete-like depositions of collagen. Collagen shrinks and contracts with time. SO these collagen depositions may stretch and distort organs, nerves, indeed, anything in their path. Nor should trauma from the instruments be ignored. Don and Gunnar Lose were prescient in their comments in 1999, and 2002 where they proposed zero tolerance for life-threatening complications.. Int.Urogynecol J 1999;10(6):351-2.) Int.Urogynecol J, 2002; 13:1-3. Maybe we should discuss the instruments as well.
The MAUDE data base of the FDA is a good resource which really needs to be included as a reference point.
One concern, leaving space for future as yet unreported complications. A formal classification may be too limiting. The initiative itself is brilliant, and sorely needed. Would a less formal classification, more in the nature of a resource be easier to handle? It could be added or subtracted to with ease. For example, already patients are presenting with urinary retention years after midurethral slings, a result of collagen contraction. How do we classify long-term effects when we do not know what they are? We need to leave space for these.

Angamuthu Arunkalaivanan  Urogynaecologist, Australia
10:53:57 GMT, Tuesday 11th May 2010

We should thank the authors for this excellent work.
I have the following comments:
1. Vaginal pain without any cause (eg. Sexual intercourse) should also be included.
2. Buttock pain following mesh repair with certain devices (eg.Capio device or Pinnacle)
3. To register into an international registry we have to get the clinical goverance approval which may be difficult in some Hospitals.

IUGA IUGA  Urogynaecologist, United States
17:49:01 GMT, Saturday 15th May 2010

I thoroughly believe that a classification like this one proposed is the inly way to compare data.Even though it looks complicated Dr.Ashok and myself used it for the work-up of > 450 surgical repairs of complications.Some aspects are missing, that seem of clinical relevance.
Very importnat is the pathology of the contralateral compartment in mesh repairs.
In our series paravaginal defects are the most frequent reason for complications, once they are only treated by slings
Lacerations of the husband by defect healings are of clinical and legal importance, they are nor classified.
Simple complications like failure, OAB or, rather frequent obstruction because of wrong technique and placement are frequent and should be included in future classifications.
Eckhard Petri

Hans Peter Dietz  Urogynaecologist, Australia
03:15:39 GMT, Saturday 22nd May 2010

The authors are to be congratulated for completing work on this challenging endeavour. However, I’m not sure whether it’s going to be of much use to the rest of us. The document was complex when I first saw it over two years ago, and with the involvement of 15 co-authors it has grown to 36 pages. The classification system now contains over 100 different categories. One has to ask what purpose is served by such excessive complexity: the more categories there are, the harder any collected results will be to analyse and use.
And then there are rather substantial problems with one of the central premises of this document. The very first definition proposed by the authors is of ‘contraction: shrinkage or reduction in size’. The term is mentioned at least 24 times. The authors seem to consider mesh contraction and shrinkage a given clinical reality, as evident from the classification, the tables and case examples. This is quite inappropriate. It may come as a bit of a surprise, but there is nothing in the literature (as yet) to prove that mesh contraction actually exists.
Apart from palpation and inspection to identify mesh erosion, ultrasound is the method of choice for assessing intravaginal mesh. To date all claims of mesh shrinkage, retraction or contraction have been based on imaging studies employing single time points, i.e., they are not based on the longitudinal observation of individual patients(1-3). The first paper on this issue, Tunn et al.(1), compared the dimensions of mesh implants prior to implantation and 6 weeks after implantation in 40 women, using introital ultrasound. They found a marked reduction in sagittal diameters of about 60% 6 weeks after implantation. Regardless of results- surely 6 weeks is a bit early for biologically mediated mesh contraction. To see true retraction one would have to compare data obtained at two postoperative time points per patient.

Hans Peter Dietz  Urogynaecologist, Australia
03:24:15 GMT, Saturday 22nd May 2010

Letouzey et al. (2), found a reduction in mesh volume of 30%, 65%, 85% at follow-up durations of 3, 6, and 8 years, respectively. I have a major problem with the imaging methodology presented in this paper. At any rate, it seems highly improbable that polypropylene mesh should shrink by 85% in volume over 8 years after implantation. Do we assume that the human body digests polypropylene? As far as I’m aware nobody has ever claimed that patients dissolve their TVTs. Velemir et al.(3) took a similar approach. Again, there was only one time point.
There is one small longitudinal study from Prague which suggested that most of the difference between in vitro and in vivo mesh dimensions was due to surgical technique, i.e., folding and warping of the mesh during or immediately after implantation(4). Midsagittal dimensions did shrink from 57.1 to 48.3 mm over 4 months, but that may be explained by lateral stretching as coronal dimensions were not determined.
We have recently used volume ultrasound data obtained in a surgical audit of anterior compartment mesh(5). There was no evidence of retraction or contraction over a follow-up of 60 woman years in total.
It seems that the entire concept of mesh contraction/ retraction/ shrinkage may well be a fallacy, a smokescreen that’s hiding the real problem: poor implant design and suboptimal surgical technique.
I would suggest that the authors remove all reference to mesh contraction or shrinkage until such time as the existence of this phenomenon has been proven by several independent, properly designed studies. For the time being, building an entire classification on unproven assumptions, and having such a document backed by two international scientific societies, seems rather imprudent.
References
1. Ultrasound in Obstetrics & Gynecology. 2007;29(4):449-52.
2. Int Urogynecol J. 2009;20(S2):S205-6.
3. Ultrasound Obstet Gynecol. 2010;34:474-80.
4. Int Urogynecol J. 2009;20 (S2):S166.
5. Int Urogynecol J. 2010;in prin

Why are they arguing over how to classify mesh complication when the evidence is in the women? Four years and six months have passed since this interaction and nothing has changed. It is time to stop putting mesh into women once and for all.

Wake up doctors. We are human beings who know what mesh complications feel like. When will you all STOP talking and DO something to stop our pain.

This is the actual link

4 Comments

  1. Andrea Robinson

    Wow. Everytime I read articles like this, I feel like I’m reading an autobiography. Something needs to be done to protect future generations. I had my surgery back in 2007, I was 24 years old, and I’m still fighting to have it removed. I see another specialist in 2 days and I’m keeping my fingers crossed. This pain I deal with daily is absolutely ridiculous. My doctors are terrified of pain medication therefore I am left to suffer everyday. Most days I wonder if today is the day that it will be just too much to bare, then I think of my kids, who are the reason I had surgery in the first place. I wanted to be able to live… Take them to the park, run around and chase them, even just take them to the pool. Now, instead of living, I just try and survive another day. I feel cheated. My kids were cheated. Something needs to be done in order to protect others from making the same mistake so many of us made. Do your research and by all means, find a qualified doctor.

    Reply
    1. lavalinda

      Andrea I wish it was not happening to so many young women. I cannot understand why the media is not taking notice and yet as I write that I know the truth is about money. Doctors will keep doing it and so many young women will struggle to take care of their children. All I can do is hope this blog makes a difference and women find it before they have these surgeries.

      Reply
  2. Patti McAninch

    These are scary & very telling reports that should have been taken seriously much sooner. I have only been dealing with mesh for less than 6 months but have had many of these complications. I am disgusted by what mesh has done to my life & the lives of many others. It makes me sad to know how much suffering has been caused by a product that should not be on the market! I really wonder if my life will ever feel normal again!

    Reply
    1. lavalinda

      Patti I know how you feel but I am afraid that I have come to the conclusion that we’ll never get it off the market. The ones with the most money and lawyers can keep this on the market and there is not anything we can do.

      Reply

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