Logged out
Site Location
Skip Navigation LinksDocuments & Forums > 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)
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)
Size: 292 Kb Uploaded By: Ashley Brookes on Wednesday 28th April 2010 at 10:48

Size: 292 Kb Uploaded By: Ashley Brookes on Wednesday 28th April 2010 at 12:25

Size: 655 Kb Uploaded By: Avicia Burchill on Friday 30th April 2010 at 11:38

IUGA IUGA  Urogynaecologist, United States United States
15:46:09 GMT, Wednesday 5th May 2010
 Photo of IUGA IUGA 
Feedback
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 United States
16:03:17 GMT, Wednesday 5th May 2010
 Photo of IUGA IUGA 
Feedback
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.

IUGA IUGA  Urogynaecologist, United States United States
16:05:11 GMT, Wednesday 5th May 2010
 Photo of IUGA IUGA 
Feedback
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 United States
21:51:05 GMT, Wednesday 5th May 2010
 Photo of IUGA IUGA 
Feedback
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 Australia
01:46:45 GMT, Thursday 6th May 2010
 Photo of Peter Petros 
Feedback
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 Australia
09:51:18 GMT, Thursday 6th May 2010
 Photo of Peter Petros 
Feedback
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 United States
15:11:54 GMT, Thursday 6th May 2010
 Photo of Donald Ostergard 
Feedback
Hi Bernie and Dirk,

You and your co-authors have done a great job with this 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 United States
15:13:08 GMT, Thursday 6th May 2010
 Photo of Donald Ostergard 
Feedback
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 United States
15:13:33 GMT, Thursday 6th May 2010
 Photo of Donald Ostergard 
Feedback
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 Australia
05:53:04 GMT, Friday 7th May 2010
 Photo of Peter Petros 
Feedback
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 Australia
10:53:57 GMT, Tuesday 11th May 2010
 Photo of Angamuthu Arunkalaivanan 
Feedback
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 United States
17:49:01 GMT, Saturday 15th May 2010
 Photo of IUGA IUGA 
Feedback
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 Australia
03:15:39 GMT, Saturday 22nd May 2010
 Photo of Hans Peter Dietz 
Feedback
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 Australia
03:24:15 GMT, Saturday 22nd May 2010
 Photo of Hans Peter Dietz 
Feedback
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

Copyright © 1971-2019 International Continence Society
Close Search Close ICS Search
Documents
Abstracts
External Sites
PubMed
Faculty Of 1000 Medicine
MedWorm
Google