National Institute for Health and Clinical Excellence

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1 1 Cook Medical, National Institute for Health and Clinical Excellence 660 Surgical repair of vaginal wall prolapse using mesh Consultation Comments table IPAC date: 17 April In point 1.1, the statement There is a risk of complications that can cause significant morbidity makes no distinction regarding the complications expected with different types of meshes, even though section 1.1 says that both efficacy and safety vary with different types of mesh. Clinicians be advised to discuss how different meshes (i.e., biologic versus synthetic and 2 Individual patient 1.1 The evidence considered is of comparative studies only. Both Perros and Linda Brubaker have gone into print with their opinions that mesh should not be used for pelvic floor repairs, as contact with sensitive vaginal tissue should not be risked. Petros advocates a bridge using patients own vaginal tissue that would otherwise be discarded. This method does not appear to feature in any of the research material considered in this exercise. 3 Individual patient 1.2 I applaud this recommendation. Clear written information, adequate time to consider it and an opportunity to ask questions is preferable to a patient being told we will use mesh. There is more detail of the different types of mesh in the efficacy and safety sections of the guidance document and the systematic review. While the recommendation makes a comparative judgment, evidence from non-randomised controlled trials and case series studies were also reviewed. Thank you for your comment. 1 of 14

2 4 Individual patient 1.3 This statement seems imprecise. What degree of special expertise is recommended? One study does point to a co-relation between erosion and the inexperienced surgeon. Other studies seem to hint at it. As these are all short-term follow-ups experienced surgeons may be linked to later date erosion we just don t know. 5 Individual patient 1.4 The level of follow-up and details of adverse outcomes are very limited. Problems experienced by patients might be better understood if there were fuller reporting of problems within the professional literature. There is blatant sexual discrimination in the research studies, in that a woman s pain and quality of life is deemed to be of no account unless it is in relation to a randy male. If a woman is not sexually active this is marked N/A and discounted. I hope that NICE is able to influence such reporting. I include a sheet detailing some of the activity areas which cause me difficulty and which could usefully be included in quality of life postal surveys which could be done 5 and 10 years post op. 6 Individual clinician 1 Would completely agree with this. These procedures offer a chance of cure where conventional techniques have or would fail. They should only be used by people who understand the options, potential problems and technique fully. There is not a one size fits all solution to prolapse and knowledge of many techniques is useful. Thank you for your comment. NICE Interventional Procedures guidance highlights the requirement for training where appropriate, but it is the role of the relevant Royal Colleges and other professional s to prepare details of the content of that training. Thank you for your comment. Section 1.4 now highlights the importance of patient-reported outcomes. 2 of 14

3 7 Boston Scientific, 1 Equal consideration should be provided to open observational studies/registries for pelvic floor reconstruction. Mesh and graft implants are challenged by the modest amount of RCTs, which is made more problematic in analysis by further dissection by anterior, posterior, and/or combined anterior-posterior repair. The wide range of materials, location, placement and technique that may be associated with their use, disables any practical or realistic opportunity for comparative effectiveness. Registry data should be extended the same consideration as RCTs. Registries reflect the 8 Individual patient I query whether mesh should be the procedure of first choice for an active woman. I would not recommend mesh repair of the vaginal wall for any woman unless she had recurrent prolapse and was already in residential care (or prepared to accept that lifestyle and quality of life). For an active woman mesh can be a disaster! 9 Individual patient A choice of anaesthetic was suggested and I chose spinal block. Saddle block, used for the 3 rd operation, proved to be the most comfortable as it allowed me full use of the intercostal muscles and thus no need for oxygen. I prefer to remain fully conscious. 10 Individual patient I was surprised that the mesh was being cut to size in the theatre rather than preformed with all the chisel like points of the edges properly smoothed. (I have used polypropylene mesh for splint making it is rough!) All relevant sources of evidence were included in the systematic review, which analysed registry data in conjunction with other sources of evidence. Section of the guidance now reads: The Committee noted that interpretation of the evidence was made particularly difficult due to the different meshes used and the variation in surgical approaches. Thank you for your comment. Section lists current treatment options for women with anterior and/or posterior vaginal wall prolapse mesh is not included here but referred to in section in terms of recurrence of prolapse. Noted. The text says that this is usually done under general anaesthesia. Noted, thank you. Section states that the technique for implanting the mesh varies. 3 of 14

4 11 Individual patient The timescale of follow-up is far too short for proper evaluation. As you rightly point out, almost none of the studies allow the patients views to be heard. What is the point of repair unless the patient is able to feel a real improvement. Postal survey at 5 or 10 years would help as I think that there is likely to be considerable underreporting of problems which take time to appear. There may be no referral to the original surgeon, or to any surgeon at all. 12 Individual patient This is presumably the injury/damage done during the operative procedure. For the result of damage due to mesh movement over time see Ginger Isom-Batz and Philippe Zimmern. Noted. This is a review/editorial article and would not have been included among the relevant evidence in the systematic review 13 Individual patient Mesh does not have to come out (erode or exposure) right through the skin to cause acute pain. In fact, once the skin has been penetrated, the pressure eases. No one records or reports on this. 14 Individual clinician 2: Indications Could comment on high failure rate and high rate of dyspareunia with conventional surgery particularly if the prolapse is 3rd degree or recurrent. 15 Individual clinician I would disagree with certainly as far as synthetic mesh is concerned. Excising any tissue is almost certainly to be avoided. Once the pressure is taken off the vaginal wall, the mucosa shrinks over the next few weeks to its original state. If tissue is excised then the risk of shrinkage and mesh 16 Cook Medical, This section is limited to the traditional treatment technique colporrhaphy, even though it is acknowledged in section that site-specific defectrepair can be performed. We suggest to include other techniques as well. The Committee considered this comment but decided not to alter the guidance. This section now reads some excess tissue may be excised. The Committee added a sentence to the end of about other procedures. Other site specific procedures such as paravaginal repair may also be undertaken using methods similar to colporrhapy 4 of 14

5 17 Boston Scientific, 2: Outline of procedure 18 Individual clinician : Efficacy - Anterior repair Excluded from consideration in the systematic review (see Sources of Evidence) used to make the provisional recommendations was Boston Scientifics absorbable biological xenograft called Xenform Soft Tissue Repair Matrix. Xenform Matrix is an acellular, noncrosslinked, bovine dermal matrix which promotes revascularization and regeneration as opposed to scarring and encapsulation No real problems with this. However please note that the risk of dyspareunia (de novo) is considerable with conventional repairs as they almost always involve narrowing to achieve a reasonable result. Also there are many cases where sexual activity is not desired but freedom from prolapse symptoms is. A colpoclesis is one solution but mesh is another. These comments refer to posterior repairs also. Noted. Thank you. Boston Scientific was contacted by the Review Body for relevant data at the outset of the systematic review - the peer-reviewed data was not supplied by at the time of the review. The guidance now says at section 2.5.2: The Committee noted that there is a rapidly accumulating evidence base for this procedure. A number of further studies on mesh repair have been published since the systematic review was carried out, or are in progress with initial results to be made available in the near future. The updated evidence base will inform the review of this guidance in due course. 5 of 14

6 19 Cook Medical, : Efficacy - Anterior repair 20 Individual clinician : Efficacy - Posterior repair 21 Cook Medical, : Efficacy - Posterior repair 22 Individual clinician : Efficacy - Anterior and/or posterior repair This sections initial paragraph, i.e. item 2.3.1, splits the types of mesh which can be used, into four possible categories: absorbable biological, absorbable synthetic, combined biological and synthetic and non-absorbable synthetic. The term absorbable used in combination with biological mesh is misleading, implying that the product degrades leaving nothing behind. Another problem is that all biological meshes were included under this category, and therefore the analysis makes no distinction between different types of biological meshes. For example Permacol/pelvicol is a crosslinked non-absorbable biologic mesh, yet included under the heading of absorbable biological meshes in this document. The term absorbable is limited and does not reflect the nature of the materials. Rather, biological meshes should be split into interactive or tissue inductive on the one hand and permanent or nontissue inductive on the other. This is an issue that applies to the remaining paragraphs of the document. See above. My experience is that repair of the posterior wall with mesh is easier, more effective, less prone to mesh protrusion (0/45 in my hands) and anatomically better than the anterior Same concerns as stated for Anterior Repair and Posterior Repair. See above. Combining traditional anterior and posterior repairs is much more likely to result in narrowing and dyspareunia if the repairs are of any size. Biological mesh has a spectrum of absorbability and differs significantly to synthetic mesh. Due to the variability in terminology, the Review Body considered totally or partially absorbable mesh under the blanket absorbable term. The Committee considered this comment but decided not to alter the guidance. It is not the purpose of the review to compare individual meshes. See response to comment 19. Noted, thank you. 6 of 14

7 23 Boston Scientific, : Efficacy - Anterior and/or posterior repair 24 Individual clinician : Safety - Anterior repair 25 Cook Medical, : Safety - Anterior repair 26 Individual clinician : Safety - Posterior repair 27 Cook Medical, : Safety - Posterior repair 28 Individual clinician : Safety - Anterior and/or posterior repair A study titled See response to comment 17. Safety comments apply to all 3 sections as described below. Points 1) These techniques have been found to give higher rates of non healing and mesh protrusion when used at the same time as a vaginal hysterectomy 2) The techniques are incredibly operator dependant. 3) Attention to detail is vital. Whilst complications will occur they can be kept to a minimum by fastidious attention to detail eg: not excising mucosa,the least avascular suturing technique, use of packs, care with tissue, knowledge of anatomy, knowing when to give up and when not to use technique 4) They are not an operation for an occasional surgeon the more you do the better you get. Thank you for your comments. Taking each in turn:1) This will be covered in our guidance on surgical repair of vaginal vault and uterine prolapse repair using mesh for which a systematic review is currently being completed. 2) This is captured in section ) This is captured in section ) This is captured in section 1.3. Same concerns as stated in the Efficacy Section. See response to comment 19. See above Same concerns as stated in the Efficacy Section. See response to comment 19. One major advantage of kits using support via the obturator route anteriorally or via a buttock approach posteriorally is that they provide support for the vault also. Almost always when dealing with a posthysterectomy prolapse, vault and wall prolapse are combined. These techniques provide a way of dealing with this in combination. 7 of 14

8 29 Cook Medical, 30 Boston Scientific, : Safety - Anterior and/or posterior repair : Safety - Anterior and/or posterior repair 31 Individual clinician 2.5: Other comments Same concerns as stated in the Efficacy Section. See response to comment 19. A study titled Xenoform. See response to comment 17. The overwhelming evidence from TOT and TVT procedures is that a monofilament macroporous mesh is the least troublesome. This is borne out by reports of the use of different materials used in these repairs (NB original TYCO posterior IVS with high rate of problems). Any other synthetic mesh should be avoided. Animal data on Pelvicol etc shows a very patchy and unpredictable absorbtion rate borne out by widely differing results from pt to pt. At least systems such as Prolift, Avaulta etc give a standardised approach which has been assessed to a degree, & can be audited refined and compared. I feel also that you should separate ad hoc use of a reinforcing patch over the conventional repair from the Prolift/Avaulta/AMS systems which provide a hammock supporting effect without narrowing or shortening whilst at the same time supporting the vault. They can give a very anatomically correct appearance. The latter have been the major advance in my opinion and are in a different league to reinforcing patches which seem to add little to the results. 8 of 14

9 32 Individual patient General As I walked and regained my normal stride the mesh flexed and snapped back. One stitch was also a source of problems so a year after insertion of the mesh, this stitch was removed and the mesh trimmed back. 8 months later, sitting was increasingly difficult and I struggled with normal tasks, using paracetamol, TENS and Lidocaine (locally applied anaesthetic). I spent time flat on the bed most days. Two years after insertion, the mesh was again trimmed back. This gave no real improvement. The mesh is so abrasive that it feels like a pan scourer under the skin of the vagina, with the edges that act like serrated knife blades. Normal walking results in swelling from this internal chafing which causes pressure which results in pain often hours after the activity that has been the cause of this reaction. I am usually reduced to a slow short-stepped waddle and sitting can be truly painful and a problem. I spend periods each day flat on the bed. Basic household tasks are possible with additional analgesics. I have dropped out of almost all my activities and driving is now painful. Mesh that was barely palpable 6 months ago is, I am told, now visible through the skin. It is on the move! Currently I am losing muscle bulk and struggle to maintain general fitness. Sections 1.1 and 1.4 of the guidance highlight the long-term morbidity and quality of life issues in relation to this procedure. NICE is revising its processes for the incorporation of patients perspectives into Interventional Procedures Guidance, and plans to consult on its proposals during of 14

10 33 Individual patient General References The female pelvic floor: Function, Dysfunction and Management Peter Petros ISBN Thank you for bringing these references to our attention. This is a book and would not have been included in the systematic review. Multidisciplinary Management of the female Pelvic Disorders Chapple, Zimmen, Brubaker et al. (NB Read the foreword as well as the main sections) ISBN This is a review chapter from a book and would not have been included in the systematic review. Systematic review of the efficacy and safety of using mesh or grafts in surgery for anterior and posterior vaginal wall prolapse October 2007 This is included in the systematic review commissioned by NICE Vaginal mesh for incontinence and/or prolapse: caution required! Ginger Isom-Batz, Philippe Zimmern Expert review of medical devices September This is a review/editorial and would not have been included in the systematic review. 10 of 14

11 34 American Medical Systems, 35 American Medical Systems, General Anterior and posterior repair General Anterior prolapse 1) Follow-up after polypropylene mesh repair of anterior and posterior compartments in patients with recurrent prolapse Gauruder-Burmester, Koutouzidou, Rohne, Gronewold, Tunn Int Urogynecol J (2007) 18: Summary: Retrospective analysis of 120 patients at one year with recurrent cystocele and/or rectocele or with combined vaginal vault prolapse who were treated by either posterior or anterior mesh interposition depending on defect. Findings suggest that the interposition of a monofilament polypropylene mesh by the vaginal route seems to be an excellent procedure for definitive repair of recurrent anterior/posterior vaginal wall prolapse or combined prolapse, has low morbidity and is well tolerated by the patients. Note: The also mentioned a confidential abstract. The Committee s attention was drawn to its existence, but details of it have not been included in this consultation comments table. 1) Low-Weight Polypropylene Mesh for Anterior Vaginal Wall Prolapse A Randomized Controlled Trial Hiltunen,Nieminen, Takal, Heiskanen, Merikari, Niemi, Heinonen Obstetrics & Gynecology, Vol. 110, No. 2, Part 2, August Summary: Study compared 201 women who were randomly assigned to anterior colporrhaphy with or without a tailored mesh. Primary outcome was recurrence of anterior vaginal prolapse at 12 months. Conclusion: Anterior colporrhaphy reinforced with tailored mesh significantly reduced the rate of recurrence of anterior vaginal wall prolapse compared with the traditional operation but was associated more The guidance now says at section 2.5.2: The Committee noted that there is a rapidly accumulating evidence base for this procedure. A number of further studies on mesh repair have been published since the systematic review was carried out, or are in progress with initial results to be made available in the near future. The updated evidence base will inform the review of this guidance in due course. Thank you for these references. See response to comment of 14

12 36 Johnson & Johnson Medical, General often with SUI (stress urinary incontinence). 2) Note: The also mentioned a confidential abstract. The Committee s attention was drawn to its existence, but details of it have not been included in this consultation comments table. 3) Prospective, Multi-center Trial Evaluating the Perigee System with Polypropylene Mesh for Cystocele Repair: Estrogenicity and Outcomes Moore, et.al. Abstract AUGS 2007 Scientific Meeting Summary: Ongoing, prospective, multi-center study to evaluate the safety and effectiveness of the Perigee System and whether there is a correlation between vaginal estrogen levels and extrusion rates. Ninety eight women underwent the procedure to repair a cystocele and were seen for follow up at 6 wks, 3, 6, 12, & 24 months and an objective assessment of vaginal estrogenicity and atrophy was made. It was found that the Perigee System with polypropylene mesh is safe and effective and resulted in a low extrusion rate in a mostly post-menopausal population with mild atrophy (moderate estrogenicity). There did not seem to be a correlation between vaginal estrogen levels and the incidence of an extrusion. 4) Note: The also mentioned a confidential abstract. The Committee s attention was drawn to its existence, but details of it have not been included in this consultation comments table. Johnson & Johnson Medical broadly agree with the conclusions reached by IPAC and support the position suggested on the use of mesh in the treatment of Pelvic Organ Prolapse (POP). Thank you for these references. See response to comment of 14

13 We would like to draw to your attention additional data we have identified which we believe further supports the role of mesh in this disease area. This evidence was either not included in the ReBIP systematic review or has been published subsequently: 1. Abdel-fattah M, Ramsay I on behalf of thewest of Scotland Study Group. Retrospective multicentre study of the new minimally invasive mesh repair devices for pelvic organ prolapse. BJOG 2008;115: Al-Nazer MA, Ismai, WA, Gomaa IA. The incidence of recurrent cystourethrocele after anterior vaginal wall repair with and without reinforcement with polypropylene mesh (Gynemesh PS) :1-year follow-up. Int Urogynecol J (2007) 18 (Suppl 1):S Altman D, Väyrynen T, Engh ME, Axelsen S, Falconer C; For the Nordic Transvaginal Mesh Group. Short-term outcome after transvaginal mesh repair of pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct Dec 12 [Epub ahead of print] 4. Carey M, Slack M, Higgs P, Wynn-Williams M, Cornish A. Vaginal surgery for pelvic organ prolapse using mesh and a vaginal support device. BJOG 2008;115: De Vita D, Araco F, Gravante G, Sesti F, Piccione E. Vaginal reconstructive surgery for severe pelvic organ prolapses: A uterine-sparing technique using polypropylene prostheses. European Journal of Obstetrics & Gynecology and Reproductive Biology 13 of 14

14 6. Neuman M, Friedman M. [Advanced mesh implants for vaginal pelvic floor reconstruction: report of 100 prolift operations] Harefuah. 2007;146(12):923-7, Additionally, a number of conference abstracts were identified and provided to ReBIP. Again, we believe this data set adds further credibilty to the evidence base supporting the role of mesh in POP surgery. We have attached a summary for consideration by the IPAC. 14 of 14