- Email: [email protected]
Managing pain after synthetic mesh implants in pelvic surgery
European Journal of Obstetrics & Gynecology and Reproductive Biology 234 (2019) 49–52
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Review article
Managing pain after synthetic mesh implants in pelvic surgery Philip Toozs-Hobsona,* , Linda Cardozob , Timothy Hillardc a
Birmingham Women’s and Children’s NHS foundation Trust, Birmingham B15 2TG, United Kingdom Kings College Hospital, London SE5 9RS, United Kingdom c Poole Hospital NHS Foundation Trust, BH15 2JB, United Kingdom b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 2 October 2018 Received in revised form 13 December 2018 Accepted 27 December 2018
Pelvic mesh surgery has courted controversy with around 10% of patients experiencing complications. This article concentrates on the factors around pain, its presentation and management. Immediate pain is related to insertion and immediate removal recommended. With later presentation excision of the mesh relieves pain in up to 80% of women. Infection may be contributory but in refractory cases other factors maybe involved. Idiosyncratic reaction to mesh without risk factors appears to be relatively rare. © 2019 Elsevier B.V. All rights reserved.
Keywords: Vaginal mesh complications
Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Estimates of complications and treatments . . . . . . . . . . . . . . . Patterns of pain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Possible mechanisms for the development of delayed pain . . Hypotheses and possible prevention of pain as a complication Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conflict of interest statement . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Introduction During the last 2 decades there has been a rapid increase in the worldwide interest and uptake of mesh technology in pelvic surgery for both prolapse and incontinence. Complications can occur with any surgery and pain may be a feature regardless of the use of synthetic implants. Currently there is controversy about the role of mesh implants and patient groups have been particularly successful in highlighting the possible additional complications associated with mesh. In the UK this has led to 3 reviews (the Scottish review, NHS England review and most recently the Welsh review), there has been a previous SCENIHR report from the European union and also the FDA rulings. Australia and New Zealand have published guidance withdrawing mini slings and vaginal mesh for prolapse
* Corresponding author. E-mail address: [email protected] (P. Toozs-Hobson). https://doi.org/10.1016/j.ejogrb.2018.12.037 0301-2115/© 2019 Elsevier B.V. All rights reserved.
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but supporting the use of retropubic and transobturator tapes for stress urinary incontinence when other options have been unsuccessful. The accompanying publicity around the risks of mesh in prolapse and incontinence surgery have highlighted several important points. Firstly it is acknowledged that some women have suffered significant complications in association with their surgery. As such, there is now an increasing diversity of opinion within the medical fraternity regarding the role of these procedures. Secondly, there has been a failure to recognize the severity of any adverse impact these complications have had on these women. This lack of recognition and subsequent poor management has fueled the discord in those who have had adverse outcomes. Thirdly, many of the complications currently being blamed on mesh are also consistent with traditional prolapse and incontinence surgery. The most controversial complication however is pain. The aim of this paper is to give a brief overview of the literature and provide a framework for categorizing pain associated with
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P. Toozs-Hobson et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 234 (2019) 49–52
vaginal surgery, explore hypotheses for how this might affect some but not others and describe possible approaches to management. When reviewing the literature associated with complications of mesh surgery it is apparent that much of the literature describes small case series. As such the authors have drawn on these and their own experiences to offer their opinion. Currently the literature is dominated by 2 large randomized prospective surgical trials of mesh vs non mesh in prolapse surgery which suggest the incidence of pain is similar between patients with native tissue repair and mesh implants [1,2]. As such the importance of closer scrutiny of factors potentially affecting adverse outcomes has become paramount. Background Primae noncore, first do no harm, is the principle that should underpin any surgery. As such the driving force behind mesh technology was originally about improving care for women and the perception that native tissue repair (particularly in the anterior compartment) had a high failure rate. This was first articulated in the literature in the widely quoted Kaiser Permenente data [3] describing the incidence of recurrence following prolapse surgery. There was equal recognition that continence surgery was perhaps not as good as we had previously thought [4] Polypropylene vaginal implants can be classified into several groups: i) sheets of mesh implanted vaginally to treat prolapse; ii) retropubic polypropylene tapes and iii) transobturator polypropylene tapes IV) mini slings the last 3 for treating stress incontinence. Whilst this paper primarily draws on literature describing tapes, the principles apply equally to mesh used for prolapse. The original retropubic tape, the tension free vaginal tape, TVTJ, was introduced as an alternative to colposuspension, which was the then gold standard procedure for stress urinary incontinence. TVT was seen as an easier less morbid procedure when compared to colposuspensionreducing the risks including haemorrhage, infection and subsequent rectocele. FDA approval for the TVT was granted in 1998 and despite early skepticism by 2005 it was viewed as a welcome advancement in practice. The original project took Ulmsten and Petros [5,6] many years and was developed following many previous failed procedures (such as GORETEX slings and endoscopic bladder neck suspensions [7]). Indeed, the original series by Ulmsten and Petros used Mersilene slings similar to the description by Moir [8]. Whilst the FDA approval process may have been less than robust the original work was not and subsequent studies probably make TVT the most widely investigated surgical procedure in the history of surgery. Between 2000–2010 there was an explosion of products following the original FDA approval. Current estimates suggest that over 10 million women worldwide have had midurethral tapes inserted for stress urinary incontinence. Estimates for mesh for prolapse are more difficult, but this certainly will run to in excess of 2 million. The widespread adoption of mesh based techniques has resulted in an explosion of the number of procedures being performed and perhaps has also contributed to the apparent increase in the number of complications reported, leading ultimately to the patient pressure groups challenging the legitimacy of mesh procedures. The discord between campaigners and the medical profession is acknowledged and the relationship between the difference in patient aspirations and clinically assessed outcomes has previously been discussed [9,10]. It is also acknowledged that many of the complications that have occurred seem to have been poorly or inadequately managed with early reports of complications being dismissed prior to wider appreciation of the issues and
representing inertia by the medical profession in reacting to the issues that mesh procedures had created, Recent concerns about the possible complications with these procedures highlight the need for accurate longer-term data to understand how these surgeries may differ from other (non mesh) procedures, although the recently published HES data in the UK are reassuring in so much as the incidence of problems does appear to decrease significantly from the first post operative year to the second and then subsequent years [11]. The use of mesh for prolapse surgery has alreadydecreased in the UK over recent years [12] and the future role of mesh in prolapse surgery has perhaps been clarified following the publication of the PROSPECT study which suggests a limited role for mesh in primary repairs [1] asthe outcomes of the surgery are similar to native tissue repairs. The incidence of complications, excluding mesh exposure but including dyspareunia, were similar in the mesh and non mesh groups at 2 years. In future we are likely to be left with a much smaller group of patients who may be affected by mesh complications as the usage will perhaps be more restricted than it has been over the last 10 years. PROSPECT, along with other studies, has highlighted that complications from prolapse mesh surgery, including pain, erosion or exposure, appear to be more prevalent than with tape surgery for incontinence; where the 3 available Consensus documents (2 UK and 1 European) [13–15] support their routine use of mid urethral tapes for stress incontinence. The draft updated NICE guidance due to be published in 2019 also support the use of mid urethral tapes. Estimates of complications and treatments The authors have drawn largely on the HES epidemiological study where Peri-procedural and 30-day complication rates in the confounded and unconfounded cohorts were 2.4 [2.3–2.5] % and 1.7 [1.6–1.8] % respectively [18]. These were most commonly due to voiding dysfunction and other “non surgical” complications which are common to any anti-incontinence procedure, with only a small number requiring surgical excision of the tape. Overall in this cohort of over 100,000 procedures the rate of any complication was 9.8% after a tape for incontinence. Estimates based on the literature reviewed consistently highlight half of all complications being due to the operation replacing incontinence with voiding difficulties. These cases often resolve spontaneously over a few weeks but if not can be managed conservatively with self catheterisation, or with either return to theatre for tape mobilization or delayed revision or division/excision of the tape causing the voiding difficulties to resolve in up to 80% with a 20% of return of incontinence [16]. 20% of complications refer to tape extrusion which may lead to pain, dyspareunia (and the appropriately named “hispareunia”, for male partner pain during intercourse) discharge or bleeding. These are often easily treated with the use of vaginal oestrogen in post menopausal women or a local excision. These predominantly present “early” and as such represent a primary failure of healing of the incision although may be “delayed”, appearing at a later date, which may be years later. Approximately 10% of complications of tapes (1–2% of total) relate to the development of urgency. The authors would suggest that up to 2/3 of these result from a worsening of pre-existing urgency rather than a new symptom. Where it is a new symptom it may reflect a failure to observe or diagnose the pre-existing condition. Finally, 20% refer to significant pain which seems more specific to the tape procedures than other anti-incontinence procedures. The exact nature and cause of pain in this group is unclear but appears to be quite diverse. Those with pre-existing pain disorders e.g. fibromyalgia may be more susceptible to developing pain
P. Toozs-Hobson et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 234 (2019) 49–52
following any operative procedureand as such the option to use a tape or any mesh product should be informed and taken with caution. Patterns of pain These may be classified (as per the IUGA mesh complications calculator) as spontaneous, provoked or dyspareunia [17]. (https:// www.ics.org/complication) 1 Direct injury [18] at surgery, is probably related to passage of the trocar and unrelated to the material used. This results in immediate pain which is highly disproportionate to the operation: Presentation is usually immediate in recovery or recognized in the following 48 h as a failure to adequately recover post operatively. Patients may have obvious loss of function e.g. unable to weight bear or walk. In these cases, patients need to have the implant removed and early return to theatre is advised. At this stage the implant has not become incorporated and is extremely easy to remove. Symptoms then usually resolve fully and quickly once the tape is removed. 2 Delayed presentation: <1% of patients attend with focal pain at their post operative review (usually at 6 weeks to 3 months after surgery). These are most likely related to nerve compromise, with the tape passing close to the nerve or with tethering of the tissue surrounding the nerve to the tape. Trigger points can usually be identified with provoked or spontaneous pain depending on severity (now often described as tension myalgia) along the course of the tape close to the nerve and most commonly involving the pudendal or obturator nerves and their tributary branches (although others have been described). These may respond to conservative management or injection of local anaesthetic with steroid solution. The quoted success rate for resolution of pain with excision of tape is between 60–90% [19,20]. Excision can be either partial removing the portion associated with pain or total excision. There is no evidence that complete excision is preferable to partial removal. 3 Longer term delayed presentation: These represent an idiosyncratic reaction with diffuse pain in keeping with a pain syndrome. By definition, being idiosyncratic these present at a varying time usually longer than 6 months. In the authors combined clinical experience and based on their involvement in medicolegal cases, these patients may have a pre-existing condition or syndrome, such as fibromyalgia, associated with pain as part of their symptomatology. There are often features or clues pre operatively, for example on basic investigation such as a bladder diary, with reduced capacity or on investigations such as urodynamics, where pain and reduced bladder capacity may be present. Based on the authors’ assessment of the literature (both through case series and the larger prospective trials) we would estimate the incidence of such problems occur in <1:300. In these patient’s excision of the mesh may not alter the clinical course as the response appears to be more systemic. This is an area where further research is urgently needed to guide appropriate management of these women as there is a lack of evidence or data relating to this group, although there are small case series suggesting solutions [21]. Data on the outcome of surgery to remove the mesh/tape is beginning to emerge [22,23], but at present patients should be warned that surgery may not resolve their symptoms. Larger series and more complete data on such cases may in time be available from National or international databases which prospectively collect routine data. 4 Late presentation: These occur years after insertion and appear to be rare. They present in several ways including pain, discharge
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and infections. Urethral erosions (if these occur early they are more likely to be related to injury at surgery) usually require excision and reconstructive surgery. In straightforward cases these do well and the challenge is what further surgery should be used if symptoms of incontinence return. There is also a group of poorly defined patients with no obvious abnormality. In these cases there may be a role for ultrasound, but again this is an area of emerging science and practice with limited data. Some insight may be gained from histological review (discussed below).
Possible mechanisms for the development of delayed pain Clavé et al. have categorized the types of histological response seen in mesh complications [24] Their work identified 3 patterns. Type 1 have a characteristic colonization with polymorphonuclear (PMN) cells present in pus. These findings are usually associated with bacterial infection but have no signs of bacterial colonization. Type 2 is more of a chronic inflammation with giant cells. They display minor containment with (unaltered) PMN. There may be evidence of partial colonization. Type 3 Sclerosis picture. These cases have pronounced fibrosis, which has a transformed hardening, disappearance of fibroblasts and maturation of collagen This work showed that any change was more common with multifilament meshes; but where these occurred with polypropylene the reaction was more commonly associated with type 1 rather than type 3 (sclerosis) which occurred more commonly with multifilament meshes. Hypotheses and possible prevention of pain as a complication Based on the work of Clave it can be hypothesized that both a septic environment and haematoma may often be key to subsequent problems. The development of a haematoma supports the accumulation of fatty acids, which in turn leads to an increased risk of infection. In an ideal world this could be shown with a control group, but this would require excising mesh from asymptomatic women or an animal model with induced infection and haematoma. Oxidation appears to be a key component of the host response to haematoma which is mediated through fatty acid diffusion (from fatty acids in the haematoma) and a septic environment. Peroxide and superoxide ions are produced and these lead to hypochlorite Acid. Oxidize C–H bond recombine in absence of O2 again in absence of carboxyl groups, which then sets up the abnormal response to the foreign body and as such this “abnormal” response may well be critical to subsequent pain. As such these hypotheses of infection and oxidation related to haematoma add to the argument that attention to haemostasis and aseptic technique are critical areas of good surgical practice and may act as key components in reducing post-operative surgical risks and improve outcomes. There is widespread agreement that in an environment where there are such disparate opinions we need to have better data. As such we would make the following suggestions 1 All papers should use the recognised classifications [25,26] as well as descriptives of complications to allow better comparisons between different reports. 2 Procedure data and outcome data collection should be mandatory and disease specific, not just procedure based. As such we can build not only on what treatment is the best, but what (or when) is the most appropriate treatment for different
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scenarios. This requires data on decision making not just outcome reporting. Clinically we suggest 1 Identify potential pre-existing factors: Patients should be screened for conditions which make them at higher risk of complications. These include obesity, pre-existing pain syndromes, pain on urodynamics or reduced bladder capacity (in the authors practice a volume of 400–500 ml s is used). 2 Prior to treatment discuss all alternative treatment options: Discuss all management strategies, even where this may involve referral to a colleague who could provide alternative treatments 3 Surgical practice: Recognise the potential role of haematoma and adopting strategies to reduce both the occurrence and impact of this, including the role of antibiotic prophylaxis. Managing blood collections more or possible sepsis aggressively may potentially reduce the incidence of adverse outcomes.
Conclusion Whilst there is discordance about the exact extent of problems resulting from the use of mesh and tape implants in pelvic surgery, this is an issue that requires addressing particularly with regard to the development of post-operative pain. The use of such implants particularly in prolapse surgery has dramatically reduced in the UK, but there continues to be a role for such techniques particularly for the treatment of stress incontinence. Greater attention to preoperative assessment and surgical technique may be critical to optimizing outcomes from such surgery; in particular reducing the risk of subclinical infections and managing any bleeding. Further research is needed to determine the optimal way of managing women who develop pain following mesh implant surgery, but in the meantime the insertion of synthetic tapes and meshes should be discussed in detail and alternatives considered in cases where mesh may be best avoided in women with pre-existing chronic pain syndromes [27]. Conflict of interest statement PTH has undertaken consultancy work for Ethicon and Boston Scientific. He was part of the NHSEngland working party on mesh complications and has undertaken medicolegal work in this area. LDC has undertaken consultancy work for Boston Scientific and previously for Ethicon and has undertaken medicolegal work involving tapes and meshes. TH was part of the NHS England working party on mesh complications All 3 authors are part of the RCOG advisory group on meshes. P. Toozs-Hobson conceived this paper after discussing its main points with the other authors in relation to a talk he gave at the RCOG world congress in Obstetrics and Gynaecology and did the main manuscript writing and editing. T. Hillard added additional information based on a talk he gave at the UKCS meeting and edited and commented on the manuscript L. Cardozo edited and commented on the manuscript.
References [1] Glazener C, Breeman S, Elders A, Hemming C, Cooper K, Freeman R. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT). Lancet 2016;389(10067):381–92. [2] Milani A, Damoiseaux A, IntHout J, Kluivers Kirsten B, Withagen M. Long-term outcome of vaginal mesh or native tissue in recurrent prolapse: a randomized controlled trial. Int Urogynecol 2018;29:847–58. [3] Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;89(Apr (4)):501–6. [4] Black N, Griffiths J, Pope C, Bowling A, Abel P. Impact of surgery for stress incontinence on morbidity: cohort study. BMJ 1997;315(1493). [5] Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol Mar 1995;29(1):75–82. [6] Ulmsten U. An introduction to tension-free vaginal tape (TVT)–a new surgical procedure for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2001;12(Suppl. 2):S3–4. [7] Petros P. Creating a gold standard surgical device: scientific discoveries leading to TVT and beyond: Ulf Ulsten Memorial lecture 2014. Int Urogynecol J 2015;26 (4):471–6. [8] Moir JC. The gauze hammock operation. J Obstet Gynaecol Br Cmnwlth 1968;75:1–13. [9] Srikrishna S, Robinson D, Cardozo L, Vella M. MOAB: are we giving women what they want? Neurourol Urodyn 2007;26:651–2. [10] Srikrishna S, Robinson D, Cardozo L, Vella M. Never the twain shall meet! Achievement of patient centred goals and objective outcome measures in pelvic floor dysfunction surgery. Neurourol Urodyn 2006;25:605–7. [11] Keltie K, Elneil S, Monga A, Patrick H, Powell J, Campbell B. Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246. Sci Rep 2017;7:, doi:http://dx.doi.org/10.1038/s41598-01711821-w. [12] Jha S, Cutner A, Moran P. The UK national prolapse survey : 10 years on. Int Urogynecol J 2018, doi:http://dx.doi.org/10.1007/s00192-017-3476-3. [13] http://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scenihr_consultation_27_en.htm. [14] https://www.england.nhs.uk/ourwork/qual-clin-lead/mesh/. [15] http://www.gov.scot/Resource/0048/00486661.pdf. [16] Huwyler Burton MC, Renganathan A, Latthe P, Robinson D, Parsons M, Cardozo L. Retrospective case modelling to assess the impact of early intervention for voiding dysfunction after retropubic tape. When is it best to intervene? Int Urogynecol J 2012;21(7):823–7. [17] https://www.ics.org/complication. [18] Vervest HAM, Bongers MY, van der Wurff AAM. Nerve injury: an exceptional cause of pain after TVT. Int Urogynecol J 2006;17(665). [19] Ridgeway B, Walters MD, Paraiso MFR, Barber MD, McAchran SE, Goldman HB, Jelovsek JE. Early experience with mesh excision for adverse outcomes after transvaginal mesh placement using prolapse kits. Am J Obstet Gynecol 2008;199:703 e1-703.e7. [20] Tijdink Myrthe M, Vierhout Mark E, Heesakkers John P, Withagen Mariëlla IJ. Surgical management of mesh-related complications after prior pelvic floor reconstructive surgery with meshTijdink. Int Urogynecol J 2011;22:1395. [21] Rouprêt M, Misraï V, Vaessen C, Cour F, Haertig A, Chartier-Kastler E. Laparoscopicsurgical complete sling resection for tension-free vaginal tape? related complications refractory to first-line conservative management: a single-centre experience. Eur Urol 2010;58:270–4. [22] Ismail S, Chartier-Kastler E, Reus C, Cohen J, Seisen T, Phé V. Functional outcomes of synthetic tape and mesh revision surgeries: a monocentric experience. Int Urogynecol J 2018, doi:http://dx.doi.org/10.1007/s00192-018-3727-y. [23] Goodall EJ, Cartwright R, Stratta EC, Jackson SR, Price N. Outcomes after laparoscopic removal of retropubic midurethral slings for chronic pain. Int Urogynecol J 2018, doi:http://dx.doi.org/10.1007/s00192-018-3756-6. [24] Clavé A, Yahi H, Hammou JC, Montanari S, Gounon P, Clave H. Polypropylene as a reinforcement in pelvic surgery is not inert: comparative analysis of 100 explants. IUJ 2010;21(30):261–70. [25] https://www.ics.org/Documents/ViewDocumentVersions.aspx?DocumentID=671. [26] https://www.assessurgery.com/clavien-dindo-classification/. [27] Geller EJ, Babb E, Nackley AG, Zolnoun D. Incidence and risk factors for pelvic pain after mesh implant surgery for the treatment of pelvic floor disorders. J Minim Invasive Gynecol 2017;24(1):67–73, doi:http://dx.doi.org/10.1016/j. jmig.2016.10.001.
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Review article
Managing pain after synthetic mesh implants in pelvic surgery Philip Toozs-Hobsona,* , Linda Cardozob , Timothy Hillardc a
Birmingham Women’s and Children’s NHS foundation Trust, Birmingham B15 2TG, United Kingdom Kings College Hospital, London SE5 9RS, United Kingdom c Poole Hospital NHS Foundation Trust, BH15 2JB, United Kingdom b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 2 October 2018 Received in revised form 13 December 2018 Accepted 27 December 2018
Pelvic mesh surgery has courted controversy with around 10% of patients experiencing complications. This article concentrates on the factors around pain, its presentation and management. Immediate pain is related to insertion and immediate removal recommended. With later presentation excision of the mesh relieves pain in up to 80% of women. Infection may be contributory but in refractory cases other factors maybe involved. Idiosyncratic reaction to mesh without risk factors appears to be relatively rare. © 2019 Elsevier B.V. All rights reserved.
Keywords: Vaginal mesh complications
Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Estimates of complications and treatments . . . . . . . . . . . . . . . Patterns of pain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Possible mechanisms for the development of delayed pain . . Hypotheses and possible prevention of pain as a complication Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conflict of interest statement . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . .
. . . . . . .. .. ..
. . . . . . . . .
Introduction During the last 2 decades there has been a rapid increase in the worldwide interest and uptake of mesh technology in pelvic surgery for both prolapse and incontinence. Complications can occur with any surgery and pain may be a feature regardless of the use of synthetic implants. Currently there is controversy about the role of mesh implants and patient groups have been particularly successful in highlighting the possible additional complications associated with mesh. In the UK this has led to 3 reviews (the Scottish review, NHS England review and most recently the Welsh review), there has been a previous SCENIHR report from the European union and also the FDA rulings. Australia and New Zealand have published guidance withdrawing mini slings and vaginal mesh for prolapse
* Corresponding author. E-mail address: [email protected] (P. Toozs-Hobson). https://doi.org/10.1016/j.ejogrb.2018.12.037 0301-2115/© 2019 Elsevier B.V. All rights reserved.
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but supporting the use of retropubic and transobturator tapes for stress urinary incontinence when other options have been unsuccessful. The accompanying publicity around the risks of mesh in prolapse and incontinence surgery have highlighted several important points. Firstly it is acknowledged that some women have suffered significant complications in association with their surgery. As such, there is now an increasing diversity of opinion within the medical fraternity regarding the role of these procedures. Secondly, there has been a failure to recognize the severity of any adverse impact these complications have had on these women. This lack of recognition and subsequent poor management has fueled the discord in those who have had adverse outcomes. Thirdly, many of the complications currently being blamed on mesh are also consistent with traditional prolapse and incontinence surgery. The most controversial complication however is pain. The aim of this paper is to give a brief overview of the literature and provide a framework for categorizing pain associated with
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vaginal surgery, explore hypotheses for how this might affect some but not others and describe possible approaches to management. When reviewing the literature associated with complications of mesh surgery it is apparent that much of the literature describes small case series. As such the authors have drawn on these and their own experiences to offer their opinion. Currently the literature is dominated by 2 large randomized prospective surgical trials of mesh vs non mesh in prolapse surgery which suggest the incidence of pain is similar between patients with native tissue repair and mesh implants [1,2]. As such the importance of closer scrutiny of factors potentially affecting adverse outcomes has become paramount. Background Primae noncore, first do no harm, is the principle that should underpin any surgery. As such the driving force behind mesh technology was originally about improving care for women and the perception that native tissue repair (particularly in the anterior compartment) had a high failure rate. This was first articulated in the literature in the widely quoted Kaiser Permenente data [3] describing the incidence of recurrence following prolapse surgery. There was equal recognition that continence surgery was perhaps not as good as we had previously thought [4] Polypropylene vaginal implants can be classified into several groups: i) sheets of mesh implanted vaginally to treat prolapse; ii) retropubic polypropylene tapes and iii) transobturator polypropylene tapes IV) mini slings the last 3 for treating stress incontinence. Whilst this paper primarily draws on literature describing tapes, the principles apply equally to mesh used for prolapse. The original retropubic tape, the tension free vaginal tape, TVTJ, was introduced as an alternative to colposuspension, which was the then gold standard procedure for stress urinary incontinence. TVT was seen as an easier less morbid procedure when compared to colposuspensionreducing the risks including haemorrhage, infection and subsequent rectocele. FDA approval for the TVT was granted in 1998 and despite early skepticism by 2005 it was viewed as a welcome advancement in practice. The original project took Ulmsten and Petros [5,6] many years and was developed following many previous failed procedures (such as GORETEX slings and endoscopic bladder neck suspensions [7]). Indeed, the original series by Ulmsten and Petros used Mersilene slings similar to the description by Moir [8]. Whilst the FDA approval process may have been less than robust the original work was not and subsequent studies probably make TVT the most widely investigated surgical procedure in the history of surgery. Between 2000–2010 there was an explosion of products following the original FDA approval. Current estimates suggest that over 10 million women worldwide have had midurethral tapes inserted for stress urinary incontinence. Estimates for mesh for prolapse are more difficult, but this certainly will run to in excess of 2 million. The widespread adoption of mesh based techniques has resulted in an explosion of the number of procedures being performed and perhaps has also contributed to the apparent increase in the number of complications reported, leading ultimately to the patient pressure groups challenging the legitimacy of mesh procedures. The discord between campaigners and the medical profession is acknowledged and the relationship between the difference in patient aspirations and clinically assessed outcomes has previously been discussed [9,10]. It is also acknowledged that many of the complications that have occurred seem to have been poorly or inadequately managed with early reports of complications being dismissed prior to wider appreciation of the issues and
representing inertia by the medical profession in reacting to the issues that mesh procedures had created, Recent concerns about the possible complications with these procedures highlight the need for accurate longer-term data to understand how these surgeries may differ from other (non mesh) procedures, although the recently published HES data in the UK are reassuring in so much as the incidence of problems does appear to decrease significantly from the first post operative year to the second and then subsequent years [11]. The use of mesh for prolapse surgery has alreadydecreased in the UK over recent years [12] and the future role of mesh in prolapse surgery has perhaps been clarified following the publication of the PROSPECT study which suggests a limited role for mesh in primary repairs [1] asthe outcomes of the surgery are similar to native tissue repairs. The incidence of complications, excluding mesh exposure but including dyspareunia, were similar in the mesh and non mesh groups at 2 years. In future we are likely to be left with a much smaller group of patients who may be affected by mesh complications as the usage will perhaps be more restricted than it has been over the last 10 years. PROSPECT, along with other studies, has highlighted that complications from prolapse mesh surgery, including pain, erosion or exposure, appear to be more prevalent than with tape surgery for incontinence; where the 3 available Consensus documents (2 UK and 1 European) [13–15] support their routine use of mid urethral tapes for stress incontinence. The draft updated NICE guidance due to be published in 2019 also support the use of mid urethral tapes. Estimates of complications and treatments The authors have drawn largely on the HES epidemiological study where Peri-procedural and 30-day complication rates in the confounded and unconfounded cohorts were 2.4 [2.3–2.5] % and 1.7 [1.6–1.8] % respectively [18]. These were most commonly due to voiding dysfunction and other “non surgical” complications which are common to any anti-incontinence procedure, with only a small number requiring surgical excision of the tape. Overall in this cohort of over 100,000 procedures the rate of any complication was 9.8% after a tape for incontinence. Estimates based on the literature reviewed consistently highlight half of all complications being due to the operation replacing incontinence with voiding difficulties. These cases often resolve spontaneously over a few weeks but if not can be managed conservatively with self catheterisation, or with either return to theatre for tape mobilization or delayed revision or division/excision of the tape causing the voiding difficulties to resolve in up to 80% with a 20% of return of incontinence [16]. 20% of complications refer to tape extrusion which may lead to pain, dyspareunia (and the appropriately named “hispareunia”, for male partner pain during intercourse) discharge or bleeding. These are often easily treated with the use of vaginal oestrogen in post menopausal women or a local excision. These predominantly present “early” and as such represent a primary failure of healing of the incision although may be “delayed”, appearing at a later date, which may be years later. Approximately 10% of complications of tapes (1–2% of total) relate to the development of urgency. The authors would suggest that up to 2/3 of these result from a worsening of pre-existing urgency rather than a new symptom. Where it is a new symptom it may reflect a failure to observe or diagnose the pre-existing condition. Finally, 20% refer to significant pain which seems more specific to the tape procedures than other anti-incontinence procedures. The exact nature and cause of pain in this group is unclear but appears to be quite diverse. Those with pre-existing pain disorders e.g. fibromyalgia may be more susceptible to developing pain
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following any operative procedureand as such the option to use a tape or any mesh product should be informed and taken with caution. Patterns of pain These may be classified (as per the IUGA mesh complications calculator) as spontaneous, provoked or dyspareunia [17]. (https:// www.ics.org/complication) 1 Direct injury [18] at surgery, is probably related to passage of the trocar and unrelated to the material used. This results in immediate pain which is highly disproportionate to the operation: Presentation is usually immediate in recovery or recognized in the following 48 h as a failure to adequately recover post operatively. Patients may have obvious loss of function e.g. unable to weight bear or walk. In these cases, patients need to have the implant removed and early return to theatre is advised. At this stage the implant has not become incorporated and is extremely easy to remove. Symptoms then usually resolve fully and quickly once the tape is removed. 2 Delayed presentation: <1% of patients attend with focal pain at their post operative review (usually at 6 weeks to 3 months after surgery). These are most likely related to nerve compromise, with the tape passing close to the nerve or with tethering of the tissue surrounding the nerve to the tape. Trigger points can usually be identified with provoked or spontaneous pain depending on severity (now often described as tension myalgia) along the course of the tape close to the nerve and most commonly involving the pudendal or obturator nerves and their tributary branches (although others have been described). These may respond to conservative management or injection of local anaesthetic with steroid solution. The quoted success rate for resolution of pain with excision of tape is between 60–90% [19,20]. Excision can be either partial removing the portion associated with pain or total excision. There is no evidence that complete excision is preferable to partial removal. 3 Longer term delayed presentation: These represent an idiosyncratic reaction with diffuse pain in keeping with a pain syndrome. By definition, being idiosyncratic these present at a varying time usually longer than 6 months. In the authors combined clinical experience and based on their involvement in medicolegal cases, these patients may have a pre-existing condition or syndrome, such as fibromyalgia, associated with pain as part of their symptomatology. There are often features or clues pre operatively, for example on basic investigation such as a bladder diary, with reduced capacity or on investigations such as urodynamics, where pain and reduced bladder capacity may be present. Based on the authors’ assessment of the literature (both through case series and the larger prospective trials) we would estimate the incidence of such problems occur in <1:300. In these patient’s excision of the mesh may not alter the clinical course as the response appears to be more systemic. This is an area where further research is urgently needed to guide appropriate management of these women as there is a lack of evidence or data relating to this group, although there are small case series suggesting solutions [21]. Data on the outcome of surgery to remove the mesh/tape is beginning to emerge [22,23], but at present patients should be warned that surgery may not resolve their symptoms. Larger series and more complete data on such cases may in time be available from National or international databases which prospectively collect routine data. 4 Late presentation: These occur years after insertion and appear to be rare. They present in several ways including pain, discharge
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and infections. Urethral erosions (if these occur early they are more likely to be related to injury at surgery) usually require excision and reconstructive surgery. In straightforward cases these do well and the challenge is what further surgery should be used if symptoms of incontinence return. There is also a group of poorly defined patients with no obvious abnormality. In these cases there may be a role for ultrasound, but again this is an area of emerging science and practice with limited data. Some insight may be gained from histological review (discussed below).
Possible mechanisms for the development of delayed pain Clavé et al. have categorized the types of histological response seen in mesh complications [24] Their work identified 3 patterns. Type 1 have a characteristic colonization with polymorphonuclear (PMN) cells present in pus. These findings are usually associated with bacterial infection but have no signs of bacterial colonization. Type 2 is more of a chronic inflammation with giant cells. They display minor containment with (unaltered) PMN. There may be evidence of partial colonization. Type 3 Sclerosis picture. These cases have pronounced fibrosis, which has a transformed hardening, disappearance of fibroblasts and maturation of collagen This work showed that any change was more common with multifilament meshes; but where these occurred with polypropylene the reaction was more commonly associated with type 1 rather than type 3 (sclerosis) which occurred more commonly with multifilament meshes. Hypotheses and possible prevention of pain as a complication Based on the work of Clave it can be hypothesized that both a septic environment and haematoma may often be key to subsequent problems. The development of a haematoma supports the accumulation of fatty acids, which in turn leads to an increased risk of infection. In an ideal world this could be shown with a control group, but this would require excising mesh from asymptomatic women or an animal model with induced infection and haematoma. Oxidation appears to be a key component of the host response to haematoma which is mediated through fatty acid diffusion (from fatty acids in the haematoma) and a septic environment. Peroxide and superoxide ions are produced and these lead to hypochlorite Acid. Oxidize C–H bond recombine in absence of O2 again in absence of carboxyl groups, which then sets up the abnormal response to the foreign body and as such this “abnormal” response may well be critical to subsequent pain. As such these hypotheses of infection and oxidation related to haematoma add to the argument that attention to haemostasis and aseptic technique are critical areas of good surgical practice and may act as key components in reducing post-operative surgical risks and improve outcomes. There is widespread agreement that in an environment where there are such disparate opinions we need to have better data. As such we would make the following suggestions 1 All papers should use the recognised classifications [25,26] as well as descriptives of complications to allow better comparisons between different reports. 2 Procedure data and outcome data collection should be mandatory and disease specific, not just procedure based. As such we can build not only on what treatment is the best, but what (or when) is the most appropriate treatment for different
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scenarios. This requires data on decision making not just outcome reporting. Clinically we suggest 1 Identify potential pre-existing factors: Patients should be screened for conditions which make them at higher risk of complications. These include obesity, pre-existing pain syndromes, pain on urodynamics or reduced bladder capacity (in the authors practice a volume of 400–500 ml s is used). 2 Prior to treatment discuss all alternative treatment options: Discuss all management strategies, even where this may involve referral to a colleague who could provide alternative treatments 3 Surgical practice: Recognise the potential role of haematoma and adopting strategies to reduce both the occurrence and impact of this, including the role of antibiotic prophylaxis. Managing blood collections more or possible sepsis aggressively may potentially reduce the incidence of adverse outcomes.
Conclusion Whilst there is discordance about the exact extent of problems resulting from the use of mesh and tape implants in pelvic surgery, this is an issue that requires addressing particularly with regard to the development of post-operative pain. The use of such implants particularly in prolapse surgery has dramatically reduced in the UK, but there continues to be a role for such techniques particularly for the treatment of stress incontinence. Greater attention to preoperative assessment and surgical technique may be critical to optimizing outcomes from such surgery; in particular reducing the risk of subclinical infections and managing any bleeding. Further research is needed to determine the optimal way of managing women who develop pain following mesh implant surgery, but in the meantime the insertion of synthetic tapes and meshes should be discussed in detail and alternatives considered in cases where mesh may be best avoided in women with pre-existing chronic pain syndromes [27]. Conflict of interest statement PTH has undertaken consultancy work for Ethicon and Boston Scientific. He was part of the NHSEngland working party on mesh complications and has undertaken medicolegal work in this area. LDC has undertaken consultancy work for Boston Scientific and previously for Ethicon and has undertaken medicolegal work involving tapes and meshes. TH was part of the NHS England working party on mesh complications All 3 authors are part of the RCOG advisory group on meshes. P. Toozs-Hobson conceived this paper after discussing its main points with the other authors in relation to a talk he gave at the RCOG world congress in Obstetrics and Gynaecology and did the main manuscript writing and editing. T. Hillard added additional information based on a talk he gave at the UKCS meeting and edited and commented on the manuscript L. Cardozo edited and commented on the manuscript.
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