SCENIHR Preliminary Opinion on. The safety of surgical meshes used in UroGynecological surgery

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1 SCENIHR Preliminary Opinin n The safety f surgical meshes used in UrGyneclgical surgery Apprved fr public cnsultatin by written prcedure n 8 June 2015 Cmments frm Pr Bernard Jacquetin, UrGyneclgic Unit, Gynaeclgy-Obstetrics-Human Reprductin Department Estaing University Hspital, CLERMONT-FERRAND, FRANCE. Frewrd: I will limit my cmments t the POP surgery; the SUI surgery is nt, tday, very cntrversial and, as a gynaeclgist, I am nt interested by males! Disclsure: I am the Prlift patent s wner, but this device was withdrawn frm the glbal market in March 2013; s I have n mre cnflict f interest t declare General assessment: My glbal feeling is half-hearted : Reassured by this Eurpean pinin less negative than the US ne, particularly the FDA warnings, and by the reasnable general recmmendatins. Disappinted by the lack f a clear cnclusin: Even the UK s MHRA recently cncluded that the vaginal mesh usage benefits utweigh the risks The SCENIHR, repeating many times that the benefits/risks balance shuld be acceptable, didn t give a clear evaluatin, and even a cnflicting pinin particularly evident cncerning the vaginal mesh indicatins: In the abstract (P.5, L. 4-5): the use f synthetic mesh fr POP repair via a transvaginal rute shuld nly be used when ther surgical prcedure have already failed r are expected t fail. In the executive summary (P.8, L.16-17): In the cntext f POP, the use f mesh placed by the vaginal rute is nly recmmended as a secndary chice after failed primary surgery. It s a MAJOR difference abut indicatin! 1

2 The literature review, excepted fr the experimental research, is largely dminated by the cmparative studies; in my pinin, the EBM is nt limited t the RCTs but have t take in cnsideratin a huge number f bservatinal studies giving the true life f the surgical devices usage, particularly fr the lng time fllw-up. The pinin text is nt hmgeneus, prbably due t the juxtapsitin f the different cntributins, reasn why there are a lt f repetitins, smetimes nly annying (like the rle f the mesh size ), but smetimes disturbing (fr example the patient risk factrs are different in number but als in quality accrding t the different chapters). A synthesis wrk appears desirable Detailed assessment: ABSTRACT: P.4: clpsuspensin is assciated with greater surgical mrbidity is nt at a gd place in the transvaginal surgery chapter. P.5: d yu cnfirm r are expected t fail (See abve) 1.EXECUTIVE SUMMARY: P.7, L.41: the Directive 93/42/EEC (including amendment 2007/47/EC) (als mentined P. 17 etc.. ) in nt prvided in Annex P.8, L. 17: add r are expected t fail (see abve) P.8, L. 33: there are absrbable (partially r ttally) synthetic meshes P.11, L.16: Taking int accunt the lack f lng term data and P.11, L.29-30: establish scientific studies t assess the lng term (at least 5 years) safety and perfrmance ; I understand very well the interest f the lng term studies s why dn t mentin them, particularly the tw prspective and parallel studies perfrmed by the French TVM grup and the US Miller D. et al grup? I will cme back n this criticism. 2. BACKGROUND: n cmment 3. TERMS OF REFERENCE: n cmment. 4. SCIENTIFIC RATIONALE: P.17, L.25: cncerning the natinal standard in France (AFNOR S94-801), it s inaccurate t mentin fr stress urinary incntinence ; this nrm is dedicated t SUI and/r POP (see slide 1, inner part). P.29, L.22: please add pre mesh PORE size P.31, L.1-3: the Figure 1 is nt understandable: 7 different meshes are mentined but nly 4 curves are n the graph? P.33, L.15-34: it s a gd synthesis f the hst respnse t implanted bimaterials. 2

3 P34, L.15: the sentence is incmplete P.34, L.24: crrect bwel INJURY P.34, L.41: be careful with the abbreviatin SIS, used in the text with tw different meanings: Single Incisin Slings and Small Intestine Submucsa. P.51, L.18: I cannt understand why and hw, in a multiple cmpartment repair (accrding t Table 3) including anterir AND psterir mesh, there are de nv POP in untreated cmpartments? P.51, L : I agree ttally with the lack f lng term results f RCT; it a very imprtant weak pint well illustrated in this paper frm OU et al (Ou R, Xie XJ, Zimmern PE: Prlapse fllw-up at 5 years r mre: myth r reality? Urlgy 2011, 78: ) P.52, L and P.53, L.1-19: I dn t understand at all, in the UK guidelines, the reasn and the interest f this lng chapter abut infracccygeal sacrpexy, cmpared t ther guidelines (US, Dutch, French ) nly quted; I will cme back later (P. 59) n the UK s recmmendatins. P.55, L.8: culd yu clarify the meaning f decade : 10 days, 10 years r 10 peratins? P.55, L.30: clarify this Errr! P.58-60: Risk assessment and recmmendatins by Natinal Assciatins: Imprtant cmments abut French recmmendatins (errneus!) and UK recmmendatins (NOT mentined!) P.58, L and P.59, L.1-3: I disagree ttally with the abstract f the French Natinal Authrity fr Health (HAS), particularly the pint 3) the use f plyprpylene meshes fr POP surgery by vaginal rute was nt recmmended. In 2006 the HAS cnclusin was vaginal meshes are in the field f the clinical research, but in January 2008, the cnclusin was vaginal meshes may have an interest in case f recurrence r in a particular clinical situatin increasing the recurrence risk (see slide 1, upper part), i.e. exactly the same cnclusin than the tday SCENIHR s ne (if yu maintain are expected t fail ). P.58-60: There are recmmendatins frm France, USA, Australia/New-Zealand, Canada, Australia again, but NOTHING frm UK! It s a pity, because this cuntry, althugh cnsidered ding less vaginal mesh implants than all thers OECD cuntries (abut 3.3% fr anterir repair) accrding t Haya et al (Haya N, Baessler K, Christmann-Schmid C, Tayrac R, Dietz V, Guldberg R, Mascarenhas T, Nussler E, Ballard E, Ankardal M, Budemaghe T, Wu JM, Maher CF: Prlapse and cntinence surgery in cuntries f the Organizatin fr Ecnmic C-peratin and Develpment in Am.J Obstet.Gynecl 2015), published very gd reviews and recmmendatins, particularly: The NICE in 2008 published a very cmplete review with clear cmparisns between the different implants cmpared t autlgus repairs (see slide 2 fr a shrt abstract) The MHRA prduced this year a large cmpilatin with a curageus cnclusin: n the safety f vaginal mesh implants and their use and has cncluded that, frm a regulatry perspective, the benefits f the use f these devices utweigh the risks. (see slide 3) 3

4 5. OPINION: 5.1. Terms f reference: P.61-64: The answers t the questins Q1-Q8 are very similar, but nt exactly identical t thse in the P.8-11; a little bit disturbing 5.2.Recmmendatins: I agree with these general recmmendatins, quite similar t these mentined P.11 excepted imprved technlgies Why? My persnal (expert?) pinin: I am srry t have t defend a persnal wrk, but I can hardly understand why ne f the rare available studies with 5 years fllw-up was never s much as cited difficult t admit it s nt unbiased! All the health regulatry agencies and all the natinal and internatinal scientific scieties are asking fr premarketing evaluatin f the new devices and fr lng term data (very ften mentined in yur pinin) After asking in 2000 t Ethicn nt t put n the market ur TVM prttype befre 5 years (the Prlift was supplied in March 2005), we (the French TVM grup) began in 2004 a prspective study, in parallel with an US grup headed by Dennis Miller (85 and 90 patients in each grup): Prspective nn cmparative studies Withut cnflict f interest: The supprt frm Ethicn was limited t Spnsring f the meetings between the 9 members f the TVM grup Statistical cunselling English translatin The Prlift patent was delivered nly in Nvember In the wrst cnditins: Hand shaped heavyweight mesh Systematic cncmitant hysterectmy (the nly difference with US patients was the largely different rate f previus hysterectmies!) Beginning f the surgens experience cause f the lack f knwledge abut the preventive techniques f mesh expsure, prgressively discvered Reasn why the mesh expsure rate was as high as respectively 15,6 and 18,8%, but als prving the hnesty f the results! 4

5 Published by the tw teams at 1, 3 and 5 years f fllw-up: French TVM grup: Jacquetin B, Hinul P, Gauld J, Fattn B, Rsenthal C, Clave H, Garbin O, Berrcal J, Villet R, Salet-Lizee D, Debdinance P, Cssn M: Ttal transvaginal mesh (TVM) technique fr treatment f pelvic rgan prlapse: a 5-year prspective fllw-up study. Int Urgynecl J 2013, 24: US TVM grup: Miller D, Lucente V, Babin E, Beach P, Jnes P, Rbinsn D: Prspective clinical assessment f the transvaginal mesh technique fr treatment f pelvic rgan prlapse-5-year results. Female.Pelvic.Med.Recnstr.Surg 2011, 17: Shwing very similar results and particularly a very stable anatmical result (nearly 90% success rate) with time which was, f curse, the majr aim f a reinfrcement mesh isn t it? The slide 4 is a cmparative table f the tw studies results The slide 5 is an abstract f the main results and cmplicatins f the tw studies The slide 6 is a synthesis f the sexual cnsequences f the TVM in the tw cuntries. We are tday planning t cntrl these patients with 10 years f fllw-up With ur huge experience, we are cnvinced that the anterir TVM is able t cmpete with sacrclppexy, particularly in case f large cystcele (and even mre in case f paravaginal defect); I tried t represent n the slide 7 the cumulative cure rate f these tw peratins. In France, we have finished the inclusins f 262 patients fr a RCT cmparing these tw techniques (Luct JP, Fritel X, Debdinance P, Bader G, Cssn M, Giraudet G, Cllinet P, Rubd C, Fernandez H, Furnet S, Lesavre M, Deffieux X, Faivre E, Tricht C, Demulin G, Jacquetin B, Savary D, Btchrichvili R, Campagne LS, Salet-Lizee D, Villet R, Gadnneix P, Delprte P, Ferry P, Aucuturier JS, Thiruard Y, de TR, Fattn B, Wagner L, Nadeau C, Wattiez A, Garbin O, Yussef Azer AC, Thma V, Bauln TE, Saussine C, Hermieu JF, Delmas V, Blanc S, Tardif D, Faucnnier A: [PROSPERE randmized cntrlled trial: Laparscpic sacrpexy versus vaginal mesh fr cystcele POP repair.]. J Gynecl Obstet.Bil.Reprd.(Paris) 2013, 42: ) allwing an abstract at the very recent IUGA meeting in Nice with the first results. T finish, if yu are really interested by my expert pinin, yu can find jined what I wrte, ne year ag, fr the EUGA newsletter the first sectin was dedicated t the SCENIHR s wrk! After a chapter cncerning the cmplicatins, I tried t update the indicatins and cntraindicatins, with references t HAS recmmendatins and AFNOR standard nrm fr France and t the IUGA rundtable as in yur Opinin. I added my wn (expert?) pinin abut these recmmendatins. My cnclusin was: It appears difficult t us nt t admit that the vaginal surgery remains the mst minimally invasive apprach We have hard time t believe that the cncept f the TVM can be challenged n an anatmical standpint as it replicates the nrmal anatmy as cnfirmed by cadaveric dissectins. The lateral vaginal defect is nt crrected by the abdminal access unless if cmbining a cncmitant technique f paravaginal repair. And we plead fr the need t assess the results f the TVM peratins in the lng term because they were designed t reduce recurrences which in their vast majrity nly appear 3 t 5 years after traditinal interventins in the absence f technical defects. It s the reasn why I tried t cnvince yu f the imprtance f ur 5 years fllw-up wrk! 5

6 Slide 1: in France, recmmendatins frm the Health authrity (HAS) and frm the AFNOR nrm cncerning vaginal implants fr SUI and/r POP. 6

7 Slide 2: in UK (1): NICE/NHS recmmendatins (2008) 7

8 Slide 3: in UK (2): the very recent MHRA recmmendatins abut vaginal mesh implants (2015) 8

9 Slide 4: Lng term results (1); cmparative table f the anatmical, functinal and cmpsite results fr the US and French studies at 5 years fllw-up. 9

10 Slide 5: Lng term results (2); abstract f the US and French studies main results at 5 years fllw-up. 10

11 Slide 6: Lng term results (3); cmparisn f the sexual results f the US and French TVM studies at 5 years fllw-up. 11

12 Slide 7: Lng term results (4); Cmparative evlutin f time t prlapse recurrence f an anterir vaginal mesh (verall prlapse n the left, cmpartmental prlapse n the right) and f a sacrclppexy. 12

13 Current indicatins and cntraindicatins n mesh use in prlapse repair. When yu will read these lines, the Eurpean Cmmissin SCENHIR (Scientific Cmmittee n Emerging and Newly Identified Health Risks) will have begun its evaluatin f the safety f surgical meshes used in urgyneclgic surgery which is due by January Obviusly, being the inventr f the Prlift device, I d nt belng t this cmmissin because f a ptential cnflict f interest. This device was withdrawn frm the market in March 2013 and I d nt have any mre direct financial interest t argue in favr f its use! Hpefully, the pinin f the SCENIHR will be mre balanced than the FDA s in the United States and will nt generate the same wind f madness : utburst f the media, slicitatin f patients fr jining class actins, multiplicatin f lawyers cnvinced that there is much mney t gain! Irny f fate, the first Prlift prvisinal patent applicatin filed in 2002 and accepted in Nvember 2006 in the USA, was granted in Eurpe n December 30th, 2011 The TVM cmplicatins: There is n dubt that the use f prstheses can lead t specific cmplicatins and this has been well dcumented by several studies. The mst cmmn is the vaginal expsure which has wrngly been put ahead while the mre frightening peri-prsthetic cntractin have been ignred fr a lng time, even by FDA! Within ur French grup, we have recgnized these cmplicatins at a very early stage thanks nt nly t ur anteririty in the use f vaginal meshes but als because f a specialised centers effect which gave us in Lille and Clermnt-Ferrand the pprtunity t treat a large number f them. This is why Michel Cssn and myself, we felt authrised t say and write in an internatinal jurnal in 2009 that these cmplicatins were at the same time ver-estimated in frequency, ften prly described, smetimes veremphasized and incrrectly managed. We definitely had t wrk at imprving the safety f the patients. A very detailed classificatin f these cmplicatins came ut after a cllabrative wrk f the IUGA and ICS. Many cmparative studies recalled us nt t frget that the traditinal techniques als had significant rate f cmplicatins. In additin, several natinal registries have bjectively assessed the rate f these cmplicatins, the latest being the Austrian register gathering 13

14 726 vaginal mesh interventins with 6,8% f per and pstperative cmplicatins, a rate f 12% f vaginal expsures and 10% f dyspareunia. Des this justify t give up using vaginal meshes, as sme peple wuld suggest? In my pinin, this wuld be a majr step-back which nly interest wuld be t rejuvenate me by resurfacing the techniques we used 2 r 3 decades ag! It is clear that the science f mesh is still in its infancy and I am quite cnvinced that, in a few years, stem cells will replace the derivatives frm il prducts Current indicatins and cntraindicatins: This is the questin I have been asked t answer but perhaps, in the current hstile cntext, wuld it be better t speak abut recmmendatins rather than indicatins In my cuntry, since 2008, the French health authrity (HAS) did nt take a clear psitin. It first stated in 2006 that the use f meshes has t be cnsidered as clinical research. In a further and rather vague statement, it stated that the use f vaginal prsthesis culd have an interest fr recurrent cases r if there were gd clinical reasns t suspect that the patient presented a high risk f recurrence. In rder t refine its pinin, this rganizatin had required a review f the literature which was carried ut by ur grup. In the lack f further actin frm the HAS, tgether with a clleague urlgist, Pr Françis Haab, we tk the respnsibility t gather a wrking grup (surgical experts and deeply invlved manufacturers) in rder t establish a standard (AFNOR nrm NF S94-801) detailing bth preclinical and clinical studies t be carried ut befre intrducing any new prducts n the market, as well as the pst marketing surveillance. One can nte that ur 2007 prpsals were very clse t the FDA s requests in 2011! Unfrtunately, the applicatin f these French standards were nt mandatry and thus they failed t slw dwn the uncntrlled intrductin f a multitude f devices n the French market (60 were indexed!) based n the cncept f equivalence which hpefully will disappear at sme stage in the near future. In this cntext, we drafted a prpsal f cnsensus and submitted it fr validatin t fur French scientific scieties by December In this dcument, we had suggested the fllwing indicatins: Beynd the hymen-cystcele, especially its lateral type (paravaginal defect): anterir TVM Severe prlapse assciating several cmpartments including an exterirised cystcele : anterir and psterir TVM r ttal TVM And especially recurrent prlapse (in particular if the previus peratin had been crrectly carried ut): anterir OR psterir TVM We emphasized the need t take int accunt the risk factrs weighing n this indicatin: family histry, high ligamentus laxity, severe muscular avulsin f the levatr ani muscles, high abdminal pressure, cllagen abnrmalities 14

15 This multi-factrial apprach f the indicatin was further discussed during a rund table rganised by the IUGA in 2010 under the directin f Willy Davila. A reprt was published in It states that it is necessary t take int accunt varius risk factrs (age, recurrence n the same cmpartment, imprtance f the cystcele, mbility f the apex, defect f the psterir cmpartment, defective fascia, abdminal high pressure, lcal r systemic painful syndrme, desire f pregnancy as well as the cmbinatin f a recurrent r bulky cystcele with ne r mre f these risk factrs) befre prpsing the use f a mesh which culd be depending n the individual situatin likely beneficial, pssibly beneficial, unlikely beneficial r nt recmmended. The cntraindicatins which we prpsed were supprted by the panel: yung age, desire f pregnancy, severe immundepressin, lng term crticid therapy, nn-cntrlled diabetes, heavy smking, and previus pelvic irradiatin. We did nt include besity (BMI > 30) despite a well-knwn increased risk f mesh expsure risk as weight excess is als a pr indicatin fr an abdminal apprach. Vulvar, vaginal r LUT infectins, severe vaginal atrphy and/r vaginal ulceratins were cnsidered as temprary cntraindicatins. We have had t wait until 2013 in rder t get a cnsensus frm the Natinal Cllege f the French Gyneclgists and Obstetricians (CNGOF) Indicatins f mesh in surgical treatment f pelvic rgan prlapse by vaginal rute after it made cmments abut the Preventin f cmplicatins related t the use f prsthetic meshes in prlapse surgery: guidelines fr clinical practice based n the natinal literature in 2011 and the Eurpean ne in This cnsensus led t 10 prpsals. My Expert Opinin: I all the mre subscribe t these recmmendatins fr which I was a prf-reader. T add my expert pinin there, let me say nce again that: The chrnic painful patient (chrnic pelvic pain, fibrmyalgia, dyspareunia ) must be excluded frm vaginal prsthetic repair. Let us g even further: patients whse mind des nt appear slid enugh t face the ptential cmplicatins must be excluded. This reinfrces the cncept that the decisin must be tailred t the patient after a lng discussin. The ideal indicatin is a bulky anterir recurrence, after a crrectly carried ut first interventin. This is the prf f the existence f a tissue deficiency. A patient wh is facing a 2 nd r 3 rd recurrence generally accepts the risks f a prsthetic peratin in the hpe f putting an end t her cncern. This was recently emphasized by a study cmparing 668 patients withut previus prlapse surgery t 142 patients with a recurrence which shwed that the rates f vaginal expsure were respectively f 10,6% and 2,8%, leading t the cnclusin by the authrs that the presence f scar tissue is prbably prtective against the mesh expsure. When a true cnnective tissue abnrmality f genetic cause is present, the indicatin f a prsthetic reinfrcement is a clear need, but mst f the surgens will prefer a 15

16 laparscpic apprach in rder t prevent any risk f dyspareunia as mst f the time, these patients are yung patients with an early recurrence and an histry f familial prlapse. The anterir paravaginal defect remains, in ur pinin, an ideal indicatin. Nevertheless, the diagnsis either by clinical examinatin r by imaging is difficult. It is ften during the curse f the peratin that ne discvers that the vesical fascia is partially r cmpletely detached frm its lateral insertins. Pelvic flr echgraphy which makes it pssible t precisely identify the indirect signs (imprtance f the muscular avulsins, dimensins f the levatr ani muscles hiatus, lack f fixity f the vaginal culs-de-sac) is the key preperative examinatin. Sme publicatins clearly demnstrated the interest f a prsthetic reinfrcement in these situatins. Uterine preservatin must be cnsidered, in agreement with the patient, each time the uterus and the varies are free frm pathlgy The use f a psterir mesh shuld nt be prhibited althugh the literature specific t the psterir cmpartment is scarce. Our experience shws that there are rather less cmplicatins with the psterir meshes than with the anterir, perhaps just because their surface is less imprtant. It is in fact the trans-gluteal and trans-sacrspinus access that many surgens fear Nevertheless, when the anterir prsthesis is effective, the psterir cmpartment is threatened: 1/3 f ur failures are in fact a decmpensatin f the cmpartment which has nt been repaired. This is dcumented in sme publicatins. The management f the prsthetic cmplicatins, in particular f the severe retractins, must be made by an experienced team t limit the number f reperatins. It is a matter f fact that ften the prblem cannt be slved in a single prcedure, but undubtedly it shuld nt either require ten r mre reperatins! A recent study shwed that 60% f 347 patients presenting prsthetic cmplicatins had required tw r mre peratins. T cnclude: It appears difficult t us nt t admit that the vaginal surgery remains the mst minimally invasive apprach We have hard time t believe that the cncept f the TVM can be challenged n an anatmical standpint as it replicates the nrmal anatmy as cnfirmed by cadaveric dissectins. The lateral vaginal defect is nt crrected by the abdminal access unless if cmbining a cncmitant technique f paravaginal repair. And we plead fr the need t assess the results f the TVM peratins in the lng term because they were designed t reduce recurrences which in their vast majrity nly appear 3 t 5 years after traditinal interventins in the absence f technical defects

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