Safety of Trans Vaginal Mesh procedure: Retrospective study of 684 patients

Transcription

1 doi: /j x J. Obstet. Gynaecol. Res. Vol. 34, No. 4: , August 2008 Safety of Trans Vaginal Mesh procedure: Retrospective study of 684 patients Fréderic Caquant, Pierre Collinet, Philippe Debodinance, Juan Berrocal, Olivier Garbin, Claude Rosenthal, Henri Clave, Richard Villet, Bernard Jacquetin and Michel Cosson Gynaecological Surgery, Hospital Jeanne de Flandre, Lille Cedex, France Abstract Aim: To study peri-surgical complications after cure of genital prolapse by vaginal route using interposition of synthetic prostheses Gynemesh Prolene Soft (Gynecare) following the Trans Vaginal Mesh (TVM) technique. Methods: The present retrospective multicentered study comprised 684 patients who underwent surgery at seven French centers between October 2002 and December All patients had a genital prolapse 3 (C3/H3/E3/R3) according to International continence society (ICS) classification. According to each case, prosthetic interposition was total, or anterior only or posterior only. Patients were systematically seen 6 weeks, 3 months and 6 months after surgery. Multivaried statistical analysis followed a model of logistic regression applied to each post-surgical complication. Results: The mean age of patients was 63.5 years (30 94). The mean follow-up period was 3.6 months. 84.3% of patients were post-menopause, 24.3% had hysterectomy, 16.7% previous cure of prolapse, and 11.1% cure of stress urinary incontinence (SUI). During the procedure, hysterectomy was combined in 50.3% of cases, cervix amputation in 1.5%, and cure of SUI in 40.9%. 15.8% were treated for a cystocele only. 14.8% had only a rectocele +/- elytrocele and 69.4% had a prolapse touching both compartments, anterior and posterior. In peri-surgical complications, (2%) were five bladder wounds (0.7%), one rectal wound (0.15%) and seven hemorrhages greater that 200 ml (1%). Among early post-surgical complications (during the first month after surgery) (2.8%) were two pelvic abscesses (0.29%), 13 pelvic hematomas (1.9%), one pelvic cellulitis (0.15%), two vesicovaginal fistulas and one rectovaginal fistula (0.15%). Among late post-surgical complications (33.6%) there were 77 granulomas or prosthetic expositions (11.3% [6.7% in the vaginal anterior wall, 2.1% in the vaginal posterior wall and 4.8% in the fornix]), 80 prosthetic retractions (11.7%), 36 relapse of prolapse (6.9%) and 37 SUI de novo (5.4%). Multivaried analysis shows that previous history of hysterectomy or placing of an isolated anterior prosthesis increase the risk of peri-surgical complication; preserved uterus and isolated posterior prosthesis lessen the risk of granulomas and prosthetic retractions; and association of a Richter s intervention increases the rate of prosthetic retractions. Conclusion: Cure of genital prolapse with synthetic prostheses interposed by vaginal route is now reliable and can be reproduced with a low rate of peri- and early post-surgical complications. However, our study shows a certain number of late post-surgical complications after insertion of strengthening synthetic vaginal implants (prosthetic expositions and prosthetic retractions). These retrospective results will soon be compared to a prospective study. Key words: early or short-range complication, genital prolapse, peri-operative, synthetic prosthesis Gynemesh Prolene Soft, vaginal surgery. Received: January Accepted: April Reprint request to: Prof. Michel Cosson, Hôpital Jeanne de Flandre, Clinique de Gynécologie, Obstétrique et Néonatalogie, Centre Hospitalier Régional Universitaire de Lille, 2 Avenue Oscar Lambret, Lille Cedex, France. m-cosson@chru-lille.fr 2008 The Authors 449

2 F. Caquant et al. Introduction A large number of surgical techniques have been described to cure genital prolapse. Classical ones have used a vaginal route without prosthetic interposition (sub-urethral plication according to Marion Kelly and simple colpectomy). In retrospective studies there was a recurrence rate of 7 to 13%; more than 40% in randomized studies. 1 4 These techniques may arise in complications (42%), infections, or vaginal stenosis (20%). 5 Moreover, these techniques used only native tissues of the patient, often pathological or fragile after surgery. 6 Nine French surgeons imagined a new surgical technique to insert a vaginal reinforcement prosthesis. The group Trans Vaginal Mesh (TVM) uses transobturator route to insert implants under the bladder and transgluteal trans-sacrosciatic to fix posterior reinforcement implants. 7,8 Tolerance of synthetic polypropylene material is excellent and lasting, especially for tension free sub-urethral tapes of trans vaginal tape (TVT). 9,10 Their mechanical properties are stable and their indications have grown in surgical treatment of prolapse by vaginal route. 11,14 Methods Patients Six hundred and eighty-four women underwent surgery in the following seven reference centers between October 2002 and December 2004: Brive-la Gaillarde, Clermont-Ferrand, Nice, Dunkerque, Lille, Schiltigheim, and Rouen. The patients underwent a complete pre-surgery clinical exam testing each item of the genital prolapse according to ICS classification. During this consultation, we also looked for urinary incontinence, which was sometimes clinically evident, sometimes only unmasked after reduction of the prolapse. Urodynamics were checked whenever symptoms suggested stress urinary incontinence (SUI). Prosthesis (Fig. 1) The synthetic prosthesis is made of a monofilament of propylene woven in interlock knitting, extensible in both directions, of low grammage (41 g/m 2 ), high global porosity of 66% and large pores ( mm). The prosthesis initially measured cm, and was then cut by the surgeon following the pattern shown in Figure 1. Figure 1 Total implant. 1, anterior TVM mesh; 2, medial part; 3, posterior TVM. Standard surgical technique TVM Intervention was performed under local regional or general anesthesia, while the patient was in gynecological position with a Foley urinary catheter. Antibioprophylaxis was systematic in all centers with a perisurgical injection. The prosthesis was laid out in one block or two, depending on eventual hysterectomy and level of prolapse. The anterior part of the prosthesis has four lateral arms to be placed through an obturator following the technique described by the group TVM. 8 The posterior part of the prosthesis has two lateral arms to be anchored to sacrospinal ligaments or pass right through them by transgluteal route. 8 We will not describe this technique here as it has explained previously by Debodinance. 8 When there is an association of urinary stress in continence (USI) with a prolapse, a sub-urethral sling was placed of the type TVT or TVT-O. A Foley catheter and an iodoformed wick were kept in place for 24 h. Post-miction residue was measured until it was lower than 100 ml. Retrospective multicenter study Files were standard and unique in all centers. For each patient the following were noted: age; weight; height; personal history (medical, surgical, gynecological, obstetrical); stage of prolapse; compartments touched; eventual urinary and digestive problems; time of intervention; different surgical parameters of the prolapse cure, sometimes specific to each center; association or not to a cure of EUI; peri- and post-surgical complications; early or late at 6 weeks, 3 months, 6 months and 1 year The Authors

3 Safety of trans vaginal mesh procedure Table 1 Incidence of peri- and early post-surgical complications Complication % Reintervention Peri-surgery Bladder wounds Rectal wounds Hemorrhagia Post-surgery Pelvic cellulitis Perineal abscess Pelvic hematoma Rectovaginal fistula Vesicovaginal fistula Total re-interventions Patients who underwent re-intervention for a late post-surgical complication, were all included in the study even if re-intervention was performed after the time of the study. Statistical analysis was performed in collaboration with CERIM (CHRU, Lille, France) and logicial SAS (SAS Institute, Cary, NC, USA). All complications (peri-surgical complications, early post-surgical complications, vaginal prosthetic expositions, and symptomatic prosthetic retractions) were matched with potential risk factors (independent variables): age; menopause status; type of vaginal incision (retrograde or not); concomitant hysterectomy or keeping of uterus; cervix amputation; use of Tissucol; (Baxter Healthcare Corporation, Maurepas, France); Richter s intervention included with placing of the prosthesis; localization of prosthesis (only anterior, only posterior or both anterior and posterior); and previous history of vaginal hysterectomy. Before being entered into our model of logistic regression, independent variables were selected by unvaried analysis only if their P-value was Beyond that point, variables were considered nonsignificantly linked and were excluded from the model of logistic regression. We used as unvaried statistical tests the following: Kolmogorov-Smirnov normality tests; c 2 tests or Fisher s exact tests for qualitative variables depending on effective numbers; and ANOVA, Wilcoxon or Student s tests to compare quantitative variables depending on effective numbers. Validity of results for logistic regression was ensured by global test of nil hypothesis in a c 2 test. The influence of each risk factor is thus displayed as an odds ratio (OR) with a security interval of 95% and corresponding P-value significant under OR >1 is a favoring factor regarding the complication, OR <1 a protecting factor. Results Statistical description Six hundred and eighty-four consecutive patients were included in the study between October 2002 and the end of Repartition between the seven sites was as follows: 77 patients (11.26%) in Brive-la Gaillarde; 75 (10.96%) in Clermont-Ferrand; 39 (5.70%) in Nice; 55 (8.04%) in Dunkerque; 239 (34.94%) in Lille; 35 (5.12%) in Schiltigheim; and 164 (23.98%) in Rouen. The mean age of the patients was years (30 to 94) with a median of 65 years and a variance of The mean follow-up period was 3.6 months (2 18 months). 84.3% ( %) of patients were postmenopause, 24.3% ( %) had previous hysterectomy, 16.7% (2.6 24%) a record of surgically cured prolapse, and 11.1% ( %) a record of surgically cured EUI. During the cure of prolapse, hysterectomy was performed for 50.3% of patients ( %), cervix amputation for 1.5% ( %), and cure of SUI for 40.9% ( %). All cures of concomitant SUI were realized with suburethral, retropubic or transobturator slings (TVT or TVT O). Four hundred and seventy-five patients had a prolapse concerning several compartments at the same time and underwent cure of prolapse by anteroposterior prosthesis (69.4%). 108 patients had a cystocele only, and prolapse was cured by isolated anterior prosthesis (15.8%). 101 patients had a rectocele only and cure of prolapse used only a posterior prosthesis (14.8%). Peri- and early post-surgical complications (Table 1) During intervention, 13 complications occurred (2.05%): seven peri-surgical hemorrhages (1.02%), 2008 The Authors 451

4 F. Caquant et al. Table 2 Incidence of late post-surgical complications and localization of reinforcing implant Late complication (475) Anterior implant (n = 108) % Posterior implant (n = 101) % Anterior and posterior implant Exposition of prosthesis Retraction Surgically treated retraction Relapse of prolapse SUI de novo % five bladder wounds (0.73%), and one rectal wound (0.15%). After intervention, 19 post-operative complications occurred for 2.78% of patients. 1.46% required new surgery. Among them were 13 pelvic hematomas (90%), two perineal abcess after surinfection of hematomas (0.29%) needed to be surgically drained. One case of pelvic cellulitis (0.15%) was seen in a 74-year-old patient after complete cure by total prosthesis and simultaneous vaginal hysterectomy. Cellulitis appeared at day 9, and required total ablation of the prosthesis and medical treatment by intravenous antibiotherapy and hyperbare oxygen therapy. The patient is now healed but has a relapse of genital prolapse. There was a rectovaginal fistula in a 76-year-old patient after complete cure by total prosthesis. Complications occurred 9.5 months after surgery with first, a vaginal erosion that was spontaneously regressive, and then protrusion of the prosthesis in the rectum. There were two cases of vesico-vaginal fistula (0.29%). One was seen after partial removal of a sub-urethral prosthesis exposed in the vagina; the other occurred in a 65-yearold woman after complete cure by mono-block prosthesis and, at the same time, vaginal hysterectomy. Diagnosis was made at day 15 by retrograde cystography. Surgery by laparoscopy was required after an ineffective local catheter. The surgeon believed that this complication was not due to the prosthesis, but to a difficult dissection too near bladder. Late post-surgical complications One hundred and fifty-seven late post-surgical complications were noted. The most frequent was vaginal exposition of prosthesis (77 cases, 11.3%). Forty-six required surgical treatment (6.7%). Brive-la-Gaillarde, Clermont-Ferrand, and Nice had a significantly higher incidence than other centers (P < ). When hysterectomy was combined with cure of prolapse, vaginal exposition of the prosthesis was 11.5% when colpotomy was median 6.9% when dissection was retrograde from peri-cervical incision. When there was no concomitant hysterectomy, the number of granulomas or vaginal prosthetic expositions was 4.7%. They were located as follows: 6.5% on vaginal anterior wall (50%), 2.1% on posterior wall (15%), and 4.8% in fornix (35%). Medical treatment alone was sufficient in 42% of cases. Surgery was required in 57.8% of the cases. Consensus has not yet been reached regarding medical treatment. Usually antibiotics or antiseptics are given by vaginal route if infection is patent, estrogens are also given by vaginal route. If there is no improvement after 2 months, surgeons will usually decide on ablation of the exposed part of the prosthesis. The vagina is cautiously unstuck, then stitched tension-free with a monofilament resorbable thread and separate stitches. The other frequent late complication is retraction of the prosthesis, symptomatic or not. Eighty were shown in this study (11.7%). Nineteen prosthetic retractions required surgery (2.8%). 52.6% of these retractions were associated with prosthetic exposition. Clermont- Ferrand, Dunkerque and Schiltigheim had a significantly higher incidence for the complication (P < ). Incidence of late post-surgical complications and localization of reinforcing implant (Table 2) For anterior prostheses only, there were nine vaginal expositions requiring surgery (8.3%); 19 prosthetic retractions (17.6%), two requiring surgery (1.9%); eight relapse of prolapse (7.4%); and four SUI de novo (3.7%). For posterior prostheses, only one vaginal exposition required surgery (1%); five prosthetic retractions (5%), one requiring surgery (1%); four relapse of prolapse (4%); and four EUI de novo (4%). Antero-posterior prostheses were responsible for 36 vaginal expositions requiring surgery (7.6%); 56 prosthetic retractions (11.8%); 16 prosthetic retractions required surgery (3.4%); 24 relapse of prolapse (5.1%); 29 EUI de novo (6.1%) The Authors

5 Safety of trans vaginal mesh procedure Table 3 Univaried statistical analysis of different complications Variables Peri-surgical complication Early post-surgical complication Vaginal exposition Peri-prosthetic retraction Age NS NS NS NS Previous hysterectomy NS NS NS Menopause NS NS NS NS Retrograde dissection NS NS NS NS Kept uterus NS NS NS Cervix amputation NS NS NS NS Associated hysterectomy NS NS NS Anterior implant NS ns Posterior implant NS NS Anterior & post-implant NS NS NS NS Richter & NS NS < Relapse of prolapse NS NS NS Retraction of prosthesis NS 0.01 NS, not significant. For 15 patients (2.2%), vaginal expositions were combined with prosthetic retractions; this suggests a statistical link between the two. We will study the link at a future date using univaried statistical analysis. We did not find any significant vesical instability de novo in the whole study. Statistic analysis Each parameter has a center effect, but no center was deviant enough to be excluded from the study. All 684 patients were kept for unvaried and multivaried statistical analysis. Univaried analysis (Table 3) Peri-surgical complications. Peri-surgical complications have a significant link with previous hysterectomy and anterior prosthesis alone with, respectively, P = and P = Links with other studied factors were not significant, P-value always >0.2. Post-surgical complications. Early: No patients had any significant link with any risk factor studied (P > 0.20). Late: Vaginal exposition is significantly linked to the factors conservation of uterus (P = ), simultaneous hysterectomy (P = ), posterior prosthesis only (P = 0.012), and association to Richter (P = ). There was also a significant link between this complication and prosthetic retractions with P = When analyzing retractions needing surgery, Fischer s exact test also showed this relation with P < Other studied factors were not significantly linked to that complication (P > 0.20). The same applies for risk factor Tissucol, which is not linked to vaginal expositions (P = 0.899). Last, the percentage of vaginal expositions is definitely lower after 30 May 2003; the half-way point in our study. c 2 test was statistically significant with c 2 = and P Complications of prosthetic retractions (symptomatic or not) were significantly linked to anterior prosthesis alone (P = ), posterior prosthesis alone (P = ) and Richter associated (P < ). Retractions and relapse of prolapse were also significantly linked, P = Other risk factors studied were not significantly linked to this complication (P > 0.20). Multivaried analysis (Table 4) Peri-surgical complications. The model of logistic regression is valid with P = The variables previous hysterectomy and anterior prosthesis alone have an OR clearly superior to 1, respectively (IC 95%, ) and (IC 95%, ). Early post-surgical complications. No variable showed a significant link to this complication in unvaried analysis; no logistic regression was performed. Granulomas and vaginal exposition of prostheses. The model of logistic regression is valid with P < Uterus conservation and posterior prosthesis alone are protecting factors with OR < 1, respectively (IC 95% ) and (IC 95% ). G&EP and prosthetic retractions had a specific link (P = 0.01) The Authors 453

6 F. Caquant et al. Table 4 Multivaried statistical analysis of complications Peri-surgical complication Independent variables Odds ratio 95% security interval P Record of hysterectomy Isolated anterior implant Exposition of implant Peri-prosthetic retraction Conservation of uterus Isolated posterior implant Peri-prosthetic retraction Relapse of prolapse Richter associated < Prosthetic retractions with or without symptoms. The model of logistic regression is valid with P < Richter associated and relapse of prolapse are favoring factors with OR superior to 1, respectively (IC 95% ) and (IC 95% ). Discussion As with all retrospective studies, ours may be biased and this must be kept in mind when interpreting our results. First, the mean follow-up of 3.6 months (6 18 months) only gives an idea of early or medium-term complications of the technique. This preliminary study should be completed by a longer-term survey of our documents. There is also the problem of center effect reflecting variability between different surgeons; different surgical experiences, training time when the technique was first introduced, time for harmonization and standardization of the technique. These problems also were an advantage allowing us to evaluate complications in a true situation. The main point of interest of this study was the very high number of reinforcement vaginal implants put in place. The technique can be reproduced and allows for the first statistical analysis of complications on a large number of patients. The incidence of peri-surgical complications in our series is 2.05%: 1% hemorrhagias and 1% vesical or rectal wounds. 15 Multivaried analysis shows previous history of hysterectomy increases hemorrhagias or vesical and rectal wounds; the risk is multiplied by 3.1 (IC 95% ). These complications are more frequent when dissection is difficult and are not directly imputable to the prosthesis itself. This is confirmed by the fact that peri-surgical complications do not occur when the prosthesis is placed with insertion needles, but at the time of dissection. Peri-surgical complications were also more frequent when there is a cure of cystocele; the risk multiplied by 4.3 (IC 95% ). Wounds were more frequent, but morbidity and hemorrhagia when dissecting paravesical fossa were moderate. Concerning early post-surgical complications, none were related to any studied factor, in particular simultaneous hysterectomy (P = 0.866). They were mostly not related to the prosthesis, apart from three cases of fistula and one of pelvic cellulitis. They might have been related to an undetected vesical or rectal wound. The most frequent complication was vaginal exposition of the prosthesis, asymptomatic if the exposition was small, or symptomatic with leucorrhea, metrorrhagias or pain. On a series of 700 patients treated for EUI by polypropylene sub-urethral sling, Wang compared the histology of tissues after surgical resection of prostheses with or without vaginal erosion. The author found a foreign body reaction, suggesting polypropylene prostheses might not be biologically inert. 16 The low rate of infections in our series follows the same pattern, as we only had one perineal cellulitis (0.4%). Law confirms the hypothesis that a net of monofilamentous prolene has a lesser risk of infection than multifilament. 17 A short review confirms that the incidence of prosthetic expositions is high in our study, with a mean value of 11.3%. In the published reports, the average rate is 7.06% (2.1 13% according to different authors), for a mean follow-up of 24.2 months. 6,18 28 Z-test shows a significant difference putting us to a disadvantage when compared to published data, P = (Table 2). Multivaried analysis of prosthetic vaginal expositions shows variables preserved uterus and posterior prosthesis alone as protecting factors, with respective OR of (IC 95% ) and (IC 95% ). It may be more important not to realize simultaneous vaginal hysterectomy than to choose the type of incision. In univaried analysis, retrograde dissection associated with simultaneous vaginal hysterectomy is not statistically significant (P = 0.193) The Authors

7 Safety of trans vaginal mesh procedure In accordance with published data, the number of vaginal prosthetic expositions decreases as surgeons acquire experience during the time of survey (P 0.001). 18 But the factor experience of operator is not independent; it includes, in the second part of the study, the reduction of simultaneous hysterectomies. Primary prevention of vaginal prosthetic expositions, until now, has been centered on surgical techniques that are still being evaluated. According to Bent, thickness of vaginal mucosa, vascularization and type of incision could influence quality of cicatrisation, and number of vaginal expositions. 29 We can add to these factors conservation of uterus if no uterine pathology forces it. If vaginal incision was of importance in our study, the observed differences were not statistically significant. Eglin reported that a supra-cervical hysterectomy might reduce the rate of perioeprative complications. 23 Lastly, the prosthesis must not be placed when a rectal wound is detected during intervention. 30 Therefore, a vascular factor might be incriminated in defects of cicatrisation after ligature and section of vaginal vessels during hysterectomy. Peri-prosthetic retractions in our study were more frequent after Richter s acrospinofixation (OR = 6.865). A reason for this might be the extra inflammation due to a non-resorbable and multifilamentous thread of Mersuture (non-resorbable braided nylon). 12,13 Moreover, in the center where it was performed, the prosthesis was fixed to the sacrospinal ligament: so prosthesis was not tension free, but fixed and more often retracted. Retractions were also more frequent when there was relapse of prolapse (OR = 3.038), but perhaps it was the prosthetic retraction of the prosthesis that favored relapse because it creates non-reinforced zones. Univaried analysis showed a statistic significant link between retraction and prosthetic vaginal exposition (P = 0.01), as well as between surgically treated retractions and vaginal prosthetic expositions (P < 0.001), in contradiction with results of multivariate analysis. Prosthetic retractions were not systematically looked for in any of the centers when the study began, so results may have been biased in our study for our different observers. Complementary studies with a standard retraction score might clarify the eventual link. Until eventual confirmation through new studies, the statistical link shown in univaried analysis between retraction and vaginal prosthetic retractions suggests early care of prosthetic vaginal expositions could prevent secondary retractions. To conclude, in univaried or multivariated analysis, no complication was significantly linked to age, menopause, retrograde dissection, amputation of cervix after subtotal hysterectomy. The results of our retrospective study need to be compared to studies currently underway. Conclusion Cure of genital prolapse by interposition of synthetic prostheses and vaginal route is reliable and easily reproduced. However, the present study shows a relatively high incidence of late post-surgical complications. First, vaginal prosthetic retractions are statistically less frequent when a posterior prosthesis is put in place. Uterine conservation is the only factor that significantly reduces their incidence. Other surgical devices, such as retrograde incision, did not show any statistical efficiency in our study. Also, symptomatic prosthetic retractions may be of handicap with pelvic pain, dyspareunia, dyschesia. It appeared that direct suspension of the posterior mesh with the sacrospinous suspension increases the rate of symptomatic retraction of the mesh and therefore we should try to avoid direct tension of vaginal meshes. 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