SELF RETAINING SUPPORT IMPLANT - NEWIMPLANT FOR THE TREATMENT OF ANTERIOR AND APICAL COMPARTMENTSPROLAPSE.
G. LEVY1, Z. FEKETE2, A. PADOA 3, N. MARCUS-BRAUN 4, G.BÁRTFAI 5, L. PAJOR 6, M. CERVIGNI 7;
1Maynei HaYeshua Med. Ctr., Bnei Brak, Israel, 2Univ.of Szeged, Hungary, Szeged, Hungary, 3Assaf Harofeh Med.Ctr., Nes Ziona, Israel, 4Ziv Med. Ctr., Zefat, Israel,5Obstetrics and Gynaecology, Univ. of Szeged, Hungary,Szeged, Hungary, 6Univ. of Szeged, Dept. Urology, Szeged,Hungary, 7Catholic Univ., Rome, Italy.
Introduction: Vaginal meshanchoring techniques are considered a major contributor to meshcomplications. A new anchorless mesh was designed to provide theanatomical benefits of vaginal implants while eliminating the intraand post-operative complications.
Objective: To report onthe clinical outcome of a novel surgical technique using ananchorless, self-retaining support (SRS) implant for the treatment ofPelvic Organ Prolapse (POP).
Methods: An international,multicenter study was carried out for the evaluation of the SRS,after approval by the relevant health ministries and local ethicalcommittees. The device is composed of an ultra-light polypropylenemesh (16 gr/m2) stretched and retained in place by aU-shaped solid flexible frame. The device is surgically placed forthe treatment of advanced anterior vaginal compartment prolapse withor without apical descent. The surgical technique includes centraldissection of the bladder from the vagina, which extends towards theparavesical space for direct palpation of the ischial spinesbilaterally. The device is inserted between the bladder and thevaginal mucosa with the lateral arms following the anatomy of thearcus tendinous fascia pelvis (ATFP). The connecting bridge ispositioned under the pubic symphysis. Appropriate location isconfirmed by visualization of a symmetrically positioned device and afully stretched mesh under the bladder. No anchoring techniques areused. The vaginal incision is closed with no tension and vaginalpacking is used for 24 hours. Exclusion criteria included: previousvaginal mesh surgery, POP-Q less than stage 2 or asymptomatic POP.Demographic data, pre-surgical POP-Q scoring and QoL questionnaires(PFDI) were collected. Surgical data included intra- andpost-operative complications, surgery duration and estimated bloodloss. Patients were followed at 2 weeks, 2, 6, 12 and 24 monthspost-surgery.
Results: Fifty three women were recruited.Average age was 63 (43-79) years old, average parity was 4.3 (1-16)deliveries, 7 patients had previous vaginal surgery and 4 had priorhysterectomy. Average BMI was 27.1, 22 patients had hypertension and6 were smokers. Pre-operative POP-Q was Aa =1.9 cm (-1 to 3 cm), Ba=3.0 cm (-2 to 6 cm) and C=0.3 cm (-8 to 6 cm). Fifty-one (96%)patients suffered from both anterior and apical compartmentsprolapse, while two (4%) patients had only anterior prolapse.Surgical time for device implantation averaged 27 (10-50) min.Estimated blood loss averaged 150 ml (25-500 ml). No intra-operativecomplications were observed. One case (1.9%) of frame erosion intothe anterior vaginal wall was documented 8 months after theprocedure. The eroded part of the frame was resected under localanesthesia in an ambulatory setting. Patient’s symptoms wererelieved immediately after the resection. This was the only casewhere a large sized frame was used and may have caused excessivepressure on the vaginal mucosa that caused the erosion. Meanfollow-up was 12.5 (range 0.5-29.1) months. Twenty patients (36%)completed their 24 months FU, 8 patients (15%) completed their 6months FU, 25 patients (47%) completed their 2 months FU. Atfollow-up the mean POP-Q measurements were: Aa= -3.0 (-3 to -2) cm,Ba= -2.9 (-3 to -2) cm and C = -7.2 (-10 to -1) cm. Forty eight(90.6%) patients with leading edge at stage 0 and 4 patients (7.5%)at stage 1. One patient (1.9%) had an asymptomatic apical descentwith C at -1 cm. No mesh erosions or chronic pelvic pain weredocumented at follow up. PFDI scores showed significant improvementof both prolapse and urinary domains as well as total scores. Nodeterioration was noted in the colorectal symptoms domain of thequestionnaire.
Conclusions: Results for the clinical use ofthe SRS implant for the treatment of anterior vaginal wall prolapsewith or without apical prolapse showed no intra-operative orimmediate post-operative complications. All patients had completesubjective cure. Fifty two (98.1%) patients had complete anatomicalcure. Out of which 20 patients completed 24 months follow up. Thesole case of frame erosion was secondary to an oversized implant andtherefore can be prevented. Our results suggest that this anchorlessimplant which retains the mesh in a flat and tension-freeconfiguration can potentially reduce the complication rate reportedwith current mesh kits. The anchorless concept is designed to mimicthe physiologic mechanism and provides a firm mechanical support,therefore providing long-term subjective and anatomical cure. Thesafety profile and performance of the SRS implant showed betteroutcome compared to previous and current vaginal implants. Theseresults need to be confirmed with a larger sample size and a longerfollow-up to clinically evaluate this new implant for the treatmentof advanced POP.