[Ajust(®): prospective study and 1-year follow-up - a series of 60 female patients]. / Ajust(®) : étude prospective et suivi à un an d'une série de 60 patientes.

OBJECTIVES: Evaluate functional and anatomical outcomes as well as complications, 1year after the implantation of the Ajust(®) sub-urethral adjustable single-incision sling. STUDY DESIGN: Prospective study on 60 female patients suffering from stress urinary or mixed urinary incontinence with quality of life assessment. Ambulatory surgeries were performed under local anesthesia with or without sedation. Pain was evaluated using the VAS scale. Postoperative follow-up was performed at 2 and 12months. RESULTS: Forty-eight patients suffered from stress incontinence only, with one of them suffering from sphincter deficiency, and the remaining 12 suffered from mixed urinary incontinence. Mean surgery time was 7.15minutes. All patients received a local anesthesia, and 33 were sedated. Per-operative pain level was equal to 31.8/100, and 17/100 upon discharge. A 100mL per-operative hemorrhage was described. At 2-month follow-up, four de novo urgency, four de novo dysuria, one urinary infection, 11 palpable lateral cords, 12 moderate postoperative pain were described. At 1-year follow-up, two mesh exposures formed, including one expelled anchor for one of them. At 1year, cure rate, improvement and failure rate were respectively 89.6%, 6.9% and 3.4%. Quality of life indexes were significantly improved. One patient required a new surgery at 2months, due to initial failure. CONCLUSIONS: The efficacy of this mini-invasive sling, without specific complication, must be compared with the other classic sub-uretral slings.

[Essure implants for tubal sterilisation in France]. / La pratique française de la pose des implants de stérilisation tubaire Essure.

OBJECTIVES: Law no. 2001-588 of 4 July 2001 liberalised the practice of tubal sterilisation in France, at the same time as a new hysteroscopic method of female sterilization appeared. The growth of this method has been spurred by the reduced need for analgesia, absence of incision and scar, reduced duration of hospitalization and diminution of costs. The aim of this study was to analyse the use of the Essure procedure in France. PATIENTS AND METHODS: This multicentre study covered seven French facilities from January 2004 through June 2006. This study included 1061 attempted placements of the Essure micro-insert, marketed by Conceptus SAS (France). RESULTS: The first placement attempt was successful in 992 cases (94.4%). The success rate for second attempts was 59% (n = 23). Mean VAS was 3,23 +/- 0.19. Ninety-three percent of patients undergoing Essure placement were satisfied or very satisfied. DISCUSSION AND CONCLUSION: Tubal sterilisation with Essure micro-inserts is a reliable and reproducible method that requires a short period of training. In the future, the hysteroscopic pathway will replace the laparoscopic route.

[Complications of urinary incontinence surgery: 800 procedures]. / Complications des cures d'incontinence urinaire: à propos de 800 interventions.

OBJECTIVE: To present the complications of urinary incontinence surgery through our experience over 13 years with 800 procedures in continuous practice. These complications were compared to those of the literature for the same type of procedure. STUDY DESIGN: From January 1988 to September 2001, 800 procedures were performed in the same hospital in the gynecology unit. The procedures were: Bologna (91 cases), laparotomic Burch (83 cases), laparoscopic Burch (62 cases), Pereyra (112 cases), Stamey (8 cases), Ingelman-Sundberg (27 cases), Mouchel (40 cases), autograft sling (22 cases), mesh sling: small size (62 cases), large size (12 cases) et TVT (tension free vaginal tape) (281 cases). These procedures were performed alone in 475 cases (125 cases with hysterectomy for other reason), and in 325 cases associated with prolapse surgery. The complications were noted during the hospitalization and at the control at 3 months and 1 year. We only noted the complications attributable to the different procedures. RESULTS: Bladder injuries are found in 3.5% (0 to 6%), hemorrhage in 1% (0 to 3.8%), urinary infection in 4.5% (0 to 11.3%), fever at 48 hours in 1.5% (0 to 9.7%), momentary urine retention in 17% (1.6 to 64.5%), de novo dysuria in 10.9% (0 to 35.5%), de novo urge in 6.9% (0 to 11%). For the other complications, which were less frequent or more procedure-specific, we noted: subcutaneous emphysema in 1.6% of the laparoscopic Burch procedures, cutting thread in 4.8% of the laparoscopic Burch procedures and 2.7% in Pereyra, rejection of prosthetic mesh in 9% of the large slings, 14% with the small sling and 28.2% with the Mouchel procedure, a wound abscess in 3.8% of the Bologna procedures, 1.2% of laparotomic Burch procedures. The percentage of women who had at least one complication was a minimum of 18% for TVT and a maximum of 62.9% for small synthetic sling. In summary, 32% of the patients presented at least one complication. Overall, we noted urinary complications in 41% of the patients, which accounted for 81% of the complications. DISCUSSION: We reviewed more than 100 references concerning complications of the procedures performed in these patients. "Blind" procedures gave more bladder injuries, slings more dysuria and urine retention and procedures using mesh gave more pool healing or rejection especially with the old materials. A particular place must be made for the TVT, recent procedure, which is widely studied. We reviewed 35 references explaining complications of TVT or proposing preventions measures. CONCLUSION: There are many complications of urinary incontinence surgery, but the majority is quickly resolved without consequence. The only after-effects are dysuria which are the most often slow micturition, and urge which are a real problem, sometimes leading to sling removal.

[Development of better tolerated prosthetic materials: applications in gynecological surgery]. / Evolution des matériaux prothétiques vers une meilleure tolérance: application en chirurgie gynécologique.

UNLABELLED: Meshes have come to be widely used for surgical repair of the dysfunctional pelvic floor. The problem to date has been mesh intolerance. History. The first meshes were made with silver filigrees or stainless steel. Non-metallic and non-absorbable synthetic prostheses include nylon, silastic, polytetrafluoroethylene as well as expansive polyester and polypropylene forms. Most of the absorbable prostheses are made of polyglycolic acid and polyglactine 910. Classification. Four groups of biomaterials can be described according to pore size. Mechanical and biological properties. The mechanical properties of meshes have been tested industrially for resistance, pliability, elasticity and ductile qualities. These properties depend on type of tissue structure (woven or knitted) and the type of fiber used (mono and multi-filaments). The goal is to obtain a "silent" material, i.e. a material which does not trigger a host tissue reaction. Introducing the foreign body induces a "scarring" response. This fibroblastic reaction replaces the inflammatory reaction, leading to progressive colonization of the prosthesis. The major risk is infection caused by a disturbance of the inflammatory phase and bacterial development. Bacteria can be trapped in fibrotic tissue, with the risk of delayed infection. Immunological reactions may have an additive effect. These problems are not encountered with absorbable meshes. An ideal implant material must: not undergo physical modification by tissue fluids, be chemically inert, not trigger inflammatory or foreign body cell response in body tissues, be noncarcinogenic and nonallergenic, be capable of resisting mechanical stress and sterilization, and be able to be manufactured in the necessary shape. Polyester, polypropylene and expansive polytetrafluoroethylene fulfill these criteria. The ideal mesh. Eleven criteria are proposed. Complications for hernia repair. Infection and seroma are the most frequent complications with micro-porous meshes. Macro-porous meshes can cause erosive phenomena and adhesions. Retraction of synthetic tissues is observed in 20 to 30% of cases. Meshes in gynecology. In gynecology surgery, meshes made their first appearance in trans-abdominal sacrocolpopexy and slings. A detailed review of complications found in 32 articles studying slings and 22 studying sacrocolpopexy with approximately 10 types of meshes shows that intolerance of slings has oscillated between 1% with Prolene and 31% with Gore-Tex; for abdominal sacrocolpopexy the rate was between 1.7% with Prolene and 20% with Teflon. Rejection phenomena appear during the first year and are proportional to the surface area of the synthetic tissue and the proximity of the vaginal scar. New materials have been proposed over the last ten years for prolapse surgery, notably for cystocele, which accounts for 70% of all repair procedures. Nearly fifteen studies have reported a level of intolerance reaching 6%, the large majority of the meshes used being Prolene meshes. Our personal experience with 87 repair procedures has led us to the conclusion that Prolene is the most adapted mesh, allowing free tension between the bladder and the anterior vaginal wall. CONCLUSION: Continuous evaluation is needed to study these replacement materials which should in theory, improve the rate of recurrence, which is at present 20% with classic procedures not using a mesh.

[Tolerance of synthetic tissues and vaginal surgery. Report of 287 cases]. / Tolérance des tissus synthétiques et chirurgie vaginale. A propos de 287 cas.

OBJECTIVE: In this presentation, we attract attention to the disadvantage of using synthetic material in functional surgery of prolapse and urinary incontinence. PATIENTS AND METHODS: Two hundred eighty seven vaginal operations using synthetic material (Gore Tex, Dacron and Lyodura) were followed. The operations were: Mouchel procedure (127 cases), small slings (118 cases), large slings (11 cases), Stamey procedure (8 cases) and patch for paravaginal repair (23 cases). These operations were performed from 01/01/89 to 31/12/95. RESULTS: Mean follow-up at study end was 49 months. The intolerance phenomenon, leading to rejection, occurred between 1 and 72 months. The Mouchel procedure gave a rejection rate of 28.3% versus 9.3% for the slings (p < 0.001). Dacron was better tolerated (rejection rate at 19.3%) than Gore tex (rejection rate at 30.2%), p < 0.05. CONCLUSION: The substratum of the intolerance process would have two explanations (infection and foreign body reaction) for the early and late rejections. We suggest that the synthetic tissue tolerance is proportional to the exposed surface and to the distance which separates it from the vaginal scar. The ideal synthetic mesh material for pelvic surgery has yet to be developed.