Safety and Efficacy of Vaginal Implants in Pelvic Organ Prolapse Surgery: A Meta-analysis of 161 536 Patients.

CONTEXT: Among the many surgical treatments for pelvic organ prolapse (POP), better results can be achieved with the use of vaginal implants. However, owing to perceived complications, vaginal implant surgeries have been restricted or banned in many countries. OBJECTIVE: To assess the real value of vaginal implants in POP surgery and compare the safety and efficacy of operations with and without implants. EVIDENCE ACQUISITION: A systematic search was performed in three medical databases. Randomised controlled trials and observational studies comparing the safety and efficacy of vaginal POP surgery with implants versus native tissue were included. Safety outcomes were defined as different types of complications (functional and non-functional) and reoperations for complications. Efficacy outcomes were parameters of anatomical success and the rate of reoperations due to recurrence. A multivariate meta-analysis framework was used to estimate pooled odds ratios (ORs) with confidence intervals (CIs) with simultaneous control for study correlations and estimation of multiple correlated outcomes. EVIDENCE SYNTHESIS: We included 50 comparative studies in the analysis. Rates of reoperation for complications (OR 2.15, 95% CI 1.20-3.87), vaginal erosion (OR 14.05, 95% CI 9.07-21.77), vaginal bleeding (OR 1.67, 95% CI 1.25-2.23), and de novo stress urinary incontinence (OR 1.44, 95% CI 1.18-1.75) were significantly higher in the implant group. Rates of anatomical success (OR 3.22, 95% CI 2.06-5.0) and reoperation for recurrence (OR 0.55, 95% CI 0.36-0.85) were superior in the implant group. CONCLUSIONS: POP surgeries with vaginal implants are more effective than surgeries without implants, with acceptable complication rates. Therefore, the complete prohibition of implants for POP surgeries should be reconsidered. PATIENT SUMMARY: We compared vaginal surgery with and without implants for repair of pelvic organ prolapse. Despite higher complication rates, vaginal implants provide better long-term results overall than surgery without implants.

The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology.

OBJECTIVE: Mid-urethral slings (MUS) are increasingly common surgical procedures for the treatment of stress urinary incontinence (SUI) in women. There are currently no adequately powered trials with sufficient length of follow-up comparing the efficacy or safety of the transobturator and retropubic MUS. As a result, no selection criteria are available to guide surgeons or patients. This article describes the methodology and rationale for the Trial Of Mid-Urethral Slings (TOMUS). PATIENTS AND METHODS: The primary aims of this randomized controlled trial is to compare subjective and objective success rates for urinary incontinence (UI) at 12 and 24 months following retropubic and transobturator MUS procedures. Secondary aims are to compare the resolution of overall and stress-specific UI, morbidity, the time to adequate voiding, satisfaction, and quality of life in the two groups. TOMUS will also assess the clinical utility of pre-operative urodynamics in women undergoing MUS procedures. The primary outcome will be obtained at 12 months and 24 months. The definition of treatment success is two-fold. Objective treatment success is defined by a negative stress test, a negative 24-hour pad test and no retreatment for SUI. Subjective treatment success is defined by no self-reported leakage on 3-day diary and no self-reported SUI symptoms. Enrollment began April 2006 and is expected to be complete in 2 years. CONCLUSIONS: The TOMUS trial is designed to provide outcome and safety information to pelvic surgeons and their patients on the two most commonly performed MUS techniques.

Autoinflammatory/autoimmunity syndrome induced by adjuvants (Shoenfeld's syndrome) in patients after a polypropylene mesh implantation.

In both hernia repair and pelvic organ prolapse surgery, polypropylene (PP) meshes are increasingly used. Although these technologies offer tremendous clinical benefits, the efficacy of these implants can be hindered by the body's immunologic reaction to the implanted material. Undesirable local effects such as chronic pain have been extensively described. Systemic effects, however, are not yet reported. Because systemic effects after implantation of other biomaterials have been described, we evaluated patients with implanted PP meshes for signs and symptoms of biomaterial-related systemic illnesses. Patients referred to an Autoimmunity Clinic between January 2014 and December 2017 were analyzed. In 40 patients, mesh implants were present. These patients were evaluated for the development of a systemic illness. Thirty-two consecutive women and eight men were included in the current study. Median age at the time of operation was 49.5 years (range, 28-75 years). Eighteen patients had a hernia repair and 22 patients had a vaginal mesh implant. Thirty-nine of 40 patients presented with chronic fatigue, and 38 of 40 patients had myalgia or muscle weakness. In most patients, these symptoms started shortly after the operation. All patients fulfilled the diagnostic criteria for autoinflammatory/autoimmunity syndrome induced by adjuvants (ASIA). In addition, most patients reported localized pain and (often-invalidating) irritable bowel syndrome. One quarter of the patients had an immunodeficiency, whereas a diagnosis of well-established systemic and/or localized autoimmune diseases was made in 45% of patients. Importantly, 75% of patients had a pre-existing allergic disease. In 6 patients, the hernia mesh could be completely removed, thereby resulting in (partial) recovery of the systemic disease. In conclusion, 40 patients developed symptoms of a systemic illness after a mesh operation. All patients fulfilled the diagnostic criteria for ASIA. One quarter of the patients had an immunodeficiency, whereas in approximately half of the patients, an autoimmune disease developed. We postulate that PP mesh implants may increase the risk of developing (auto)immune diseases by acting as an adjuvant.

How to achieve long-term success in the treatment of female urinary stress incontinence? Novel modification on vaginal sling.

PURPOSE: Modest long-term success is one of the most disappointing issues facing patients undergoing anti-incontinence surgery. Herein we introduce a novel surgical modification of the vaginal sling to address the mechanisms that may lead to a reduction in the success rate at the long-term follow-up. MATERIALS AND METHODS: Twenty-three female patients with mean age of 48.2 years (range, 22-73 years) underwent anti-incontinence surgery to correct their stress urinary incontinence (SUI) between August 2006 and January 2008. The in situ anterior vaginal wall sling, reinforced with equi-size monofilament polypropylene tape, was used as an anti-incontinence surgical procedure. The mean follow-up period was 30.2 months (range, 24-38 months). RESULTS: The surgical technique was successful in 22 patients (95.65%); 20 of them were cured and 2 patients showed clinical improvements. Urinary retention was observed in one patient (4.34%), which was resolved after decreasing the tension of the suspension sutures. No significant post-voiding residue was detected postoperatively. CONCLUSIONS: Cost-effectiveness and a low risk of urethral erosion, due to the presence of intervening vaginal mucosa, are important advantages of this technique. Long-term success is expected, because relaxation of the non-tension-free suspension sutures and dislocation of the midurethral sling are less likely.