Tension-free Polypropylene Mesh-related Surgical Repair for Pelvic Organ Prolapse has a Good Anatomic Success Rate but a High Risk of Complications

• Published in: Chinese medical journal Vol. 128; no. 3; pp. 295 - 300
• Main Authors: Zhang, Lei, Zhu, Lan, Chen, Juan, Xu, Tao, Lang, Jing-He
• Format: Journal Article
• Language: English
• Published: China Medknow Publications Pvt Ltd 05.02.2015; Medknow Publications and Media Pvt. Ltd; Lippincott Williams & Wilkins Ovid Technologies; Department of Gynecology and Obstetrics, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,Beijing 100730, China%Department of Epidemiology and Statistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences and School of Basic Medicine,Peking Union Medical College, Beijing 100730, China; Medknow Publications & Media Pvt Ltd; Wolters Kluwer
• Subjects: Aged; Care and treatment; Clinical outcomes; Cohort Studies; Complications and side effects; Gynecology; Hospitals; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Obstetrics; Original; Patient outcomes; Patients; Pelvic organ prolapse; Pelvic Organ Prolapse - surgery; Pelvic Organ Prolapse; Postoperative Complication; PROSIMA™ Mesh Kit; Quality of Life; Polypropylenes - chemistry; Prolapse; Prospective Studies; Quality of Life; Questionnaires; Surgery; Surgical Mesh; Survival analysis; Urine; Variance analysis; Womens health; 修复; 器官; 并发症; 手术; 无张力; 盆腔; 聚丙烯; 解剖; China; Postoperative Complication; Quality of Life; Pelvic Organ Prolapse; PROSIMATM Mesh Kit
• ISSN: 0366-6999; 2542-5641
• DOI: 10.4103/0366-6999.150088

Background： Food and Drug Administration announcements have highlighted the standard rate of mesh-related complications. We aimed to report the short-term results and complications of tension-free polypropylene mesh （PROSIMATM） surgical repair of pelvic organ prolapse （POP） using the standard category （C）, timing （T）, and site （S） classification system. Methods： A prospective cohort study of 48 patients who underwent PROS1MATM mesh kit-related surgical repairs were followed for two years at Peking Union Medical College Hospital. Recurrence was defined as symptomatic POP quantification （POP-Q） Stage II or higher （leading edge ≥ -1 cm）. The Patient Global Impression of Change Questionnaire, the Chinese version of the Pelvic Floor Impact Questionnaire short-form-7 and POP/Urinary Incontinence Sexual Questionnaire short-form- 12 were used to evaluate the self-perception and sexual function of each patient. Mesh-related complications conformed to the International Urogynecological Association/International Continence Society joint terminology. The paired-sample t-test, one-way analysis of variance, Fisher＇s exact test, Kaplan-Meier survival analysis and log-rank test were used to analyze data. Results： All patients were followed up for ≥12 months; 30 （62.5%） patients completed the 24 months study. We observed a 93.8% （45/48） positive anatomical outcome rate at 12 months and 90.0% （27/30） at 24 months. Recurrence most frequently involved the anterior compartment （P 〈 0.05）. Pelvic symptoms improved significantly from baseline （P 〈 0.05）, although the patients＇ impressions of change and sexual function were not satisfying. Vaginal complication was the main complication observed （35.4%, 17/48）. The survival analysis did not identify any relationship between vaginal complication and anatomical recurrent prolapse （POP-Q 〉 Stage II） （P = 0.653）. Conclusions： Tension-free polypropylene mesh （PROSIMA^TM）-related surgical repair of POP has better short-term anatomical outcomes at the apical and posterior compartments, but a low patient satisfaction rate. The mesh complications were not the definitive cause of recurrence.