PATIENTS’ CONCERNS ABOUT VAGINAL MESH IN PELVIC RECONSTRUCTIVE SURGERY
L. LI, P. E. LEE;
Department of Obstetrics and Gynecology, Sunnybrook Hlth.Sci. Ctr., Toronto, Canada.
Introduction: In recent years, governing bodies have issued public health notifications about adverse events related to vaginal mesh use in pelvic reconstructive surgery (1,2). Class action lawsuits have been launched against the manufacturers of mesh, with some mesh kits subsequently recalled and withdrawn from the market. The media has also negatively portrayed vaginal mesh, leading many patients to be concerned about vaginal mesh use in surgery (3).
Objective: To determine patients’ concerns about vaginal mesh use in pelvic reconstructive surgery before and immediately after initial medical consultation.
Methods: From April 2015 to December 2016, new patients referred for pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI) to a single urogynecologist at a tertiary referral centre voluntarily completed pre- and post- consultation questionnaires. The pre-consultation questionnaire consisted of 12 questions regarding demographic and background knowledge and concerns about vaginal mesh use. If surgery was discussed, then patients completed a post-consultation questionnaire. Descriptive statistics were used for all demographics and background knowledge variables. Two-tailed Student’s t-test was used to compare the patients’ ‘level of concern’ (1=not at all concerned, 10=very concerned) and Chi square for willingness to proceed with surgery, and vaginal mesh if medically appropriate, before and after medical consultation. P<0.05 was considered statistically significant.
Results: Of 178 new patients, 172 (96.6%) completed the pre-consultation questionnaire. The average age was 60.4±12.9 years (range 30 - 91), and 57/172 (33.3%) had completed college. Consultation indications were not exclusive; 87/172 were referred for POP (50.9%) and 100/172 for SUI (58.5%). The majority had heard of vaginal mesh prior to consultation (128/172, 74.9%), and 22/172 (12.9%) had previously undergone pelvic reconstructive surgery with vaginal mesh. The most common sources of information were the media (70/172, 40.9%), followed by healthcare professionals (66/172, 38.6%) and family and friends (47/172, 27.5%). Prior to consultation, the most common concerns cited involved complications such as erosion, pelvic pain, and dyspareunia (35/78, 44.9%), followed by efficacy (17/78, 21.8%), safety (10/78, 12.8%), and side effects (10/78, 12.8%). Surgery was discussed with 86/172 (50.0%), and 86/86 (100.0%) completed the post-consultation questionnaire. The average ‘level of concern’ about mesh use prior to consultation was 5.79±3.07, which decreased to 4.34±2.74 after consultation (p=0.002). After medical consultation, patients’ concerns were fewer and the majority involved possible complications (22/31, 70.9% of written, free text comments). Furthermore, while a <5% complication rate was discussed at consultation, only 53/86 (61.6%) recalled this in the post-consultation questionnaire. Pre-consultation, 51/83 (61.4%) were prepared to proceed with surgery, which increased to 65/79 (82.2%) after consultation (p=0.00013). In particular, 31/83 (37.3%) were willing to have vaginal mesh used if medically appropriate, compared to 53/78 (67.9%) post-consultation (p<0.000001).
Conclusions: The majority of patients presenting with POP/SUI have heard of vaginal mesh and are very concerned about complications, efficacy, safety, and side effects. The most common sources of information were the media, healthcare professionals, and family and friends. After medical consultation, patients’ ‘level of concern’ decreased significantly and most felt comfortable proceeding with surgery and allowing the use of mesh if medically appropriate. By recognizing patients’ concerns and their sources of information, healthcare providers can better engage with and advise patients on the risks of vaginal mesh used in pelvic reconstructive surgery.
References: 1) FDA Public Health Notification: Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. Available at: http:// www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ PublicHealthNotifications/ucm061976.htm. Issued 10/20/2008. Accessed February 2, 2017. 2) FDA Safety Communication: Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Issued 7/13/2011. Accessed February 2, 2017. 3) Brown LK, Fenner DE, Berger MB et al. Defining Patients’ Knowledge and Perceptions of Vaginal Mesh Surgery. Female Pelvic Med Reconstr Surg 2013; 19:282-287.