Long-Term Outcomes of Restorelle® Direct Fix Anterior Mesh in the Treatment of Pelvic Organ Prolapse

Abstract

Objective The objective of this study was to evaluate the efficacy and long-term outcomes of the use of Restorelle® Direct Fix (Coloplast, Humlebæk, Denmark) anterior mesh for transvaginal surgical management of anterior compartment prolapse. Methods A retrospective case series review was conducted for 123 patients who underwent surgery for Baden-Walker Grade three and four anterior compartment prolapse with the Restorelle Direct Fix anterior mesh between July 1, 2017 and September 30, 2018 in a single center. Follow-up was conducted at one, six, 12, 24, and 36 months after treatment. A standardized questionnaire and pelvic examination were conducted at each visit to assess operative complications and subjective and objective cure rates. Results Sixty patients were included in the analysis with a three-year follow-up rate of 70.0%. At three years post-operatively, subjective and objective cure rates were 97.7% and 95.3% respectively. Seven (11.7%) patients complained of de novo stress urinary incontinence, four (6.7%) complained of de novo urge urinary incontinence and one (1.7%) complained of symptomatic recurrence. Significantly, six (10.0%) patients had transvaginal mesh exposure over the three-year follow-up, mostly presenting within the first year. One (2.4%) patient developed new asymptomatic mesh erosion at the 36-month visit and one patient required mesh loosening one month post-surgery. Conclusions Management of anterior compartment prolapse with transvaginal surgery using the Restorelle® Direct Fix anterior mesh was associated with good subjective and objective cure rates. However, significant rates of post-operative mesh exposure were noted within three years post-surgery, which hinders the recommendation of this device for augmentation of repair for anterior compartment prolapse.