Serious complications and recurrences after pelvic organ prolapse surgery for 2309 women in the VIGI-MESH registry

Abstract

Objective: To assess the incidence of serious complications and reoperations for recurrence after pelvic organ prolapse (POP) surgery and compare the three most common types of repair. Design: Prospective cohort study using a registry. Setting: 19 surgical centres in France. Population: 2309 women participated between 2017 and 2019. Methods: a multivariate analysis including an inverse probability of treatment weighting approach was used to obtain three comparable groups. Main outcome measures: Serious complications and subsequent reoperations for POP recurrence Results: Mean follow-up was 16.6 months. Surgeries included in the analysis were native tissue vaginal repair (N=504), transvaginal mesh placement (692), and laparoscopic sacropexy with mesh (1113). Serious complications occurred among 52 women (2.3%), and reoperation for recurrence was required for 32 (1.4%). At one year, the cumulative weighted incidence of serious complications was 1.8% for native tissue vaginal repair (95% confidence interval 0-3.9), 3.9% for transvaginal mesh (2.0-5.9), and 2.2% for sacropexy (1.1-2.6). Compared with the native tissue vaginal repair group, the risk of serious complications was higher in the transvaginal mesh group (weighted-HR 3.84, 2.43-6.08), and the sacropexy group (2.48, 1.45-4.23), while the risk of reoperation for prolapse recurrence was reduced in both groups (transvaginal mesh [0.22, 0.13-0.39] and sacropexy [0.29, 0.18-0.47]). Conclusions: Laparoscopic sacropexy with mesh appears to have a better risk profile (few serious complications and few reoperations for recurrence) than transvaginal mesh placement (more serious complications) and native tissue vaginal repair (more reoperations for recurrence). These results are useful for informing women and for shared decision making.

Transvaginal mesh implant for pelvic organ prolapse: Huaxi protocol

“…Responding to these concerns, the US Food and Drug Administration, England, and so on, banned the sale and distribution of commercial TVM kits designed for POP in April 2019 [11,16] . Nevertheless, the TVM procedure remains an option for POP treatment and still appeals to many surgeons and patients today in Asia and most European countries, which suggests that a considerable number of POP patients can benefit from its continued refinement [11,17,18] .…”

Regional practice variation in pelvic organ prolapse surgery in Tuscany, Italy: a retrospective cohort study on administrative health data

“…Pelvic organ prolapse (POP) can affect up to 40% of women, with a 7–11% lifetime surgical risk 1 2. Transvaginal surgery, generally supported by concomitant hysterectomy, is the traditional and least invasive approach but has high recurrence rates in the presence of high-grade multicompartmental POP 3 4. So, abdominal surgery (such as sacrocolpopexy, sacrohysteropexy or lateral suspension) is preferable for multicompartmental POP to achieve better anatomical outcomes 5–7.…”