Recurrent prolapse rates after native tissue repair is significant at 38%. Concerns due to mesh-related complications in treatment of pelvic organ prolapse (POP) highlight the need to improve patient selection for transvaginal mesh. This is especially important in light of the recent FDA decision to stop sales and distribution of transvaginal mesh products as a treatment option for POP. 

Gynecare Prolift® is a polypropylene transvaginal mesh (TVM) system used to treat pelvic organ prolapse (POP). It was used in our centre from 2005 until the product was withdrawn from the market in 2012.

A retrospective review of POP surgeries using Gynecare Prolift® System performed in the department of Urogynaecology was done. Patients were selected from the urogynaecology department's patient database from 1st January 2011 to 30th September 2012. All the surgeries were performed by a single urogynaecologist. Characteristics and outcomes of patients, including intraoperative and postoperative management up to 5-year follow-up were recorded. Institutional review board approval was obtained.

148 patients were enrolled in this study. 120 (81.1%), 24 (16.2%) and 4 (2.7%) patients had the Total, Anterior and Posterior Prolift respectively. The mean age was 66.0 ± 10.1 years

All (100%) patients presented with a symptomatic vaginal bulge. 136 (91.9%) patients also reported symptoms of urinary frequency while 125 (84.5%) patients reported nocturia. At the time of presentation, 118 (79.7%) patients had Grade 4 cystourethroceles, 103 (70.1%) patients had Grade 4 uterine or vault prolapse and 49 (33.1%) had Grade 4 rectoceles.

Concomitantly, 110 (74.3%) patients had a vaginal hysterectomy and 135 (91.2%) patients underwent a posterior colporrhaphy. Intraoperatively, there was one bladder perforation (0.68%) and 2 rectal perforations (1.35%). One patient sustained a rectal perforation due to insertion of the posterior trocar. The other, sustained rectal perforation during the concomitant posterior colporrhaphy. 

The mean duration of hospital stay and urinary catheterisation were 3.9 ± 2.6 days and 3.6 ± 4.0 days respectively.

Follow up rates for patients at 1-, 2-, 3-, 4- and 5-years post-surgery were 70.9% (n=105), 63.5% (n=94), 52.7% (n=78), 43.9% (n=65) and 37.8% (n=56) respectively. Mesh exposure occurred only in one patient in this cohort who returned for follow up. This accounted for 1.0%, 1.1%, 1.3% and 1.5% annually over the first 4 years of follow up. This patient then defaulted her 5-year appointment. Only 1 patient required re-operation due to Grade 4 vault prolapse recurrence in this cohort. This patient underwent a posterior pelvic floor repair (PFR) and sacrospinous fixation (SSF). This occurred in the third post-operative year accounting for 1.3% of the follow up group.

The rate of dyspareunia was 1.0% at 1 year, 1.3% at 3 years and 1.5% at 4 years. There were no reported cases of dyspareunia in years 2 and 5 of follow up. 

Rates of de novo stress urinary incontinence (SUI) at 1-, 2-, 3-, 4- and 5- years post-surgery were 11.4% (n=12), 12.8% (n=12), 12.8% (n=10), 10.8% (n=7) and 10.7% (n=6) respectively. For de novo urgency or urge incontinence (UI) at 1-, 2-, 3-, 4- and 5- years post-surgery, 7.6% (n=8), 10.6% (n=10), 10.3% (n=8), 6.2% (n=4) and 1.8% (n=1) reported these symptoms respectively. Only 4 (2.8%) patients presented with pelvic pain at 1-month post-operation. No wound dehiscence was observed in any patents post-operation. 

Subjective and objective cure rates at 5 years were 98.2% and 92.9% respectively. One patient presented with both recurrent rectocoele and cystocoele from years 2-4, accounting for the objective cure rates at 2, 3 and 4 years being 91.5% (n=86), 89.7% (n=70) and 93.8% (n=61) respectively. 

Table 1 shows the baseline characteristic of the patients in this cohort. Table 2 shows the post-operative follow-up outcomes from 1 month, 6 months, 1-, 2-, 3-, 4- and 5-years.

Gynecare Prolift® is an effective and safe option for treatment of severe POP in the local context with an experienced surgeon, with considerably lower complication rates compared to existing literature. Studies demonstrating long-term outcomes are useful in determining the role of TVM in the management of POP.