Mesh-augmented suspension systems became commercially available in 2004 for transvaginal repair of uterovaginal and/or vaginal prolapse. Several studies reported short-term anatomical success rates of 94%, with demonstrated benefit in the anterior compartment. Pelvic surgeons rapidly adopted mesh-augmented systems (some with minimal training) despite the few outcome studies available and inadequate characterization of their risk-benefit profile. The need for more detailed and extended outcome studies using validated measures was demonstrated in 2008 by a Food and Drug Administration report of several adverse outcomes associated with use of the mesh kits.
The aim of this prospective observational study was to investigate anatomical and functional outcomes 2 years after prolapse repair using the Prolift mesh kits. Participants were women enrolled in a previously published 12-month study of outcomes following transvaginal prolapse repair. Subjective outcomes were evaluated with questionnaires assessing pelvic symptoms, quality of life, sexual function, and global satisfaction. Objective data were obtained by a pelvic examination for anatomical support and mesh complications. Uterine and vaginal support was measured by the Pelvic Organ Quantification (POPQ) examination.
Of 118 eligible women enrolled in the index study who presented for their 1-year visit, 85 were enrolled. At the 2-year follow-up, subjective outcomes were evaluated for 82 women, and pelvic examination/POPQ data were available from 79 women. Total Prolift was used for repair in 47 (55%), anterior Prolift in 25 (29%), and posterior Prolift in 13 (15%). At baseline, 75% of the women had stage III prolapse; the anterior compartment constituted the leading edge in 71% of subjects. At the 2-year follow-up, POPQ measures were significantly improved from baseline values in all compartments, with 51 (65%) stage 0/I, 25 (31%) stage II, and 3 (4%) stage III (P < 0.001); quality-of-life scores were also improved (P < 0.001), with the exception of sexual function. Symptomatic pelvic organ prolapse was reported by 7 women (8.5%); 4 of these had prolapse in the nonoperated compartment. Persistent pelvic pain was reported by 3 patients (4%). The rate of mesh exposure at 2 years was at least 13% (11/85). There was no difference between the rate of dyspareunia at baseline and at the 2-year follow-up (15/45 [33%] vs 13/45 [28.9%] women, respectively). The median global satisfaction reported in the 1-year study (9.2) was maintained at 2 years (9.3; range, 2.0–10.0).
These data show that at the 2-year follow-up, the Profit system achieves anatomical support, significant symptom relief, and high patient satisfaction. However, mesh exposure and new-onset prolapse of the nonoperated compartment are not uncommon.