Lower exposure rates of partially absorbable mesh compared to nonabsorbable mesh for cystocele treatment: 3-year follow-up of a prospective randomized trial
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Introduction and hypothesis
In surgery for pelvic organ prolapse (POP) the use of alloplastic meshes has become common. Among possible complications, mesh exposure is the most frequent problem. It is hypothesized that exposure rates are correlated to mesh weight and the amount of foreign material. Therefore, we conducted a prospective open-label randomized multicenter trial comparing a conventional polypropylene mesh (PP) with a partially absorbable polypropylene mesh (PA) for cystocele treatment.
A total of 200 patients with POP > stage I were randomized either to a conventional or a partially absorbable mesh. Exposure rates were observed after 3, 12, and 36 months and correlated to mesh material, patient characteristics, intraoperative data, and treatment centers. Furthermore, management of mesh exposure, satisfaction with surgery, and postoperative pain were evaluated.
At all follow-up intervals mesh exposure rate was smaller in the group of the partially absorbable mesh (3 months PP 11.3 % vs PA 3.2 %, p = 0.0492; 12 months 6.6 % vs 6.3 %; 36 months 7.5 % vs 3.4 %). Over the course of time, mesh exposure was observed in 27 patients, with surgical intervention necessary in 11 patients. The rate of recurrent POP was higher (p > 0.05) in patients with the partially absorbable mesh. The majority of patients were fully satisfied with the operation (52.8 %) and had no pelvic floor pain (67.5 %).
In this prospective, randomized trial with a long-term follow-up there was a low exposure rate in both treatment groups with a trend toward fewer exposures in the group of the partially absorbable mesh.
KeywordsMesh exposure Pelvic organ prolapse Cystocele Polypropylene mesh
Pelvic organ prolapse
Conventional nonabsorbable mesh
Partially absorbable mesh
US Food and Drug Administration
International Continence Society
Conflicts of interest
The study was sponsored by Serag Wiessner KG, Naila, Germany. J. Farthmann: consultant for pfm medical; honoraria and travel expenses from Serag Wiessner, Johnson & Johnson, AMI. D. Watermann: travel expenses from Serag Wiessner, AMS and Johnson & Johnson, acceptance of payment for research from Serag Wiessner, consultant for Serag Wiessner, AMS, Johnson & Johnson. A. Niesel: honoraria from Serag Wiessner, BARD, AMS, AMI; consultant for Serag Wiessner, BARD, AMI. C. Fünfgeld: consultant and honoraria from Serag Wiessner, BARD, AMS, AMI, pfm medical, Astellas, Merckle. A. Kraus: honoraria from Serag Wiessner. A. Lenz: honoraria from Serag Wiessner. H. J. Augenstein: consultant for Serag Wiessner. E. Graf: none. B. Gabriel: travel expenses and payment for research from Serag Wiessner.
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