Pelvic organ prolapse (POP) is defined as descending of the one or more of the pelvic organs such as the uterus, bladder, bowel or vaginal vault after hysterectomy through the genital hiatus. The definition is provided by the International Urogynecological Association (IUGA) and International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction in 2010 (1). It is estimated to affect about 50% of parous women and 10-20% of these look for medical care. The lifetime risk of surgery for POP in every single woman is approximately 7% (2). Using meshes to reinforce endopelvic fascia and to obtain the reconstruction of pelvic floor anatomy and bladder sphincter support in women, begins with the Ulmstein’s ‘‘Integral Theory’ from 1996.  FDA notification on high complications associated with transvaginal polypropylene (PP) meshes in pelvic reconstructive surgery high lights “the need for new material” (3). Recent animal experiments and clinical trials have presented polyvinylidene fluoride (PVDF) as an effective and compatible material in transvaginal POP repair. Therefore, the desire to know more about the result and outcome of using PVDF in POP reconstructive surgeries has been increased recently. The objective of the study is to examine the behavior of polyvinylidene fluoride (PVDF) meshes as new material suggested for the treatment of POP.

Between 2010-2018 and in 2 departments of urology in 3 hospitals, women with symptomatic stage III or IV POP according to POP-questionnaire included in the study. In this prospective nonrandomized interrupted time series trial, 133 women underwent Double TOT surgery of symptomatic prolapse of anterior vaginal wall with or without uterine prolapse and stress urinary incontinence by using PR4 Dynamesh kits, 4 hands fashioned PVDF meshes. Informed consent was obtained from all participants before inclusion in the study. The technique consisted of an infrasacral sacrospinous colposuspension (posterior TOT) and synchronize mid-urethral sling (anterior TOT). All surgical procedures were performed by two experienced urogynecologic surgeons (M.Z., M.E.) according to a previously described surgical technique. To assess the objective and subjective outcomes, all patients were examined with the POP-Q for POP classification and vaginal erosion. Urinary and vaginal symptoms were assessed using the validated ICIQ-FLUTS and ICIQ-VS questionnaire. For urinary incontinence, patients underwent a stress test while supine at maximum physiological bladder capacity. All patients followed at 1, 6, 12 and 24 months after surgery.

Polyvinylidene fluoride (DynaMesh-PR4 soft 07cm*04cm, FEG Textiltechnlk, Aachen, Germany) were used along with Double TOT technique. Ninety-nine patients (74.4%) presented stage III and 34 patients (25.6%) presented stage IV prolapse. The median follow-up was 28 months (range 24-47 months).  One hundred and thirteen patients (85%) had complete resolution of the prolapse (stage 0 or I based on POP-Q) and 110 patients (83%) recovered from stress urinary incontinence (defined as no accidental release of urine after asking to cough). Four patients had vaginal mesh erosion, one after chemotherapy due to bladder cancer, one following vaginal bleeding 3 months after mesh insertion and another 2 patients following vaginitis and discontinuation of topical estrogen. Of these, 3 patients underwent surgical mesh removal and in 2 patients, symptoms recurred and outpatient treatment was performed. Five patients (3.7%), after the symptoms were resolved, presented with the recurrence of prolapse. In the first week after surgery, 27 patients (20.3%) had urinary retention (defined as post-void residual volume (PVR)>200ml) and received a urinary catheter. After a month of surgery, urinary retention sustained in only 3 patients (2.2%) and founded the need for surgical intervention to remove the obstruction and urinary retention.

These findings in comparison to the same reconstructive vaginal surgery by polypropylene mesh showed lower complications but the same success rate.

This study suggests that even in a 2-year follow-up, PVDF meshes had a low rate of erosion and can effectively repair the pelvic organ prolapse. However, it is not clear whether the effectiveness and the biocompatibility are sustained in the long term or not. Further studies with longer follow up and greater study population with the same surgical technique is recommended to further corroborate our result. In reaction to FDA warning on mesh associated complications, our study introduces an effective and biocompatible material for pelvic organ prolapse surgery.

Haylen BT, De Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourology and Urodynamics: Official Journal of the International Continence Society. 2010;29(1):4-20.
Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstetrics & Gynecology. 1997;89(4):501-6.
ADMINISTRATION USFAD. FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks January 4, 2016 [Available from: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm479732.htm.