Transvaginal Synthetic Mesh Research Articles

Single-incision apical and posterior mesh repair: 1-year prospective outcomes

The objective of this study was to assess the safety and efficacy of the Elevate Apical and Posterior single-incision mesh system (SIMS) with IntePro Lite for pelvic organ prolapse repair. This prospective multicenter study included 139 women with ≥ stage II posterior vaginal prolapse and/or apical descent who underwent placement of type I polypropylene mesh through a single transvaginal incision with no external needle passes. Primary endpoint was the percent of patients with posterior and/or apical stage ≤ I ("cure") at follow-up. Secondary endpoints included, but were not limited to, rate of mesh extrusion and disease-specific quality of life outcomes. At 12 months, objective posterior wall and apical cure rates were 92.5 and 89.2 %, respectively, with an extrusion rate of 6.5 %. The SIMS appears to be effective and safe in treating patients with posterior vaginal and/or apical prolapse. The risks and benefits of transvaginal synthetic mesh insertion should be considered.

Sexual function in women following transvaginal mesh procedures for the treatment of pelvic organ prolapse

Synthetic mesh kits recently adopted in pelvic reconstructive surgeries have achieved great surgical efficacy, but the effects of transvaginal synthetic mesh procedures on women's sexual function are still controversial. This study was conducted to demonstrate sexual function in women before and after surgery with transvaginal mesh (TVM) repair for pelvic organ prolapse (POP). A total of 93 sexually active women scheduled for correcting POP with synthetic mesh kits were recruited. In addition to urogynecological history, pelvic examination by the Pelvic Organ Prolapse Quantification system, and urodynamic testing, consenting participants were asked to complete the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) to evaluate sexual function before and after surgery. At the 3-month urodynamic studies, among the 25 patients with coexistent urodynamic stress incontinence (USI) who had undergone a concomitant transobturator suburethral tape procedure (TOT), 1 (4 %) had persistent USI; 8 of 68 (11.8 %) patients with a negative pessary test developed postoperative USI. Six-month prolapse recurrence rates following TVM alone and TVM with concomitant TOT were 9 and 12 %, respectively. The total PISQ-12 score after surgery showed worse results in the TVM alone group but not in the TVM with concomitant TOT group. The individual scores of PISQ-12 after surgery demonstrated prolapse-related items improved in both TVM groups; sexual function worsened in dyspareunia and behavior domains. Our data revealed that transvaginal synthetic mesh procedures for the treatment of POP generated favorable clinical outcomes, but situations might worsen in dyspareunia and behavior domains, thereby invoking a negative emotional reaction during intercourse after surgery.

Informed Consent and the Use of Transvaginal Synthetic Mesh

In 2008 and again in July of this year, the U.S. Food and Drug Administration (FDA) issued safety communications regarding the use of transvaginally placed surgical mesh. These FDA communications have been the subject of much discussion in the literature. One issue raised by these communications and in the medical literature is the matter of informed consent. Informed consent is an established bioethical principle in modern health care, but it is evolving. The legal interpretations of informed consent are also in flux. A review of contemporary ethical and legal elements of informed consent is presented as it relates to the use of medical innovation, with a focus on transvaginally placed surgical mesh.

Do we need meshes in pelvic floor reconstruction?

Transvaginally placed mesh in pelvic reconstructive surgery for women with pelvic organ prolapse has gained popularity because of excellent anatomical outcomes, but postoperative mesh-related complications have lead to a number of cautious reviews and warnings. This review focuses on functional outcomes after synthetic transvaginal mesh placement. MEDLINE database was searched from 2010 to August 2011 for original articles on transvaginal mesh surgery for pelvic organ prolapse not included in recent reviews. The following search terms were used: pelvic organ prolapse, genital prolapse, cystocele, rectocele and mesh, synthetic graft, and repair. Studies were assessed and appropriate data extracted and tabularized. Studies were excluded if the follow-up time was less than 12months and if studies did not contain original data or data on subjective outcome. Eleven studies irregularly reported functional outcomes. After trocar-guided transobturator vaginal mesh surgery, symptomatic recurrence of pelvic organ prolapse was reported between 7 and 33%. If analyzed cumulatively, 76 of 370 patients (21%) complained of prolapse symptoms postoperatively. De novo stress urinary incontinence occurred in 12-17% and persisted in up to 68% after trocar-guided mesh surgery. De novo dyspareunia was present between 2 and 15%, worsened or de novo dyspareunia between 25 and 44%. Deteriorating coital incontinence was described in 6 of 16 women after anterior Prolift in one trial. When counseling women for pelvic reconstructive surgery, we should provide them with evidence-based information on functional outcomes and subsequently take the patient's concerns and preferences into account. Pelvic floor symptoms were scarcely reported in reviewed trials, but demonstrated a worse scenario than anatomical outcomes.