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Numerous mesh products have been made available for transvaginal apical prolapse repair.
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Although data are limited, studies indicate that transvaginal mesh placement does not result in superior anatomic or subjective outcomes compared with native tissue for apical prolapse.
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Given unique complications specific to mesh use, it is reasonable to reserve mesh use for high-risk cases.
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Current trials are underway comparing native tissue with ultralightweight mesh for transvaginal apical prolapse repair.
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Surgery for Apical Vaginal Prolapse after Hysterectomy: Transvaginal Mesh-Based Repair
Section snippets
Key points
Types of mesh products
Synthetic and biologic grafts have been used for the treatment of pelvic organ prolapse. Although mesh is usually used to refer to synthetic mesh, “transvaginal mesh” is used to describe synthetic mesh, xenografts, allografts, and autografts.
Synthetic mesh
Synthetic meshes were initially categorized into four types based on pore size (macroporous or microporous), filament type (monofilament or multifilament), surface properties (coated or noncoated), and architecture (knit or woven). Pore size determines which cells can enter the mesh and affects infection risk, mesh density, and flexibility. Transvaginal mesh is usually classified by pore size, where pore size greater than 75 μm is considered macroporous, and less than 10 μm is considered
Biologic mesh grafts
Several biologic grafts have been marketed to augment vaginal prolapse repair. Surgeons may choose to use biologic mesh in patients who have a high recurrence risk, such as those with poor tissue quality, increased intra-abdominal pressure from obesity, chronic constipation, chronic coughing or heavy lifting, or those who have failed previous native tissue repairs. The complications and success rates of biologic mesh grafts are varied because these meshes differ in origin (autograft, allograft,
Xenograft mesh
Xenograft meshes consist of acellular extracts of collagen harvested from nonhuman (bovine, porcine) sources. They pose a foreign body infection risk and some patients may refuse the implantation of animal-derived material because of cultural or religious beliefs.
ACell MatriStem
MatriStem Pelvic Floor Matrix (ACell, Columbia, MD) is composed of a porcine-derived extracellular matrix and is intended for implantation during anterior, posterior, and apical defect repair to reinforce soft tissue. The device is supplied in a multilayer sheet configuration in sizes up to 10 cm × 15 cm. ACell MatriStem is currently being compared with native tissue prolapse repair as part of an FDA 522 postmarket surveillance study, but the company recently announced that it was putting
Allografts
Allograft mesh is composed of tissue transplanted between genetically nonidentical individuals of the same species and is most often derived from cadaveric fascia of human donors. Allograft mesh is biocompatible, but still may trigger a host immunologic response, even after decellularization removes nonhost antigens. By using allograft mesh, the morbidity of autologous fascia harvest is avoided but multiple prospective studies have shown that outcomes are less beneficial when compared with
Autografts
Autograft meshes are donor tissues that are harvested from a different site on the same individual’s body. The most commonly used autografts are fascia lata and rectus fascia. Autograft mesh does not trigger a host-immune response but clear disadvantages are that a surgical procedure is necessary to harvest an unpredictable quantity and quality of tissue.12
Indications and contraindications of transvaginal mesh for apical prolapse
Transvaginal mesh for apical vaginal repair still remains a durable option for high-risk patients with severe or recurrent prolapse. There are no evidence-based guidelines regarding absolute contraindications for the use of vaginal mesh, so surgeons performing apical repair with transvaginal mesh should use good judgment when selecting patients. Increasing body mass index has been associated with increased risk of mesh exposure and wound infections.13 Diabetes and smoking are associated with
Outcomes associated with transvaginal apical mesh repair
The benefit of transvaginal mesh placement has been assessed with respect to the separate compartments of repair. A large meta-analysis performed by the Society of Gynecologic Surgeons’ Systematic Review Group16 found that, when directly comparing the benefit of transvaginal apical mesh-based repair with suture-based repair, outcomes were similar. The benefit of mesh-based repair was only obvious in the anterior compartment, but the group notes that high-quality studies directly comparing
Type of Apical Repair
There have been limited studies comparing the role of transvaginal mesh placement for treatment of apical prolapse with different types of apical suspension. A study by de Tayrac and colleagues20 compared fixation of a polypropylene intravaginal sling with an infracoccygeal sacropexy versus a sacrospinous suspension for uterine or vaginal vault suspension. With 24 patients randomized to infracoccygeal sacropexy and 25 patients randomized to sacrospinous suspension, they found that prolapse cure
Complications
Numerous complications have been described that are specific to use of mesh, which include vaginal erosion, urinary tract erosions, immobility of the vagina, pain, and vaginal shortening.17
Erosion rates in the VAMP Study using Prolift were 15.6% at 3 months, and some patients required intraoperative intervention.22 At 12 months, the only patients who required reoperation were in the mesh group, for mesh erosion.23 Withagen’s group reported similar rates of erosion of 16.9%.19
With regards to
Food and Drug Administration history
When transvaginal mesh was presented to the FDA, it was approved as a class II medical device. A class II device (low- to moderate-risk) poses slightly higher risks than a class I device (low-risk) and has special controls concerning labeling and postmarket surveillance. However, class II devices do not need premarket long-term safety and efficacy trials as would have been needed for a class III device (high-risk device). In 2001, the FDA found vaginal mesh to be similar to mesh used for
Society opinions
In December 2011, The American Congress of Obstetricians and Gynecologists and the AUGS released a committee opinion offering recommendations for safe and effective use of vaginal mesh for pelvic organ prolapse repair. They recommended restricting transvaginal mesh to high-risk patients with recurrent prolapse or medical conditions. They also agreed with the FDA assessment that long-term clinical trials and follow-up were needed to compare the benefits and safety of transvaginal mesh repair
Summary
Many transvaginal mesh products have been created to address vaginal vault suspension. These synthetic-based mesh products have not been shown to reliably improve outcomes with respect to apical compartment repair. Although data are limited, recurrence rates and subjective measures of improvement are equivalent compared with native tissue repair, and the different types of vaginal kits have not proven superior to one another. Given the known unique complications specific to mesh with equivalent
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Cited by (3)
Mesh induced fibrosis: The protective role of T regulatory cells
2019, Acta BiomaterialiaCitation Excerpt :Up to 20% of women will undergo surgery to correct pelvic organ prolapse (POP) or stress urinary incontinence (SUI) before the age of 80 [1]. While the use of polypropylene mesh in these surgeries improves durability and reduces operative time, it also increases the risk of complications which may necessitate removal, most commonly dues to pain at the site of the implanted mesh and/or exposure of the mesh through the vaginal epithelium [2–4]. While a variety of patient and surgical factors could influence the onset of these complications, very little is known about the role of the host immune response in these patient outcomes.
Update in native tissue vaginal vault prolapse repair
2020, International Urogynecology JournalPelvic organ prolapse
2019, Journal fur Urologie und Urogynakologie
Disclosure Statement: No disclosures (S.L. Wallace, R. Syan). Board of Directors, American Urogynecologic Society. Grant support: National Institutes of Health, ACell, Coloplast, Cook MyoSite, and Foundation for Female Health Awareness. Equity - Pelvalon (E.R. Sokol).