Repair of Pelvic Organ Prolapse Using Synthetic Mesh Kits

8 Repair of Pelvic Organ Prolapse Using Synthetic Mesh Kits




Since the mid-1990s, much discussion has taken place regarding the use of synthetic and biological materials to increase the durability of pelvic organ prolapse repair. There has also been considerable dialogue about whether the use of nonnative materials carries excess risk for patients. This has led to research and development of a variety of synthetic and biological implant kits specifically marketed for repair of pelvic organ prolapse in the hope of providing improved long-term anatomical durability compared with native tissue suture repairs.


Level I literature, such as the 2008 review by Maher et al, supports the use of synthetic mesh for applications like open abdominal and laparoscopic sacral colpopexy. This has led surgeons to begin using synthetic implants in transvaginal procedures in the hope of duplicating the long-term outcomes achieved with sacral colpopexy. Although long-term level I data are still unavailable, transvaginal placement of mesh to repair prolapse has become increasingly popular.


In their 2010 Cochrane review of treatment modalities for pelvic organ prolapse, Maher et al examined mesh augmentation procedures performed via both abdominal and vaginal approaches. The review supported the use of mesh in the anterior compartment based on findings of decreased recurrence of anterior wall prolapse after surgery as determined by objective examination, but it was noted that general reviews addressing specific complications were lacking. In addition, Maher et al found a lack of evidence to support the use of mesh in the posterior compartment to improve repair durability.


In this chapter, we discuss the mesh kits currently approved by the U.S. Food and Drug Administration (FDA) for use in prolapse repair. These include mesh overlay kits containing customizable sheets of mesh that the surgeon fashions intraoperatively into implants of the appropriate shape and size and places over the prolapsed tissue; trocar-based anterior and posterior synthetic mesh kits; and trocarless, or direct-access, synthetic mesh kits. In general, mesh kits aim to provide apical support as well as anterior and posterior vault support through anchoring to structures such as the coccygeus muscle–sacrospinous ligament (C-SSL) complex, the obturator membrane, and levator and inner thigh muscles. It is critical to thoroughly understand the anatomy and the proper sites for anchoring these mesh implants to ensure a safe and successful anatomical and functional repair. Because of this, we also discuss the appropriate anatomical landmarks, proper placement of anchoring devices or sutures, proper tensioning of the synthetic materials, and potential complications associated with these products.


Editor’s note: Permanent synthetic mesh grafts have unique complications, including vaginal extrusion, urinary tract erosion, and infection. These risks must be carefully weighed against the potential benefits. In July 2011, the FDA issued a notification regarding the use of transvaginal synthetic mesh for the repair of POP.*



Finding the Ideal Mesh


Certain properties make synthetic materials desirable for use in the pelvis. Ideally, surgical foreign bodies should be nontoxic and noncarcinogenic, and should have minimal potential for infectious or expulsive rejection. In addition, mesh should be strong but macroporous to allow fibroblast integration, as well as be pliable to allow the natural flexibility of the vaginal walls to be maintained. It should be inexpensive and easy to obtain, and made of material that is not greatly altered by the native tissues before a durable and well-incorporated repair is achieved.


Both absorbable and nonabsorbable synthetic mesh implants are currently available on the market, although as of 2012 macroporous polypropylene derivatives (nonabsorbable) dominated the industry. In general, it is not acceptable for intrafiber pores to be smaller than 50 µm because of risk of infection and difficulty with collagen integration. Microporous meshes tend to become encapsulated rather than integrated into the surrounding native tissues, which leads to higher rates of infection-associated morbidity.


Although the suitability of synthetic mesh for sacral colpopexy has been well established in the literature, studies report variable rates of erosion at the apex, most often noted as being in the range of 3% to 5%. Vaginal mesh procedures are associated with a considerably higher rate of vaginal extrusion, in the range of 8% to 20%, and higher rates of dyspareunia are also reported in patients undergoing transvaginal mesh placement.


Surgeons must also keep in mind the ideal characteristics of candidates for synthetic mesh placement. Generally, patients who have risk factors associated with poor healing or who have had complications after previous mesh procedures should not be offered augmentation with a mesh kit. Patients with severe genital atrophy, a history of radiation therapy, or baseline chronic pelvic pain may experience more postoperative complications after mesh placement. In addition, patients who desire to maintain sexual function should be informed that mesh augmentation may cause some loss of elasticity, which can lead to dyspareunia in either partner. Ensuring that the patient thoroughly understands the benefits and potential risks of synthetic mesh–augmented pelvic organ prolapse procedures is an essential part of the consent process. The potential risks must be weighed against the perceived advantage of better durability with mesh augmentation.


In July 2011, the FDA released the safety alert “Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse” to inform providers and patients that “serious complications associated with synthetic mesh for transvaginal repair of POP [pelvic organ prolapse] are not rare.” The FDA had issued its initial public health notification regarding the urogynecological use of surgical mesh in 2008, and after continued surveillance of adverse event postings to the Manufacturer and User Facility Device Experience (MAUDE) database, the 2011 update stated that complications with mesh had been reported in over 2800 cases, in approximately 1500 of which the mesh was placed to repair pelvic organ prolapse. In addition, the FDA cited a review of the literature indicating that 10% of women implanted with mesh during pelvic organ prolapse surgery experienced vaginal erosion within 1 year of surgery and that dyspareunia was increasingly reported. The type of mesh or mesh kit used was not further categorized. In addition, the FDA did not report the total denominator of mesh procedures in determining the rate of serious complications. It is recommended that any surgeon implanting mesh transvaginally read the FDA warning and share it with his or her patient. Specifically, the FDA made the following recommendations:




Trocar-Based Mesh Kits


Several FDA-approved trocar-based kits are available for both anterior and posterior approaches to repair of pelvic organ prolapse (Fig. 8-1, Box 8-1, and Table 8-1). All of the available trocar-based devices use the C-SSL complex for apical support. The obturator membrane is used as a distal anchor by the majority of anterior kits, with the superior arms placed in much the same way as a transobturator midurethral sling and the inferior arms passed through an avascular portion of the obturator membrane and through the ischiococcygeus complex overlying the sacrospinous ligament.





Posterior approach devices are designed to correct apical and posterior vaginal wall defects. They also use the C-SSL complex for apical suspension via a posterior and extraperitoneal approach with the trocars introduced pararectally in the gluteal fossae.


The design of these devices is such that a sheet of mesh will cover the anterior and posterior vaginal wall in a tension-free fashion with minimal bunching or excess. Theoretically, this sheet of support, along with apical suspension of the vaginal cuff or cervix to the C-SSL complex, achieves restoration of the vaginal axis and provides additional durability to protect against anterior and posterior vaginal wall prolapse.



Surgical Technique for Anterior Trocar-Based Mesh Kits


All patients should receive antibiotics perioperatively, have a Foley catheter inserted, and be placed in the dorsal lithotomy position. Thromboembolic precautions should also be taken during and after anesthesia. We recommend that the vaginal epithelium be well estrogenized before these procedures when possible and routinely prescribe the use of vaginal estrogen cream before and after surgery to optimize tissue condition. Procedures for using several of the available mesh kits are described; however, we stress again that surgeons should be appropriately trained in the specific procedure they are performing in keeping with the FDA recommendations cited previously.



Anterior Gynecare Prolift System




1. For repair using the Gynecare Prolift Anterior Pelvic Floor Repair System (Ethicon Women’s Health and Urology, Somerville, NJ), the procedure begins with hydrodissection of the anterior vaginal wall using anesthetic and epinephrine to a level of 1 to 2 cm above the cuff or cervix.


2. A vertical incision is made full thickness through the epithelium and underlying vesicovaginal fascia and into the true vesicovaginal space. Use of this dissection plane allows the mesh to be placed with a thicker layer of tissue (generally 5 to 7 mm) between the mesh and vaginal vault. The desired plane is often described as a glossy, gray, gelatinous-appearing area that may have some perivesical adipose tissue within it. Anatomically, proper hydrodissection and careful identification of the vesicovaginal plane are essential for repair.


3. Dissection with Metzenbaum scissors to the superior pubic rami can be accomplished by keeping the scissors parallel to the vaginal epithelium and pointing toward the ipsilateral shoulder.


4. Once this level of lateral dissection is obtained, blunt dissection of the paravaginal space until all areolar connective tissue is freed allows excellent palpation of the ischial spines and palpation medially to the C-SSL complex.


5. The Prolift kit uses two anchoring arms that pass through two sites in the inferior portion of the obturator foramen to avoid the neurovascular supply in the superior portion of the membrane. Before the trocars are passed, the proposed entry sites are marked and infiltrated with the surgeon’s choice of local anesthetic. The superior incision in the groin is identical to that used in transobturator sling procedures and can be marked in the superior medial notch just below the adductor longus tendon in the midclitoral line.


6. The inferior incision is made 1 cm lateral and 2 cm inferior to the superior incision to allow passage of a second trocar through the inferolateral portion of the membrane. The inferior trocar with cannula is placed in a trajectory that penetrates the obturator membrane toward the ischial spine.


7. Once the spine is reached, the trocar handle is elevated and advanced into the iliococcygeal fascia and then into the dissected paravaginal space. The cannula is then left in place as the trocar is removed.


8. The superior trocar is passed in an out-to-in fashion following the curve of the pelvis after initial penetration of the obturator membrane. The cannula is similarly left in the dissected paravaginal space, and the trocar is removed.


9. Once the cannulae are in place, it is important to confirm that the distance between them is great enough to avoid bunching of a properly sized piece of mesh. Generally, this distance is estimated to be 5 cm or greater.


10. The mesh is appropriately trimmed to the specific size of material needed by measuring the distance from the junction of the bladder neck and the apex, whether it is the cervix or the vaginal cuff. The mesh is tacked in place with 2-0 delayed absorbable suture at the level of the bladder neck and the cuff or cervical stroma.


11. The mesh arms are then fed through the cannulae and appropriately adjusted to achieve good apical suspension that does not cause bunching or excessive tension on the mesh.


Cystoscopy and copious irrigation should always be part of the procedure after mesh placement to ensure that no bladder, ureteral, or urethral injury has occurred and to decrease the risk of infection from vaginal flora.


May 30, 2016 | Posted by in GASTOINESTINAL SURGERY | Comments Off on Repair of Pelvic Organ Prolapse Using Synthetic Mesh Kits

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