Objective
The purpose of this study was to evaluate the anatomic position and relations to neighboring neurovascular structures of polypropylene implants after vaginal repair with nonanchored mesh and a vaginal support device in a cadaver model.
Study Design
We undertook anatomic dissection of 6 cadavers, with and without prolapse after surgery.
Results
All polypropylene implants were positioned in accordance with the prescribed surgical technique. This surgery reconstructed the entire anterior and posterior pelvic floor compartments without extension beyond the pelvic cavity. A safe distance between the implants and their neighboring neurovascular structures (obturator nerve and vessels, 2.8-3.3 cm; pudendal nerve and internal pudendal vessels, 1.8-2.2 cm; sacral plexus, 2-2.2 cm) was observed.
Conclusion
Anatomic cadaver dissection confirmed the accurate and safe placement of the polypropylene implants with the use of the prescribed surgical technique.
New procedures for pelvic organ prolapse require appropriate evaluation to establish their safety and effectiveness before being marketed. Anatomic cadaver studies play an important role in the preclinical evaluation of new procedures.
The success of prolapse surgery may be compromised by excessive movement of the healing vaginal tissues, with rises in intraabdominal pressure with coughing, straining, and physical activity in the early postoperative period. With augmentation of the surgery with polypropylene implants and support for the vagina with a vaginal support device (VSD) for 3-4 weeks after surgery, the risk of recurrent prolapse may be reduced. Consistent with orthopedic wound healing principles, the VSD acts as an intravaginal splint to support both the vaginal tissues and the positioning of the polypropylene implants. At 3 weeks, the polypropylene implants have become incorporated into the body’s tissues as a result of tissue in-growth. By supporting the positioning of the polypropylene implants until they become incorporated, the VSD avoids the need for implant fixation by sutures or anchors or the use of trocars. This makes surgery simpler to perform and avoids the specific complications that can occur with trocars or suture and anchor placement. The PROSIMA Pelvic Floor Repair System (Ethicon, Somerville, NJ) was developed to provide durable vaginal support by the use of polypropylene implants and splinting the healing vaginal tissues with the VSD with the use of a trocar-free technique. The balloon replaces the traditional gauze vaginal pack. The balloon also serves to provide optimal contact between polypropylene implants and the fibromuscular layer of the vaginal epithelium during the first 24 hours when fibrin exerts its adhesive effect.
Limited visualization often makes vaginal prolapse surgery technically difficult to perform; therefore, a precise knowledge of the relevant pelvic anatomy is essential.
The aim of this cadaver study was to evaluate the anatomic position of polypropylene implants after reconstruction of the anterior and posterior compartments of the pelvic floor with this new surgical procedure. We also aimed to determine the relation of the mesh implants to important neighboring neurovascular structures.
Materials and Methods
Female cadavers, which were donated for medical education and research to the Institute of Anatomy, Tübingen, were studied. The anatomic specimens were preserved with an alcohol-glycerol solution. The injection solution consisted of 5 parts ethanol and 2 parts glycerol. Depending on the size of the corpse, 21-30 L of embalming solution was injected into the femoral artery. A volume of 50 mL of Lysoformin (Dr Hans Rosemann GmbH, Berlin, Germany) was added to the injection solution as a disinfecting agent. The corpses were kept air-tight under refrigerated conditions (8°C). This preservation technique maintains tissue plasticity and, in particular, allows the legs to be positioned with hyperflexion.
The cadavers were placed in the lithotomy position with hyperflexion of the hips. Surgery was performed in accordance with a prescribed and standardized technique as set out in the “Instructions for Use” brochure that accompanies the surgical kit. In all cadavers, combined anterior and posterior compartment repairs were performed. After surgery, anatomic dissection of the pelvis was performed.
The surgical kit is available as an anterior, a posterior, or a combined kit. The combined kit comes with anterior and posterior preshaped polypropylene implants, a VSD, a balloon, an anterior inserter, a posterior inserter, and a 60-mL syringe ( Figure 1 , A). The apical part of the VSD contains removable sections so that its size can be adjusted according to each patient’s vaginal dimensions. The balloon is attached to the VSD and, with the syringe, is inflated with air. The balloon replaces the postsurgical vaginal gauze pack and is removed 24 hours after surgery. In the living subject, the VSD remains in the vagina for 3-4 weeks after surgery. The polypropylene implants, which are composed of Gynecare GYNEMESH PS (Ethicon), have a central body and 2 extension arms (straps). They have preformed pockets at the ends of each extension arm. The anterior and posterior inserters are inserted into the pockets to facilitate placement of the polypropylene implants. The mesh straps are designed to provide apical support. In the anterior compartment, the straps abut the parietal fascia of the obturator internus muscle immediately anterior and above the ischial spines on each side. In the posterior compartment, the straps abut the middle portion of the sacrospinous ligament on each side. In the living subject, the VSD maintains the position of the mesh for 3-4 weeks by which time the mesh has become fixed into position by tissue in-growth into the interstices of the mesh. The polypropylene implants are placed without fixation or tension and are fully deployed to avoid any folding or crimping of the implant. An important function of the VSD is to aid in the full deployment of the implant ( Figure 1 , B).
Surgery commenced with a full-thickness incision in the anterior vaginal wall. This incision extended 3 cm above the external urinary meatus in the sagittal plane towards the vaginal apex. The lower 3 cm of the vagina was not dissected to preserve the functional and anatomic integrity of the urethra and bladder neck in the living subject. The full-thickness of the vaginal wall (ie, the superficial squamous epithelial and the deeper muscularis layers) was dissected off the underlying prevesical tissue all the way to the vaginal apex. Laterally, dissection was continued toward the pelvic side-walls and to the ischial spines. Anterior channels for the polypropylene implant straps were made on each side by the creation of a space (approximately 2 cm in width and 3 cm in height) immediately anterior and superior to the ischial spine and superficial to the parietal fascia of the obturator internus muscle. The dissection of the anterior channels began with scissors with a push-spread technique followed by gentle finger dissection.
The anterior polypropylene implant was introduced into the vesicovaginal plane. The implant straps were placed into the anterior channels with the aid of the anterior inserter instrument so that the implant straps laid flush against the parietal fascia of the obturator internus muscles. The apical tab and distal grove of the implant were tacked to the prevesical tissue with a 2/0 Monocryl suture (Ethicon). In a subject with the uterus still present, the apical tab of the mesh is sutured to the anterior cervix at the level of the pubocervical ring. The vaginal epithelium was closed in 2 layers. The deeper fibromuscular layer was closed with a continuous noninterlocking stitch of 2/0 Monocryl Plus (Ethicon). The superficial squamous epithelial layer was then closed by a noninterlocking continuous everting mattress stitch with 2/0 Vicryl Plus (Ethicon). In the living subject, noninterlocking stitches are used to avoid devascularization of the vaginal epithelium along the incision line. The 2-layered closure, which included the everting mattress stitch, was used to obtain a relatively thick suture line at the site of the vaginal incision. This closure technique is used to reduce mesh exposure.
During the posterior vaginal repair, the rectovaginal plane was exposed by dissection of the full-thickness of the vaginal epithelium off the underlying prerectal tissue all the way to the vaginal apex. Dissection continued laterally on each side to the levator ani muscles. Posterior channels for the implant straps were created on each side by dissection in a superior and lateral direction above the rectal pillars to each ischial spine and sacrospinous ligament. With the use of a push-spread technique with scissors followed by gentle finger dissection, the right and left channels to the sacrospinous ligament were created. The posterior mesh implant was introduced into the rectcovaginal plane. The implant straps were placed into the posterior channels with the aid of the posterior inserter instrument so that the implant straps abutted the sacrospinous ligaments. The apical tab and distal grove of the mesh implant were tacked to the prerectal tissue with a 2/0 Monocryl suture (Ethicon). In a subject with the uterus still present, the apical tab of the mesh is sutured to the supravaginal part of the posterior cervix. The posterior vaginal epithelium was closed in the same method described for the anterior vaginal epithelium.
The VSD can be modified into 3 sizes: large, medium, and small. At the completion of surgery, an appropriately sized VSD, with attached balloon, was placed in the vagina and sutured in place with 2/0 Vicryl Plus (Ethicon) to prevent dislodgement. The balloon was inflated with air with the 60-mL syringe.
At the completion of surgery, a laparotomy was performed, and the retropubic and retroperitoneal spaces were dissected. The anatomic position of polypropylene implants and the relation to the neighboring neurovascular structures were evaluated.