The Use of Synthetic Mesh in Central and Apical Compartment Repair

A review article published in the Current Urology Reports Journal in June, 2012, describes the various methods used in the repair of central and apical compartment pelvic organ prolapse using synthetic mesh. This article details the FDA’s recommendations and concerns regarding the use of synthetic mesh in these particular procedures. Pelvic organ prolapse is a relatively common condition which affects women, particularly those who have gone through childbirth, menopause or surgery. When the muscles and tissue of the pelvic floor weaken the organs begin to drop down, causing discomfort and pain. Age increases the risk of developing pelvic organ prolapse, and because the muscle and tissue are already weakened, there is a high recurrence rate of POP after surgery.

This high recurrence rate when using traditional surgical procedures led to the use of synthetic meshes which have been used successfully in the repair of abdominal wall hernias for decades. Synthetic meshes are classified according to type, pore size and filament type and are believed to be less invasive with a more standardized approach to placement. The typical placement techniques include surgeon-fashioned patches and tension-free vaginal kits which can be trocar, anchor or suture-based. The first kits designed specifically for the treatment of apical compartment repair in POP cases used trocars—sharp-edged instruments inside a cylinder—which passed through the membrane which closes the “hole” in the pelvis. Such kits are marketed under such brand names as Gynecare, Anterior Prolift, Perigree and Avaulta.

Single-incision kits using needle drivers or self-fixating tips include brand names such as Pinnacle, Uphold and Elevate. Finally, the Procima kit is a single-incision, non-fixation system which is held in place for three weeks by a vaginal support device which is sewn into place during the surgical procedure. Mesh patches are typically used in single or multi-compartment repairs with the approach depending on the individual case and the surgeon.

Apical vaginal compartment repair is usually accomplished through abdominal sacrocolpopexy (ASC) although highly skilled surgeons have developed their own technique to address defects in the anterior and posterior compartments during ASC. ASC, typically performed on younger, sexually active patients, may be performed in three ways: open, laparoscopic or robotic surgery. Aside from the variation in approach, the ASC surgical procedure has remained largely unchanged. A permanent mesh graft is secured to the sacral promontory and vaginal cuff. Enteroceles are reduced using culdoplasty which reduces the chance of recurrence. The laparoscopic procedure is suitable for elderly patients as it results in decreased loss of blood and a shorter hospital stay.

ASC can lead to both intraoperative and postoperative complications; a study of 1,500 patients concluded that subsequent operations following mesh procedures occur more frequently following transvaginal mesh placement into the anterior compartment.  Smoking, sexual activity, mesh placement and age contribute to the risks associated with mesh surgery. A report released in 2008 by the FDA discussed potential complications associated with pelvic organ prolapse surgery using transvaginal mesh. This report was updated in 2011 at which time the FDA stated it was unclear whether there were any advantages in using mesh over more traditional methods and that complications from transvaginal mesh were not as rare as previously reported.

Further clinical studies were proposed, and mesh kits which had previously been classified as Class II were moved up to a Class III which required that manufacturers submit study design demonstrating mesh procedures were not inferior to native tissue repairs. Mesh used in ASC was specifically excluded as their safety and efficacy have been well-established. Supporters of the use of surgical mesh believe it is difficult to make comparisons as data comparing mesh and non-mesh procedures are not entered into a device database. Further, they attribute mesh complications to technical deficiencies and the lack of skilled surgeons, leading the authors to emphasize the fact that training for mesh placement should be increased.