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.
