Women who have undergone
menopause, childbirth or surgery are at particular risk for developing pelvic
organ prolapse. As women age, their risk increases with approximately 11% of
women requiring pelvic organ prolapse surgery by the age of 80. A history of
smoking, being overweight or a compromised immune system can all increase the
risk of pelvic organ prolapse as well as the risk of recurrence following
surgery. A Current Urology Reports
Journal article published in June, 2012 assesses the risks and benefits of
using synthetic mesh when repairing posterior vaginal wall prolapse.
As many as 30% of women who
undergo this surgery will experience a recurrence of POP. In an effort to lower
this number, the procedures for using grafts to expand native tissue have been
updated and in the past ten years the use of synthetic mesh has become more
common. Surgical mesh kits designed specifically to repair anterior, posterior
and vaginal vault pelvic organ prolapse have been FDA approved, although there
is not enough post-market manufacturer’s data to thoroughly evaluate results.
The data reviewed in the article listed above comes from publicly available
research.
The posterior compartment is traditionally
repaired using a sort of “folding” and suturing of the connective tissues to
restore normal anatomy which is compromised when those tissues lose their
elasticity and the organs drop from their normal positions. This “traditional”
type of surgery typically has few complications and recurrence rates are low.
Anatomic surgery is generally reserved for women with stage 0-1 of prolapse
severity although approximately 35% have stage II. When failure is defined as
prolapse beyond the hymen, presence of symptoms or recurrence, posterior pelvic
organ prolapse repair cure rates are at least 90%, with recurrence following
traditional methods at 3%. When synthetic mesh is used, complication rates are
almost 17% and recurrence rates range from 4.1-16.9%.
Patients presenting symptoms
of pelvic organ prolapse may need multiple-compartment repair requiring either
a total vaginal mesh or combination of anterior-posterior mesh. Most
complications noted occurred following anterior compartment or total vaginal
repair using synthetic mesh. The complications occurred during the surgery, from
the operating room to recovery unit or post-op. Complications ranged from
puncture to bleeding and infection during or immediately following surgery.
Delayed complications included mesh extrusion, retraction, chronic pain and
sexual dysfunction.
In 2008 the FDA issued a
safety communication which they later updated in 2011 regarding complication
related to transvaginal mesh. Additional information was collected using the
FDA database known as MAUDE or Manufacturer and User Facility Device Experience.
Voluntary reports of adverse events involving medical devices such as surgical
mesh are entered into this database although the data is not sufficient to
compare rates across devices. The updated communication in 2011 was based on an
analysis of 3,000 complication reports submitted between 2008 and 2011 and
concluded that complications from transvaginal mesh were “not rare.” Further,
the FDA stated there was little evidence to support the use of synthetic mesh
over more traditional methods in the repair of pelvic organ prolapse. Since
that 2011 FDA communication, lawsuits against manufacturers of synthetic mesh
are on the rise with close to 700 cases being filed.
The authors of the Current Urology Reports Journal article
state that the post-market studies requested by the FDA will result in a higher
level of safety and efficacy data being made available which will in turn allow
a thorough assessment of the use of synthetic mesh in posterior POP repair.
Based on current data, however, traditional methods involving native tissue
appear to have similar outcomes to synthetic mesh used in the repair of
posterior pelvic organ prolapse however synthetic mesh has a higher risk of
complications. The standard treatment for posterior compartment POP will remain
traditional, using native tissue for a positive outcome and few complications.
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