3.
Slings implant narrow 1cm tapes which harness the wound reaction from
the implantation to create new collagen to reinforce weak ligaments,
fig1. This is the core principle of the MUS and other sling operations.
Slings attach the organs directly to the skeleton in a transverse
manner, fig1. They have very little contact with the vagina, so they
have very little opportunity to entrap nerves to cause de novo pain and
they preserve vaginal elasticity needed for bladder function.
The Cumberlage report, though emphasizing the need for thorough
scientific and clinical analysis for devices before being implanted in
patients, has, in fact, abolished the most validated operation in the
history of surgery. The MUS was not released until 1996, 10 years after
the first animal experiments started in 1986, ironically, to test the
safety and efficacy of the tape implantation, fig1, the very concern
which seemed to dominate the Cumberlage report!
The animal testing included clinical monitoring over 3 months,
anatomical studies, biomechanical testing of the neoligament on an
Instron tensiometer, histology, bacteriology, radioactive Gallium
studies, xray studies, regular biochemical and hematology testing of the
animals8.
The first prototype operations commenced under strict EC surveillance
between 1988 and 1993 at Royal Perth Hospital. They, too, were subjected
to thorough clinical, bacteriological, radiological, hematological,
biochemical, histological observations1,3. By the time
the MUS was released in 1996, the MUS had undergone 10 years study for
safety and efficacy under Ethics Committee surveillance in several
international locations and after several published papers. Since 1996,
the MUS has been the subject of >1000 scientific papers,
(including 17year data), 10,000,000 MUS surgeries, endorsement by almost
every learned body. By comparison, mesh sheet surgery for prolapse has
had virtually no scientific testing.2
The poor anecdotal evidence presented by the Baroness Cumberlage for
abolition of the MUS did not meet its stated clinical/scientific
criteria. Quoted was not data, but one expert’s singular case report of
delayed onset of pelvic pain after MUS. As an expert, he should have
known about Shull’s famous observation9, that
repairing one part of the vagina, such as a cystocoele, diverts
pressure, to cause prolapse in another part of the vagina, for example,
the apex. Apical prolapse is caused by decompensation of the uterosacral
ligaments. Uterosacral ligament laxity is known to cause a number of
co-occurring symptoms, pelvic pain, urge, frequency, nocturia, abnormal
emptying, known collectively as the “posterior fornix
syndrome”4,5,6,10. Pelvic pain is an important
element in this syndrome. The posterior fornix syndrome should be
excluded in cases of de novo pelvic pain occurring weeks or months after
the original MUS operations. Cardinal/uterosacral ligament repair of the
prolapse4 would most likely have cured the pain
symptoms as reported by the singular Cumberlage expert. Clearly not
considered by the Cumberlage report were next generation MUS
slings11, 90% cure at 3 years, with no erosions at 3
years. They would put a whole new perspective on the Cumberlage
complaints.
One cannot extrapolate a series of individual cases, (undoubtedly worthy
in themselves) to a general ban on the most documented operation in the
history of surgery. As things stand in the UK, the 30% of women with
SUI have very little to help them now. The scientific evidence needs to
be re-assessed. Slings work by reinforcing ligaments; mesh sheets work
by blocking descent, a totally different technology. Let’s hope reason
prevails, that the scientific evidence is reviewed and the Cumberlage
“pause” is just that.
Conflicts No financial conflict of interest
Contribution Sole author
Funding Nil
Ethics NA