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 observations^1,3. 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