Should surgeons continue to implant mesh sheets behind the vagina?

International Urogynecology Journal https://doi.org/10.1007/s00192 Should surgeons continue to implant mesh sheets behind the vagina? P E P Petros 0 1 2 4 Bernhard Liedl 0 1 2 4 Darren Gold 0 1 2 4 Bernhard Liedl 0 1 2 4 Darren Gold 0 1 2 4 0 Chefartz Centre of Reconstructive Urogenital Surgery, Urologische Klinik München-Planegg , Germeringer Strasse 32, D-82152 München-Planegg , Germany 1 University of Western Australia School of Mechanical and Chemical Engineering , Perth, WA , Australia 2 University of NSW Professorial Department of Surgery, St Vincent's Hospital Sydney , Sydney , Australia 3 P E P Petros 4 St Vincent's Clinical School , UNSW, Sydney , Australia Aims of this editorial are to explain how discrete ligament repair using the artificial neoligament principle exactly as used in the highly successful midurethral sling differs substantially from transvaginal mesh sheets that work only by blocking organ descent. What is it about MUS that makes it work reasonably well, with manageable complications? Introduction In 2011, the US Food and Drug Administration (FDA) warning on transvaginal mesh implantation for pelvic organ prolapse (POP) was the start of a major controversy with seismic manifestations: media stories; government inquiries; legal suits; closure of mesh companies. Expert committees endorsed the midurethral sling (MUS) but expressed caution about mesh implantation for POP. No anatomical reasons were advanced by these experts. Yet anatomical answers are required for the two questions below if a solution is to be found. 2. What is it about transvaginal mesh sheets that can cause severe quality of life (QOL) complications that are not easily manageable? On weighing up 2, the answer is not legal, more comprehensive, consent forms, or stating that benefits outweigh risks. The question is ethical. Should surgeons be performing an operation that can have such catastrophic effects on QOL, albeit in a minority of patients? This is the thrust of the hostile media campaign. Going back to native tissue repair is clearly not the answer. The Lancet Prolapse Surgery: Pragmatic Evaluation and Randomised Controlled Trials (PROSPECT) [ 1 ] proved the futility of surgical intervention to the vagina with >80% failure rate at 6 months and further attrition at 1 year. The answers to questions 1 and 2 and the alternative ligament-based tape surgery described below can be found in the 1990 publication of the Integral Theory [ 2 ]. It states ligament integrity is essential for structure and vaginal elasticity for function: “Essential to the understanding of this theory is the appreciation that the vagina has two distinct anatomical segments, which are pulled in opposite directions against the pubourethral ligament (PUL) to close the urethra. PUL acts as a fulcrum (Fig. 1). In order to transmit (mediate) these movements, sufficient elasticity is needed in the zone of critical elasticity of the vagina.” The same publication described experimental animal work on which the transvaginal tape (TVT) was based; tapes were implanted in the precise position of the PUL to strengthen it by creating a collagenous neoligament. Experimental animal and clinical studies between 1986 and 1997 demonstrated that alloplastic strips of tape were essential for long-lasting strengthening of damaged PUL and uterosacral (USL) ligaments. Emphasis was placed on the preservation of vaginal elasticity and avoidance of vaginal scarring: it can cause massive uncontrollable urine loss attributabe to what is known as tethered vagina syndrome [ 2 ]. That: “like the intestine, the vagina has an autonomic nerve innervation and crushing or stretching may cause severe Fig. 1 How a lax pubourethral ligament (PUL) causes urinary stress incontinence. Schematic sagittal view, sitting position. The urethra has two separate closure mechanisms activated by oppositely acting muscle forces (arrows). Adequate elasticity in the bladder neck area of the vagina is required for these to function separately [ 3 ]. Distal closure: pubococcygeus muscle (PCM) (arrow) contracts against competent pubourethral ligaments (PUL). This stretches the suburethral vagina forward to close the distal urethra (3). Bladder-neck closure: levator plate (LP) stretches the urethra backward against the PUL. Conjoint longitudinal muscle of the anus (LMA) (arrow) rotates the bladder base down and around the arc of Gil-vernet to close the urethra at the bladder neck. Extension of the PUL to L indicates PUL loosening; the PCM weakens; LP/LMA pull open the posterior urethral wall (small diagonal arrow). Intraurethral resistance exponentially decreases. The patient loses urine on effort. Surgical restoration of the PUL with tape restores muscle strength for both striated muscle vectors and therefore continence PVLpubovesical ligament pain." All of this was published and therefore known, which begs a third question: Did the developers of the mesh kits who used “substanti (...truncated)