Safety considerations for synthetic sling surgery

Journal name:
Nature Reviews Urology
Volume:
12,
Pages:
481–509
Year published:
DOI:
doi:10.1038/nrurol.2015.183
Published online
Corrected online

Abstract

Implantation of a synthetic midurethral sling (SMUS) is the most commonly performed anti-incontinence operation in women worldwide. The effectiveness of the SMUS is comparable to that of the historical gold standards—autologous fascial slings and the Burch colposuspension. Much controversy, however, has evolved regarding the safety of this type of sling. Overall, the quality of the studies with respect to assessing risks of SMUS-associated complications is currently poor. The most common risks in patients with SMUS include urethral obstruction requiring surgery (2.3% of patients with SMUS), vaginal, bladder and/or urethral erosion requiring surgery (1.8%) and refractory chronic pain (4.1%); these data likely represent the minimum risks. In addition, the failure rate of SMUS implantation surgery is probably at least 5% in patients with stress urinary incontinence (SUI). Furthermore, at least one-third of patients undergoing sling excision surgery develop recurrent SUI. Considering the additional risks of refractory overactive bladder, fistulas and bowel perforations, among others, the overall risk of a negative outcome after SMUS implantation surgery is ≥15%.

At a glance

Figures

  1. Identification of urethral obstruction.
    Figure 1: Identification of urethral obstruction.

    a | Urodynamic trace showing severe urethral obstruction (Blaivas–Groutz nomogram type 2) caused by the presence of a urethral stricture in a 52 year-old woman 4 years postimplantation of a SPARC (American Medical Systems, MN, USA) SMUS. Urethral obstruction is confirmed by the presence of strong, sustained detrusor contraction (PdetQmax = 56 cm H2O and Qmax = 1 mL/s). b | Cystourethrogram confirming the presence of an obstruction owing to the presence of a midurethral stricture (arrows). c | Urodynamic trace showing high-flow urethral obstruction in a 52 year-old woman 6 years after midurethral SMUS implantation. Urethral obstruction was confirmed by PdetQmax = 56 cm H2O (Blaivas–Groutz nomogram type 1). Owing to a technical error, infused volume was not recorded on this trace. d | Voiding cystourethrogram showing the site of urethral obstruction to be in the distal third of the urethra (arrows). Abbreviations: EMG, electromyogram; Pabd, abdominal pressure; Pdet, detrusor pressure; PdetQmax, voiding pressure at peak flow; Pves, intravesical pressure; Qmax, peak flow; SMUS, synthetic midurethral sling; VH2O, bladder filling volume.

  2. Identification and removal of eroded mesh.
    Figure 2: Identification and removal of eroded mesh.

    a | Eroded mesh can be difficult to see during cystoscopy owing to its almost translucent appearance in some patients. b | In this erosion, the sling is nearly obscured by the presence of calcium deposits. c | Appearance of eroded Amid Type I mesh at urethroscopy. This mesh had no appreciable tissue ingrowth and pulled out of the urethra easily, leaving a small urethrotomy that was closed with a few sutures. d | Surgical explantation of eroded silicone mesh. In this case, removing the mesh was relatively easy because it was an Amid type IV mesh, which was encapsulated. e | Transvesical explantation of an eroded mesh sling. This type I mesh had tissue ingrowth and required delicate surgery and sharp dissection to enable removal. f | Following sharp dissection, the mesh was completely excised from the bladder wall. It coursed over, but did not damage, the ureter. Permission obtained from Fred Govier and Kathleen Kobashi, Virginia Mason Hospital & Seattle Medical Center, Seattle, WA, USA.

  3. Identification and removal of Amid type I eroded mesh surrounding the
                    urethra.
    Figure 3: Identification and removal of Amid type I eroded mesh surrounding the urethra.

    a | Urethroscopic view of urethral erosion. In this case the erosion was very subtle and located in the distal urethra, such erosions are very easy to miss. b | Transvaginal dissection and isolation of the mesh shown in image a reveals marked scarring and tissue ingrowth. c | Removal required sharp dissection that left a large defect in the urethra (arrow) that required urethral reconstruction, Martius flap and implantation of an autologous fascial sling. d | The sling being placed over the urethra. e | Creation of a Martius flap (arrow) between the reconstructed urethra and sling, thus repair is completed before vaginal wound closure.

  4. Vaginal complications and removal of SMUS.
    Figure 4: Vaginal complications and removal of SMUS.

    a | View of mesh extrusion into the vagina. This extrusion was both readily visible and appeared palpable on physical examination. b | Transvaginal view of eroded mesh obscured by a granuloma. The erosion was neither visible nor palpable. c | Transvaginal view of fistula obscured by granuloma. d | Transvaginal explantation of an Amid type I RP sling. Note the dense tissue ingrowth and scar that requires sharp dissection in order remove the suburethral portion in its entirety. This portion of the sling felt thickened and stiff. e | Retropubic view in the same patient, as shown in image d. The retropubic portion of the mesh after dissection showed fatty tissue ingrowth. This portion was pliable and not scarred. Abbreviations: RP, retropubic; SMUS, synthetic mid-urethral sling.

  5. Scar encapsulating mesh and surrounding pre-existent normal adipose and
                    muscular tissues.
    Figure 5: Scar encapsulating mesh and surrounding pre-existent normal adipose and muscular tissues.

    a | ×2.5 image of a histological section showing a cross-section of mesh filaments as they appear in section, without colouring. Some filaments were labelled blue by the manufacturer. Adipose tissue had been present in the area before mesh placement. Tissue reaction to surgical injury and the mesh generated scar tissue encapsulating the mesh appears as dense pink collagenous tissue. The scar spans, or bridges, across mesh pores, which is termed bridging fibrosis. In this case a terminal pore contains nonscar adipose tissue (arrow with AT). This section has been labelled with a haematoxylin and eosin stain. b | ×2.5 image of a histological section showing cross-sections of mesh filaments. Note that the mesh is surrounded by a halo of fibrous tissue separating it from the pre-existent tissue of the vaginal wall, containing smooth muscle. Smooth muscle is labelled with anti α smooth muscle actin (brown), mesh filaments are filled yellow. The blue colour is a haematoxylin background stain. Abbreviations: AT, adipose tissue; BF, bridging fibrosis.

  6. Tissue interactions with explanted sling materials.
    Figure 6: Tissue interactions with explanted sling materials.

    a | ×10 images of a histological section showing a neurovascular bundle penetrating through a mesh pore. This section has been labelled with a haematoxylin and eosin stain. Cross sections of mesh filaments are filled yellow for demonstration purposes. The neurovascular bundle is within a mesh pore, orientated perpendicular to the mesh plane. b | ×10 image of innervation between the mesh and the vaginal mucosa (portions of squamous mucosa in the upper corners). This section has been labelled with S100 stain. The thin layer of superficial innervated tissue is at risk for compression against the mesh during intercourse. c | ×10 image of a histological section showing muscle interposition between mesh filaments. This section has been anti-desmin-labelled (brown) to highlight the presence of striated muscle. Interlocked striated muscle is commonly observed in explanted transobturator tapes. d | ×10 image of a histological section showing α-smooth-muscle-actin-labelled smooth muscle from the vaginal wall, urethra or urinary bladder surrounding the sling material. Depending on the muscle origin, smooth muscle is likely to interact with mesh during physiological contractions (such as those that occur during urination or intercourse). Abbreviations: N, nerve branch; V, blood vessel.

  7. Inflammatory reaction to the mesh.
    Figure 7: Inflammatory reaction to the mesh.

    a | ×40 image of a histological section showing a cross-section of mesh filaments surrounded by foreign-body-type inflammation. Epithelioid macrophages (between arrows 'M'), which are the main component of granulomatous inflammation can be observed. A smaller number of lymphocytes ('L') can be seen seen surrounding the mesh filament. This section has been labelled with a haematoxylin and eosin stain. b | ×40 image of a histological section showing a cross-section of mesh filaments, characterized by the presence of neutrophils (multiple neutrophils are scattered in the infiltrate, two are labelled 'N' as examples). Acute inflammation is a feature of bacterial infection and is seen in patients with mesh exposure through the vaginal, urethral or bladder mucosa. Abbreviations: L, lymphocytes; M, macrophages; N, neutrophils.

  8. Oedema within mesh compartments.
    Figure 8: Oedema within mesh compartments.

    ×20 image of a histological section showing ooedema in mesh compartments, note separation of collagen and low density of tissue in the area of the oedema (E). Oedema is usually seen in semi-enclosed mesh compartments. Mesh filaments are filled yellow in this image. This section has been labelled with a haematoxylin and eosin stain. Abbreviation: E, oedema

  9. Curling of the edges of explanted sling materials.
    Figure 9: Curling of the edges of explanted sling materials.

    a | Segment of a sling, which was explanted with very little adherent tissue and a structure that is readily visible. b | Segment of a mesh sling, which was excised with adherent tissue remaining attached to the sling material.

Change history

Corrected online 24 August 2015
In the legend of Figure 6, Figure 6b was incorrectly labelled in the originally published version of this article. This error has been corrected in the HTML, PDF and print versions of this article.

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Author information

Affiliations

  1. Department of Urology, Weill Cornell Medical College, Cornell University, 445 East 77th Street, New York, NY 10075, USA.

    • Jerry G. Blaivas &
    • Rajveer S. Purohit
  2. Institute for Bladder and Prostate Research, Weill Cornell Medical College, Cornell University, 445 East 77th Street, New York, NY 10075, USA.

    • Matthew S. Benedon
  3. Hahnemann University Hospital, 230 North Broad Street, Philadelphia, PA 19102, USA.

    • Gabriel Mekel
  4. SUNY Downstate College of Medicine, 450 Clarkson Avenue, Brooklyn, NY 11203, USA.

    • Michael Stern &
    • Mubashir Billah
  5. SUNY Downstate Medical Center, 450 Clarkson Avenue, Brooklyn, NY 11203, USA.

    • Kola Olugbade
  6. Shouldice Hospital, 7750 Bayview Avenue, Thornhill, ON L3T 4A3, Canada.

    • Robert Bendavid
  7. St Michael's Hospital, University of Toronto, 30 Bond Street, ON M5B 1W8, Canada.

    • Vladimir Iakovlev

Contributions

All authors made a researched data for this article, J.G.B., M.S.B., G.M., R.B. and V.I. contributed to discussions of content, J.G.B., R.S.P., M.S.B., G.M., R.B. and V.I. wrote the manuscript and J.G.B., R.S.P., M.S.B., R.B. and V.I. made a substantial contribution to reviewing and/or editing of this manuscript prior to submission.

Competing interests statement

V.I. and J.G.B. have provided opinions as medico-legal expert witnesses in mesh litigation cases. J.G.B. has acted as a consultant for Astellas Pharma and is a shareholder in P Square Medical and is a shareholder and co-owns intellectual property with LLC and Symptelligence Medical Informatics. The other authors declare no competing interests.

Corresponding author

Correspondence to:

Author details

  • Jerry G. Blaivas

    Dr Blaivas is an internationally renowned urologist with over thirty years of clinical experience. He is Clinical Professor of Urology at Weill Cornell Medical College, Adjunct Professor at SUNY Downstate and Attending Surgeon at New York Presbyterian Hospital and Lenox Hill Hospital. He is the founder of the major scientific journal Neurourology & Urodynamics and was Editor-in-Chief from 1982–2006. He is the primary author of over 400 peer-reviewed scientific articles, book chapters and reviews and has edited seven books.

  • Rajveer S. Purohit

    Dr Rajveer Purohit is Clinical Assistant Professor of Urology and attending urologist at Weill Medical College of Cornell University in New York City. He specializes in voiding dysfunction and reconstructive urology and completed a urological residency at the University of California in San Francisco (UCSF) and fellowship with Dr Blaivas.

  • Matthew S. Benedon

    Matthew Benedon is the current Research Coordinator for the Institute for Bladder and Prostate Research. He completed his undergraduate education at the University of Pennsylvania in Philadelphia, where he received a Bachelor of Arts.

  • Gabriel Mekel

    Dr Gabriel Mekel is currently an intern in General Surgery at the Hahneman University Hospital. After completing his medical education at Unversidad Central de Venezuela, Dr Mekel spent a year conducting research at the Institute for Bladder and Prostate Research.

  • Michael Stern

    Michael Stern is currently a 4th year medical student at the SUNY Downstate College of Medicine, New York. Next year, he will begin his residency in urology at New York Medical College.

  • Mubashir Billah

    Mubashir Billah is currently a 3rd year medical student at the SUNY Downstate College of Medicine, New York. He graduated from Brooklyn College with a Bachelor of Arts in Chemistry with minors in both computer science and finance.

  • Kola Olugbade

    Kola Olugbade is currently a resident in urology (PGY-1) at SUNY Downstate Medical Center, New York. After attending Johns Hopkins University for his undergraduate education, he completed medical school at the University of Michigan.

  • Robert Bendavid

    Robert Bendavid is a Surgical Consultant and Director of Research at Shouldice Hospital, Ontario, Canada. Dr Bendavid is a Graduate of the University of Manitoba Medical School, Canada, followed by post-graduate studies and certification in general surgery at McGill University, Montreal, Canada. Dr Bendavid has spent the last 35 years in research and surgical treatment of Abdominal Wall Hernias, in association with the Shouldice Hospital since 1976. Dr Bendavid has published over 100 scientific articles on hernias and edited three textbooks on abdominal wall anatomy and hernia surgery. Dr Bendavid is a founding father of the American Hernia Society, in the last few years, his research has centered around the complications arising from the use of polypropylene meshes in hernia surgery.

  • Vladimir Iakovlev

    After residency training in Anatomic Pathology, Dr Iakovlev completed dedicated research training at Ontario Cancer Institute/Princess Margaret Hospital, Toronto, Canada. His research was originally focused upon the 3-dimensional distribution of biomarkers in neoplasms. After accepting a faculty position at the University of Toronto he practiced diagnostic Anatomic Pathology at St Michael's Hospital and continued his research in the analysis of histological structures and molecular/genomic markers with an emphasis on 3-dimensionality and heterogeneity of tissues from tumour lesions. Later his research interests expanded to implantable devices, which he found to be understudied from a histological perspective.

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