TY - JOUR
T1 - Making surgery safer through adequate communication with the stakeholders
T2 - vaginal slings
AU - Elmer, Sandra
AU - Brennan, Janelle
AU - Mathieson, Rebecca
AU - Norris, Briony
AU - Carey, Marcus
AU - Dowling, Caroline
N1 - Publisher Copyright:
© 2019, Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2020/6/1
Y1 - 2020/6/1
N2 - Purpose: In this review, we explore the evidence behind mid-urethral sling (MUS) surgery, review the rising reports of complications and the subsequent US Food and Drug Administration (FDA) and society statements, and evaluate risk perception and communication with patients, doctors, governing bodies, manufacturers and insurance companies. Our aim was to explore the pitfalls in communication that may be contributing to the decline in MUS use, and develop strategies to make MUS surgery safer. Methods: We searched the English language literature using PubMed for articles related to the management of stress urinary incontinence (SUI), MUS, safety and monitoring of transvaginal mesh (TVM), and reviewed all online FDA publications and international position statements regarding MUS for SUI. Results: Polypropylene mesh has been used in MUS since the 1990s, with robust evidence to support its use. There has been a decline in the use of MUS ever since the FDA notifications. In response to the controversy surrounding TVM, position statements have been released portending the safety of, and advocating for the continued use of, MUS for the management of SUI. Conclusions: MUS is a viable, effective and safe treatment for SUI management. Physicians should obtain and document informed consent, be adequately trained, and monitor and report their outcomes using registries. With publication of registry results and ongoing health advocacy, the perception of the safety of MUS can improve and MUS can still be offered as a treatment option for SUI.
AB - Purpose: In this review, we explore the evidence behind mid-urethral sling (MUS) surgery, review the rising reports of complications and the subsequent US Food and Drug Administration (FDA) and society statements, and evaluate risk perception and communication with patients, doctors, governing bodies, manufacturers and insurance companies. Our aim was to explore the pitfalls in communication that may be contributing to the decline in MUS use, and develop strategies to make MUS surgery safer. Methods: We searched the English language literature using PubMed for articles related to the management of stress urinary incontinence (SUI), MUS, safety and monitoring of transvaginal mesh (TVM), and reviewed all online FDA publications and international position statements regarding MUS for SUI. Results: Polypropylene mesh has been used in MUS since the 1990s, with robust evidence to support its use. There has been a decline in the use of MUS ever since the FDA notifications. In response to the controversy surrounding TVM, position statements have been released portending the safety of, and advocating for the continued use of, MUS for the management of SUI. Conclusions: MUS is a viable, effective and safe treatment for SUI management. Physicians should obtain and document informed consent, be adequately trained, and monitor and report their outcomes using registries. With publication of registry results and ongoing health advocacy, the perception of the safety of MUS can improve and MUS can still be offered as a treatment option for SUI.
KW - Mid-urethral sling
KW - Stress urinary incontinence
KW - Transvaginal mesh
UR - https://www.scopus.com/pages/publications/85068862235
U2 - 10.1007/s00345-019-02859-8
DO - 10.1007/s00345-019-02859-8
M3 - Article
C2 - 31273442
AN - SCOPUS:85068862235
SN - 0724-4983
VL - 38
SP - 1351
EP - 1358
JO - World Journal of Urology
JF - World Journal of Urology
IS - 6
ER -