Making surgery safer through adequate communication with the stakeholders: vaginal slings
- PMID: 31273442
- DOI: 10.1007/s00345-019-02859-8
Making surgery safer through adequate communication with the stakeholders: vaginal slings
Abstract
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.
Keywords: Mid-urethral sling; Stress urinary incontinence; Transvaginal mesh.
References
-
- Petros PE, Ulmsten UI (1993) An integral theory and its method for the diagnosis and management of female urinary incontinence. Scand. J. Urol. Nephrol. Suppl. 153:1–93 - PubMed
-
- Ford AA et al (2017) Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst. Rev. 7:Cd006375 - PubMed
-
- Nilsson CG (1998) The tensionfree vaginal tape procedure (TVT) for treatment of female urinary incontinence. A minimal invasive surgical procedure. Acta Obstet. Gynecol. Scand. Suppl. 168:34–37 - PubMed
-
- Khan AA, Brucker RN, Nitti V (2017) Changes in management of stress urinary incontinence following the 2011 FDA Health Notification. J Clin Urol 10(5):440–448 - DOI