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International Urogynecology Journal

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Open Access 01-11-2017 | Clinical Opinion

Informed consent checklists for midurethral slings: a common-sense approach

Authors: G. Alessandro Digesu, Steven Swift, Victoria Handley

Published in: International Urogynecology Journal | Issue 11/2017

Abstract

Introduction and Hypothesis

Following the US Food and Drug Administration’s (FDA’s) warning about the use of transvaginal mesh to treat pelvic organ prolapse (POP) and the use of single-incision slings to treat incontinence, the number of lawsuits for medical negligence regarding the use of any polypropylene mesh in the vagina has increased tremendously.

Methods

This same FDA document did not question the use of polypropylene midurethral slings and polypropylene for sacrocolpopexies. Surprisingly, despite all the evidence and recommendations from respected international scientific societies, we are constantly being called upon by our patients to defend the use of midurethral slings. The most common reasons for the new rash of medicolegal proceedings involving midurethral slings has to do with “breach of duties” resulting from undisclosed postoperative complications on the consent form and/or the lack of information in the medical records confirming that all possible alternative treatment options were presented to and discussed with the patient.

Results

One response to these lawsuits involves the addition of preoperative checklists when performing informed consent with patients electing surgical correction of stress urinary incontinence (SUI).

Conclusions

This clinical opinion provides an expert clinician’s perspectives and legal point of view on this controversial topic and discusses the role of a preoperative checklist supplementary to the standard informed consent form.

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FDA. FDA safety communication: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. 2011. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm.

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Statement on Mid-Urethral Slings (Draft, June 18, 2014). http://www.iuga.org/?page=slings.

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Title: Informed consent checklists for midurethral slings: a common-sense approach
Authors: G. Alessandro Digesu
Steven Swift
Victoria Handley
Publication date: 01-11-2017
Publisher: Springer London
Published in: International Urogynecology Journal / Issue 11/2017
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-017-3456-7

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Informed consent checklists for midurethral slings: a common-sense approach

Abstract

Introduction and Hypothesis

Methods

Results

Conclusions

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Introduction and Hypothesis

Methods

Results

Conclusions

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