Informed surgical consent for a mesh/graft-augmented vaginal repair of pelvic organ prolapse
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Introduction and hypothesis
Complex issues surround informed surgical consent for pelvic reconstructive surgery.
Vaginally placed mesh/grafts are used with the intent to increase durability of the repair but potentially introduce unique complications, offering new challenges in informed surgical consent counseling.
Informed consent is a process that takes place throughout the entire consultation with the patient. A written document often accompanies that process. This paper outlines necessary components of informed surgical consent and the theory behind each component.
We explore elements that should be included in the consent process with regard to expected benefits, alternatives, and material risks that are specific to the use of a mesh/graft-augmented vaginal repair of prolapse. Included is an appendix that may serve as a template for the creation of a surgeon’s own written informed consent document.
KeywordsPelvic organ prolapse Mesh Graft Transvaginal mesh Informed consent Pelvic reconstructive surgery
Conflicts of interest
Dennis Miller, M.D. has received royalties, research grants, and consulting fees from Boston Scientific Corporation and research grants from Ethicon Endosurgery. Alfredo L. Milani, M.D. has received consultancy agreement and speakers bureau fees, research grants, and honoraria for lectures from Ethicon Women’s Health & Urology. Suzette E. Sutherland, M.D. is a consultant, a clinical research PI, and a trainer/speaker of American Medical Systems, Medtronic, Uromedica, and Allergan and a consultant and a trainer/speaker of Uroplasty and Pfizer. Rebecca G. Rogers, M.D. serves as the chair of the Data Safety Monitoring Board for the TRANSFORM trial sponsored by American Medical Systems.
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