This toolkit is designed to facilitate the informed consent process, and the documentation thereof, regarding the use of mesh in the surgical treatment of pelvic floor disorders. Although much of the concerns in this area derive from the use of mesh for the correction of prolapse, as outlined by the 2011 FDA Update, providers may wish to use these materials in the informed consent process for any procedures involving the implantation of permanent mesh. Download a PDF copy of the toolkit.
If you have any suggestions for improvements or materials to add to the toolkit, please email firstname.lastname@example.org.
Patient Background Information
Providers can print and distribute this document to assist patients in understanding the issues surrounding the use of mesh.
This page provides links to the FDA Documents and Public Health Notification, as well as formal responses from professional societies and patient advocacy groups.
Prepared Responses to FDA Suggested Questions
These materials can provide assistance in the development of prepared responses to the questions that the FDA suggests that patients ask their providers.
Surgeons may use these materials to prepare their own practice-specific responses to distribute to patients to supplement their counseling process. Surgeons may choose to prepare separate versions of this document for each specific mesh-based procedure that they offer.
Informed Consent Supplement Checklist
This document can be printed and initialed by the patient to outline and document the materials and counseling the patient has received.
Collection of Manufacturers’ Literature
This will serve as a resource for providers to access and print the most applicable manufacturer literature (“patient labeling”) that is available for each device.
We have developed a collection of materials that may be helpful for providers and patients making decisions about surgical repair of pelvic organ prolapse. These include:
This project has been supported through an educational grant from American Medical Systems, Boston Scientific, and Bard Medical Division.
The informed consent toolkit reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed, or as dictating the standard of care. The ultimate judgment regarding any specific procedure or treatment is to be made by the physician and patient in light of all circumstances presented by the patient.