Two recent FDA notifications (2008 and 2011) have ignited a nationwide debate on the use of synthetic materials in the surgical repair of stress urinary incontinence and pelvic organ prolapse. This debate has been fueled by a limited amount of scientific data, a rising trend in complications reported by experts and the MAUDE database, internet-based advocacy groups, and legal advertisements. This presentation covers a review of the materials currently available on the market, the FDA notifications, and the impact of this “mesh mess” on patients, physicians, and researchers.
Contact hours available until 3/7/2015.
Requirements for Successful Completion: Complete the learning activity in its entirety and complete the online CNE evaluation.
Conflict of Interest Disclosure: Planning Committee Disclosures:
Donna J. Carrico, WHNP, MS/ Consultant/Presenter Bureau: Uroplasty Inc.
Commercial Support and Sponsorship: No commercial support or sponsorship declared.
Non-Endorsement of Products: Accreditation of activities for contact hours does not imply approval or endorsement of any product, advertising, or educational content by the Society of Urologic Nurses and Associates (SUNA) or the American Nurses Credentialing Center’s Commission on Accreditation.
Accreditation Statement: Society of Urologic Nurses and Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
Accreditation status does not imply endorsement by the provider or ANCC of any commercial product.
SUNA is a provider approved by the California Board of Registered Nursing, provider number, CEP 5556.
State the rationale for considering mesh repair for prolapsed organs.
Discuss the current situation with mesh complications and the FDA notifications.