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ODADV02 - The FDA and Vaginal Mesh; Where do we go from here?

‐ Oct 16, 2020 9:15am

Credits: None available.

This presentation details the series of escalating safety actions by the U.S. Food and Drug Administration (FDA) from 2008 to the present related to use of surgical mesh intended for transvaginal repair of pelvic organ prolapse. Many questions arise and are explored, including: Might regulations change again in light of emerging availability of post market surveillance studies ("522 Studies") and new randomized controlled trials? Most importantly, how should we be counseling our patients moving forward?

Continuing Education Instructions and Disclosure Information:

Contact hours available until 10/18/22.

Requirements for Successful Completion:

Complete the learning activity in its entirety and complete the online CNE evaluation. You will be able to print your CNE certificate at any time after you complete the evaluation.

Faculty, Planners, and Speakers Conflict of Interest Disclosure:

Planning Committee Disclosures:

Christina Hegan, MS, APRN, WHNP-BC
Consultant for Urovant Sciences
Spouse is a distributor for CBD rich hemp oil

There are no other Planning Committee disclosures to declare.

Speakers Conflict of Interest Disclosure:
David D. Rahn, MD
Research Support from Pfizer, Inc.
Grant Support from NIH (NICHD and NIA)

There are no other speaker disclosures to declare.

Commercial Support and Sponsorship:
No commercial support or sponsorship declared.

Accreditation Statement:
Society of Urologic Nurses and Associates (SUNA) is accredited with distinction as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

The SUNA accreditation is reciprocal in the states and specialty organizations that recognize the ANCC-COA accreditation process. SUNA is also a provider approved by the California Board of Registered Nursing, Provider Number CEP 5556. Accreditation and approved provider status of CE in nursing does not imply ANCC-COA approval or endorsement of any product, advertising, or educational content. SUNA urges all participants to be aware of the CE requirements for re-licensure in the states in which they hold a license.

Learning Outcome:
After completing this education activity, the learner will be able to describe the past, current, and emerging state of the science examining benefits and risks associated with the use of transvaginal mesh for prolapse repair and to be able to effectively counsel patients on their surgical options moving forward.


Credits Available

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