The promise of NEST is clear: real-time device safety information means better outcomes for patients who depend on devices to improve their health. We’re committed to making the promise a reality by prioritizing NEST’s development and ensuring it’s set up for long-term success to advance public health.

Focusing on Women’s Health


As we implement our active surveillance system to quickly detect new safety signals, we will continue our efforts to strengthen our Coordinated Registry Networks (CRN), which link different real-world data sources to generate clinical evidence about medical products used by patients. In particular, we’re focusing on addressing clinical questions on device therapies that are unique to women, such as treatment of uterine fibroids, pelvic floor disorder, female sterilization and long-acting reversible contraception. The FDA partnered with the American College of Obstetricians and Gynecologists, the American Urogynecologic Society, the National Library of Medicine and others on this, known as the Women’s Health Technologies CRN, or WHT-CRN. We targeted part of the additional $3 million in funding for NESTcc for this effort.

Over the past six months, notable successes of the WHT-CRN include the development and international harmonization of core data sets in four clinical areas – stress urinary incontinence (SUI), pelvic floor disorders, uterine fibroids, and long-acting, reversible contraception and sterilization therapies. We’re tapping into anonymous payer claims data from New York State and data from the New York Clinical Data Research Network to enable us to answer crucial clinical questions, such as the long-term safety and efficacy of urogynecologic mesh for stress urinary incontinence. The next step is to develop an implementation guide for the participating registries so they can develop tools to efficiently extract clinical data from electronic health records.

Additionally, to help inform the health care community’s understanding of how the WHT-CRN could ultimately be more broadly applied, the FDA has initiated surveillance pilot projects using payer claims data and will undertake a pilot assessing the feasibility of using electronic health records (EHR) to study mesh.

Similar to NEST, the WHT-CRN holds great promise as we advance new tools and approaches for using data to improve outcomes for women and ensure they have access to safe, effective and innovative devices.

--Breast Implants

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