Is one outdated warning label standing between millions of women and safe, effective care? In this episode of BackTable Urology, Dr. Yahir Santiago-Lastra, a urologist specializing in female pelvic medicine and reconstructive surgery at UC San Diego, joins host Dr. Suzette Sutherland to discuss the black box warning on vaginal estrogen, its historical context, and the ongoing advocacy efforts to update outdated FDA guidelines. --- SYNPOSIS The conversation covers the importance of low-dose vaginal estrogen in treating genitourinary syndrome of menopause (GSM), the fear surrounding hormone therapy due to misinterpreted data from the Women's Health Initiative (WHI) study, and the inequities faced in women's health, particularly in the context of hormone replacement therapies. They discuss the legislative and advocacy strategies needed to enact change, emphasizing the role of professional societies, legislative efforts, patient advocacy, and industry support in overcoming the barriers to updating the black box warning. --- TIMESTAMPS 00:00 - Introduction03:43 - History Behind the Estradiol Black Box Warning13:44 - The FDA Citizen Petition18:18 - Gender Inequity in Medicine24:05 - The Role of Organizational Guidelines in Patient Advocacy28:51 - Vaginal Estrogen for Genitourinary Syndrome of Menopause (GSM)32:57 - Medicare Spending and Legislative Advocacy44:56 - Recap and Future Directions --- RESOURCES (TRAVERSE Trial) Cardiovascular Safety of Testosterone-Replacement Therapyhttps://www.nejm.org/doi/full/10.1056/NEJMoa2215025 Systemic or Vaginal Hormone Therapy After Early Breast Cancer: A Danish Observational Cohort Studyhttps://doi.org/10.1093/jnci/djac112 (ASCO Study) Use of local estrogen therapy among breast cancer patients in SEER-MHOS databasehttps://doi.org/10.1200/JCO.2025.43.16_suppl.578 Vaginal estrogen use in breast cancer survivors: a systematic review and meta-analysis of recurrence and mortality riskshttps://doi.org/10.1016/j.ajog.2024.10.054