Unboxing the Black Box: The FDA has removed or revised the boxed warnings on many estrogen-containing menopause therapies, but what does that actually mean?

In this episode, I explain what a black boxed warning is, why it was applied decades ago, why newer evidence shows the situation is more nuanced, especially for low-dose vaginal estrogen, and what the label change means for people in perimenopause and menopause. Links to FDA, HHS, and JAMA commentary in the episode notes below.

⏱️ Timestamps:

[00:00] — Major Change in Women's Health

[01:27] — FDA's Black Box Warning Removal

[02:04] — Understanding the Black Box Warning

[03:04] — Personal Prescription Example

[04:00] — What is a Black Box Warning?

[05:49] — Detailed Breakdown of the Black Box Warning

[11:43] — The Women's Health Initiative Study

[13:34] — Media's Role in Spreading Misinformation

[15:33] — Scientific and Advocacy Groups' Response

[16:36] — Key Factors in Reversing the Black Box Warning

[23:22] — The Unboxing Menopause Campaign

[24:45] — FDA's Official Announcement

[25:52] — Impact on Perimenopausal and Postmenopausal Women

[26:21] — Challenges in Accessing Hormone Therapy

[27:18] — Dr. Rachel Rubin's Personal Story

[30:00] — The Importance of Advocacy

[31:57] — Steps to Advocate for Yourself

[32:56] — Resources for Hormone Replacement Therapy

[36:47] — Client's Story: Empowerment Through Advocacy

[40:15] — Encouraging Conversations and Education

[41:15] — Conclusion

Resources and Readings:

FDA announcement and fact sheet on the label changes:

https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy

HHA press announcement and fact sheet on the removal of black box warnings:

https://www.hhs.gov/press-room/fact-sheet-fda-initiates-removal-of-black-box-warnings-from-menopausal-hormone-replacement-therapy-products.html

JAMA article Nov 10 2025, Updated Labeling for Menopausal Hormone Therapy

https://jamanetwork.com/journals/jama/fullarticle/2841321

Book The New Menopause by Dr Mary Claire Haver MD

Dr Rachel Rubin’s Education Resources for Clinicians and Patients:

https://www.rachelrubinmd.com/education

The Menopause Society website, includes Practitioner Directory

https://menopause.org/

🎧 Connect & Share:

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The Pelvic Connection with Laura McKaig PT

https://www.youtube.com/channel/UCE7zyN28inZxCovuMqInzSA

👉 Follow on Facebook:

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Do you need a special device to strengthen your pelvic floor?

In this episode of Down There, Pelvic Floor Physical Therapist Laura McKaig PT, explores 7 tools, some unconventional, some everyday, that actually support pelvic floor strength. Inspired by a viral Instagram reel from urologist Dr. Kelly Casperson, Laura shares three expert-recommended “devices” and four additions based on clinical insight and experience.

You’ll learn why orgasms, lifting weights, and even breathing matter more than you think and how consistency, intention, and movement are more powerful than any “quick fix.”

⏱️ Timestamps:

[00:00] – Top 7 Pelvic Floor Devices

[01:33] – Dr. Kelly Casperson's Surprising Recommendations

[03:27] – Why Use Devices?

[03:48] – Biofeedback and E-Stim Devices

[05:02] – Considerations Before Buying a Device

[06:46] – Dr. Kelly Casperson's Top 3 Recommendations

[07:00] – Recommendation 1: Orgasms

[07:21] – Recommendation 2: Lifting Weights

[08:19] – Recommendation 3: Pelvic Floor Physical Therapy

[08:58] – Laura's Additional Recommendations

[09:05] – Laura's Recommendation 1: Pilates

[09:43] – Laura's Recommendation 2: Yoga

[10:13] – Laura's Recommendation 3: Mindful Movement

[12:34] – Laura's Recommendation 4: Breathing

[13:47] – Summary of Top 7 Recommendations

[14:52] – Final Thoughts

🎧 Connect & Share:

Have questions or want to connect?

👉 Subscribe on YouTube:

The Pelvic Connection with Laura McKaig PT

https://www.youtube.com/channel/UCE7zyN28inZxCovuMqInzSA

👉 Follow on Facebook:

https://www.facebook.com/lauramckaigpt/

👉 Follow on Instagram:

https://www.instagram.com/lauramckaigpt/

👉 Visit for programs, resources, or in-person support:

https://www.pelvicconnection.com/

👩‍⚕️ Find a pelvic floor therapist near you:

https://pelvicglobal.com/directory/

🎵 Music Credits:

Original composition “Down There” by Forest Stewart

***DISCLAIMER***The content of this video, description, links, and comments, is intended for educational and informational purposes. It is not intended as medical advice or a personalized treatment plan. Pelvic Connection Physical Therapy & Wellness LLC is not liable for any injuries or damages related to the practice of any exercise or activity shown on this video. Injury risk is possible if you do not follow due diligence and seek qualified professional advice about your medical condition or injury. Please consult your healthcare professional for specific concerns. No guarantees of specific results are expressly made or implied from this content.

If you had told me a few years ago that I’d be grateful for rejection, pain, and almost losing my career… I wouldn’t have believed you. But today, I can honestly say: I’m thankful for the hard stuff. And I want to share why.

In this deeply personal and reflective episode, Laura McKaig shares a tradition she’s carried for over a decade, her annual “Thankful for the Pain” letter. You’ll hear the real story behind how challenges, physical, emotional, and financial, sparked the founding of her pelvic health practice, reshaped her mindset, and deepened her empathy for others.

This isn’t about toxic positivity... it’s about learning to face discomfort and still choose gratitude. Whether you’re in a season of struggle, rebuilding after a setback, or just need encouragement, this episode offers raw honesty, hope, and practical reflection.

⏱️ Timestamps:

[00:00]  – People just need to be heard

[01:50] – Personal Vulnerability and Tradition

[02:14] – The Start of a Gratitude Journey

[03:14] – Reading from Past Emails

[04:27] – Thankful for the Pain Series

[05:15] – Physical Pain and Career Change

[06:15] – Financial Struggles and Career Change

[06:57] – Facing Rejection and Building Resilience

[09:42] – Support and Gratitude for Others

[10:24] – Unexpected Challenges in 2020-2021 and Opportunities

[11:10] – Writing the Book 'Piss Off'

[12:07] – Unexpected Health Challenges

[13:08] – Physical Injuries and Business Adaptation

[15:31] – Developing Online Education Programs

[18:59] – Embracing Pain and Offering Support

🎧 Connect & Share:

Have questions or want to connect?

👉 Subscribe on YouTube:

The Pelvic Connection with Laura McKaig PT

https://www.youtube.com/channel/UCE7zyN28inZxCovuMqInzSA

👉 Follow on Facebook:

https://www.facebook.com/lauramckaigpt/

👉 Follow on Instagram:

https://www.instagram.com/lauramckaigpt/

👉 Visit for programs, resources, or in-person support:

https://www.pelvicconnection.com/

👩‍⚕️ Find a pelvic floor therapist near you:

https://pelvicglobal.com/directory/

🎵 Music Credits:

Original composition “Down There” by Forest Stewart

***DISCLAIMER***The content of this video, description, links, and comments, is intended for educational and informational purposes. It is not intended as medical advice or a personalized treatment plan. Pelvic Connection Physical Therapy & Wellness LLC is not liable for any injuries or damages related to the practice of any exercise or activity shown on this video. Injury risk is possible if you do not follow due diligence and seek qualified professional advice about your medical condition or injury. Please consult your healthcare professional for specific concerns. No guarantees of specific results are expressly made or implied from this content.