FDA 2019 Transvaginal Mesh Meeting: Balancing the Rhetoric

Following is a transcript of the speech given by Sherrie Palm at the FDA Obstetrics and Gynecology Devices Panel transvaginal mesh meeting on February 12, 2019. 

I’m Sherrie Palm, the founder of the Association for Pelvic Organ Prolapse Support (APOPS). Neither me nor APOPS has any financial conflicts of interest. In full disclosure, I am a transvaginal mesh success story, 11 years post transvaginal mesh cystocele and rectocele repair, and native tissue enterocele repair.

Pelvic organ prolapse is not an American women’s health issue, it is a global women’s health pandemic. Since 2010, APOPS has been engaging with women, healthcare, academia, research, industry and policy, a 177 nation strong network. The women we serve are mid-teens through end of life, navigating every diverse POP issue, including the mesh vs native tissue debate. APOPS has considerable following in the UK and Australia; obviously mesh comes up regularly.”

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The Next Evolution of Women's Wellness SCREENING: Pelvic Organ Prolapse

Research frequently estimates that 1 in 2 women will experience pelvic organ prolapse (POP). There has been considerable media exposure related to mesh complications, associated litigation, and FDA commentary. What has yet to surface is the substantial gap in women’s wellness screening related to POP, a common but highly closeted condition. A collaborative effort to address a massive gap in women’s wellness protocol is underway.

Childbirth and menopause, 2 of the most significant life events women experience, are the leading causes of pelvic organ prolapse. Pelvic exams are considered the gold standard in female wellness protocol, but women are seldom informed of or effectively screened for POP during their routine pelvic exams.

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Vaginal Tissue Rejuvenation to Treat Pelvic Organ Prolapse Symptoms: FDA Media Blitz, Fear vs Fact

I wouldn’t see an aesthetician or dermatologist to provide a vaginal treatment, and I wouldn’t see a gynecologist to fix wrinkles on my face. Call me crazy. I prefer my parts remain fully optimized and relatively functional. Walking the walk of a pelvic organ prolapse (POP) patient advocate, I get to see, touch, and explore a multitude of treatments and tools utilized to treat this condition, and that includes some that have made me wonder what…were….they….thinking? But I’ve also seen a couple over the years that have made me sit right up in my chair and immediately go down the Google rabbit hole to capture more data. Energy based vaginal tissue regeneration (VTR) is a nonsurgical treatment I’ve had my eyes on for years.  

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The Evolution of Treatment for Uterine Prolapse

Global, systemic evolution of research and treatments related to pelvic organ prolapse (POP) are not a maybe, they are a must, considering up to 50% of women are estimated to experience this condition. The needs of women vary based on type(s) of POP and country of residence. There is significant prevalence of uterine prolapse, both in developed zones such as the US, UK, Europe and Australia, as well as in developing zones such as Nepal, India, and Africa. While we ponder the numerous quality of life issues women experiencing POP navigate, the women in developing zones have additional struggles to overcome, such as little access to adequate healthcare or qualified surgeons. A new medical device, NeuGuide, may provide solutions for the women navigating uterine prolapse in developing and developed zones alike.  

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The Toll of Emotional Abuse on Health Recovery: When Pelvic Organ Prolapse Healing Resists Traditional Standards of Care

We are all to some degree products of how we were raised, at times a good thing, at others not so much. The most difficult aspect of navigating emotional abuse, is never knowing when an abuser is going to spew their venom, often leaving behind a life-long reflex that continues to impact daily navigation. The stuff that goes bump in the night. The whispers that occur inside our heads when life events raise ripples. It’s what we choose to do with life’s garbage that separates us into those who are successful sifting the issues that come with life, and those who can’t seem to capture ballast no matter how hard they try.

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60 Minute Mesh expose: One-Sided Noise Generates Fear on Mother's Day

Mother’s Day is a day we shine a light on the members of society that birth us, raise us, and nurture us. It is a day to cherish moms, giving back for all they have done and do for us daily.

Childbirth is the leading cause of pelvic organ prolapse (POP), a condition that impacts the lives millions of women around the world, with estimates indicating up to 50% prevalence. On this special day once a year, we should fill moms’ hearts with joy. The airing of a program like the mesh segment shared by 60 Minutes on Mother’s Day, Gynecological Mesh: The Medical Device that has 100,000 Women Suing, was unfortunate and inappropriate on this special day.

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