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.”

Read More

POP SURGERY; DO WE EVER GET PAST THE FEAR OF MESH SURGERY FAILURE?

You have overcome the shock of being diagnosed with pelvic organ prolapse. You’ve moved past the frustration of exploring multiple non-surgical treatments in your quest to resolve frustrating, uncomfortable POP symptoms such as vaginal tissue bulge, incontinence, pressure, and pain. You’ve made the choice to move forward with POP mesh surgery after navigating several non-surgical treatment options. Surgery went well. You are now over a year past the surgical heal curve. You feel good, have an active lifestyle, but just can’t quite shake the fear of POP returning. You swear from time to time you feel vaginal pressure, or some type of pelvic pain, or your constipation seems to be a bit more frequent than acceptable, and your mind immediately navigates to “what if my POP is back?

Read More