Here is your “Doctor A Day,” Costas Apostolis, MD at Akron General. You know what to do!
Akron Urogynecology Associates
Akron, Ohio, United States, 44333
Contact: Connie Cottrell 330-344-7681
Principal Investigator: Costas Apostolis, MD
Science with Hope
Many of you may have seen the recent video posted by Dr. Shlomo Raz and his team at UCLA. Associate Professor, Division of Pelvic Medicine and Reconstructive Surgery, Department of Urology, Ja-Hong Kim, MD, and a fellow of Dr. Raz, hosts a 20-minute video presentation titled, “What You Need to Know About Vaginal Mesh for Female Pelvic Surgery.” Dr. Kim opens her talk by saying, she will provide a “clear, concise overview of mesh.” Finally, a well-respected surgeon is putting transvaginal mesh in plain English. This video will surely provide a much better education for women who are considering mesh as an option for repair of POP or SUI. Please watch the video below, and then read the rest of my post.
- 1:25 – Dr. Kim defines Stress Urinary Incontinence (SUI) as a loss of urine during physical activity due to weaknesses of the pelvic floor. Dr. Kim notes that a woman’s lifetime risk for developing SUI is 20% – 40%. A 20% variability represents several standard deviations. I believe it is the most conservative approach to cite the highest level of known risk in treating SUI with mesh: 40% LIFETIME RISK.
- 1:42 – Dr. Kim defines Pelvic Organ Prolapse (POP) as a vaginal bulge of pelvic organs resulting from weaknesses of the pelvic floor and cites that a woman’s a lifetime risk for POP is 30% – 50%. Again, with a 20% variability, I believe the most conservative approach, when contemplating repair with mesh, would be to use the highest incidence of lifetime risk: 50% LIFETIME RISK.
The Coloplast Restorelle® Mesh Versus Native Tissue Repair for Prolapse study for which I’ve been posting “A Doctor A Day,” has INCLUSION and EXCLUSION criteria.
I’m concerned about two of the INCLUSION criterion, specifically:
- Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥0 and C≥ -1/2 tvl or Bp ≥0 and C≥ -1/2 tvl
- Subject reports a bothersome bulge they can see or feel per PFDI-20 question 3, response of 2 or higher (i.e. responses of “somewhat”, “moderately” or “quite a bit”)
These two criterion for INCLUSION are part of a longer list of criteria that defines a “good candidate” for the study. A woman who has early stage prolapse (Ba ≥0 and C≥ -1/2 tvl or Bp ≥0 and C≥ -1/2 tvl) and/or answers questions about how “bothersome” a “bulge” is with the answer of “somewhat” or “moderately” bothersome is considered a “good candidate” for the study.
In my many discussions with urogynecologists, some of them have been shocked, and even quite upset, that a mesh implant was used for a woman in early or moderate stage prolapse. These physicians said,
“Treatment of POP with surgical intervention and mesh implant should be a TREATMENT OF LAST RESORT.”
According to the University of Virginia, there are stages of POP, 0-4.
- Stage 0 means that there is no prolapse. The pelvic organs like the vagina, bladder and rectum are perfectly supported by the ligaments in the pelvis.
- Stage 1 means that there is virtually no prolapse. The pelvic organs are very well-supported by the ligaments in the pelvis.
- Stage 2 prolapse means that the pelvic organs are not as well supported by the ligaments and have begun to fall down. In Stage 2 prolapse, the organs are still inside the vagina.
- Stage 3 prolapse means the pelvic organs are beginning to bulge to or beyond the opening of the vagina.
- Stage 4 prolapse means the pelvic organs are completely outside of the vagina.
Do you know which stage of prolapse you have/had at the time of mesh implant?
Do you think it is ethical for a study to recruit NEW patients who are in early-stage prolapse?
If you could talk to a woman who is considering participation in this study, what would you tell her?
NOTE: MY OBSERVATIONS SHOULD NOT BE TAKEN AS MEDICAL ADVICE AND SHOULD NOT BE A REPLACEMENT FOR SEEKING THE MEDICAL OPINION OF YOUR DOCTOR. THIS INFORMATION IS PROVIDED AS AN EDUCATIONAL TOOL ONLY. MY COMMENTARY IS MY OWN OPINION, BASED ON MY OWN RESEARCH AND MY OWN EXPERIENCE. THE QUESTIONS I RAISE ARE MEANT TO BETTER EDUCATE YOU, SO THAT YOU MIGHT HAVE A MORE PRODUCTIVE CONVERSATION WITH YOUR MEDICAL CARE TEAMS.