Thread by @Stan_JMoore, [1] Hi @Uro_Stream! I’m Stan Moore, MS4 from UWSOM, I’m excited to [...]

[1] Hi @Uro_Stream!

https://abs.twimg.com/emoji/v2/... draggable="false" alt="👋" title="Waving hand" aria-label="Emoji: Waving hand"> I’m Stan Moore, MS4 from UWSOM, I’m excited to explain some of the public confusion surrounding mesh Midurethral slings for Stress Urinary Incontinence and its implications. Special thanks to my mentors @SmigsM and @SuzetteESutherl

[2] Here’s some alphabet soup

https://abs.twimg.com/emoji/v2/... draggable="false" alt="🥣" title="Schüssel mit Löffel" aria-label="Emoji: Schüssel mit Löffel">
MUS = Midurethral slings
SUI = Stress Urinary Incontinence
RMUS = Retropubic MUS
TOT = Transobturator MUS
SIS = Single Incision Sling
POP = Pelvic Organ Prolapse
RCT = Randomized control trial
AE/SAE = Severe/Adverse Events
SOC = standard of care

[3] History/MUS types:

https://abs.twimg.com/emoji/v2/... draggable="false" alt="⏳" title="Sanduhr mit fließendem Sand" aria-label="Emoji: Sanduhr mit fließendem Sand">Mid 1990s–RMUS→Why? Integral theory - fulcrum action @ mid-urethra from intact pubourethral ligaments maintains continence during valsalva

https://abs.twimg.com/emoji/v2/... draggable="false" alt="⏳" title="Sanduhr mit fließendem Sand" aria-label="Emoji: Sanduhr mit fließendem Sand">Early 2000s–TOT→Why? Avoid Retropubic space = Avoid Bladder/Bowel perf, Large vessel injury

https://abs.twimg.com/emoji/v2/... draggable="false" alt="⏳" title="Sanduhr mit fließendem Sand" aria-label="Emoji: Sanduhr mit fließendem Sand">Mid 2000s–SIS…

[4] SIS provided improvements:

https://abs.twimg.com/emoji/v2/... draggable="false" alt="✅" title="Fettes weißes Häkchen" aria-label="Emoji: Fettes weißes Häkchen">Less Mesh

https://abs.twimg.com/emoji/v2/... draggable="false" alt="✅" title="Fettes weißes Häkchen" aria-label="Emoji: Fettes weißes Häkchen">Strong, direct anchoring system

https://abs.twimg.com/emoji/v2/... draggable="false" alt="✅" title="Fettes weißes Häkchen" aria-label="Emoji: Fettes weißes Häkchen"> Avoid RP and TO spaces → Less risk than both, RMUS and TOT

https://abs.twimg.com/emoji/v2/... draggable="false" alt="✅" title="Fettes weißes Häkchen" aria-label="Emoji: Fettes weißes Häkchen"> Minimal Post-op pain

https://abs.twimg.com/emoji/v2/... draggable="false" alt="✅" title="Fettes weißes Häkchen" aria-label="Emoji: Fettes weißes Häkchen"> Minimal Anesthesia – even just local

…wait, sounds like MUS are improving, so where’s the confusion?

[5] FDA conflates diff conditions & products→Public confusion
FDA ‘08-potential SAE w/ vaginal mesh for POP&SUI but noted that these were “rare”
FDA ‘11-Reversed position on “rare” AE w/ vaginal mesh for POP but not for SUI. Confusing since doc was riddled w/ references to SUI

[6] Confusion exemplified in litigation

https://abs.twimg.com/emoji/v2/... draggable="false" alt="📃" title="Seite mit Eselsohr" aria-label="Emoji: Seite mit Eselsohr"> Souder et al. reviewed 1% sample of 74k vaginal mesh legal claims 2000-2014

https://abs.twimg.com/emoji/v2/... draggable="false" alt="⬆️" title="Pfeil nach oben" aria-label="Emoji: Pfeil nach oben"> 700 in 2011 to 34k in 2013!
Overrepresented:

https://abs.twimg.com/emoji/v2/... draggable="false" alt="🚩" title="Dreieckige Fahne an einem Pfosten" aria-label="Emoji: Dreieckige Fahne an einem Pfosten">Cases involving only SUI (>60%)

https://abs.twimg.com/emoji/v2/... draggable="false" alt="🚩" title="Dreieckige Fahne an einem Pfosten" aria-label="Emoji: Dreieckige Fahne an einem Pfosten">Full-length MUS overall (~60%)

[6] Confusion exemplified in litigationhttps://abs.twimg.com/emoji/v2/... draggable=

Souder et al. reviewed 1% sample of 74k vaginal mesh legal claims 2000-2014https://abs.twimg.com/emoji/v2/... draggable="false" alt="⬆️" title="Pfeil nach oben" aria-label="Emoji: Pfeil nach oben"> 700 in 2011 to 34k in 2013!Overrepresented:https://abs.twimg.com/emoji/v2/... draggable="false" alt="🚩" title="Dreieckige Fahne an einem Pfosten" aria-label="Emoji: Dreieckige Fahne an einem Pfosten">Cases involving only SUI (>60%)https://abs.twimg.com/emoji/v2/... draggable="false" alt="🚩" title="Dreieckige Fahne an einem Pfosten" aria-label="Emoji: Dreieckige Fahne an einem Pfosten">Full-length MUS overall (~60%)" title="[6] Confusion exemplified in litigationhttps://abs.twimg.com/emoji/v2/... draggable="false" alt="📃" title="Seite mit Eselsohr" aria-label="Emoji: Seite mit Eselsohr"> Souder et al. reviewed 1% sample of 74k vaginal mesh legal claims 2000-2014https://abs.twimg.com/emoji/v2/... draggable="false" alt="⬆️" title="Pfeil nach oben" aria-label="Emoji: Pfeil nach oben"> 700 in 2011 to 34k in 2013!Overrepresented:https://abs.twimg.com/emoji/v2/... draggable="false" alt="🚩" title="Dreieckige Fahne an einem Pfosten" aria-label="Emoji: Dreieckige Fahne an einem Pfosten">Cases involving only SUI (>60%)https://abs.twimg.com/emoji/v2/... draggable="false" alt="🚩" title="Dreieckige Fahne an einem Pfosten" aria-label="Emoji: Dreieckige Fahne an einem Pfosten">Full-length MUS overall (~60%)">

[7] More from the FDA…
FDA 2013 statement finally clarifies that “full-length slings” (RMUS and TOT) are safe and effective,
but orders Postmarket Surveillance for SIS due to insufficient long-term data available

[8] Why were SIS singled out? 1/2
No long-term data available (2007 market launch) but also…
TVT-Secur was the first SIS, but was a flawed product; thus removed from market
One e.g.: Cornu et al. HIGH FAILURE RATES >40% at ~30 mo!

[9] Why were SIS singled out? 2/2
Moreover, high short-term failure rates: Andrada Hamer et al. INFERIOR subj/obj cure rates vs RMUS (RCT

https://abs.twimg.com/emoji/v2/... draggable="false" alt="🛑" title="Stop sign" aria-label="Emoji: Stop sign">based on 2-mo interim analysis +SAEx3)

https://abs.twimg.com/emoji/v2/... draggable="false" alt="1️⃣" title="Tastenkappe Ziffer 1" aria-label="Emoji: Tastenkappe Ziffer 1"> specific & inferior brand (TVT-Secur)→confusion & controversy around feasibility of SIS→“Bad

https://abs.twimg.com/emoji/v2/... draggable="false" alt="🍏" title="Grüner Apfel" aria-label="Emoji: Grüner Apfel">”

[10] A call for more data…
Cochrane 2017: b/c, most data has been for TVT-Secur – more high-quality, comparative trials are needed to assess whether the other types of SISs are as good as or safer than standard MUS.
However, some evidence that SIS are quicker and have less pain

[11] Attempts to parse out the bad

https://abs.twimg.com/emoji/v2/... draggable="false" alt="🍏" title="Grüner Apfel" aria-label="Emoji: Grüner Apfel">…
Mostafa et al 2014 meta-analysis of SISs (excluding TVT-Secur) vs RMUS+TOT:
Similar subj & obj efficacy – NOT INFERIOR!
Also noted with SIS:
↓operative time
↓pain scores (incisional, suprapubic, groin…)
Faster return to activities/work

[12] Emerging data for SIS
White et al 2020 compared Solyx (SIS) to Obtryx II (TOT) over 3 years
No difference in treatment success, time to discharge
No differences in AE such as mesh exposure, dyspareunia, pelvic pain and urinary retention

[13] Conclusion 1/2
Important to explain this controversy to those worried about mesh for SUI.
RMUS/TOT are the SOC for surgical treatment of female SUI with urethral hypermobility due to favorable benefit/risk ratio.

[14] Conclusions 2/2
RMUS/TOT are well studied, highly effective, safe, with quick return to work/activities.
And NOW... long-term data has emerged on the comparable efficacy and safety of currently available SISs (NOT TVT-Secur)

[15] References
1 – none
2 – none
3 - https://www.elsevier.com/books/urogynecology-and-reconstructive-pelvic-surgery/walters/978-0-323-11377-9">https://www.elsevier.com/books/uro... (Ch. 20, pg 272-294)
https://www.us.elsevierhealth.com/campbell-walsh-wein-urology-9780323546423.html">https://www.us.elsevierhealth.com/campbell-... (Ch. 125, pg 2830-2876)
4 – ibid, ibid &
https://www.youtube.com/watch?v=FCZeEgw_rPE
5">https://www.youtube.com/watch... - http://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/UCM262760.pdf
6">https://www.fda.gov/downloads... - https://pubmed.ncbi.nlm.nih.gov/28657986/ ">https://pubmed.ncbi.nlm.nih.gov/28657986/...

[16] More References
7- https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/fdas-activities-urogynecologic-surgical-mesh
8">https://www.fda.gov/medical-d... - https://pubmed.ncbi.nlm.nih.gov/20434258/
9-">https://pubmed.ncbi.nlm.nih.gov/20434258/... https://pubmed.ncbi.nlm.nih.gov/22707006/
BONUS:">https://pubmed.ncbi.nlm.nih.gov/22707006/... https://pubmed.ncbi.nlm.nih.gov/21756280/
10">https://pubmed.ncbi.nlm.nih.gov/21756280/... - https://pubmed.ncbi.nlm.nih.gov/28746980/
11">https://pubmed.ncbi.nlm.nih.gov/28746980/... - https://pubmed.ncbi.nlm.nih.gov/24055431/
12">https://pubmed.ncbi.nlm.nih.gov/24055431/... - https://www.ajog.org/article/S0002-9378(20)30330-6/">https://www.ajog.org/article/S...

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