The Vaginal Mesh Mania: Consultant Johnson & Johnson Facts - PowerPoint PPT Presentation

Disclosures The Vaginal Mesh Mania: • Consultant – Johnson & Johnson Facts & Fiction Olga Ramm, MD MS Division of Urogynecology - FPMRS Department of OB/Gyn Kaiser Permanente East Bay Fellowship Director, KPEB - UCSF FPMRS Fellowship Program 1 2 What this lecture is NOT about: • Transvaginal mesh kits • Mesh placed abdominally for Background: The State of Mesh Today sacrocolpopexy • Hand-cut non-anchored transvaginal mesh 3 4

Lecture Objectives: SUI: Epidemiology • 25% of US women are affected by 1+ pelvic floor disorders 1 • Understand the indications for mid-urethral sling (MUS) surgery • SUI is the most common pelvic floor disorder, with 17% of US women affected by moderate-severe SUI 2 • Discuss patient selection and surgical treatment options for stress urinary incontinence (SUI) • 14% of US women undergo surgical treatment of SUI in their lifetime 2 • Be aware of the incidence and presentation of mesh complications • Mid-urethral slings account for the majority of these operations following MUS surgery • 80% between 2000 and 2009 3 , closer to 95% now • Be aware of the complication profile of non-mesh surgical treatment for SUI 1. Nygaard et al. JAMA 2008 2. Wu et al. Obstet Gynecol 2014 3. Johnsson Funk et al. Obstet Gynecol 2012 5 6 SUI: Pathophysiology SUI: Non-surgical treatment Many factors contribute to urinary • Behavioral modifications continence: • Nerves (central & peripheral) • Pelvic Floor Muscle Strengthening • Urethral sphincter • Pessary • Accessory muscles (Levator ani) • Urethral coaptation • Tissue elasticity • Tissue turgor • Blood flow 7 8

SUI: Surgical Treatment SUI: Surgical Treatment Patient goals inform patient-important outcomes Pubovaginal sling Burch urethropexy Midurethral slings • Retropubic • Transobturator • Single Incision Resolution of SUI symptoms is not the only measure of surgical success Elkadry et al. AJOG 2003 9 10 SUI: Complications of ANY Surgical SUI: Postsurgical Complications Treatment • Urinary tract infection Complication Burch Native Tissue Sling Midurethral Synthetic Sling • Urinary retention Dyspareunia 2.7-19% ??? 0.15% Short-term • Wound infection 7-20% 3% 0.75% Long-term • Foreign body complication <1% 0.8% (23% for cadaveric) 2% • Voiding dysfunction Pelvic pain / Groin pain 6.8% ??? 1.5% (RP); 6.5% (TO) Voiding dysfunction 3.4-22% 14% 1.6% • Pain / Dyspareunia Reoperation 7% 9% 2.4-3.7% • Urgency-frequency • Urgency incontinence Gurol-Urganci et al. JAMA 2018 • Foreign body complications (erosion, exposure) Athanasopoulos et al. Urology 2010 Maguire et al. J Urol 2002 Demirci et al. Gynecol Obstet Ivest 2001 Schimpf et al. AJOG 2014 Dwyer et al. IUJ 1999 Chaliha et al. BJOG 1999 11 12

SUI: Postsurgical Outcomes Synthetic Midurethral Slings Ford et al. Cochrane Database Systematic Review 2015: %; (years of follow up) “mid-urethral sling operations have been the most extensively researched surgical Burch Native Tissue Sling Midurethral Synthetic Sling treatment for stress urinary incontinence in women and have a good safety profile. Objective 80% (5) 80-91% (17) Irrespective of the routes traversed, they are highly effective in the short and medium Subjective 44-75% (6, 14) 80-89% (17) term, and accruing evidence demonstrates their effectiveness in the long term. This Combined 13% (7) 27% (7) 60-75 (5) review illustrates their positive impact on improving the quality of life of women with Patient Satisfaction 70-90% (5) 83% (5) 77-94% (5) stress urinary incontinence”. Reoperation for SUI 26% (7) 2% (7) 4% (17) Demirci et al. Gynecol Obstet Invest 2001 Bakas et al. IUJ 2018 Braga et al. BJU 2018 Trabuco et al. Obstet Gynecol 2018 Brubaker et al. J Urol 2012; Richter et al. J Urol 2012 Ward et al. BJOG 2008 13 14 Properties of preferred surgical mesh: Type 1 Synthetic Midurethral Slings ACOG Bulletin #155: Urinary Incontinence in Women (2015) Monofilament “Synthetic midurethral slings demonstrate efficacy that is similar to traditional suburethral fascial slings, open colposuspension, and laparoscopic colposuspension. Compared with suburethral fascial slings, Large Flexible fewer adverse events have been reported with synthetic midurethral pores slings. Voiding dysfunction is more common with open colposuspension than with synthetic midurethral slings. There are substantial safety and efficacy data that support the role of Lightweight synthetic mesh midurethral slings as primary surgical treatment option for stress urinary incontinence in women.” Amid PK. Classification of biomaterials and their related complications in abdominal wall hernia surgery. Hernia. 1997 15 16

Midurethral Sling Mesh The Present Medicolegal Climate Inert 100,000+ women filed federal lawsuits Thousands more filed state lawsuits • Falconer C et al. IUJ 2001 Two state attorney generals (WA, CA) have sued device manufacturers Non-degradable Medical device manufacturers have agreed to pay billions of dollars to • Thames SF et al. IUJ 2016 tens of thousands of injured women. Safe The final tally could exceed $10 billion. Three dozen women whose cases • Linder BJ et al. IUJ 2016 have gone to trial have won an average award of $14 million. • King AB et al. Urology 2014 • Chughtai B et al. AJOG 2017 Goldstein. New York Times 2019. 17 18 The Present Medicolegal Climate The Present Medicolegal Climate “Previously undisclosed deposition transcripts and Reuters interviews Plaintiffs are manipulated to have the implants removed without with mesh patients have discovered businesses investing in surgeries for indication for the financial benefit of physicians and lawyers: injured plaintiffs. It's a practice that has become deeply entangled with • Federal prosecutors in Brooklyn indicted a doctor and a consultant medical device litigation”. Alison Frankel and Jessica Dye. Reuters 2015 . in a scheme to profit from removing mesh implants. NYT May 2019. • Three women contend in a federal suit in TX that lawyers helped The big settlements drew interest from hedge funds and private equity arrange for them to have costly removal procedures that would firms, which provided loans to finance some of the lawyers bringing the increase the value of the women’s claims and lift the lawyers’ fees. suits. Goldstein & Silver-Greenberg. NYT 2018. NYT June 2019 . 19 20

The Present Medicolegal Climate The Present Medicolegal Climate AUGS/ACOG 2017 Committee Opinion 694: • Meticulous patient selection Preoperative pelvic pain Management of Mesh and Graft Complications in Gynecologic Surgery. • • Preoperative dyspareunia • In cases of exposure or pain, removal of mesh in its entirety is not indicated and • Preoperative urgency-frequency mesh removal surgery should not be performed unless there is a specific Preoperative voiding dysfunction • therapeutic indication • Shared, patient-centered decision-making with an emphasis on patient-selected postsurgical goals Patient goal attainment = Patient satisfaction AUA 2019 Position Statement: • • Close follow-up with early diagnosis and management of • Any restriction of the use of synthetic polypropylene mesh suburethral slings complications would be a disservice to women who choose surgical correction of SUI 21 22 Thank you! Happy to take questions 23