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

The Vaginal Mesh Mania: 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

Disclosures

• Consultant – Johnson & Johnson

Background: The State of Mesh Today What this lecture is NOT about:

• Transvaginal mesh kits
• Mesh placed

abdominally for sacrocolpopexy

• Hand-cut non-anchored

transvaginal mesh

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Lecture Objectives:

• Understand the indications for mid-urethral sling (MUS) surgery
• Discuss patient selection and surgical treatment options for stress

urinary incontinence (SUI)

• Be aware of the incidence and presentation of mesh complications

following MUS surgery

• Be aware of the complication profile of non-mesh surgical

treatment for SUI

SUI: Epidemiology

• 25% of US women are affected by 1+ pelvic floor disorders 1
• SUI is the most common pelvic floor disorder, with 17% of US women

affected by moderate-severe SUI 2

• 14% of US women undergo surgical treatment of SUI in their lifetime 2
• Mid-urethral slings account for the majority of these operations
• 80% between 2000 and 2009 3, closer to 95% now

1. Nygaard et al. JAMA 2008 2. Wu et al. Obstet Gynecol 2014 3. Johnsson Funk et al. Obstet Gynecol 2012

SUI: Pathophysiology

Many factors contribute to urinary continence:

• Nerves (central & peripheral)
• Urethral sphincter
• Accessory muscles (Levator ani)
• Urethral coaptation
• Tissue elasticity
• Tissue turgor
• Blood flow

SUI: Non-surgical treatment

• Behavioral modifications
• Pelvic Floor Muscle Strengthening
• Pessary

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SUI: Surgical Treatment

Pubovaginal sling Burch urethropexy Midurethral slings

• Retropubic
• Transobturator
• Single Incision

SUI: Surgical Treatment

Patient goals inform patient-important outcomes Resolution of SUI symptoms is not the only measure of surgical success

Elkadry et al. AJOG 2003

SUI: Complications of ANY Surgical Treatment

• Urinary tract infection
• Urinary retention
• Short-term
• Long-term
• Voiding dysfunction
• Pain / Dyspareunia
• Urgency-frequency
• Urgency incontinence
• Foreign body complications (erosion, exposure)

SUI: Postsurgical Complications

Complication Burch Native Tissue Sling Midurethral Synthetic Sling Dyspareunia 2.7-19% ??? 0.15% Wound infection 7-20% 3% 0.75% Foreign body complication <1% 0.8% (23% for cadaveric) 2% Pelvic pain / Groin pain 6.8% ??? 1.5% (RP); 6.5% (TO) Voiding dysfunction 3.4-22% 14% 1.6% Reoperation 7% 9% 2.4-3.7%

Gurol-Urganci et al. JAMA 2018 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

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SUI: Postsurgical Outcomes

%; (years of follow up)

Burch Native Tissue Sling Midurethral Synthetic Sling Objective 80% (5) 80-91% (17) Subjective 44-75% (6, 14) 80-89% (17) Combined 13% (7) 27% (7) 60-75 (5) Patient Satisfaction 70-90% (5) 83% (5) 77-94% (5) 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

Synthetic Midurethral Slings

Ford et al. Cochrane Database Systematic Review 2015:

“mid-urethral sling operations have been the most extensively researched surgical treatment for stress urinary incontinence in women and have a good safety profile. Irrespective of the routes traversed, they are highly effective in the short and medium term, and accruing evidence demonstrates their effectiveness in the long term. This review illustrates their positive impact on improving the quality of life of women with stress urinary incontinence”.

Synthetic Midurethral Slings

ACOG Bulletin #155: Urinary Incontinence in Women (2015) “Synthetic midurethral slings demonstrate efficacy that is similar to traditional suburethral fascial slings, open colposuspension, and laparoscopic colposuspension. Compared with suburethral fascial slings, fewer adverse events have been reported with synthetic midurethral

• 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 synthetic mesh midurethral slings as primary surgical treatment option for stress urinary incontinence in women.”

Properties of preferred surgical mesh: Type 1

Monofilament

Large pores

Lightweight Flexible

Amid PK. Classification of biomaterials and their related complications in abdominal wall hernia surgery.

• Hernia. 1997

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Midurethral Sling Mesh

Inert

• Falconer C et al. IUJ 2001

Non-degradable

• Thames SF et al. IUJ 2016

Safe

• Linder BJ et al. IUJ 2016
• King AB et al. Urology 2014
• Chughtai B et al. AJOG 2017

The Present Medicolegal Climate

100,000+ women filed federal lawsuits Thousands more filed state lawsuits Two state attorney generals (WA, CA) have sued device manufacturers Medical device manufacturers have agreed to pay billions of dollars to tens of thousands of injured women. The final tally could exceed $10 billion. Three dozen women whose cases have gone to trial have won an average award of $14 million.

• Goldstein. New York Times 2019.

The Present Medicolegal Climate

“Previously undisclosed deposition transcripts and Reuters interviews with mesh patients have discovered businesses investing in surgeries for injured plaintiffs. It's a practice that has become deeply entangled with medical device litigation”. Alison Frankel and Jessica Dye. Reuters 2015. The big settlements drew interest from hedge funds and private equity firms, which provided loans to finance some of the lawyers bringing the

• suits. Goldstein & Silver-Greenberg. NYT 2018.

The Present Medicolegal Climate

Plaintiffs are manipulated to have the implants removed without indication for the financial benefit of physicians and lawyers:

• Federal prosecutors in Brooklyn indicted a doctor and a consultant

in a scheme to profit from removing mesh implants. NYT May 2019.

• Three women contend in a federal suit in TX that lawyers helped

arrange for them to have costly removal procedures that would increase the value of the women’s claims and lift the lawyers’ fees.

NYT June 2019.

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The Present Medicolegal Climate

AUGS/ACOG 2017 Committee Opinion 694: Management of Mesh and Graft Complications in Gynecologic Surgery.

• In cases of exposure or pain, removal of mesh in its entirety is not indicated and

mesh removal surgery should not be performed unless there is a specific therapeutic indication

AUA 2019 Position Statement:

• Any restriction of the use of synthetic polypropylene mesh suburethral slings

would be a disservice to women who choose surgical correction of SUI

The Present Medicolegal Climate

• Meticulous patient selection
• Preoperative pelvic pain
• Preoperative dyspareunia
• Preoperative urgency-frequency
• Preoperative voiding dysfunction
• Shared, patient-centered decision-making with an emphasis on

patient-selected postsurgical goals

• Patient goal attainment = Patient satisfaction
• Close follow-up with early diagnosis and management of

complications

Thank you! Happy to take questions

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