Mesh Erosion and What to do

Transcription

1 Disclosures Mesh Erosion and What to do None Michelle Y. Morrill, MD Chief of Urogynecology, TPMG Director of Urogynecology, Kaiser San Francisco Assistant Professor, Volunteer Faculty Dept of Ob/Gyn, UCSF Goals for Today Review the history of the use of vaginal mesh in surgery Discuss common and serious complications that can arise from vaginal mesh surgery Mesh - Synthetic Current standard: Polypropylene Type 1 Mesh Permanent, Monofilament and Macroporous Learn about the efficacy of various techniques for approaching vaginal mesh complications 1

2 Stress urinary incontinence (SUI) : Variety of abdominal and vaginal surgeries 1997 AUA SUI Guidelines recommend retropubic suspensions or (traditional) pubovaginal slings based on 4y outcomes *Both are abdominal surgeries with noted morbidity 1995 Ulmsten presents the mid-urethral sling (MUS) Funk et al. Trends in the Surgical Management of Stress Urinary Incontinence. Obstet Gynecol 2012;119: SUI continued 2014 Systematic Review of English language RCTs with 12m follow-up 127 papers on 49 unique trials MUS equivalent or superior to Burch and pubovaginal sling by subjective, objective and adverse event outcomes SUI continued 2014 AUGS/SUFU Position Statement on MUS The polypropylene mesh midurethral sling is the recognized worldwide standard of care for the surgical treatment of stress urinary incontinence. The procedure is safe, effective, and has improved the quality of life for millions of women. Schimpf MO, Rahn DD, Wheeler TL, et al. Sling surgery for stress urinary incontinence in women: a systematic review and metaanalysis. Am J Obstet Gynecol 2014; Jul;211(1):71.e1-71.e27. 2

3 Pelvic organ prolapse (POP) Vaginal vs. Abdominal approach 1996 Benson et al. RCT avg f/u 2.5y Abd 16% repeat surgery Vaginal 33% repeat surgery 1997 Olsen et al. 30% of surgeries for POP or UI were repeats Benson et al. Am J Obstet Gynecol, 1996; 175(6): Olsen et al. Obstet Gynecol 1997;89:501-6 POP continued 2001 FDA approves mesh device for prolapse 510k based on similarity to mesh for hernia repair ~100 devices developed over the following years Ellington DR, Richter HE. The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk. Obstetrics and Gynecology International. Volume 2013, Article ID Events reported in MAUDE Erosion Pain Infection Bleeding Dyspareunia Organ Perforation 88 7 Urinary Problems 80 8 Vaginal Scarring/Shrinkage 43 9 Neuromuscular Problems Recurrent Prolapse 32 POP continued 2008 FDA Public Health Warning >1000 reports in 3y of mesh device complications Recommend specialized training Recommend patient education A. I. Brill, The hoopla over mesh: what it means for practice,. Obstetrics & Gynecology News, pp ,

4 POP continued 2008 FDA Public Health Warning >1000 reports in 3y of mesh device complications 2011 July FDA Safety Communication >2800 reports in 3y of mesh device complications Serious adverse events are NOT rare, contrary to what was stated in the 2008 PHN Transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair. POP continued 2011 ACOG/AUGS Committee Opinion POP vaginal mesh repair should be reserved for high-risk individuals in whom the benefit of mesh placement may justify the risk Surgeons need particular training Further research recommendations POP continued 2012 FDA mandates postmarket studies (522 studies) for transvaginal mesh devices for POP Mesh Today Multi-incision MUS Gold Standard Single incision MUS Sacrocolpopexy Abdominal or Laparoscopic approach Vaginally placed mesh for POP 4

5 Adverse Events Adverse Events 1 Erosion Pain Infection Bleeding Dyspareunia Organ Perforation 88 7 Urinary Problems 80 8 Vaginal Scarring/Shrinkage 43 9 Neuromuscular Problems Recurrent Prolapse 32 1) Mesh erosion in vagina Intimate partner pain (His-pareunia) 2) Mesh erosion into urinary tract or bowel 3) Dyspareunia or Pelvic Pain 4) Voiding dysfunction 5

6 Mesh Erosion in the Vagina Presentation / Symptoms Symptoms : vaginal discharge, odor, vaginal pain, dyspareunia, or pain by the sexual partner Often asymptomatic Wong et al. 56% incidentally found May present years after surgery Wong K, et al. Adverse Events Associated With Pelvic Organ Prolapse Surgeries That Use Implants. Obstet Gynecol 2013;122: Mesh Erosion Rates Vaginal approach prolapse surgery Cochrane 2013 Anterior mesh 11% erosion Multiple compartments 18% erosion Mesh Erosion Rates Sacrocolpopexy 2.2% Mesh erosion or infection in 52 studies of >5600 patients mean 26m f/u 10% Mesh erosion at 5y in RCT of open sacrocolpopexy (84% f/u) Maher C et al. Surgical management of pelvic organ prolapse in women. Cochrane Database of Systematic Reviews 2013, Issue 4. Art. No.: CD Diwadkar et al. Complication and Reoperation Rates After Apical Vaginal Prolapse Surgical Repair A Systematic Review. Obstet Gynecol 2009;113: Nygaard I, et al. Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse JAMA. 2013;309(19):

7 Mesh Erosion Rates Mesh Erosion Mid-Urethral Slings 1.4%-2.2% (retropubic & trans-obt) Risk Factors Concomitant hysterectomy Vaginal Perforation Diabetes Smoking Age Hematoma / Blood transfusion Trans-obt > Retropubic Schimpf MO, Rahn DD, Wheeler TL, et al. Sling surgery for stress urinary incontinence in women: a systematic review and metaanalysis. Am J Obstet Gynecol 2014; Jul;211(1):71.e1-71.e27. Abed et al. Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review. Int Urogynecol J (2011) 22: Osborn DJ et al. Analysis of patient and technical factors associated with midurethral sling mesh exposure and perforation. Int J Urol Jul 14. Kokanali MK, et al. Risk factors for mesh erosion after vaginal sling procedures for urinary incontinence. Eur J Obstet Gynecol Reprod Biol Jun;177: POP Mesh Erosion Management POP Mesh Erosion Management Treatment Observation Vaginal Estrogen Office Excision OR Excision Efficacy Treatment Efficacy Observation?30% 1 Vaginal Estrogen 20% 1,2 Office Excision 43% 1 OR Excision 90-95% 1,3 Deffieux X, et al. Long-term follow-up of persistent vaginal polypropylene mesh exposure for transvaginally placed mesh procedures. Int Urogynecol J (2012) 23: Wong K, et al. Adverse Events Associated With Pelvic Organ Prolapse Surgeries That Use Implants. Obstet Gynecol 2013;122: Abed et al. Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review. Int Urogynecol J (2011) 22: Crosby EC, et al. Symptom Resolution After Operative Management of Complications From Transvaginal Mesh. Obstet Gynecol 2014;123:

8 POP Mesh Erosion Management Treatment Efficacy Observation?30% Vaginal Estrogen 20% Office Excision 43% OR Excision 90-95% OR excision may be best initial approach for symptomatic erosion Skoczylas LC, et al. Managing mesh exposure following vaginal prolapse repair: a decision analysis comparing conservative versus surgical treatment. Int Urogynecol J 2013;24: MUS Mesh Erosion Management Observation / Vaginal Estrogen TOMUS most did not require surgery 1 Vaginal mucosa flap 2 2/8 exposure recurrence, 8/8 persistent d/c Excision 1 Brubaker L, et al; for the Urinary Incontinence Treatment Network. Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study. Am J Obstet Gynecol 2011;205:498.e Kim SY, et al. Vaginal Mucosal Flap as a Sling Preservation for the Treatment of Vaginal Exposure of Mesh. Korean J Urol 2010;51: Mesh Excision Approach Small / Focal Dissect overlying epithelium off of mesh ~1cm from edge of erosion Mesh Excision Approach Small / Focal Dissect overlying epithelium off of mesh ~1cm from edge of erosion Incise mesh and dissect from underlying tissue Close epithelium Barber MD. Surgical Techniques for Removing Problematic Mesh. CLINICAL OBSTETRICS AND GYNECOLOGY Volume 56, Number 2, Barber MD. Surgical Techniques for Removing Problematic Mesh. CLINICAL OBSTETRICS AND GYNECOLOGY Volume 56, Number 2,

9 Mesh Excision Approach Mesh Erosion or Perforation into Urinary Tract or Bowel Large / Recurrent Remove as much mesh as possible vaginally Know the implant Consider epithelial augmentation with biologic graft Barber MD. Surgical Techniques for Removing Problematic Mesh. CLINICAL OBSTETRICS AND GYNECOLOGY Volume 56, Number 2, Mesh Erosion or Perforation into Urinary Tract or Bowel May happen early or late May be asymptomatic or have subtle symptoms Increased risk with perforation, even if repaired Tip: Don t lay mesh over a repaired -otomy Paine M, et al. Transrectal mesh erosion remote from sacrocolpopexy: management and comment. Am J Obstet Gynecol Aug;203(2):e11-3. Mesh in Bladder Consider options for approach Vaginal Laparoscopic / Laparotomy Cystoscopic with Suprapubic port Consider possibility of ureteral involvement Stenting / need for reimplantation Detailed counseling Appropriate consults 9

10 Mesh in Bowel Consider options for approach Rectal Vaginal Laparoscopic / Laparotomy Detailed counseling Appropriate consults Mesh in Urethra Approaches: transvaginal or transurethral Optimize visualization Nasal speculum Hysteroscope Grasp ie with Endoclose Mesh in Urinary Tract or Bowel Overall : Optimize Surgery Mesh and Pain Multi-Disciplinary Team Wait for ideal time for patient Very Carefully 10

11 Dyspareunia 9% Mesh and Pain RF = posterior colporrhaphy and mesh erosion Dyspareunia rates are similar for mesh and native tissue prolapse repairs Excision resolves pain ~50% of the time Possible confounder: reporting / identifying pain pre-op Mesh and Pain Consider Physical Therapy Before Pelvic Reconstructive Surgery if patient has pain In conjunction with surgical management of post-operative pain Abed et al. Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review. Int Urogynecol J (2011) 22: Crosby EC, et al. Symptom Resolution After Operative Management of Complications From Transvaginal Mesh. Obstet Gynecol 2014;123:134 9 Voiding Dysfunction Voiding Dysfunction Persistent voiding dysfunction Retropubic MUS Trans-obturator MUS 2.7% 2.4% Schimpf MO, Rahn DD, Wheeler TL, et al. Sling surgery for stress urinary incontinence in women: a systematic review and metaanalysis. Am J Obstet Gynecol 2014 Jul;211(1):71.e1-71.e27. 11

12 Voiding Dysfunction Retrospective of patients with voiding dysfunction who had Simple incision or Partial excision ~10% persistent retention 50% if new incontinence procedure included 2% (simple) vs. 23% (partial) had repeat incontinence surgery Review Surgical mesh around the vagina provides effective and long lasting treatments But is still a developing story Mesh exposure in the vagina often does not require intervention Surgical excision usually is effective for mesh exposure treatment But some women require multiple surgeries Agnew G, et al. Functional outcomes for surgical revision of synthetic slings performed for voiding dysfunction: a retrospective study. Eur J Obstet Gynecol Reprod Biol. Jul;163(1):113-6 Review Questions? Mesh in the bladder or bowel Avoid placing mesh over organ repair Multi-disciplinary approach Pelvic pain / dyspareunia should be queried + treated before PFD surgery Simple sling incision > Partial excision for Tx of post-op voiding dysfunction 12