(ws 26) management of complications from trans...

(WS 26) Management of Complications From Trans-vaginal Mesh:

TREATMENT ALGORITHM

IUGA 41st Annual MeetingAugust 3, 2016

Management of Complications From Trans-vaginal Mesh:

Learning Objectives

“At the end of this lecture, the learner will be able to…”.

• Describe the Scope of Complications from Trans-vaginal mesh

• Review the literature on management of complications

• Define an evidence informed treatment algorithm

Disclosure

I have the following relationships that could provide the perception of a conflict of interest:

• Research grants: – no direct corporate grants

• Speaker’s Bureau: – none

• Consultant:– Expert witness for defense in malpractice cases

• Investment: – none

Levels of Evidence• Level I: Based on RCTs *

• Level II-1: Cohort or case-control study *

• Level II-2: Comparisons between times and places with or without comparison*

• Level III: Opinions of respected authorities, descriptive studies, case reports

• Level 0: no evidence

*(at least 1 and well designed)Canadian Task Force on Periodic Helath Examination Can Med Assoc J 121(9) 1193-1254.

The morbidity and treatment of sling erosions vary significantly from procedures for POP using mesh.1-3 (III)

Patient presents with mesh complication

Mesh used for POPMesh used for MUS

The management of sling complications should be stratified by presenting symptoms.3,4 (III)

Functional Failure PainErosion

Voiding dysfunction immediately after surgery should be treated promptly with sling lengthening or release.5-7 (III)

Voiding Dysfxn Persistent SUI

Immediate Release

Later presentation should be evaluated with Urodynamics (UD).8(III)

Mesh used for MUS

Functional Failure Erosion

Delayed UDImmediate

Release

Sling release or incision is preferred to partial or complete removal.3 (II-2)

Mesh used for MUS

Delayed UDImmediate

ReleaseSling Release

Delayed sling release has a success rate of ~40%, with better results in younger patients(OR = 3.2), and those

without symptoms of OAB (OR = 3.1). 7 (II-2)

Mesh used for MUS

Delayed UDImmediate

ReleaseSling Release

Persistent USI should be evaluated with UD and a dynamic ultrasound to guide therapy.9(III)

Mesh used for MUS

Delayed UDImmediate

ReleaseUD Dynamic US

UD parameters do not predict outcome.10(II-1)

Office treatment of erosion rarely works.2,3,11(III)

Mesh used for MUS

Office Mgmt Surgical Mgmt

Trimming + EstrogenRarely works

Erosion by it self, can be treated with excision of

mesh to the point of tissue in-growth, and epithelial closure.3,11(III)

Trimming + EstrogenRarely work

Excision & Closure

Transurethral or endoscopic treatment in the urethra and bladder is often successful and less invasive.12-

14(III)

Excision & Closure

LUT Erosions

Endoscopic: may work, less morbid

Cystotomy or urethrotomy, excision and closure may be more effective.15(III)

Excision & Closure

LUT Erosions

Radical excision more effective

Erosion with pain, should be managed as for pain.3,11(III)

Excision & Closure

LUT Erosions Erosion & Pain

Pain usually includes a component of Levator Ani

Spasm. Consequently, all patients should pursue pelvic floor PT pre & postoperatively.16(III)

Ambulatory Mgmt Surgical Mgmt

Pelvic Floor PT

Pelvic pain, including groin pain from TOT, should

be treated with division of the vaginal portion of the sling.17(III)

PainErosion

Pelvic Floor PTVaginal Sling

Division .

There is limited evidence, that complete removal of

the vaginal wall portion of the sling provides better

outcomes then partial removal, but with greater complications.3,18 (III)

PainErosion

Pelvic Floor PTVaginal Sling

Division/Extirpation

Excision of sling arms, (legs or retropubic), generally

doesn’t impact symptoms, and is not without

morbidity. Reserve for patients with inflammatory response to the mesh material.18(III)

PainErosion

Pelvic Floor PTExcision of sling arms

Vaginal SlingDivision/Extirpation

Persistent pain may be due to obturator nerve entrapment. While MRI and EMG are not diagnostic,

improvement with injection of local anesthetic supports the diagnosis. Early complete excision is indicated.19 (III)

PainErosion

Vaginal excision has a recurrent SUI rate of ~20-36%.3,18(III)

PainErosion

Recurrent SUI ~20-36%

For POP procedures, management differs based on whether mesh is placed trans-vaginally (trocars or loose graft), versus sacral colpopexy.3,20 (III)

Sacral ColpopexyTrans-vaginal

Diagnostic Ultrasound is the best modality for imaging mesh, and has been shown to be more accurate than exam.21 (III)

Diagnostic U/S

Preferred Imaging Better than Exam

There is no compelling evidence to support a peri-operative role for ultrasound. (0)

Preferred Imaging Better than Exam

Diagnostic U/S

Peri-operative benefit not shown

The management of POP mesh complications should be stratified by presenting symptoms.3,4,22 (III)

Recurrent POP Erosion Pain Sexual Dysfxn

Management of isolated recurrent POP should not use additional trans-vaginal mesh or grafts.22(III)

Avoid trans-vaginal mesh & grafts

Vaginal excision for erosion and pain has a

recurrent POP rate of ~10-15%.3,23 Concurrent native tissue repair is recommended.24(II-2)

Trans-vaginal

Recurrent POP Erosion Pain

Avoid trans-vaginal mesh & grafts

Concurrent native tissue

Office treatment of erosion rarely works.2,3,11(III)

Trans-vaginal

Recurrent POP Erosion Pain

Excision & Closure

Erosion by it self, can be treated with a small

excision of mesh to the point of tissue in-growth, and epithelial closure.11(III)

Sacral Trans-vaginal

Excision & Closure

Endoscopic treatment of mesh in the urethra and

bladder generally is insufficient. Cystotomy or

urethrotomy, excision and closure seems to be more effective.15(III)

LUT Erosions Radical excision more effective

Erosion & PainExcision &

Closure

Erosion with pain, should be managed as for pain.3,11,22(III)

LUT Erosions

Because pain almost always includes a

component of Levator Ani Spasm, all patients

should pursue pelvic floor PT pre and post operatively.16(III)

Pelvic Floor PT

Vaginal Extirpation

Pelvic pain, including groin pain, should be treated

with division of the vaginal portion of the mesh and

complete removal of the vaginal wall portion of the mesh.11,22,25(III)

Pelvic Floor PT

Vaginal Extirpation

PudendalRelease

Pudendal neuralgia should be considered in patients with mesh arms in the SSL.17(III)

Pelvic Floor PT

Hispareunia Loss of TissueDyspareunia

Sexual dysfunction can relate to dyspareunia, hispaerunia, and loss of tissue.22,26(III)

Hispaerunia is generally cured with successful closure of an erosion.27(III)

Erosion Pain Sexual Dysfxn

Pelvic Floor PT

Sexual dysfunction can relate to LAS, and postop patients should pursue pelvic floor PT.16(III)

Pelvic Floor PTVaginal

Extirpation

Sexual dysfunction can relate to the mesh, so

division of the vaginal portion of the mesh and

complete removal of the vaginal wall portion of the mesh may be appropriate.22(III)

Extirpation

Pudendal neuralgia should be considered in patients with mesh arms in the SSL.17(III)

PudendalRelease

Vaginal Extirpation

Extirpation

Reconstructing the vagina in those with loss of

tissue is more effective when all mesh is

removed.(0)

PudendalRelease Flap

The most common mesh complication after sacral

colpopexy, is erosion. Vaginal pain is uncommon.

Low back pain due to osteomyelitis or discitis is

much rarer.28-30(III)

Erosion Low Back Pain

Vaginal erosions should initially be managed with

partial excision and partial colpocliesis, with or

without vaginoscopy, which is curative in 50% of

cases.3,31-33(II-2)

Sacral Colpopexyvaginal

Mesh used for POP

Partial colpocliesis

Failed cases should be managed with complete

extirpation by laparotomy. Morbidity is high.31,33(II-2)

Mesh used for POP

Extirpation by Lap

Manage visceral erosions by Lap

Visceral erosions should also be managed by

laparotomy. Morbidity is high.(0)

Mesh used for POP

Extirpation by Lap

MRI is the preferred imaging modality for

osteomyelitis and discitus.34(III)

Mesh used for POP

Extirpation by Lap

Prolonged IV Abx

Osteomyelitis may respond to prolonged

parenteral antibiotics.29(III)

Mesh used for POP

Extirpation by Lap

Prolonged IV AbxOrthopedic

debridement

Patients who do not respond will require

orthopedic debridement.30,31(III)

Mesh used for POP

Extirpation by Lap

References

1. Hammett J, Peters A et al. Short-term surgical outcomes and characteristics of patients with mesh complications from pelvic organ prolapse and stress urinary incontinence surgery. Int Urogynecol J. 2014 Apr;25(4):465-70.

2. Nguyen JN, Jakus-Waldman SM et al. Perioperative complications and reoperations after incontinence and prolapse surgeries using prosthetic implants. Obstet Gynecol. 2012 Mar;119(3):539-46.

3. Ozel B, Minaglia S, et al. Treatment of voiding dysfunction after transobturator tape procedure. Urol 2004 Nov;64(5):1030.

4. Carr LK, Webster GD. Voiding Dysfunction Following Incontinence Surgery: Diagnosis and Treatment With Retropubic or Vaginal Urethrolysis. 1997 Mar;157(3):821-3.

5. Hoon AJ, Bae JH, Lee JG. Incidence and Risk Factors of Postoperative De Novo Voiding Dysfunction following Midurethral Sling Procedures. Korean j Urol. 2009 Aug;50(8):762-6.

6. Hedge A, Davila W. Multi-compartment Imaging of Slings.

7. Deffieux X, de Tayrac R, et al. Vaginal mesh erosion after transvaginal repair of cystocele using Gynemesh or Gynemesh-Soft in 138 women: a comparative study. IntUrogynecol J, 2007Jan;18(1):73-9.

8. Shah K, Nikolavsky D, et al. Surgical management of lower urinary mesh perforation after mid-urethral polypropylene mesh sling:mesh excision, urinary tract reconstruction and concomitant pubovaginal sling with autologous rectus fascia.IntUrogynecol J. 2013 Jul 4 [epub ahead of print]

9. Talli Y, Rosenbaum PT Owens A. Continuing Medical Education: The Role of Pelvic Floor Physical Therapy in the Treatment of Pelvic and Genital Pain-Related Sexual Dysfunction. J Sex Med. 2008 Mar,5(3);513-23.

10. Marcus-Braun N, Bourret A, von Theobald P. Persistent pelvic pain following transvaginal mesh surgery: a cause for mesh removal. Eur J Obstet GynecolReprod Biol. 2012 Jun;162(2):224-8.

11. Lazare D, Stothers L, Geoffrion R, Cundiff GW. Patient Outcomes And Morbidity In The Management Of Pain Following Incontinence Surgery Using Synthetic Grafts. Presented at Society of Gynecologic Surgeons 40th Annual Scientific Meeting, Orlando FL, USA, 2014.

12. Alvarez J, Cvach K, Dwyer P. Complications in pelvic floor surgery. Minerva Ginecol. 2013 Feb;65(1):53-67.

13. Manonai J, Rostaminia G, Denson L, Shobeiri SA. Clinical and ultrasonographicstudy of patients presenting with transvaginal mesh complications. NeurourolUrodyn. 2015 Jan 25. doi: 10.1002/nau.22725.

14. Jonsson FunkM, Visco AG, Weidner AC, Pate V, Wu JM. Long-term outcomes of vaginal mesh versus native tissue repair for anterior vaginal wall prolapse. IntUnrogynecol J. 2013 Aug;24(8):1279-85.

15. Brubker L. Editorial: partner dyspareunia (hispareunia). IntUrogynecol J Pelvic Floor Dysfunct. 2006 Jun;17(4):311.

16. Jeffrey ST, Nieuwoudt A. Beyond the complications: medium-term anatomical, sexual and functional outcomes following removal of trocar-guided transvaginal mesh. A retrospective cohort study. Int Urogynecol J. 2012 Oct;23(10):1391-6

17. Tsia-Shu Lo, Yiap Loong Tan, et al. Clinical outcomes of mesh exposure/extrusion: presentation, timing and management. Aust NZ J obstetGynecol 2015 Jun; 55(3):284-90.

18. Nygaard IE, Cundiff GW et al. Abdominal Sacral Colpopexy: A comprehensive Review. Obstet Gynecol 2004, 104:805-23

19. Weidner A, Cundiff GW, et al. Sacral Osteomyelitis: An unusual complication of abdominal sacral colpopexy.Obstet Gynecol, Oct 1997; 90(4)689-91.

20. Taylor G, Bernnard MD, et al. Osteomyelitis secondary to sacral colpopexymesh erosion requiring laminectomy. Obstet Gynecol Feb 2006;107(2):475-7.

21. Quiroz LH, Gutman RE, Fagen MJ, Cundiff GW. Partial colpocleisis for the treatment of sacrocolpopexy mesh erosions. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Feb;19(2):261-6.

22. Nosseir S, Kim Y, et al. Sacral osteomyelitis after robotically assisted laparoscopic sacral colpopexy. Obstet Gynecol; Aug 2010;116(2):513-5

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