ACOG/AUGS Guidance Update: Diagnosis and Management of Pelvic Organ Prolapse Including Role of Mesh

Table of Contents  

SUMMARY:

ACOG and AUGS have updated the Pelvic Organ Prolapse (POP) recommendations. Guidelines now address the FDA order for manufacturers to discontinue sale and distribution of mesh for treatment of POP in the US. The FDA order applies only to mesh placed vaginally for POP and does not apply to (1) transvaginal mesh for SUI or (2) sacrocolpopexy (abdominal placement). POP is considered ‘benign’, but symptoms can seriously impact quality of life, affecting defecatory, voiding and sexual function.

CLINICAL ACTIONS:

POP Definition and Staging

Definition

  • Descent of uterus or vagina which may result in organ prolapse
    • Anterior wall
      • Cystocele (bladder) | Urethrocele | Cystourthrocele
    • Posterior wall
      • Rectocele (rectum) | Enterocele (small bowel)
    • Apical
      • Uterine | Vaginal vault (post hysterectomy)
  • ACOG/AUGS state

Pelvic organ prolapse only should be considered a problem if it is causing prolapse symptoms (ie, pressure with or without a bulge) or sexual dysfunction or if it is disrupting normal lower urinary tract or bowel function

POP-Q Staging

See below in ‘Learn More – Primary Sources’ for link to AUGS POP-Q tool

  • Stage 0
    • No prolapse
  • Stage 1
    • Criteria for stage 0 are not met
    • Most distal prolapse is more than 1 cm above the level of the hymen
  • Stage 2
    • Most distal prolapse is between 1 cm above and 1 cm below the hymen
  • Stage 3
    • Most distal prolapse is >1 cm below the hymen but no further than 2 cm less than the total vaginal length
  • Stage 4
    • Complete procidentia or vault eversion

History

  • Women presenting with POP should undergo a careful history and physical examination with attention to the degree of bother caused by the prolapse
    • Assess urinary incontinence and bladder emptying
      • Gravitational effect (increased organ displacement): Is voiding more difficult after standing?
      • Does manually reducing the bulge (‘splinting’) improve urinary flow?
    • Assess bowel function
      • Straining | Laxative use | Splinting to reduce rectocele and improve rectal emptying
    • Impact on sexual function
      • Dyspareunia | Coital continence

Physical

  • Comprehensive abdominal and physical exam
  • For some patients, extent of descent can be evaluated in the supine position but if unclear, having patient stand may uncover extent of prolapse
  • Pelvic floor tone
    • Ask patient to contract and relax musculature and grade on following scale
      • Absent | Weak | Normal | Strong
  • Use single blade to hold away opposite vaginal wall during visual exam of the vault and apex
  • Urinary symptoms
    • Voiding symptoms or prolapse is evident beyond hymenal ring
      • Perform postvoid residual volume (catheter or ultrasound)
      • Note: Consider urodynamics in the presence of incontinence and ≥stage II prolapse or voiding dysfunction
    • Urgency or other UTI symptoms
      • Perform urinalysis: Culture and microscopy
  • Assess the pelvic organs and perform a pelvic organ prolapse quantification (POP-Q)
    • The POP-Q system is recommended before treatment of POP to quantify the degree of prolapse
  • Note: If findings do not match symptoms, referral to urogynecologist “may be needed”

KEY POINTS:

Risk Factors

Increasing parity | Vaginal delivery | Age | Menopausal status | Obesity | Connective tissue disorders | Chronic constipation

Treatment

Nonsurgical

  • Consider nonsurgical treatment options when appropriate
    • Modifiable risk factors include obesity and constipation
    • Pelvic muscle exercises
    • Pessary – generally considered low-risk option and a good alternative for women who wish to maintain fertility
      • Follow up 3 to 4 months if patient can not replace own pessary; Otherwise annual visit sufficient
      • In case of erosion, remove pessary for 2 to 4 weeks and apply local estrogen therapy (may resolve without estrogen therapy) | Consider more frequent pessary removal and cleaning

Surgical Therapy for Failed/Declined Nonsurgical Treatment

  • Upper vaginal prolapse
    • Abdominal sacrocolpopexy
    • Uterosacral ligament suspension
    • Sacrospinous fixation
  • Anterior wall prolapse
    • Anterior colporrhaphy
  • Posterior wall prolapse
    • Posterior colporrhaphy

Additional Notes on Surgical Treatment

  • Vaginal apex suspension (uterosacral or sacrospinous ligament suspension) should be performed at the time of hysterectomy for uterine prolapse
  • Anterior wall prolapse is commonly associated with apical prolapse
    • Both should be surgically corrected if present to reduce risk of recurrent POP
  • Posterior wall prolapse repair is more effectively done vaginally rather than transanally
  • Candidates for abdominal sacrocolpopexy (mesh or biologic graft from vaginal apex to anterior longitudinal ligament of sacrum) include those at high risk for recurrence
    • Age <60 years
    • POP-Q stage 3 or 4
    • BMI >26
    • Authors of the Cochrane Review (2016) of sacrocolpopexy for apical repair concluded that mesh was not superior to native tissue repair

Sacral colpopexy is associated with lower risk of awareness of prolapse, recurrent prolapse on examination, repeat surgery for prolapse, postoperative SUI and dyspareunia than a variety of vaginal interventions

Synthetic Mesh and Biologic Graft Materials in Vaginal POP Surgery

  • FDA (April 2019) ordered manufacturers of synthetic mesh for POP to discontinue sale and distribution in the US
  • This order applies to transvaginal mesh only and not transabdominal POP or SUI

Vaginal Prolapse Repair

  • Both mesh or biologic grafts are associated with greater likelihood of repeat surgery for combined outcomes of prolapse, stress incontinence or mesh exposure
  • Data on biologic grafts (e.g. cadaver) are limited and of low quality (most no longer available for use)

Posterior Wall Prolapse

  • Use of synthetic mesh or biologic grafts is associated with increased complications (mesh exposure) and no improvement in outcome
  • Mesh or grafts should not be used routinely in the primary repair of posterior wall prolapse

Anterior Wall Prolapse

  • Biologic grafts show minimal/ no difference in recurrence risk vs native tissue repair
  • Synthetic mesh improves anatomic outcome, but is associated with
    • Increased risk of repeat surgery for prolapse, urinary incontinence and mesh exposure
    • Longer operating times and greater blood loss
    • 11% risk of mesh erosion following anterior vaginal repair
    • 7% of cases that will require surgical correction
    • Dyspareunia rate of approximately 9%

Notes:

  • Use of mesh or biologic grafts should only be undertaken by surgeons who have training specific for these procedures
    • Training should include patient selection, anatomy, intraoperative and postoperative techniques, treatment of any adverse outcomes
  • Routine intraoperative cystoscopy should be performed during POP surgery when there is risk to the bladder or ureter
  • AUGS 2013 position statement on credentialing includes the following

It is imperative that local hospitals and health systems establish and strictly enforce robust processes to both/credential and audit surgeons with specific expertise, experience, training and skill to perform these procedures. AUGS has developed, and published credentialing guidelines for transvaginal mesh surgery for pelvic organ prolapse and sacrocolpopexy for the treatment of pelvic organ prolapse.

Learn More – Primary Sources:

ACOG Practice Bulletin 214: Pelvic organ prolapse

ACOG Committee Opinion 694: Management of Mesh and Graft Complications in Gynecologic Surgery

AUGS: Update on FDA Announcement on Transvaginal Mesh for Prolapse

FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices

Cochrane Review: Surgery for women with anterior compartment prolapse. Cochrane Database of Systematic Reviews

Incidence and Management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systemic review. Systematic Review Group of the Society of Gynecologic Surgeons.

AUGS Position Statement on Restriction of Surgical Options for Pelvic Floor Disorders, March 26, 2013

AUGS POP-Q Tool

FIGO review of statements on use of synthetic mesh

AUGS-SUFU_Joint Position Statement on Midurethral Slings for Stress Urinary Incontinence

Mesh and Pelvic Organ Prolapse: ACOG Practice Advisory & ACOG/AUGS Recommendations 

SUMMARY:

FDA (April 2019) ordered manufacturers of synthetic mesh for the treatment of Pelvic Organ Prolapse (POP) to discontinue sale and distribution in the US. ACOG responded with a Practice Advisory, which  emphasizes that the FDA order applies only to mesh placed vaginally for POP and does not apply to (1) transvaginal mesh for SUI or (2) sacrocolpopexy (abdominal placement). POP is considered ‘benign’, but symptoms can seriously impact quality of life, affecting defecatory, voiding and sexual function.

Clinical Considerations

  • Women presenting with POP should undergo a careful history and physical examination with attention to the degree of bother caused by the prolapse
    • Assess urinary incontinence and bladder emptying
    • Assess bowel function
  • Carefully assess the pelvic organs and perform a pelvic organ prolapse quantification (POP-Q)
    • The POP-Q system is recommended before treatment of POP to quantify the degree of prolapse
  • Consider nonsurgical treatment options when appropriate
  • If surgery is necessary, the procedure should address all areas of prolapse
  • Vaginal apex suspension (uterosacral or sacrospinous ligament suspension) should be performed at the time of hysterectomy for uterine prolapse
  • Anterior wall prolapse is commonly associated with apical prolapse
    • Both should be surgically corrected if present to reduce risk of recurrent POP
  • Posterior wall prolapse repair is more effectively done vaginally rather than transanally

Synthetic Mesh and Biologic Graft Materials In Vaginal POP Surgery

  • Both mesh or grafts are associated with greater likelihood of repeat surgery for combined outcomes of prolapse, stress incontinence or mesh exposure
    • Data on biologic grafts (e.g. cadaver) is limited
  • Synthetic mesh has been reclassified by the FDA from a class II (moderate risk) medical device to class III (high risk)

Posterior Wall Prolapse

  • Use of synthetic mesh or biologic grafts is associated with increased complications (mesh exposure) and no improvement in outcome
  • Mesh or grafts should not be used routinely in the primary repair of posterior wall prolapse

Anterior Wall Prolapse

  • Biologic grafts show no difference in recurrence risk vs native tissue repair
  • Synthetic mesh improves anatomic outcome, but is associated with
    • Increased risk of repeat surgery for prolapse, urinary incontinence and mesh exposure
    • Longer operating times and greater blood loss
    • 11% risk of mesh erosion following anterior vaginal repair
    • 7% of cases that will require surgical correction
    • Dyspareunia rate of approximately 9%

KEY POINTS:

  • Use of mesh or biologic grafts should only be undertaken by surgeons who have training specific for these procedures
    • Training should include patient selection, anatomy, intraoperative and postoperative techniques, treatment of any adverse outcomes
  • Routine intraoperative cystoscopy should be performed during POP surgery when there is risk to the bladder or ureter
  • AUGS 2013 position statement on credentialing includes the following:

It is imperative that local hospitals and health systems establish and strictly enforce robust processes to both/credential and audit surgeons with specific expertise, experience, training and skill to perform these procedures.  AUGS has developed, and published credentialing guidelines for transvaginal mesh surgery for pelvic organ prolapse and sacrocolpopexy for the treatment of pelvic organ prolapse.

Learn More – Primary Sources

ACOG Practice Bulletin 214: Pelvic organ prolapse

AUGS: Update on FDA Announcement on Transvaginal Mesh for Prolapse

FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices

Cochrane Review: Surgery for women with anterior compartment prolapse. Cochrane Database of Systematic Reviews

Incidence and Management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systemic review. Systematic Review Group of the Society of Gynecologic Surgeons.

AUGS Position Statement on Restriction of Surgical Options for Pelvic Floor Disorders, March 26,2013

AUGS POP-Q Tool

FIGO review of statements on use of synthetic mesh