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

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