Mesh and Pelvic Organ Prolapse: ACOG Practice Advisory & ACOG/AUGS Recommendations
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.
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%
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.
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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
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presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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