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

Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. List key clinical considerations when assessing a patient with POP
2. Discuss the potential risks associated with synthetic mesh and grafts for the treatment of POP

Estimated time to complete activity: 0.25 hours

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Faculty: Susan J. Gross, MD, receives consulting fees from Genoox, Inc., and has financial interest in The ObG Project, Inc.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from Dec 31 2017 through Dec 31 2019, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.

Read Disclaimer & Fine Print

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.