Treatment of Pelvic Organ Prolapse: Controversies in Surgical Care and

Nonsurgical Options

Raymond T. Foster, Sr., M.D., M.S., M.H.Sc.Assistant Professor of Obstetrics and Gynecology

University of Missouri School of Medicine

Objectives• Correlate abdominal hernia disease with vaginal prolapse• Review the controversy regarding surgical technique• Understand the FDA’s position regarding mesh products• Be aware of surgical data related to prolapse surgery• Review nonsurgical options for treating POP• Understand the chance for treatment success without surgery

Prolapse Animation

Hernia

“Pelvic support defects can be compared to hernias in that a visible defect in the connective tissue contributes to development of pelvic organ prolapse.”

Shull BL, Bachofen C, Coates KW, and Kuehl TJ, A transvaginal approach to repair of apical and other associated sites of pelvic organ prolapse with uterosacral ligaments, Am J Obstet Gyncol, Dec 2000

Hernia

SSAT Patient Care Guidelines:Surgical Repair of Incisional Hernias

Primary closure of an Incisional Hernia:25%-50% recurrence rate

Closure of an Incisional Hernia (open) with synthetic mesh:

5%-35% recurrence rate

Closure of an Incisional Hernia (laparoscopic) with synthetic mesh:

1%-10% recurrence rate

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Historical Timeline

Surgical mesh was introduced into the operating room for the treatment of hernias in the 1950’s

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NEW FUNCTIONAL REPAIR OF POST HYSTERECTOMY VAGINAL VAULT PROLAPSE WITH MARLEX MESH.Dr. W. Ferguson

Historical Timeline

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Historical Timeline

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Dr. Al Addison et al published their experience with Mersilene mesh in the treatment of prolapse in 56 patients

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1987: Dr. Desai publishes early report of transvaginal mesh placement to treat prolapse (Boston University)

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Professor Ulf Ulmsten, with his colleague Papa Petros, describes intravaginal slingplasty as a minimally invasive treatment for stress urinary incontinence in women.

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1998: U.S. FDA approves TVT for marketing

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2001: The FDA begins a series of 510k approvals for the marketing of transvaginal mesh kits used to treat pelvic organ prolapse.

Historical Timeline

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October 20, 2008: FDA issues a Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

Highlights from FDA’s 2008 Public Health Notification

• In 36 months, the FDA received over 1,000 reports from 9 different surgical mesh companies that described complications related to surgical mesh devices used to treat pelvic organ prolapse and urinary incontinence.

• Most common complications reported• Mesh erosion• Infection• Pain• Urinary symptoms• Disease recurrence

• Rare complications included injury to bowel, bladder, and blood vessels

Highlights from FDA’s 2008 Public Health Notification

Recommendations• Physicians should seek specialized training for procedures involving the use

of vaginal mesh• Be alert and recognize complications early• Inform patients that implantation of surgical mesh is permanent, and that

some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication

• Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair)

Stand by, more information to follow . . . . .

Historical Timeline

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July 13, 2011: FDA issues a “Safety Communication”: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

Highlights from FDA’s 2011 Safety Communication

• Surgical mesh for transvaginal repair of POP is an area of continuing serious concern

• Surgical complications related to transvaginal mesh placement are NOT RARE• There is not a clear evidence to support increased efficacy of repairs when

comparing mesh to traditional repairs AND patients undergoing mesh placement may be exposed to greater risk

• Mesh placed abdominally to treat POP appears to have a lower rate of mesh complications than mesh placed vaginally

• Mesh used to treat SUI is under continued study

TV Commercial for Vaginal Mesh Legal Assistance

What’s Happening Currently?

• FDA is working with “expert” panels to develop recommendations• Kits for transvaginal mesh placement have been reclassified by the FDA and

companies will be forced to conduct large scale clinical trials demonstrating safety and efficacy

• Based on available evidence, the FDA did not reclassify midurethral slings or require any additional scientific evidence. Therefore, most slings remain approved with a “safe and effective” endorsement.

• “Mini-slings” and/or transobturator slings may be reclassified and subsequently required to submit safety and efficacy evidence from large scale clinical studies

Do we really need synthetic graft material for an

acceptable outcome when performing transvaginal

prolapse surgery?

Two hundred eighty-nine patients (96%) returned for at least one postoperative visit. Two hundred fifty-one patients (group 1, 87%) had optimal anatomic outcomes, with no persistent or recurrent support defects at any site. Thirty-eight patients (group 2, 13%) had one or more sites with at least grade 1 loss of support during the follow-up interval. Twenty-four of these 38 patients had grade 1 defects that were detectable only on careful pelvic examination. Fourteen of these patients (5%) had grade 2 or greater persistent or recurrent support defects. The anterior segment (bladder) was the site with the most persistent or recurrent support defects, which means that it was the site of the least durable repair.

A transvaginal approach to repair of apical and other associated sites of pelvic organ prolapse with

uterosacral ligamentsBob L. Shull, MD, Claudia Bachofen, MD, Kimberly W. Coates, MD,

and Thomas J. Kuehl, PhD

What about women who can’t or won’t have

surgical management?

Predisposing Factors-gender -racial

-anatomic -neurologic

-collagen -muscular

-cultural -environmental

Inciting Factors -childbirth -nerve damage

-muscle damage -radiation

-tissue disruption -radical surgery

Promoting Factors-constipation -occupation -chronic cough

-recreation -smoking -obesity

-surgery -menopause -lung disease

-menstrual cycle -infection -medications

Decompensating Factors-ageing -dementia

-debility -disease

-medications -environment

Bump R, and Norton P, Epidemiology and Natural History of Pelvic Floor Dysfunction, Obstetrics and Gynecology Clinics of North America, 25(4): 723-46, 1998.

Development and Progression of Pelvic Organ Prolapse

Summary• There are striking similarities between hernias on the anterior abdominal wall

and vaginal prolapse• Hernia surgery success is markedly improved with the use of synthetic mesh• It is not clear that transvaginal mesh products increase the efficacy of surgical

treatment for vaginal prolapse• It is clear that the frequency of surgical complications is increased with the use

of transvaginal mesh• Surgical mesh placed abdominally to treat pelvic organ prolapse appears to be

safe and efficacious• Mesh products used in the treatment of stress incontinence are under

continued review by the FDA, but are likely to be found safe and efficacious• Pelvic organ prolapse can be treated conservatively with excellent outcomes