Pelvic Organ Prolapse Treatment & Management

Nonsurgical (conservative) management of pelvic organ prolapse is recommended by both the Agency for Health Care Policy and Research and the ACOG Committee on Practice Bulletins ^[19] and should be attempted before surgery is contemplated. Conservative management confers several advantages: it is safe and inexpensive, it is not usually associated with morbidity and mortality, it is minimally invasive, it can lead to a high patient satisfaction, and it may be used for patients awaiting surgery or patients who are not interested in surgical management. Pelvic muscle exercises (PMEs) and vaginal support devices (pessaries) are the main nonsurgical treatments for patients with pelvic organ prolapse.

Pelvic muscle exercises can improve pelvic floor muscle tone and stress urinary incontinence, but in any prospective, randomized trials no evidence indicates that improvement of pelvic floor muscle tone leads to regression of pelvic organ prolapse. ^[20]

Vaginal support devices (pessaries) are manufactured from medical-grade silicone and are safe, cost-effective, and minimally invasive options for treating patients with pelvic organ prolapse. A study of pessary use showed that 75% of urogynecologists used pessaries as first-line therapy for prolapse. ^[21] Pessary use has few contraindications: lack of patient’s ability to comply with follow-up and instructions (eg, dementia), vaginal fistulas, uterovaginal erosions, and undiagnosed uterovaginal bleeding. An important adjunct is application of topical estrogen prior to pessary use, particularly if signs of hypoestrogenism (atrophic vaginitis) exist. Once the pessary is in place, continued vaginal estrogen cream application (ie, 1-2 times per week) or application of a vaginal estrogen ring once every 3 months is indicated, unless estrogen is contraindicated (ie, estrogen-dependent breast tumors). Vaginal erosions are indications for temporary pessary removal and treatment with topical estrogen.

A study by Cheung et al found that prolapse symptoms and quality of life were improved in women with symptomatic stage I to stage III POP using a vaginal pessary in addition to pelvic floor exercises. ^[22]

Many different types of pessaries can be used. Pessaries may be classified as supportive (eg, ring), or space-occupying (eg, doughnut, cube, Inflatoball). In 2000, a survey of the American Urogynecologic Society (AUGS) members showed that the most common pessaries in use today are the ring (with or without support), Gellhorn, doughnut, and cube. Other types are the Inflatoball (Milex Products, Inc, Chicago, Ill), and Smith, Hodge, Risser, and Shaatz pessaries.

In one study, the severity of pelvic organ prolapse was associated with the type of pessary that can be successfully fitted. ^[23] Thus, ring pessaries were used more successfully with stage II (100%) and stage III (71%) pelvic organ prolapse. The stage IV prolapse was most successfully treated with Gellhorn pessaries (64%). The Smith, Hodge, and Risser pessaries may help retrodisplacement of the uterus and should be used for patients with a well-defined pubic notch and an adequate vaginal width. The smallest pessary that reduces pelvic organ prolapse should be used. A well-supported pessary should not be visible at the introitus, and the patient should not feel vaginal pressure or discomfort while ambulating with the pessary in place. The ring pessary should fit snugly between the posterior fornix and the symphysis pubis. The pessary should not obstruct urinary flow.

A patient who is able to manipulate the pessary on her own may remove the pessary each night and replace it in the morning, or at least 1-2 times per week. If the pessary falls out with Valsalva maneuvers or with abdominal straining (eg, constipation), a larger pessary or a different pessary type may be fitted. Vaginal odor and discharge is common and it may be alleviated by the use of Trimo-San gel (Milex Products, Inc, Chicago, Ill). Vaginal bleeding should always be investigated by inspection for vaginal erosions, and endometrial biopsy and Papanicolaou test may be required.

After a successful pessary fitting, 50% of patients will continue to use the pessary beyond the first year of use. The primary reasons for pessary discontinuation, which occurred in 40% of patients, were patient inconvenience and inadequate relief of symptoms. In the author’s experience, women with more severe degrees of pelvic organ prolapse (stages III-IV) are more likely to continue pessary treatment and women with concomitant stress urinary incontinence symptoms and mild-to-moderate pelvic organ prolapse (stages I-II) are more likely to undergo surgery. ^[24]

The recommended management strategy for severe symptomatic pelvic organ prolapse for patients who failed or refused a trial of pessary management is surgery. A variety of surgical approaches are available to correct pelvic organ prolapse.

A thorough history and physical examination should distinguish a central or a transverse vaginal defect from a paravaginal defect. However, most patients have a combination of these.

The purpose of anterior vaginal repair, or anterior colporrhaphy, is to plicate the vaginal muscularis fascia overlying the bladder (pubocervical fascia) to diminish the bladder and anterior vaginal protrusion. Anterior colporrhaphy is indicated especially for patients with a central vaginal defect. The vaginal mucosa is incised in the midline, and then it is sharply dissected away from the pubocervical fascia laterally to the inferior pubic ramus. Several layers of interrupted delayed absorbable sutures are placed laterally on the pubocervical fascia in a mattress fashion. Excess vaginal mucosa is trimmed and the resulting vaginal mucosa is closed with running or interrupted sutures.

Paravaginal defect repair may be performed laparoscopically, abdominally, or vaginally. In this procedure, the retropubic space of Retzius is entered to reattach the anterolateral vaginal sulcus with its overlying endopelvic fascia to the obturator internus and pubococcygeus muscles and fascia at the level of the arcus tendineus fascia of the pelvis (ATFP) bilaterally, and thus restores the lateral vagina to its normal place of attachment (DeLancey’s level II support).

For a discussion of mesh augmented vaginal repairs, see Future and Controversies.

Posterior vaginal repair (posterior colporrhaphy) is performed to repair the posterior vaginal defect, usually a rectocele. Traditionally, posterior colporrhaphy has been performed via a transvaginal approach and involves posterior colpoperineorrhaphy with levator ani muscle plication. In this surgery, the rectovaginal fascia is plicated in the midline, thus eliminating the posterior vaginal protrusion, and the excess vaginal mucosa is excised and repaired with absorbable sutures.

Defect-specific, or site-specific defect repair, was introduced by Richardson in 1972. It attempts to identify and repair specific areas of deficiency in the rectovaginal fascia. This type of repair does not attempt to plicate the levator ani fascia and, thus, may be associated with a lower incidence of postoperative morbidity. Transanal repair is performed mainly by colorectal surgeons. This technique involves plication of the rectal muscularis fascia and its attachment to the bilateral levator ani muscles. Transvaginal posterior vaginal repair is generally recommended over transanal repairs (see Outcome and Prognosis). Posterior vaginal repair using synthetic (eg, Vicryl) or allogenic materials have variable results and have not been shown to improve surgical outcome.

Abdominal approach

The main abdominal operations performed for apical vaginal prolapse and uterine prolapse are abdominal sacral colpopexy and total abdominal hysterectomy with high uterosacral ligament suspension. These operations allow fixation of the upper vagina or the uterus to the sacrum, with the help of grafts and sutures through the anterior sacral ligament (presacral fascia) at the level of the sacral promontory or at S1-S2. Biomechanical anatomic studies suggest that the strongest presacral fascia is found at the sacral promontory. ^[25] The abdominal approach allows a higher vaginal fixation in the pelvis and provides durable repairs with an adequate vaginal length. Few reports in the literature describe uterine suspension for women who elect to retain their uterus, and no long-term data are available to make this practice a recommendation.

Sacrocolpopexy repair for apical vaginal prolapse

This procedure may be performed by an open laparotomy, traditional laparoscopy, or robotic-assisted laparoscopic approaches. The graft is sutured to the posterior and anterior vaginal wall after the peritoneum covering the vagina is dissected from the vaginal wall. The peritoneum covering the sacral promontory is incised and the vascular structures are avoided (particularly the common iliac and the middle sacral vessels) by performing careful blunt and sharp dissection. The graft is sutured over the anterior sacral longitudinal ligament over the S2-S3 vertebrae or preferentially over the sacral promontory, thus correcting the apical vaginal prolapse. The peritoneum over the presacral space is closed and the graft is peritonealized to prevent mesh erosions.

A variety of grafts have been used for sacropexy procedures (eg, harvested fascia lata abdominal fascia, cadaveric fascia lata, Marlex, Prolene, Gore-Tex, Mersilene, Vipro-II) with variable success rates (see Future and Controversies section on vaginal mesh). The ideal biocompatible material used should be chemically and physically inert, durable, noncarcinogenic, noninflammatory, readily available, and inexpensive.

The synthetic polypropylene mesh has been shown to be superior to autologous fascia lata. ^[26] Multifilament mesh (ie Gore-Tex, Mersilene) has been associated with chronic inflammation that can be detrimental compared with monofilaments, which produce an acute inflammatory reaction and formation of fibrous tissue. ^[27] Moreover, mesh with large pore size (>75 micrometers) allows ingrowth of fibroblast, collagen, and blood vessels, and allows for macrophage and leukocyte infiltration and passage, thus decreasing the chance of mesh infection and mesh erosion. ^[28] Women receiving ultralight-weight mesh (≤20 g/m) versus heavier-weight mesh (≤35 g/m) are more likely to experience earlier anatomic failure in the anterior vaginal compartment. ^[29]

Grafts are placed from the vaginal cuff, or the amputated cervical stump to the presacral fascia with permanent suture in a tension-free fashion. The graft is peritonealized and some surgeons obliterate the rectovaginal pouch (pouch of Douglas) to prevent future enterocele.

The Marion-Moschcowitz procedure entails a spiral suture placed around the rectovaginal pouch to close it circumferentially. The Halban procedure involves placement of several sutures in the sagittal plane that close the anterior and posterior leaves of the pouch of Douglas. Whether performing a total hysterectomy at the time of sacralcolpopexy increases the chance of vaginal exposure or erosions is debatable. Erosion rates vary from 6.9-27% with concurrent hysterectomy to 1.3-4.7% with a prior hysterectomy. ^{[30, 31, 32]} At this time, no strong evidence shows that performing a supracervical hysterectomy at the time of sacrocolpopexy decreases the erosion rate; however, the authors favor this approach in patients with no evidence of cervical dysplasia.

Vaginal approach

Vaginal surgery is preferred by many surgeons because the patient may have a shorter recovery time and it may take less intraoperative time compared with abdominal surgery. The most common vaginal procedures to suspend the prolapsed vaginal apex are sacrospinous ligament fixation, modified McCall culdoplasty, iliococcygeus suspension, and high uterosacral ligament suspension.

Sacrospinous ligament fixation

Sacrospinous ligament fixation is usually performed on the patient's right side to avoid rectum and sigmoid colon injury. The right perirectal space is dissected, and a window is made to expose the coccygeus muscle overlying the sacrospinous ligament on the right side with the help of Breisky-Navratil retractors. The ischial spine is palpated with the index finger and 2 pulley sutures of permanent or delayed absorbable material are placed through the sacrospinous ligament, 2 fingerbreadths medial to the ischial spine to avoid injury to the pudendal neurovascular bundle. In the authors’ cadaveric studies, they found that the location of the pudendal nerve and the sacral nerves that innervate the levator ani significantly varied in the area of the sacrospinous ligament. Their study suggests that a safe and nerve-free zone for placement of the sacrospinous ligament sutures is situated approximately in the middle of the sacrospinous ligament, more than 2.6 cm medial to the ischial spine. ^[33]

The passage of sutures through the sacrospinous ligament may be facilitated by a series of instruments that include the long-handled Deschamps ligature carrier, ^[34] Miya hook ligature carrier, ^[35] or the Capio suture-capturing device (Boston Scientific, Natick, Mass). The sacrospinous ligament pulley sutures are then attached to the vaginal vault and tied to pull up the vaginal cuff.

Sacrospinous ligament suspension procedure for apical vaginal prolapse: Following retroperitoneal dissection and exposure of the coccygeus muscle (sacrospinous ligament [SSL] complex), a permanent suture is placed 2 fingerbreadths medial to the ischial spine through the SSL, which is attached to the posterior vagina by a figure-eight stitch. When the stitch is tied, the vagina is drawn up to the SSL at the level of the ischial spine.

Endopelvic fascia repair

Endopelvic fascia repair (or modified McCall culdoplasty) aims to suspend the prolapsed vaginal vault to the endopelvic fascia. The vaginal apex is opened, the enterocele sac is dissected, the redundant sac is excised, and the enterocele is reduced. Next, the bilateral uterosacral ligaments are identified and up to 3 modified McCall sutures are placed to incorporate the posterior vaginal vault, the peritoneum, the uterosacral ligaments, and the endopelvic fascia of the upper vagina and rectum. Sutures are then tied, thus securing the vaginal vault to the upper portion of the endopelvic fascia, and ensuring an adequate closure of the cul-de-sac peritoneum.

Iliococcygeus suspension

Iliococcygeus suspension was describe initially by Inmon in 1963 ^[36] and has the purpose of suspending the vaginal vault to the fascia of the iliococcygeus muscle in patients with attenuated uterosacral ligaments. Iliococcygeus muscle is a component muscle of the levator ani; it originates from the arcus tendineus levator ani and inserts into the anococcygeus raphe and the coccyx. The procedure is similar to the sacrospinous ligament fixation; however, the securing suture is placed into the iliococcygeus fascia bilaterally 1-2 cm caudad and posterior to the ischial spine.

High uterosacral ligament suspension

High uterosacral ligament suspension aims to suspend the prolapsed vaginal vault bilaterally to the uterosacral ligaments. Similarly to the modified McCall culdoplasty procedure, the enterocele sac is dissected, the redundant sac is excised, and the enterocele is reduced. The uterosacral ligaments are identified, and 2-3 delayed absorbable sutures are placed through the middle portion of the uterosacral ligaments (at approximately the level of the ischial spine) taking care to avoid ureteral injury.

The distal portions of the uterosacral ligaments are plicated across the midline with 1-3 permanent sutures to obliterate the cul-de-sac. Each uterosacral ligament suture is then passed through the full thickness of the posterior vaginal wall. The vaginal vault is then closed medial to uterosacral sutures. Tying the vault suspension sutures will suspend the vagina deep into the pelvis, up to the level of the ischial spine. Cystoscopy should be performed at the end of each procedure to rule out ureteral injury.

Manchester procedure

Manchester procedure for pelvic organ prolapse is indicated for patients with anterior vaginal defects, an elongated cervix, no evidence of uterine descent, and those who wish to retain their uterus. This procedure was developed initially to shorten the duration of exposure to general anesthesia and consists of an anterior colporrhaphy, amputation of the cervix, and elevation of the upper vagina using transverse cervical ligament sutures.

Other procedures

Vaginal obliterative procedures, partial (LeFort) colpocleisis and total colpocleisis, are indicated for patients who are not able to tolerate general anesthesia or long surgical procedures, and who are not contemplating sexual activity. These procedures may be performed under local analgesia with intravenous sedation or local anesthesia. Since the uterus is retained with partial colpocleisis, preoperative uterine evaluation is indicated prior to surgery (see Preoperative Details).

With the LeFort colpocleisis, a rectangular portion of anterior and posterior vaginal mucosa is removed. The anterior pubocervical septum is sutured to the posterior rectovaginal septum using Lembert inverting sutures and, as the approximation is continued progressively on each side, the most dependent portion of the prolapse is gradually inverted. A perineorrhaphy is also usually performed to support the inverted vagina and help prevent pelvic organ prolapse recurrence.

Total colpocleisis procedures are performed for patients with posthysterectomy vaginal vault prolapse. These procedures do not intend to correct an enterocele since they are both extraperitoneal procedures. Also, these procedures carry risk of postoperative de novo stress urinary incontinence, and thus a concomitant anti-incontinence procedure may be performed in at-risk patients prior to closing the vagina.

In most patients, surgery for pelvic organ prolapse repair is an elective procedure. Preoperatively, a thorough discussion with the patient should lead to patient acknowledgment of the possibility of incomplete resolution or recurrence of pelvic organ prolapse and complications of surgery (eg, injury to bladder, urinary dysfunction, urinary retention, possible need for prolonged catheterization). The vaginal tissue wall may be optimized with vaginal estrogen for 1-2 months prior to the surgery. Women with pelvic organ prolapse and pelvic pain and sexual dysfunction need to be counseled that, while pelvic organ prolapse surgery repairs the anatomic vaginal defect, surgery does not necessarily lead to relief of pelvic pain or improvement of sexual function.

The choice of procedure depends largely on the surgeon's experience and preference, but other factors to consider are the patient's general health status, degree and type of pelvic organ prolapse, need for preservation or restoration of coital function, concomitant intrapelvic disease, and desire for preservation of menstrual and reproductive function. Patients who wish to retain their uterus and who are not candidates for prolonged general anesthesia (eg, patients with worsening cardiac function), may undergo a Manchester Repair or a LeFort colpocleisis. A Papanicolaou test, ultrasonography, and endometrial biopsy should be performed prior to surgical repair to rule out any pathology.

The pelvic surgeon’s challenge is to recreate normal anatomy while maintaining normal genitourinary function. Intraoperatively, gynecologic surgeons may reassess the anatomy, noting the strength and consistency of the various support structures (eg, uterosacral ligaments). If these structures are weak, stronger reattachment sites may be used for the correction of the pelvic organ prolapse, such as the sacrospinous ligament or the presacral fascia. In addition, a concomitant culdoplasty may avoid the formation of a future enterocele.

In a study of robotic-assisted laparoscopic sacrocolpopexy (RASC) with or without concomitant midurethral sling (MUS), for patients with urodynamic stress urinary incontinence, patients who underwent RASC and concomitant MUS scored significantly lower on the Urinary Distress Inventory-6 (UDI-6) urinary questionnaire, indicating fewer urinary distress symptoms. ^[37]

In a study of women undergoing a robotic sacrocolpopexy, early transurethral catheter removal (6 hours postoperative), versus removing the catheter the morning following surgery (control group), the early group was associated with an increased rate of incomplete bladder emptying, recatheterization, and urinary tract infections. ^[38] This study reflects the authors’ practice of catheter removal the morning following surgery.

Enhanced recovery after surgery (ERAS) protocols were developed for colorectal surgery to hasten postoperative recovery. ERAS in a urogynecology population resulted in a greater proportion of same-day discharge and high patient satisfaction; however, ERAS patients had higher 30-day hospital readmission rates (n=8, 6.7% vs n=2, 1.5%; P=.048). ^[39]

Patients must avoid strenuous exercise or heavy lifting and refrain from intercourse for 6 weeks postoperation. Following the 6-week follow-up visit, the patient is instructed to progressively return to usual daily activities. Patients must avoid any cause of increased intra-abdominal pressure, such as constipation, weight lifting, and cigarette smoking, for at least 3 months. This will facilitate adequate healing and may prevent pelvic organ prolapse recurrence. For postmenopausal patients, the authors recommend continuation of vaginal estrogen therapy (unless it is contraindicated) to maintain the integrity of pelvic tissues. When grafts are used for pelvic floor reconstruction, a postoperative follow-up visit is an opportunity to check for any graft erosions.

Follow-up after pessary insertion is essential. All patients should be seen 2-4 weeks after initial insertion and evaluated for problems (eg, voiding difficulties, vaginal bleeding and erosions, defecatory problems). Patients who self-insert and remove the pessary should be observed every 6-12 months. Patients who are not able to change the pessary should be seen every 3 months in the first year, and this interval could be increased to every 6 months in subsequent years in patients with successful pessary use.

Anterior colporrhaphy carries a risk of direct injury to the bladder, urethra, and ureters. Rates of ureteral damage are 0-2% (more common if injury occurs in the trigone area of the bladder). Injury to the urethra and the bladder neck is rare and may lead to intrinsic sphincteric deficiency. Voiding difficulty may occur after anterior colporrhaphy and may require bladder drainage or intermittent self-catheterization. In a study of sexual dysfunction after vaginal repair for anterior vaginal prolapse, up to 9% of women reported deterioration in sexual function; however, 24% of patients reported improvement and 67% experienced no change. ^[40]

Several retrospective studies showed an association with dyspareunia in up to 50% of women who underwent posterior colporrhaphy with levator ani muscle plication. ^[41] Use of mesh for posterior vaginal repair carries a reported erosion risk of up to 13% ^[42] Lower erosion rates have been reported with biografts ^[43] ; however, no long-term data are available that demonstrate better outcomes for these procedures when compared with routine posterior colporrhaphy.

Abdominal sacrocolpopexy carries a risk of several complications, including new onset or worsening of detrusor overactivity, de novo or worsened stress urinary incontinence in 12.5% of patients and dyspareunia in 9.7% of patients. ^[44] Sacrospinous ligament fixation carries a risk of temporary buttock pain in 6% of patients that improves with conservative management, cystocele in 8%, dyspareunia in 2.7%, new onset stress urinary incontinence in 2.6%, and new onset fecal incontinence in 4% of patients. ^[45]

High uterosacral ligament suspension carries a risk of ureteral injury or kinking that ranges from 1% ^[46] to 11%. ^[47] Intraoperative cystoscopy should be performed after each of these procedures. A lack of ureteral jet one side should prompt removal of the ipsilateral suspension sutures.

The success rate of anterior colporrhaphy is operator dependent, and the reported failure rates range from 0-20%. ^[48]

Objective success rates for paravaginal repairs have been reported to be 98% ^[49] for the vaginal route at 1-year follow-up, and range from 76% ^[50] to 97%, ^[13] but data from prospective head-to-head trials are needed for complete evaluation of these procedures.

The success rate of traditional posterior vaginal repair ranges from 76-96%. The success rate for site-specific defect repair with posterior colporrhaphy ranges from 80-90% at 1-year follow-up. After defect-specific posterior colporrhaphy, resolution of several symptoms associated with rectocele includes reduction in constipation in 84%, dyspareunia in 66%, and splinting in 55%. ^[21] Transanal repair has been reported to alleviate constipation in 22-85% of patients. ^[51] A trial comparing transanal and transvaginal repairs showed the transvaginal approach to be more effective for symptom relief and with less objective pelvic organ prolapse recurrence and postoperative enterocele. ^[52]

The success rate of abdominal sacrocolpopexy surgery varies from 88-100% cure of enterocele at the 2 year follow-up. ^{[44, 53]} The success rate of vaginal sacrospinous ligament fixation ranges from 88% at 6 weeks ^[54] to 97% at 1 year. ^[44] The abdominal sacrocolpopexy had a lower rate of prolapse recurrence compared with vaginal sacrospinous ligament fixation; however, the sacrospinous ligament fixation resulted in earlier return of daily activities, took less intraoperative time, and was cheaper. ^[52]

Modified McCall culdoplasty has achieved a success rate of 88-93% after a follow-up of 1-12 years.

In a matched case control study ^[52] iliococcygeus suspension was found to be equally effective and with similar complication rates when compared with sacrospinous colpopexy surgery for vaginal vault prolapse.

High uterosacral ligament suspension success rates have been reported to range from 87% ^[46] to 89%. ^[55]

The use of augmentation grafts in pelvic reconstructive surgery has revolutionized this operative field.

Newer techniques may involve the use of synthetic mesh (eg, polypropylene mesh) to strengthen the vaginal repair during anterior colporrhaphy procedures. Success rates range from 75% ^[56] to 100% ^[57] at 2-3 years follow-up with the use of a synthetic material at the time of anterior vaginal repair. The use of vaginal mesh for anterior colporrhaphy procedures carries a risk of mesh erosion in 2.1-13% of cases, ^{[58, 59]} and a significant number require operative mesh removal. Studies in which posterior vaginal repair was performed using synthetic (eg, Vicryl) materials reported a reduced rate of recurrent central cystocele but no reduction in the incidence of recurrent rectocele. ^[60]

Newer techniques for pelvic organ prolapse repair include complete vaginal mesh kits that consist of synthetic mesh placed using small incisions with minimal dissection. Reports show excellent short-term outcomes ^[61] ; however, long-term data on efficacy and risks of these procedures have not been evaluated in long-term prospective trials.

A randomized trial by Maher et al found that laparoscopic sacral colpopexy had a higher satisfaction rate and objective success rate than total vaginal mesh, with lower perioperative morbidity and reoperation rate at 2 years. ^[62]

Mesh for vaginal repairs

Despite the widespread use of polypropylene mesh for transabdominal correction of apical vaginal prolapse, the use of grafts for transvaginal prolapse repair has been controversial. Few prospective randomized controlled trials have been published on the use of grafts in transvaginal anterior vaginal prolapse repair, and few human studies exist comparing various grafts and techniques.

In October 2008, the FDA issued an alert informing patients and clinicians of potential complications associated with transvaginal mesh use for incontinence and prolapse. ^{[63, 64]} In this alert, the FDA warns of several potential complications that have been reported with the use of mesh. These complications include erosion through the vagina, infection, urinary problems, recurrence of the prolapse and/or urinary incontinence, discomfort, and pain, including pain during sexual intercourse. However, the FDA did not elaborate on the complication rates since a uniform and mandatory reporting system for perioperative complications does not exist at this time.

On July 13, 2011, the FDA issued a statement that serious complications are not rare with the use of surgical mesh in transvaginal repair of pelvic organ prolapse. The FDA reviewed the literature from 1996-2011 to evaluate safety and effectiveness and found surgical mesh in the transvaginal repair of pelvic organ prolapse does not improve symptoms or quality of life more than nonmesh repair. The review found that the most common complication was erosion of the mesh through the vagina, which can take multiple surgeries to repair and can be debilitating in some women. Mesh contraction was also reported, which causes vaginal shortening, tightening, and pain.

The FDA’s update states, “Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.” The FDA is continuing to review the literature regarding surgical mesh in the treatment of stress urinary incontinence and will issue a report at a later date. See the full update regarding surgical mesh in pelvic organ prolapse here: FDA Safety Communication: Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.

In 2016, the FDA reclassified surgical mesh for transvaginal repair of POP from a moderate-risk device (class II) to a high-risk one (class III) and gave manufacturers 30 months to prove that their products are safe and effective. ^{[65, 66]}

Light-weight monofilament, macroporous, knitted, and polypropylene meshes are currently used for prolapse repair. The success for anterior vaginal prolapse repair with Gynemesh (Johnson & Johnson, Somerville, NJ) was reported to range from 89-95% and vaginal erosion rates were 7.5-9%. Another 5.5% of patients experienced mesh contraction and pain. ^{[67, 68]}

Several small randomized controlled trials reported lower prolapse recurrence rates with polypropylene mesh-reinforced repair compared with traditional anterior vaginal prolapse repair. ^[69] Recurrent anterior wall prolapse (P < 0.001) occurred at 12 months in 38.5% of patients in the anterior colporrhaphy group and 6.7% in the mesh group. Vaginal mesh erosion occurred in 17.3% of patients.

According to a study by Altman et al standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment compared with the standard anterior colporrhaphy; however, it also resulted in higher rates of surgical complications and postoperative adverse events. ^[70]

Use of mesh kits

The success of the midurethral slings for management of stress urinary incontinence has prompted an increase in the use of mesh kits for prolapse repairs. Specially designed devices are used to attach a preconfigured mesh to the pelvic sidewall, using the transobturator approach, or to the sacrospinous ligament. Some reported benefits of mesh kits over sutured mesh placement include decreased operative time, less extensive dissection, and more precise mesh tensioning.

Reported experience with the Prolift Pelvic Floor Repair System (Ethicon, Somerville, NJ) is limited. Three-month outcomes were reported for 106 women who underwent Prolift vaginal prolapse repair. Recurrent anterior vaginal prolapse occurred in 2 of 78 women (2.6%) who had either total mesh or anterior mesh procedures. Two patients (1.8%) had hematomas that required surgical intervention. Mesh-related complications included mesh contraction (17%), mesh exposure (4.7%), and granuloma without exposure (2.8%). ^[71] van Raalte et al reported on the anatomic and quality-of-life outcomes at 1-year follow-up after treatment of posthysterectomy prolapse with Prolift. At 1 year, POP-Q values were significantly improved, and anatomical success (defined as ≤POP-Q stage 1 in the treated compartment) was 86.6%. Three patients experienced recurrent apical prolapse. ^[72]

In a prospective study for the management of anterior vaginal wall prolapse, a total of 70 patients underwent surgical repair using the Perigee system (American Medical Systems, Inc, Minnetonka, Minn) with more than 1-year follow-up. Only 3 patients (4.28%) had recurrence of stage 2 or more anterior vaginal wall prolapse, and 5 patients (7.1%) were found to have mesh extrusion through the vagina. ^[73]

In another study performed on 120 women using the Perigee and Apogee mesh kit (American Medical Systems, Inc, Minnetonka, Minn) for recurrent anterior or posterior vaginal prolapse, the 1-year outcomes showed an anatomic cure rate of 93%, with 8 failures (7%) occurring in the anterior compartment. Anterior vaginal mesh erosion occurred in 4 patients (3%). ^[74]

Nguyen and Burchette randomized 76 women to either anterior colporrhaphy or polypropylene mesh (Perigee). Success rate was achieved in 21 of 38 patients (55%) in the colporrhaphy group and 33 of 38 patients (87%) in the mesh group (P< 0.005), with 1-year follow-up. Patients in both groups had improved pelvic floor distress inventory (PFDI-20) and pelvic floor impact questionnaire (PFIQ-7) scores. The rates of de-novo dyspareunia were 16% (4 of 26 patients) and 9% (2 of 23 patients) in the colporrhaphy and mesh groups, respectively. Two of 37 patients (5%) had vaginal mesh extrusion. ^[75]

Currently, long-term prospective studies of mesh-reinforced vaginal prolapse repairs are lacking. Present studies show evidence that the anatomic success rates are improved with graft-reinforced repair, and mesh kit procedures are minimally invasive and quick. However, significant improvement has not been shown in postoperative quality of life and sexual function between ungrafted and grafted prolapse repairs in the short and medium term. As the long-term durability and safety of graft-reinforced repair is unknown, surgeons should consider using these procedures in selected patients. Well-designed, prospective, randomized clinical trials are needed to demonstrate long-term effectiveness.

Some experienced clinicians who are adept in using mesh kits to repair prolapses recommend using several surgical tricks to avoid potential complications associated with these procedures: (1) performing an initial thick vaginal dissection technique, (2) placement of the mesh in a tension-free fashion, (3) avoiding trimming of the vaginal epithelium, and (4) proper postoperative follow-up to ascertain that no long-term complications have developed.

As a response to the FDA warning ^[76] on the use of vaginal mesh, the American Urogynecologic Society (AUGS) recommends (1) that physicians obtain specialized training for each mesh placement technique, (2) vigilance for potential mesh-related adverse events (ie, erosion and infection) and intraoperative complications (ie, bladder, bowel, blood vessel perforation), and (3) proper counseling of the patient with regard to the permanence of the mesh, its potential for serious complications, its effect on the quality of life, including dyspareunia and vaginal scarring. Moreover, patients should be informed that additional surgery may be needed to correct potential complications. Patients should be provided with a written copy of the patient labeling from the surgical mesh manufacturer. ^[77]

On April 16, 2019, the FDA mandated that all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) stop selling and distributing their products. ^[78] The FDA has determined that the vaginal mesh kit manufacturers have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the FDA reclassified them into class III (high risk) in 2016. ^[79]

Please note that the FDA restrictions for transvaginal mesh for POP do not affect the abdominally or laparoscopically placed mesh for POP (sacrocolpopexy mesh), nor the mesh sling used to treat stress urinary incontinence.