Uterine Prolapse Treatment & Management

Updated: Mar 05, 2020
  • Author: George Lazarou, MD, FACOG, FACS; Chief Editor: Kris Strohbehn, MD  more...
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Treatment

Medical Therapy

Patients with mild uterine prolapse do not require therapy because they are usually asymptomatic. However, when symptoms occur, many patients initially opt for conservative treatment. Patients who are poor surgical candidates or are strongly disinclined to surgery can be offered pessaries for symptom relief. Topical estrogen is an important adjunct in the conservative management of patients with UP. When operative repair for prolapse of the uterus is chosen, a clear surgical plan must be formulated. The pelvic surgeon should consider surgical risks, coital activity, and normal vaginal anatomy. The correct operation must be tailored to the individual patient (see Indications).

Other questions that must be answered include whether the operation is performed abdominally, vaginally, or laparoscopically and whether a hysterectomy should be performed. A hysterectomy is not necessarily a mandatory part of the surgical repair for UP because various types of uterine suspensions can be performed via the abdominal or vaginal route. However, for practical reasons, the uterus is often removed to provide better access to the apical reattachment points, particularly the uterosacral, cardinal, sacrospinous, and anterior sacral ligaments.

Conservative treatment

Pelvic exercises (Kegel exercises) and pessaries are the current mainstays of nonsurgical management of patients with UP. Although routine Kegel exercises performed routinely can improve pelvic floor muscle tone and stress UI, no evidence in any prospective, blinded, randomized trials indicates that improvement of pelvic floor muscle tone leads to regression of UP.

Vaginal support devices are excellent options for treating patients with UP conservatively, and pessary use has few contraindications aside from acute pelvic inflammatory disease and pain after insertion. Recurrent vaginitis is a relative contraindication and may require removal of the pessary. An important adjunct is application of topical estrogen to the everted vagina, particularly if signs of hypoestrogenism exist.

Many different types of pessaries can be used, and pessary fitting is far from an exact science. Trial and error is the rule. Initially, the authors try the two most commonly used types, ie, the ring with support, the Gellhorn, and the donut pessaries depending on concomitant pelvic floor defects. The Gellhorn pessary is most often used for patients with significant UP and a large introital diameter who have not obtained relief with other pessaries. The Smith-Hodge, Gehrung and the Risser pessaries facilitate retrodisplacement of the uterus and should be used for patients with a well-defined pubic notch and adequate vaginal width.

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Surgical Therapy

The primary management strategy for severe UP is surgical. For patients in whom conservative management has failed, various surgical approaches are available to correct POP.

Abdominal/laparoscopic approach

Abdominal sacrocolpopexy procedure allows the upper vagina to regain its normal anatomic axis (sitting upon and parallel to the pelvic floor) by securing the polypropylene mesh applied to apical vagina/cervix or the uterus, to the sacrum with sutures through the presacral fascia at the promontory or at S1 or S2 if it is strong and free of vessels.

The authors' biomechanical anatomic studies have demonstrated that the presacral fascia is strongest at the promontory. [17] If the promontory is chosen, the intervening material must be applied loosely so that there is no tension on the vagina during straining and the vagina rests on the levator plate. These abdominal forces can be hypothetically tested intraoperatively by means of gentle downward traction on the vagina and graft material before trimming the material and securing the suture. The abdominal approach generally allows higher fixation in the pelvis and provides durable repair with sufficient vaginal length.

Various 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. 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. [18] Multifilament mesh (ie, Gore-Tex, Mersilene) has been associated with chronic inflammation that can be detrimental compared to monofilaments, which produce an acute inflammatory reaction and formation of fibrous tissue. [19] 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. [20]

The graft is peritonealized to prevent any bowel entrapment. Some surgeons also routinely perform a culdoplasty. This procedure involves obliterating the cul-de-sac by suturing the peritoneal surfaces together, usually incorporating the uterosacral ligaments in the repair. 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 sacrocolpopexy 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. [21, 22, 23]

Abdominal sacrocolpopexy success rates at 3-36 months are as follows: [24]

  • Apical POP - 78-100%

  • Subjective cure – 85-100%

A study was performed as a follow-up of the initial 2-year CARE study; 92% (215/233) of eligible CARE trial participants were enrolled in the extended CARE study (≤7-y follow-up). Overall, long-term follow-up after sacrocolpopexy showed a time progression for failure rate both for anatomic and symptomatic criteria. However, only 5% of patients required surgical retreatment for recurrent prolapse. [25]

Sacrocolpopexy may also be performed laparoscopically. Several studies looked at outcomes of laparoscopic versus open sacrocolpopexy. A study with 14 months' follow-up included 56 patients who underwent laparoscopic sacrocolpopexy and 61 who underwent abdominal sacrocolpopexy; the study found showed that the laparoscopic approach had less blood loss, less hospital stay, and a longer operative time (>50 min). However, the two groups of patients had similar complication rates and reoperative rates. A higher incidence of lower urinary tract injury was associated with the laparoscopic approach. [26]

Robotic sacrocolpopexy has become more common than laparoscopic sacrocolpopexy due to the advanced technology provided by the robot; this includes better instrument dexterity, 3-dimensional (3D) vision, and forgoing the need for a skilled surgical assistant. In a randomized controlled trial of 78 patients, 38 underwent laparoscopic sacrocolpopexy and 40 underwent robotic sacrocolpopexy. The anatomic results were similar between the two groups, with an 85-90% success rate. Anesthesia time, total time in the operating room, total sacrocolpopexy time, and total suturing time were all significantly longer in the robotic group. Also, more pain was reported in robotic group. The initial cost of the procedure was more than $1900 in the robotic group. [27]

Across several studies, a higher mesh erosion was associated with concomitant total hysterectomy; however, mesh erosion was not shown to be statistically significantly increased with total hysterectomy. At this time, no strong evidence shows that performing a supracervical hysterectomy at the time of sacrocolpopexy decreases the erosion rate; in the authors' anecdotal experience with sacrocolpopexy performed concomitantly with cervical sparing supracervical hysterectomy, the mesh complication of mesh erosion was reduced to less than 0.3%. Thus, the authors favor this approach in patients with no evidence of cervical dysplasia, and in patients without cervical elongation. There are studies that confirm our approach, thus in a retrospective 390 laparoscopic sacrocolpopexy case study, in cases where a concomitant hysterectomy was performed, a higher mesh exposure rate was seen in open-cuff hysterectomy compared to laparoscopic supracervical hysterectomy (4.9% (9/185) vs. 0% (0/92), P = 0.032). In patients with a prior hysterectomy, a higher mesh exposure rate was seen in cases where the cuff was opened (6.3% [1/16] vs 1.1% [1/92]; RR, 5.7;P = 0.276). [28]

In cases where laparoscopic or robotic-assisted laparoscopic supracervical hysterectomy is performed, uterus can be placed in an endoscopic pouch and removed through one of the laparoscopic ports, or it may be taken out in pieces with the assistance of a power morcellator. In 2014 FDA issued a safety communication on the issue of laparoscopic uterine power morcellation for hysterectomy and myomectomy. FDA noted that most women will develop uterine fibroids at some point in their lives, and data analysis estimated that 1 in 350 women undergoing hysterectomy or myomectomy for treatment of fibroids is found to have an unsuspected uterine sarcoma or leiomyosarcoma. Furthermore, if laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, worsening the patient’s long-term survival. Thus, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids. [29] The authors agree with the FDA that power morcellators may pose unknown risks in patients with unsuspected uterine sarcomas until more data becomes available, and for laparoscopic or robotic assisted supracervical hysterectomy procedures for POP, we recommend the removal of uterus through an enlarged laparoscopic incision in a laparoscopic pouch, without any intraperitoneal spillage of uterine content. This technique, as well as a contained electromechanical morcellation in an endoscopic pouch has been described to be safe and effective without any complications. [30]  However, more long-term studies are necessary to demonstrate the most appropriate technique for safe and effective uterine removal during laparoscopic supracervical hysterectomy for POP management.

Vaginal approach

Vaginal surgery is preferred in some cases when the patient desires to avoid any abdominal or laparoscopic incision, or if the patient has a history of complex abdominal surgeries. Moreover, together with laparoscopic surgery, most patients have shorter recovery time with this approach. In addition, a vaginal approach is preferred if a vaginal procedure is planned for the correction of incontinence (eg, for placement of a suburethral sling), to avoid a combined abdominal vaginal approach.

The 3 common vaginal procedures to suspend the prolapsed vaginal apex are sacrospinous ligament fixation, high uterosacral ligament fixation, and iliococcygeus fascia suspension. As originally described by Amreich and modified by Richter and Nichols, sacrospinous ligament fixation is usually performed on the patient's right side to avoid the rectosigmoid. [31] The vaginal apex is attached, using permanent sutures, to the sacrospinous ligament. A thorough knowledge of pelvic anatomy is critical to avoid complications. Take care to place the sutures 1-2 cm medial to the ischial spine to avoid injury to the pudendal bundle and the inferior gluteal vessels. Place the suture through—rather than around—the ligament. Excellent results have been reported for correcting vaginal vault prolapse using fixation to the sacrospinous ligament. However, in 1992, Shull and colleagues reported a predisposition for recurrence of anterior vaginal wall relaxation after sacrospinous ligament fixation. [32]

The high uterosacral ligament fixation, which is a modification of the McCall culdoplasty may be used to correct apical descent or as prophylaxis against future prolapse. [33] This procedure uses the uterosacral ligaments, which, if strong, are shortened and reattached to the vaginal cuff after completion of the vaginal hysterectomy. In the authors' opinion, attaching the prolapsed vagina to stretched prolapsed uterosacral ligaments is of little value.

A study by Jelovsek et al that included 244 women with pelvic organ prolapse reported no significant difference between uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in surgical failure rates (61.5% vs 70.3%) and no significant difference between perioperative behavioral muscle training and standard care on anatomic success rates (45.6% vs 47.2%). [34]

The surgeon may perform a high uterosacral colpopexy. The vagina is attached to the proximal uterosacral ligaments at the level of the ischial spines, where they are usually strong and undetached but careful enough to avoid the ureters situated superior and lateral. Uterosacral vaginal suspension is most commonly performed as an intraperitoneal procedure. A meta-analysis showed an objective success rate of 85 % (48-96%) and a mean reoperation rate of 5.8% (0-12%). The anatomic success was 81.2% (anterior vagina), 98.3% (vaginal apex) and 87.4% (posterior vagina). [35] . The ureteral obstruction rate with uterosacral vaginal suspension was 0.3-11% (87% recognized intraoperatively). [36] Intraoperative cystourethroscopy is therefore essential to be sure the ureters have not been ligated or kinked.

The iliococcygeus fascia suspension provides effective cuff suspension, since it attaches the apex to the obturator internus fascia and iliococcygeus fascia with less risk of neurovascular damage than does the sacrospinous ligament fixation. [37] Alternatively, the authors have described placing the suture through the iliococcygeus and the periosteum at the ischial spine, where it is attached. [38]

If an enterocele is encountered after removing the uterus, the sac is separated from the vagina. This redundant "hernia sac" is ligated at its neck and excised. Take care to avoid any loops of small bowel, which may also prolapse into the cul-de-sac between the vagina and the rectum. If the enterocele is not adequately repaired, the patient may have recurrence of apical, posterior, or anterior defects, with prolapse of the vagina vault.

Uterine prolapse surgery generally involve a concomitant hysterectomy. However, for patients who desire to keep the uterus, or desire a future pregnancy, a uterine preservation surgery may be performed. Several procedures have success rates varying between 70-97%, including the following:

  • Vaginal hysteropexy

  • The Manchester procedure (partial trachelectomy, uterosacral ligament uterine suspension)

  • Sacrospinous hysteropexy

  • Vaginal mesh hysteropexy

  • Abdominal sacral hysteropexy

  • Laparoscopic sacral hysteropexy

  • Laparoscopic uterosacral hysteropexy

Several studies have compared sacrospinous hysteropexy with vaginal hysterectomy and uterosacral vaginal vault suspension; success rates range from 79%-94% and from 96-97%, respectively. Vaginal hysterectomy and uterosacral suspension are generally seen as more successful than sacrospinous uteropexy. [39]

In a recent study comparing robotic or laparoscopic sacrohysteropexy versus open sacrohysteropexy with uterine preservation for women with POP, the robotic/laparoscopic group had shorter operating time (120.2 vs 187.5 min, p <  0.0001), less operative bleeding (median estimated blood loss 50 vs 150 ml; p <  0.0001; mean hemoglobin drop 1.4 vs 2.0 g/dl; p <  0.0001), and fewer postoperative symptoms (13 vs 45.6 %; p <  0.0001). Patients' overall satisfaction (94.4 vs 91.2 %; p = 0.717) and required reoperation due to postoperative complications (3.7 vs 1.8 %; p = 0.611) did not differ between groups. Robotic or laparoscopic sacrohysteropexy versus open sacrohysteropexy for uterus preservation in pelvic organ prolapse. [40]

Limited long-term data and randomized controlled studies on uterine preservation procedures are available for pelvic organ prolapse; thus, these procedures should be reserved for premenopausal patients with bothersome advanced POP who desire future pregnancy. Patients undergoing a uterine preservation procedure for POP should understand all the risks and potential benefits of the procedure, and patients should be made aware of the risk for reoperation for recurrent POP after childbirth is complete.

Vaginal mesh repairs have been advocated by some surgeons who sought to combine the minimally invasive nature of vaginal surgery with the potential durability provided by polypropylene mesh. However, vaginal mesh procedures have been associated with complications related to vaginal mesh exposure/erosions and vaginal pain and dyspareunia. 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. [41]  Moreover, FDA reclassified surgical mesh for transvaginal POP repair, from class II to a class III device. Please see Complications section below. [42]

A Cochrane review compared traditional vaginal procedures (uterosacral vaginal suspension, sacrospinous suspension, iliococcygeus vaginal suspension) with sacrocolpopexy and vaginal mesh kits. For uterine or vaginal vault POP, abdominal sacralcolpopexy had a lower rate of recurrent vault prolapse and dyspareunia versus vaginal sacrospinous vaginal suspension. However, sacrocolpopexy procedure was associated with increased cost, longer operative time, and longer time to return to activities of daily living. Sacrocolpopexy procedure had a higher success rate on examination and a lower re-operative rates versus both transvaginal polypropylene mesh and vaginal uterosacral procedures. Trials comparing native tissue repairs with polypropylene kit mesh for vaginal POP in multiple compartments showed no difference in postoperative symptomatic POP, however objective POP recurrence rate on examination was higher in the native tissue repairs versus transvaginal polypropylene mesh group (RR 2.0, 955 CI 1.3 to 3.1). The mesh erosion rate was 18%, and 9% of patients underwent surgical excision or revision for vaginal mesh erosion. The reoperation rate for complications after transvaginal pop propylene mesh repair (11%) was higher than after native tissue repairs (3.7%) (RR 3.1, 95% CI 1.3 to 7.3). Sacrocolpopexy had a balanced rate for re-operation for POP recurrence (2.3%) and total reoperation rate (7.1%). [43, 44]

Two pragmatic, parallel-group, multicenter, randomized controlled trials by Glazener et al that included 1348 women (865 in the mesh trial [430 women underwent standard repair alone, and 435 had mesh augmentation] and 735 in the biological graft trial [367 women underwent standard repair alone, and 368 had biological graft augmentation]) reported no improvement in the rates of effectiveness, quality of life, adverse effects and other short term outcomes, when standard anterior and posterior vaginal repair was compared with vaginal repair with mesh or  biological graft material. The study also reported that 12% of the women in the mesh group had a mesh complication. [45]

For patients who cannot undergo long surgical procedures and who are not contemplating sexual activity, obliterative procedures, such as the Le Fort colpocleisis or colpectomy and colpocleisis, are viable options. With the Le Fort colpocleisis, a patch of anterior and posterior vaginal mucosa is removed. The cut edge of the anterior vaginal wall is sewn to its counterpart on the posterior side. As the approximation is continued on each side, the most dependent portion of the mass is progressively inverted. A tight perineorrhaphy is usually also performed to help support the inverted vagina and prevent recurrence of the prolapse. The authors have described and reported a procedure for denuding the anterior and posterior vaginal mucosa with a dermatome. [46]

The main problem specific to these obliterative operations is that they limit coital function. Neither corrects an enterocele because they are both extraperitoneal procedures. Also, there is a 25% incidence of postoperative urinary stress incontinence caused by induced fusion of the anterior and posterior vaginal walls and flattening of the posterior urethrovesical angle. In addition, if the uterus is retained, the patient can later bleed from many causes, including carcinoma. An unusual and rare complication of pyometra has also been reported after Le Fort colpocleisis, necessitating abdominal hysterectomy. [47]

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Preoperative Details

Although the choice of procedure largely depends on the surgeon's preference and experience, also consider factors such as the patient's general health status, degree and type of POP, need for preservation or restoration of coital function, concomitant intrapelvic disease, and desire for preservation of menstrual and reproductive function.

When deciding on the type of surgery to correct UP, the pelvic surgeon should remember that UP is the result and not the cause of POP. Therefore, performing a hysterectomy does not correct the apical defect. A careful preoperative evaluation should identify all concomitant defects associated with UP, which should be repaired in order to avoid recurrence of POP.

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Intraoperative Details

The challenge to the pelvic surgeon is to recreate normal anatomy while maintaining normal function. Experienced gynecologic surgeons can reevaluate the anatomy intraoperatively, noting the strength and consistency of the various support structures (eg, uterosacral ligaments). If these structures are found to be weak, it may be necessary to use other, stronger reattachment sites, such as the sacrospinous ligament or the presacral fascia, for the correction of the defect. In addition, make every attempt to prevent a recurrence of POP. For example, when performing a retropubic urethropexy for UI, a concomitant culdoplasty may avoid the formation of an enterocele in the future.

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Postoperative Details

Postoperatively, we instruct the patient to avoid any exercise or heavy lifting and to refrain from intercourse for 6 weeks after her discharge from the hospital. Subsequent to the 6-week follow-up visit, the patient is instructed to progressively return to her usual daily activities. Stress the need to avoid causes of increased intra-abdominal pressure, such as constipation, weight lifting, and cigarette smoking, for at least 3 months. This facilitates adequate healing and prevents surgical failures. For postmenopausal patients with significant vaginal atrophy, the authors often recommend ca short-term course of vaginal estrogen therapy (unless contraindicated) in order to maintain the integrity of pelvic tissues and to maximize surgical success.

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Follow-up

If conservative treatment is used, depending on symptoms, instruct patients to remove and clean the pessary and/or to douche weekly with a weak vinegar solution to lessen the chances of complications (see Complications). After fitting the patient with the appropriate size and type of pessary, instruct her to return for a follow-up examination at 1-2 weeks to assess any inflammatory response, ulceration, or urinary or defecatory problems. If the patient cannot clean and replace the pessary satisfactorily, the provider should clean and replace it every 8-12 weeks.

For excellent patient education resources, visit eMedicineHealth's Women's Health Center. Also, see eMedicineHealth's patient education article Prolapsed Uterus.

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Complications

Conservative treatment

Pessaries may cause vaginitis, bleeding, ulceration, UI, urinary obstruction with retention, fistula formation, and erosion into the bladder or rectum. Most complications are from a long-forgotten pessary. [48] Rarely, carcinoma at the site of contact has been reported. [49]

Abdominal /Laparoscopic approach

Bleeding is the most serious complication of sacral colpopexy. [50] Injuring the presacral venous plexus or the middle sacral artery while operating in the presacral space is possible. Other complications include ureteral injury, graft erosion, and suture pullout (causing recurrence of the prolapse). Erosion of synthetic grafts through the vagina has been reported at a rate of 3% in a series of 370 patients who had undergone sacral colpopexy. [51]

Vaginal approach

Surgical correction of UP has a low complication rate. Reported complications (other than the risks associated with general anesthesia) include pelvic infection, hemorrhage, and injury to the ureters or lower urinary tract with fistula formation, bowel injury, sacral osteomyelitis, and graft rejection. The two most serious complications from sacrospinous ligament fixation are hemorrhage and nerve injury from the pudendal neurovascular bundle. Despite the reported long-term success rates after correction of UP [52] , surgical failure does occur. For patients who have recurrent POP, a careful evaluation is warranted in order to determine the cause of failure. Most surgical failures are probably related to surgical technique or inaccurate preoperative diagnosis of other concomitant defects. [53]

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Outcome and Prognosis

For the outcome of uterine prolapse surgery, please refer to section on surgical therapy regarding the success rates of vaginal, abdominal, and laparoscopic procedures.

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Future and Controversies

Abdominal/laparoscopic approach

When operating on patients with UP, rationales for performing a concomitant hysterectomy include the long-term success of the surgery (which can theoretically be affected by the prolapsed uterus) and removal of a nonfunctioning organ in postmenopausal women. In addition, any uterine or cervical pathology (eg, large fibroid uterus, endometriosis, pelvic inflammatory disease, endometrial hyperplasia, carcinoma) may require removal of the uterus.

No evidence indicates that hysterectomy has any effect on long-term success of sacropexy. Furthermore, the efficacy of incontinence surgery, with complete pelvic floor reconstruction, is not affected by whether a hysterectomy is performed. [54] The authors advocate deferring surgical treatment of UP for patients who desire future childbearing until completion of childbearing. Hysteropexy for those patients who elect to retain their uteri has been reported, but the data is limited. [55, 56]

If the uterus is too bulky, hysterectomy is preferable. The decision may be made intraoperatively, and the patient should be appropriately counseled. If the uterus is to be preserved, preoperative endometrial biopsy and/or ultrasound imaging is strongly recommended.

Vaginal approach

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 found that surgical mesh in the transvaginal repair of pelvic organ prolapse does not improve symptoms or quality of life more than native tissue 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.”

Moreover FDA noted that “Mesh placed abdominally for POP repair results in lower rates of mesh complications compared to transvaginal POP surgery with mesh. There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh. While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.” [41] The FDA recommended that health care providers obtain specialized training for each mesh placement technique, and be vigilant of the potential adverse events from of surgical mesh, especially erosion and infection. Additionally patients should be informed 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 using vaginal mesh; FDA recommended further that patients should be informed about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives completed to transvaginal surgery with mesh. [41]

In January 2016 the FDA reclassified surgical mesh for transvaginal POP repair, from class II to a class III device, and issued a final order to require the filling of a premarket approval application (PMA), prior to approval of new surgical mesh products for transvaginal POP repair.

The FDA notifications and warnings do not specifically apply to the transabdominal mesh used with the sacrocolpopexy procedure, the FDA panel consensus was that the safety and effectiveness of surgical mesh indicated for sacrocolpopexy is well-established and that reclassification of this group of devices is not necessary. [42]

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. [57] 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. [58]

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.

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Conclusions

With ever increasing life-expectancy, larger numbers of women are developing pelvic floor disorders; 76% of women have been shown to have some POP, and 38% have symptomatic POP with vaginal bulge or protrusion. [59]

UP is one of the more common pelvic floor defects and is a challenge to the practicing gynecologist and reconstructive pelvic surgeon. A complete pelvic examination, with particular attention to pelvic support defects, is vital to accurate diagnosis and treatment. Close communication with the patient, her family, and her primary care physician is essential for optimal understanding, informed consent, and management.

Offer conservative treatments as the first option, and always try them before any surgical endeavor. Educating the patient and her family strengthens the doctor-patient relationship and improves compliance. When a surgical intervention is undertaken, the primary goals are to restore anatomy and to maintain normal function. Preoperatively, a thorough assessment of all risks or possible complications and a complete discussion of alternatives with the patient are key elements in the decision-making process. Age alone should not be a factor in the decision; rather, the patient's baseline function is an important guideline to selecting the treatment that will provide the best quality of life.

The management of uterine prolapse may involve conservative versus surgical therapies. A thorough and candid discussion between the patient and her physician should take place prior to initiating any therapies. The patient should be made aware of all the risks and benefits and alternatives to any management option involved for the management of her UP.

With a trend toward minimally invasive endoscopic surgery, procedures have been developed to accomplish repair of pelvic defects via laparoscopic approaches. Although results in short-term subjective reports are excellent, long-term randomized controlled trials are lacking. The attractive advantages of laparoscopic vault suspension are shorter hospitalizations, better cosmetic results, less morbidity, and shorter postoperative recovery periods.

Any advanced laparoscopic reconstructive pelvic surgery requires good operative skills and determination on the part of the surgeon. Most experts agree that the learning curve is usually steep, and complications are more likely to occur in early experiences. A review of techniques for endoscopic repair of UP is beyond the scope of this article, but the goal of any laparoscopic approach is to perform the equivalent abdominal procedures through the laparoscope.

Prospective randomized trials comparing laparoscopic approaches to open procedures generally show a benefit regarding shorter hospital stay, less postoperative pain but also show potential for higher intraoperative complications and significantly higher costs. The patients planning minimally invasive surgery for vaginal prolapse should be counseled thoroughly regarding the risks and benefits involved, the potential complications and cost and benefit ratio of laparoscopic and robotic surgical techniques, with or without the use of mesh, versus open or vagina surgical approaches.

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