Anterior and Posterior Repair with Polypropylene Mesh (Prolift ® ) for Pelvic Organ Prolapse: Retrospective Review of the First 323 Patients

Abstract

Background: Recently, the technique for the repair of pelvic organ prolapse has shifted from conventional colporrhaphy to the use of meshes. In this article, we report our experience with the first 323 patients treated with the Prolift^® (Ethicon, Sommerville, NJ) Gynecare mesh. Methods: We performed a retrospective review of all 323 patients who received a Prolift mesh since we adopted the procedure. We evaluated patient characteristics as well as intra- and postoperative problems and compared our outcomes to the literature. We divided complications in to the following groups: intraoperative, early postoperative, and late postoperative. The most prevalent late postoperative problems were postoperative stress incontinence, erosion, and recurrence of prolapse. Results: Our figures were comparable to those previously reported: 20.1% incontinence, 11.5% erosions, and 2.5% recurrence. According to a Medline search performed in January 2009, our study appears to be the largest group and longest follow-up of this type of mesh. Conclusions: More studies are needed to evaluate suggested ways to reduce the occurrence of incontinence, mesh erosion, and recurrence of prolapse. (J GYNECOL SURG 26:1)

Introduction

Pelvic organ prolapse is a common complaint in women, especially after menopause. It most likely originates from stretching of the connective tissues of the endopelvic fascia during vaginal birth and is exacerbated by estrogen depletion after menopause. Until recently, the only available surgical treatment was classical repair by colporrhaphy. Due to high percentages of recurrence after these procedures,¹ several artificial meshes have been developed since 1996² and incorporated into clinical practice. We retrospectively evaluated the first 323 patients operated on in our clinic with using the Gynecare Prolift^® System (Ethicon, Somerville, NJ).

Materials and Methods

We began using a polypropylene mesh (Prolift) in May 2005. Since this was an entirely new technique at the time, for which no formal training program was available, our surgeons were taught one on one by representatives of the firm supplying the mesh. Between May 2005 and November 2008, 323 Prolift procedures were performed on 316 patients. All procedures were done by one of two authors (EP and GB).

The technique used was that described by the manufacturer, with the exception of hydrodissection, which was not performed. The reason for this was that neither of the two surgeons had ever used hydrodissection before, and both were convinced they could perform the procedure without it. All patients received an indwelling catheter during surgery and a vaginal tampon after, both of which were removed on postoperative day 1. Patients were selected by degree of prolapse, according to the International Continence Society staging system.³ Only compartments with a prolapse degree II or more were operated on. (The deepest point of prolapse extends to between 1 cm above the hymen to 1 cm below.)

Initially, a hysterectomy was routinely performed concomittantly in cases of prolapse of the middle compartment; but later on, this was abandoned, as anterior and posterior repair alone showed sufficient anatomic results, in most cases. Incontinence surgery, such as the TVT-O^® system (Ethicon), was performed only in the case of preoperative symptomatic urinary stress incontinence. This was evaluated preoperatively by taking an oral history. In case of any complaints of incontinence, the patient was referred to the urology clinic for urodynamic testing. If no complaints were present, we let the patient cough on the table. When no incontinence was visible, we assumed there was none.

The Prolift procedure was performed both as a primary repair and after previous prolapse surgery (both classical colporrhaphy and other meshes). Follow-up was at 2 and 6 weeks postoperatively, after which routine care was given.

Results

Operative characteristics are shown in Table 1. The average age of patients was 64 years (range, 30–95) (Table 2). We established a learning curve of around 20 patients for both surgeons, where 35% of patients required another procedure due to repeat prolapse, stress urinary incontinence, or erosion. After the first 20 patients, this percentage dropped considerably to around 20%. Average duration of hospitalization was 5 days (range, 2–27), and average follow-up was 20 months (range, 1–43).

Table 1.

Operative Characteristics

Type of surgery ^a	N	%
Anterior repair with hysterectomy	9	2.8
Anterior repair without hysterectomy	79	24.5
Posterior repair with hysterectomy	8	2.5
Posterior repair without hysterectomy	83	25.7
Anterior and posterior repair with hysterectomy	35	10.8
Anterior and posterior repair without hysterectomy	109	33.7
Total	323	100
Concomittant stress urinary incontinence surgery	33	10.2
Other concomittant surgery	13	4.0
Total	46	14.2

N = 323.

Table 2.

Patient Ages

Patient ages ^a	N	%
30–39	7	2.2
40–49	31	9.6
50–59	59	18.3
60–69	109	33.7
70–79	100	31.0
>80	17	5.3
Total	323	100

N = 323.

Complications were divided into the following groups: intraoperative, early postoperative, and late postoperative, as well as technique related and general (Table 3). We experienced 8 bladder injuries, 3 of which occurred during dissection and 5 during insertion of the needles. Of these 5, 3 were identified and corrected immediately and 2 were diagnosed and corrected at a later date. In our series, we had no bowel perforations. Five hemorrhages occurred, one of which necessitated laparotomy and exploration of the retroperitoneum.

Table 3.

Patient Complications

Complications	N	%
Total intraoperative (all technique related)	13	4.0
Bladder injury (3 dissection, 5 perforation)	8	3.5^a
Hemorrhage	5	1.5
Total early postoperative	24	7.4
Technique related
Anemia with need for suppletion	6	1.6
Urinary retention and discharge with indwelling catheter	7	3.0^a
Neglected intravaginal gauze	1	0.3
General
Fever	4	1.2
Pneumonia	3	0.9
Other	3	0.9
Total late postoperative (all technique related)	133	41.2
Incontinence (3 urge, 60 stress, 2 undetermined)	65	20.1
Recurrence of prolapse	17	5.3
Other compartment	4	1.2
Same compartment	13	4.0
Erosion	37	11.5
Other	14	4.3

Percentage of patients who had at least an anterior repair (with or without posterior repair or hysterectomy) who experienced this complication.

During the immediate postoperative period (i.e., between leaving the operating room and discharge from the hospital), 4 other complications occurred: in 1 patient, a neglected intravaginal gauze was discovered, another experienced an asthma attack, a third suffered heart decompensation, and the fourth had watery vaginal discharge. This patient turned out to have developed a fistula between the vagina and the bladder. The mesh was visible on cystoscopy and later removed, which led to complete closure of the fistula. In addition, 6 patients suffered from anemia with the need for suppletion (with 3 requiring transfusion of packed cells and 3 only needing oral iron suppletion) and 7 needed an indwelling catheter due to problems with micturition.

In total, 34 patients (10.5%) were lost to follow-up and never showed up for their postoperative check ups. More than half of our study patients (50.2%) had no further problems after the procedure. We had 65 patients who reported incontinence after the Prolift operation. Nine (9) of these had had concomittant incontinence surgery. Of these 9, 2 had developed urge urinary incontince postoperatively and 7 still had stress urinary incontinence. The other 56 patients had de novo stress urinary incontinence. Of these 65 patients, 35 (10.8% of all patients) needed a further operation to correct their incontinence.

Seventeen (17) patients reported prolapse during follow-up, 4 of whom had prolapse of the compartment, which was not operated on. Eight (8) patients (2.5%) had a repeat prolapse of the same compartment, which necessitated a new operation. All but 1 patient had another Prolift procedure.

We encountered 37 erosions, 22 of which were symptomatic and were not cured by topical therapy. They were excised during a second procedure performed during a 1-day hospital stay. The overall number of patients who required a second procedure was 66 (20.4%). We did not actively enquire after dyspareunia, but 5 patients (1.5%) reported this complaint spontaneously.

Discussion

As stated in the Introduction, pelvic prolapse surgery with polypropylene mesh is a relatively new technique. Several series on the use of Prolift have been reported, to date, but none exceeding 123 patients⁴ (Medline, January 2009). Follow-up is usually short, with only one study describing results after more than 1 year.⁵ Median follow-up in this study was 19 months, but only 97 patients were included. Our current series appears to be the largest reported so far, with the longest average follow-up of 216 patients, who were followed for over 1 year. Our median follow-up was 20 months (range, 1–43).

We would like to stress that this was a retrospective review of all our Prolift procedures since we started using the technique. There were no inclusion or exclusion criteria. No comparison was made between two treatments, so no randomization occurred. Our aim was to report a large cohort of patients who were treated with a new technique and describe the problems and pitfalls that we encountered.

Our percentages of intra- and early postoperative complications are comparable with other reports.^2,5–7 De novo stress urinary incontinence occurred in 56 patients (17.3%). Of these, 35 (10.8% of all patients) needed a second operation for this reason. This percentage is comparable to what is reported in the literature,⁶ but it is still high. In an attempt to ameliorate this, we have now started to perform our procedures under spinal anesthesia. After the mesh is in place and tightened, we let our patients cough. If there appears to be de novo stress incontinence, we then proceed with placement of a TVT-O suspension mesh. This approach is, as yet, untested and needs to be evaluated in a randomized, controlled clinical trial.

As mentioned earlier, urodynamic evaluation with reduction of the prolapse was not performed in all patients, only in those with a history of incontinence. The reason for this is that there seems to be no consensus in the literature about its predictive value, whereas the procedure is decidedly unpleasant for the patients. A recent study, however, seems to demonstrate a good predictive value of such a test for postoperative stress urinary incontinence.⁷

We had 8 postoperative failures (2.5%) who needed a new prolapse procedure. This number is somewhat lower than that reported in the literature.^5,8 We counted 11.5% erosions in our study, most of which did not respond adequately to local estrogen cream and metronidazole vaginal ovules and needed surgical revision. The patients developing erosions ranged in age from 36 to 86 years and underwent all types of prolapse procedures, such as those listed in Table 1. The erosions were a minimum of 0.5 cm across. Revision (under local anesthetic) entailed excision of the exposed mesh, tunneling under the walls of the vagina lateral to the exposed mesh (for a distance of about 2–3 cm), and closure of the defect with a running stitch of 2/0 Vicryl (rapid). The percentages of erosion described in the literature vary between 5% and 45%,^2,8 depending on the definition used. One study reported erosions to be more frequent in younger patients,⁹ but our findings did not confirm this. However, problems with mesh exposure remain an issue. Our approach to try to reduce the occurrence of this problem has been to leave vaginal mucosal flaps intact and not trimmed, as is common during traditional colporrhaphy. Vaginal incisions are kept as small as possible, and when a vaginal hysterectomy is performed at the same time, T-shaped incisions are avoided. We also try to prevent hematomas by meticulous attention to hemostasis. Finally, early postoperative check-ups and treatment with topical estrogen and metronidazole are used to try and heal small erosions before they become troublesome enough to have to be excised. Again, none of these measures have been proven beneficial in a randomized, controlled clinical trial, and such a trial would be very welcome.

Conclusions

Pelvic organ prolapse is a common occurrence. Due to a very high recurrence rate after traditional repair, several artificial mesh techniques have been developed. So far, the recurrence rates have vastly improved with the new techniques. Complications include bladder and bowel perforations with the needles, de novo stress urinary incontinence, relapse of the operated compartment, mesh erosions, and severe dyspareunia. As with every new technique, adjustments will be made over the years.

We describe the results of our first 323 patients treated with the Prolift mesh. Further studies need to be done to evaluate ways to reduce the above-mentioned complications and examine the use of Prolift repair in young patients and patients who may wish to bear (more) children. In addition, the effect of meshes on sexual function needs to be evaluated.

Footnotes

Acknowledgments

The authors would like to thank the staff of the pharmacy of Klina General Hospital (Brasschaat, Belgium) for providing a list of patients who have been operated on when using the technique and during the time frame mentioned above.

Disclosure Statement

No competing financial interests exist.

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