Experience with Prolift Mesh System for Correction of Uterovaginal Prolapse: Analysis of 149 Cases

Introduction

Pelvic organ prolapse (POP) is a common problem, as it affects 50% of parous women older than age 50, with a lifetime prevalence between 30% and 50%. ¹ Moreover, it is estimated that 11% of women in the Western world will undergo surgery to correct POP, and 30% of these women will undergo subsequent procedures for recurrence of POP. ² Prolapse is typically managed vaginally with native-tissue repairs; however, several studies have shown a high failure rate, especially for repair of the anterior vaginal wall. ³ This led to augmentation of native-tissue repair with synthetic mesh. Initially, this was accomplished with individually cut pieces of mesh, which produced adequate success, ⁴ and this was followed by the landmark prototype Prolift^® system independently worked out by the French TVM (Transvaginal Mesh) group^5,6 and a U.S. group, ⁷ —both groups were followed for 5 years.

Despite the excellent results published by the TVM group with the prototype Prolift mesh system, ⁸ there were several complications reported to the U.S. Food and Drug Administration that resulted in the FDA reclassifying the mesh as Class III. ⁹ The FDA then instructed the mesh manufacturers to stop selling the kits, as there were significantly more complications reported and as there was absence of any satisfactory evidence to show that vaginal-mesh procedures added any benefit to native-tissue repairs for POP. ¹⁰ This led to a backlash from practicing surgeons who believed that vaginal mesh did have a role in select groups of subjects and that it should not have been completely withdrawn. The growing consensus among pelvic floor surgeons has been that vaginal-mesh surgery is complex and should be performed in select groups of patients with POP by surgeons who are experienced in performing these procedures and willing to follow these patients.

This article reports the current authors' experience with the original Prolift system (Gynecare Prolift^® Pelvic Floor Repair System [Somerville, NJ]) for the correction of genital organ prolapse. Prolift mesh is a 100% type IA polypropylene mesh that is delivered by a trocar system. There are 3 mesh kits: (1) anterior; (2) posterior; and (3) a combined (or total) kit.

The goal is to report the success of the Prolift system for correcting POP, based upon a combination of anatomical outcomes, as measured by the Pelvic Organ Prolapse–Quantification (POP-Q) system score POP-Q < Stage II and the subject-bother symptoms as determined by the Pelvic Floor Distress Inventory—Short Form 20 (PFDI-20).

Materials and Methods

This was a retrospective study of subjects who underwent Prolift vaginal mesh reconstructive surgery for POP and who presented for at least a 12-month postoperative visit.

This retrospective chart review was approved by the institutional review board of the Oakwood Hospital and Medical Center, Dearborn, MI. The inclusion criteria were subjects who underwent Prolift surgery and were followed up at least 12 months after surgical intervention.

Treatment success was defined as POP-Q stage <II and lack of subjective bother of prolapse as determined by the PFDI-20¹¹ question #3, “do you usually have a bulge or something falling out that you can see or feel in the vaginal area?” answered as “no,” or if answered “yes,” considered not at all bothersome.

Each subject provided a detailed urogynecologic history and underwent examinations including the POP-Q assessment. ¹² All definitions and descriptions conformed to the standards recommended by the International Continence Society. ¹² All subjects with anterior vaginal-wall prolapse or symptoms of urinary incontinence underwent urodynamic testing. Occult stress urinary incontinence (SUI) on urodynamics was assessed by elevating the anterior vaginal wall with a sponge stick in order to simulate a postsurgical repair. Subjects who had overt or occult SUI underwent concomitant midurethral sling procedures.

The Gynecare Prolift (Ethicon Inc., Somerville, NJ) surgical procedure was performed per the Instructions for Use. Subjects who had uteri required total Prolift mesh cut into 2 pieces with the anterior mesh attached to the anterior cervix and the posterior mesh attached to the posterior lip of the cervix, respectively. This anchoring was performed with a permanent prolene suture. Hysterectomy was not performed in uterine prolapse cases. Cystourethroscopy was performed in all subjects with anterior or total mesh surgeries or in subjects undergoing concomitant sling procedures. A systematic rectal examination was performed at the end of each case involving the posterior Prolift mesh to rule out rectal injury and to ensure that the mesh arms in the sacrospinous ligaments were not too tight.

Each subject completed examinations, including the POP-Q and a postoperative PFDI-20 questionnaire, at follow-up visits. The PFDI-20 was used as a condition-specific questionnaire for prolapse, specifically the inventory subscale (Pelvic Organ Prolapse Distress Inventory–6). The PFDI-20 is comprised of 3 subscales assessing pelvic floor, colorectal, and urinary complaints. ¹¹

Data were represented as means with standard deviations, medians with ranges, and frequencies, when appropriate. POP-Q values and prolapse stages were compared, using a Wilcoxon signed-rank test. A p-value <0.05 was considered statistically significant.

Results

One hundred and forty-nine subjects underwent Prolift surgery from 9/9/2005 to 3/9/2009 and followed-up at least 1 year postoperatively (mean follow-up was 18.6 months). Of the procedures performed, 48 were anterior mesh repairs, 42 were posterior mesh repairs, and 59 were total mesh repairs. Demographic and surgical information are presented in Table 1. One hundred and thirty-two (88.6%) subjects were postmenopausal, and 133 (89.3%) subjects were nonsmokers. Sixty-seven (45.0%) subjects had prior hysterectomies, 18 (12.1%) had prior prolapse surgeries, and 75 (50.3%) underwent concomitant midurethral sling placements.

Preoperative and postoperative POP-Q stages are presented in Table 2, and the distribution of individual POP-Q values is presented in Table 3. Preoperatively, 15.4% subjects had stage II prolapse, 55.7% had stage III prolapse, and 28.8% had stage IV prolapse. Surgical success as defined by this study was 80.5% (120/149). The pure anatomical success rate (i.e., POP-Q stage <II) was 89.6% (132/149). With respect to subjective perception of a vaginal bulge in PFDI-20 question #3, 132 (88.6%) subjects reported no bothersome prolapse symptoms at all. Of those reporting subjective bother, 10 answered “somewhat,” 3 “moderately,” and 4 “quite a bit.”

The success rate of the treated compartment was 96.6% (144/149). The failure rate per preoperative stage of prolapse was: stage II, 2/23 (8.7%); stage III, 14/83 (16.9%); and stage IV, 7/43 (16.3%). Successes per types of Prolift were: anterior Prolift 72.9%; posterior Prolift 73.8%; and total Prolift 91.5%.

The mean blood loss was 111.5 mL (range: 10–1500 mL). Three subjects had blood loss >500 mL. One subject who had a blood loss of 1500 mL had a massive uterovaginal procidentia with her preoperative POP-Q point C (uterus) value being +10, and her genital hiatus was 10 cm. There was 1 case of a postoperative hematoma. This patient presented with bleeding and fever 10 days postoperatively and was found to have a confined hematoma that measured 7.5 × 11.6 × 4.0 cm in the left paravaginal space. The hematoma was infected and had a foul odor. She was admitted to the hospital and managed with intravenous antibiotics. She did very well, defervesced, and was discharged to go home in 2 days. The Prolift mesh was not removed, as the prolapse was completely corrected. The hematoma eventually resolved with the only sequela being a 1-cm anterior vaginal mesh exposure, which was managed expectantly. She was one of the successful prolapse corrections.

Cystourethroscopy, performed on all eligible 127 subjects, was normal without any injuries. Most of the subjects stayed overnight in the hospital. The mean hospital stay was 1.2 days (range: 1–5 days). There were no rectal injuries. From the perspective of postoperative voiding function, 84.6% (126/149) subjects were discharged voiding normally, 12.1% (18/149) subjects went home with an indwelling Foley catheter, and 3.4% (5/149) subjects went home self-catheterizing. Of the subjects who were not voiding normally, a concomitant sling procedure for stress incontinence was performed in 10 of these 18 subjects discharged with a Foley catheter and in all 5 subjects who were taught self-catheterization. All but 1 subject were voiding normally within a few weeks after surgery. The 1 subject who continued to have high post-void residuals had had retention preoperatively due to detrusor hypofunction noted on urodynamics. She was asymptomatic and stopped catheterizing.

Mesh exposure into the vagina was noted in 13.4% (20/149) of subjects. Exposures were first noted at a median follow-up of 3 months (range: 1–36 months). The dimensions of exposures were between 1 and 2 cm. Of these subjects with exposures, 12 underwent a total Prolift, 5 an anterior Prolift, and 3 a posterior Prolift. Nine mesh exposures were located on the anterior vaginal wall, 6 on the posterior wall, and 5 at the vaginal apex. Of these exposures, 5 were managed expectantly, 9 were excised in the office, and the remaining 6 were excised in the operating room. None of the subjects had the entire mesh removed. There were no cases of mesh erosions into other viscera, such as the urinary system or the bowel, and there were no cases of fistulae.

Regarding sexual disposition of the patients, 53 of 149 subjects (35.6%) were sexually active preoperatively, whereas 25.5% (38 of 149) were sexually active postoperatively. Postoperatively, 4 subjects had resolution of dyspareunia, 6 had persistent dyspareunia, and 5 had de novo dyspareunia with a postoperative de novo dyspareunia rate of 5/34 (14.7%).

Discussion

This was a retrospective review of 149 subjects who underwent the first-generation Prolift procedure for correction of POP, from September 2005 to March 2009. The composite success in subjects who were at least 12 months postsurgery was 80.5%. The pure anatomical success rate (i.e., POP-Q stage < II) was 89.6% (132/149). These results were consistent with prospective multicenter studies reporting 1-year anatomical outcomes ranging from 79% to 91% after POP repair with the Prolift system.^13–15 Interestingly, in the current study, the success rate of the treated compartment was 96.6% (144/149).

Therefore, almost all anatomical failures (12 of 17) occurred in the untreated compartments. This was similar to the findings of Milani et al. (20.5% failure) ¹⁶ and Withagen et al. (23% failure). ¹⁴ Thus, the contralateral walls should be carefully assessed preoperatively, as some weakness in this wall might become evident once the vaginal vectors are changed with differential support being offered to a treated compartment. This was confirmed from the current study in which the success of subjects undergoing total Prolift mesh procedures was 91.5%, compared to those who had the anterior Prolift (72.9%) or the posterior Prolift (73.8%). The failure rate in the current study was higher for greater stage of POP. This is consistent with what has been found in the literature and might have some connection with the integrity of the levator ani muscles and the genital hiatus.^17,18

Most of the mesh exposures in this series were small (averaging 1–2 cm). There were no cases of mesh erosion into the neighboring viscera. The incidence of mesh exposure into the vagina was 13.4%. This is similar to those incidences reported by several large studies—both retrospective ones^8,19 and prospective ones.^13,16 It was, in fact, very similar to the mesh exposures seen after sacrocolpopexy procedures (10.5%) at 6 years. ²⁰

The safety profile of the Prolift mesh was well-demonstrated in 1 patient who had an infected hematoma and was treated with antibiotics alone. It was not necessary to remove the mesh, and this subject did very well with an excellent postoperative course.

One subject had an ongoing voiding dysfunction, which was not de novo. All of the remaining subjects were voiding spontaneously.

Most of the subjects (84%) went home after an overnight stay. This is one of the major attributes of vaginal surgery, and this mainly is important for the elderly subjects who get disoriented when they are admitted to the hospital for prolonged durations. ²¹

Vaginal wall retraction is now being discussed as a possible cause of postoperative dyspareunia due to vaginal wall/mesh shrinking. At the time of this current study, this was not being assessed; however, total vaginal length did not change from preoperative (8 cm) to postoperative (7 cm) measures. The incidence of de novo dyspareunia in this current study was 14.7%. This was similar to that after conventional prolapse repairs (14.5%–36.1%), and a retrospective study quoted a similar rate (16.7%) following repair with the original polypropylene mesh.^22,23

There were strengths and limitations to this study. Strengths included a large subject volume, 1 year follow-up, use of subjective and objective criteria to define success, and use of a validated questionnaire. The drawbacks are those inherent to a retrospective study without a control group, mainly selection bias, the POP-Q measurements were not performed by an independent observer, and this was a single-center study, which might limit its generalizability.

Conclusions

The past 2 decades has seen a significant upheaval in the management of POP. The high failure rates seen with native-tissue repairs led to a surge in vaginal mesh kit surgeries, which, in turn, resulted in a high number of reported complications and ultimately to the withdrawal of vaginal mesh entirely from clinical practice. The truth is somewhere in the middle of these extremes. Vaginal mesh surgery is clearly not indicated for all POP cases, especially those with isolated primary failure of the posterior vaginal wall. However, there are some cases, such as recurrent vaginal prolapse in patients at high risk for abdominal surgery, for whom vaginal augmentation surgery may be suitable. It is now becoming increasingly clear that these procedures are complex and should be performed by surgeons who are experienced in the technique.

Merely possessing a urology or urogynecology subspecialty certificate is not enough. Most societies, including the American Urogynecologic Society, recommend a specific number of cases to maintain competence. ²⁴ The current authors' experience in the short-term shows that Prolift mesh is safe and effective, and is associated with minimal postoperative morbidities and allows for short hospital stays.