Prolift Procedure Research Articles

Morbidity and functional mid-term outcomes using Prolift pelvic floor repair systems.

We assess midterm morbidity and functional outcomes using the Prolift (Gynecare/Ethicon, Somerville, NJ) system and identify potential related risk factors. The Prolift mesh system to treat genital prolapse was introduced in 2005. It was withdrawn from the market in early 2013 after rising doubts about safety. Over a 7-year period, we retrospectively analyzed a cohort of 112 consecutive patients who underwent the Prolift procedure since 2006. Intraoperative and postoperative complications, anatomical and functional outcomes were recorded. The median follow-up was 49.5 months (range: 16-85). The mean age was 64.7 ± 10.9 years (range: 40-86). Of the 112 patients, 74 patients had stage 3 (66.1%) and 8 patients had stage 4 (7.14%) vaginal prolapse. Prolift surgery was performed for pro-lapse recurrence for 26 patients (23.2%). Total mesh was used in 32 patients (29%), an isolated anterior mesh in 57 patients (51%) and an isolated posterior mesh in 23 patients (21%). Concomitant surgical procedures were performed for 44 patients (39.3%). Overall, 72% (18/25) of the complications were managed medically. We reported a failure rate of 8% (n = 9) occurring after a median follow-up of 9.5 months (range: 1-45). Among the 64 patients who had preoperative sexual activity (57.1%), de novo dyspareunia occurred in 9 patients (16.07%). We extracted predictive factors concerning failure, complications and sexuality. Despite its market withdrawal, the Prolift system was associated with good midterm anatomic outcomes and few severe complications. Long-term follow-up data are still lacking, but surgeons and patients may be reassured.

Perioperative complications in abdominal sacrocolpopexy, sacrospinous ligament fixation and prolift procedures.

Pelvic organ prolapse is an important problem for women. To overcome this issue, different operational technics are in use, such as abdominal sacrocolpopexy, sacrospinous fixation, and the total Prolift procedure. This study assessed perioperative complications in abdominal sacrocolpopexy, sacrospinous fixation, and the total Prolift procedure. Retrospective comparative study. Perioperative complications were defined as any complication occurring during surgery or the first 6 weeks postoperatively. Forty-five patients underwent abdominal procedures, 60 patients underwent sacrospinous fixation, and 43 patients underwent the total Prolift procedure. In the abdominal group, one bladder injury, four hemorrhages, and three wound dehiscences occurred. In the sacrospinous group, one rectal injury and one postoperative vault infection occurred. In the Prolift group, one bladder injury and one hemorrhage occurred. Minor complications were more frequent in the abdominal group than the others. The operating time and hospital stay of the abdominal group were significantly longer than the others. The Pro-lift procedure had less operating time and hospital stay than other procedures. The total Prolift may be a novel alternative for apical prolapse with low perioperative morbidities and complications.

Dyspareunia caused by a vaginal adhesion band following a transvaginal mesh repair

Surgery with synthetic mesh or graft materials has become increasingly popular over the past decade due to the excellent short-term success rate. However, concern about mesh-related complications still exists. Here we report a case experiencing sexual pain after a transvaginal mesh repair with a total Prolift procedure. Also, her husband experienced painful intercourses due to a vertical adhesion band between the anterior and posterior vaginal wall. Under local anesthesia, the adhesion band was dissected. She restarted her sexual life 3 weeks after the procedure without any further complaint. A postoperative vaginal adhesion band formation may occur during the healing process, which may cause postoperative sexual dysfunction. This rare complication may aid in preoperative counseling about the potential adverse events on postoperative sexual function.

The improvement of pelvic floor muscle function in POP patients after the Prolift procedure: results from surface electromyography

Patients with pelvic organ prolapse (POP) have lower pelvic floor muscle (PFM) function. We hypothesized that pelvic reconstructive surgery could improve PFM function and strength. The controlled, nonrandomized study recruited 37 POP patients in the Prolift group and 30 non-POP patients in the control group. Two urogynecologists performed the Prolift procedure. One experienced physiotherapist who was blinded to the grouping conducted the surface electromyography (SEMG) evaluation using an intravaginal probe. The patient was considered objectively cured if she had stage 0 or I according to the Pelvic Organ Prolapse Quantification system (POP-Q) at the 3rd month postoperatively. Two types of contractions, namely maximum voluntary contraction (MVC) and short, fast contractions (SFC) in 6 s were performed at each SEMG measurement. The SEMG data were collected once in the control group on admission and twice in the Prolift group (on admission and at the 3rd month postoperatively). The t test, Mann-Whitney U test, and Wilcoxon test were used for statistical analysis. A total of 36 POP patients were cured by the Prolift procedure. At the 3-month follow-up, the voltage and duration of MVC as well as the numbers and voltage of SFC increased significantly in the Prolift group. These variables were lower in POP patients compared to women without POP. The restoration of pelvic anatomy may account for the improved PFM function with increased electrical activity in POP patients verified by SEMG. Evaluation of PFM function may be used as a clinical tool in the overall assessment of pelvic reconstructive surgeries.

Pelvic floor abscess secondary to gossypiboma following a total Prolift procedure

Gossypiboma, which is derived from the Latin term “gossypium” (cotton), is retention of cotton material, where usually a gauze or abdominal sponge frequently causes morbidity and may result in death. Nonresorbable hemostatic aides include various forms of cotton and rayon-based hemostats (cottonoids and kites). Histologic examination typically shows a core of degenerating hemostatic agent surrounded by an inflammatory reaction. If the foreign body cannot be extruded, it remains in the abscess cavity and creates multiple fistulae. In such a case, the patient who is recovering well after surgery becomes chronically unwell and complains of multiple symptoms. Pelvic organ prolapse (POP) is a growing gynecologic problem because of the increased life expectancy of women and the many available medical resources in our country. Women now have a lifetime risk of 11% for surgery intervention for POP [1]. Surgical therapy for POP has been a proliferation in techniques and materials that are intended to improve prolapse reduction. Therefore, surgery with implantation of mesh or graft materials has become increasingly popular over the past decade due to the excellent short-term cure rate [2]. Although synthetic mesh has the advantage of strength and durability, it has a drawback of graft encapsulation with subsequent infection and erosion. In addition, estrogen deficiency in menopause alters vaginal vascularization [3] and pH, which causes symptoms of urogenital atrophy, including pruritus, dryness, and dyspareunia. Consequently, these changes may contribute to poor healing of a vaginal wound following transvaginal mesh surgery, making the exposure of

Outcome of Prolift mesh repair in treatment of pelvic organ prolapse and its effect on lower urinary tract symptoms: 5‐year retrospective case study

To assess the outcome of the Prolift Gynecare (Ethicon, Somerville, NJ, USA) mesh repair in the treatment of pelvic organ prolapse. This includes the anatomical success, complication rate and effect on associated lower urinary tract symptoms. Retrospective case analysis of the above outcomes of 41 Prolift mesh repairs performed on 40 women over a 5-year period by a single surgeon in a private hospital in Australia. Successful anatomical correction and bulge symptom resolution were observed in 100% (2/2), 91.6% (11/12) and 100% (27/27) of anterior, posterior and total Prolift, respectively. Prolapse in a non-treated compartment occurred in one woman. Two patients developed postoperative hematomas requiring surgical evacuation; one of whom developed urinary retention for 2 weeks. Preoperative urinary symptoms were reported in 35/40 (92%) of women, 8 of whom reported only urge symptoms and experienced complete resolution after Prolift. Resolution of stress urinary incontinence in women who had urodynamic stress incontinence with and without urge symptoms was reported in 60% (12/20) and 20% (1/5), respectively. This represented 62.5% (10/16) and 33.3% (3/9) of women who had total Prolift and posterior Prolift respectively. Average follow-up periods were 7 and 39 weeks in 38 and 18 women, respectively. This study shows that Prolift procedure is safe and effective in women with severe pelvic organ prolapse with resolution of most of the bulge and urinary urge symptoms. Total Prolift was effective in the treatment of associated mixed urinary incontinence.

Anatomic and Functional Outcomes with the Prolift Procedure in Elderly Women with Advanced Pelvic Organ Prolapse Who Desire Uterine Preservation

Study ObjectiveTo assess the clinical outcomes of total mesh repair with the Prolift technique as treatment of advanced pelvic organ prolapse in elderly patients who desire uterine preservation. DesignCase control series study (Canadian Task Force classification II-2). SettingMedical school–affiliated hospital. PatientsSixty-eight patients over the age of 70 years with advanced pelvic organ prolapse, Pelvic Organ Prolapse Quantification stage III (n = 59) or IV (n = 9), underwent a total Prolift procedure and were followed up for a minimum of 2 years. InterventionsTransvaginal pelvic floor repairs were performed with a total Prolift system. The concurrent pelvic surgery included midurethral sling operation with a TVT-O, if indicated. The assessment included intraoperative and postoperative complications, Urogenital Distress Inventory scores, and Incontinence Impact Questionnaire scores. Measurements and Main ResultsObjective and subjective data were available for 68 patients. The anatomic success rate was 97.1% after 2 years. Complications included bladder perforation in 1 patient (1.5%), de novo stress urinary incontinence in 20 patients (29.4%), dyspareunia in 4 patients (22.2%), and vaginal erosion in 1 patient (1.5%). The Pelvic Organ Prolapse Quantification stages, Urogenital Distress Inventory scores, and Incontinence Impact Questionnaire scores all improved significantly after surgery. ConclusionsThe total Prolift procedure is an alternative surgical option that uses a minimally invasive transvaginal approach to surgically treat elderly patients with advanced pelvic organ prolapse.

Surgical treatment of uterine prolapse in women with bladder exstrophy: report of two cases with modified Prolift™ procedure

The incidence of pelvic organ prolapse is 18% in women with bladder exstrophy. A vaginal technique to correct the prolapse may be preferable in these women with multiple abdominal operations in their histories. We have performed a modified Prolift™ procedure for the repair of severe uterine prolapse in two young women. A review of the literature is presented.

Impact of Prolift procedure on bladder function and symptoms in women with pelvic organ prolapse

This study aims to investigate the impact of the Prolift procedure on bladder function and symptoms in women with pelvic organ prolapse. Seventy-one consecutive patients who underwent the Prolift procedure were evaluated on the subjective reporting of symptoms and objective urodynamic measurements pre- and 1 year postoperatively. Subjective symptoms significantly improved after surgery included frequency, urgency incontinence, straining to void, incomplete bladder emptying, and poor urine stream but the incidence of stress urinary incontinence was unchanged. Compared with preoperative urodynamic measurements, the residual urine volume, maximal bladder capacity, and urethral closure pressure significantly decreased postoperatively. After 1-year follow-up, the Prolift procedure resulted in reduced storage function and impaired bladder capacity urodynamically, but emptying function improved. Lower urinary tract symptoms were significantly improved, except for an unchanged incidence of stress urinary incontinence. Women should be informed of the possible impacts before the procedure.

Pelvic magnetic resonance imaging for assessment of the efficacy of the Prolift system for pelvic organ prolapse

The purpose of this study was to compare pre- and postoperative pelvic organ prolapse-quantification (POP-Q) and magnetic resonance imaging (MRI) measurements in patients who undergo total Prolift (Ethicon, Inc, Somerville, NJ) colpopexy. Pre- and postoperative MRI and POP-Q examinations were performed on patients with stage 2 or greater prolapse who underwent the Prolift procedure. MRI measurements were taken at maximum descent. Correlations between changes in MRI and POP-Q measurements were determined. Ten subjects were enrolled. On MRI, statistically significant changes were seen with cystocele, enterocele, and apex. Statistically significant changes were seen on POP-Q measurements for Aa, Ba, C, Ap, Bp, and GH. Positive correlations were demonstrated between POP-Q and MRI changes. Minimal tissue reaction was seen on MRI. The Prolift system is effective in the surgical management of pelvic organ prolapse as measured by POP-Q and MRI. Postoperative MRIs support the inert nature of polypropylene mesh.

Does trocar-guided tension-free vaginal mesh (Prolift™) repair provoke prolapse of the unaffected compartments?

Introduction and hypothesisThe objective of this study was to assess the effect of the tension-free vaginal mesh (Prolift™) procedure on the non-treated and initially unaffected vaginal compartments.MethodsThis prospective observational cohort study involved 150 patients who underwent a Prolift™ procedure. Pelvic organ prolapse (POP) quantification and evaluation of prolapse symptoms with validated questionnaires was performed pre-operatively and 6 and 12 months postoperatively. Primary outcome was the rate of POP stage ≥II in the non-treated vaginal compartments.ResultsTwenty-three percent of all patients developed a de novo POP stage ≥II in the untreated compartment. This occurred in 46% and 25% of patients after an isolated anterior and isolated posterior Prolift™, respectively.ConclusionTension-free vaginal mesh treatment of one vaginal compartment seems to provoke the development of vaginal prolapse in initially unaffected vaginal compartments, particularly after an isolated anterior Prolift™ procedure.

Short Term Impact on Female Sexual Function of Pelvic Floor Reconstruction with the Prolift Procedure

The Prolift system is an effective and safe procedure using mesh reinforcement for vaginal reconstruction of pelvic organ prolapse (POP), but its effect on sexual function is unclear. To evaluate the impact of transvaginal pelvic reconstruction with Prolift on female sexual function at 6 months post-operatively. Thirty-three sexually active women who underwent Prolift mesh pelvic floor reconstruction for symptomatic POP were evaluated before and 6 months after surgery. Their sexual function was assessed by using the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) before and after surgery. The quality of life was also evaluated with the short forms of the Urogenital Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7) as a control for efficacy of the procedure. The Pelvic Organ Prolapse Quantification system was used to evaluate the degree of prolapse. PISQ-12 scores at 6 months post-operatively. The total PISQ-12 score decreased from 29.5 +/- 9.0 to 19.3 +/- 14.7 (P < 0.001), indicating worsening of sexual function 6 months post-operatively. The behavioral, physical, and partner-related domains of PISQ-12 were each significantly reduced (5.2 +/- 3.7 vs. 2.9 +/- 3.7, P = 0.016; 15.4 +/- 4.7 vs. 10.4 +/- 8.6, P = 0.001; 8.9 +/- 3.8 vs. 6.4 +/- 5.5, P = 0.01, respectively). UDI-6 and IIQ-7 scores were significantly improved at the 6-month follow-up, as was anatomic recovery. Of the 33 subjects, 24 (73%) had worse sexual function 6 months after the procedure. The Prolift procedure provided an effective anatomic cure of POP, but it had an adverse effect on sexual function at 6 months after surgery.

Four Month and One Year Results of Transvaginal Mesh Placement (Prolift Procedure) in the Treatment of Pelvic Organ Prolapse

Study Objective: To report perioperative and anatomical outcome data following the surgical placement of transvaginal mesh, the Prolift TM procedure, in the treatment of pelvic organ prolapse among patients with 4 months and 1 year or greater follow-up.

Changes in levator ani muscle after vaginal hysterectomy and prolapse repair using the Total Prolift procedure

Objective To assess changes in the levator plate angle (LPA), anteroposterior length of the levator hiatus (H-line), and pelvic floor descent (M-line) after vaginal hysterectomy and prolapse repair using the Gynecare Prolift Total Pelvic Floor Repair System. Methods Before and after the intervention, 20 women with pelvic floor prolapse underwent dynamic magnetic resonance imaging in supine position during the Valsalva maneuver to measure the LPA, H-line, and M-line. Paired t tests were performed and Pearson correlation coefficients calculated from values obtained using the pelvic organ prolapse quantification system. Results After the intervention the LPA was smaller (46.92° vs 55.39°, P < 0.05), the H-line was shorter (53.70 cm vs 60.46 cm, P < 0.05), and the M-line was shorter (19.58 cm vs 25.27 cm, P < 0.05). Conclusion These changes suggest an efficient reconstruction and reinforcement of the pelvic floor after the surgery.

One-year anatomic and quality-of-life outcomes after the Prolift procedure for treatment of posthysterectomy prolapse

To evaluate anatomic and quality-of-life outcomes at 1-year or greater after treatment of posthysterectomy prolapse with the Prolift procedure. A retrospective repeated measures study comparing preoperative and 1-year or greater postoperative outcomes, including Pelvic Organ Prolapse Quantification measurements, Urogenital Distress Inventory, and Incontinence Impact Questionnaire scores. Ninety-seven patients were included, with a median follow-up of 19.0 months. Forty-six anterior, 28 posterior, and 23 total Prolift procedures were performed. At 1 year, Pelvic Organ Prolapse Quantification values were significantly improved, as were scores for Incontinence Impact Questionnaire, the Urogenital Distress Inventory, and its subscales, with the greatest improvement seen in the obstructive/discomfort subscale. Anatomical success (</= stage 1 in the treated compartment) was 86.6% at follow-up. Three patients experienced recurrent apical prolapse. An additional 15 patients presented with >/= stage 2 in the untreated vaginal compartment. Significant anatomic and quality-of-life improvements among patients undergoing the Prolift procedure for posthysterectomy prolapse were demonstrated.

Laparoscopic sacral colpopexy with Gynemesh as graft material—Experience and results

Study objective To evaluate the safety and efficacy of Prolene (Ethicon, Inc., Johnson and Johnson, Somerville, NJ) graft for sacral colpopexy and ease of use laparoscopically. Design Retrospective analysis (Canadian Task Force classification II-1). Setting Academic university hospital. Patients Seventy-four patients with recurrent prolapse of the apex or severe uterine prolapse (stage II-IV). Interventions Seventy-four patients with recurrent prolapse of the apex or severe uterine prolapse (stage II–IV) underwent laparoscopic sacral colpopexy or cervicopexy with Gynemesh (Ethicon, Inc.) used as the graft material. Measurements and main results Seventy-four patients, from March 2003 through March 2006, underwent a sacropexy. Fifty-one patients had recurrent apical prolapse, 22 patients had uterovaginal prolapse stage III or IV, and 1 patient had uterovaginal prolapse stage II and insisted on retaining the uterus. Fifty-two patients also had a concurrent sling procedure performed for incontinence. Intraoperative and postoperative complications included 1 middle sacral bleed managed by suturing in the middle sacral region and 1 postoperative cervical abscess requiring reoperation and removal of the graft at 10 days. All patients were evaluated at 2 weeks and 6 weeks after surgery, and pelvic examination was performed. They were then followed up biannually. Median age was 63 years (range 48–76 years), and median body mass index was 35 (range 24–41). Laparoscopic sacral colpopexy or cervico or uteropexy was performed successfully in 72 patients. Median blood loss was less than 25 mL (range 25–150 mL), and the median hospital stay was 1 day (range 1–2 days). One surgery was terminated because of dense rectosigmoid adhesions to the cuff requiring a laparotomy and partial sigmoid resection because of redundancy and postdissection trauma to the sigmoid. Another procedure was completed as a Prolift (Johnson and Johnson) procedure because of finding of a prior Mersilene (Phillips Sumika Polypropylene Co., Houston, TX) mesh that was densely adherent to the pelvic contents. Seventy patients are extremely happy and satisfied with the surgery. Postoperative recovery has been uneventful, and subjective and objective cure is 97% and 100%, respectively. One patient with sacrouteropexy still has stage I prolapse of her cervix, but it feels well supported. There have been no cases of colpopexy graft exposure or recurrence with a median follow-up of 24 months (range 9–36 months). The patient with cervical abscess and graft removal has also healed with no recurrance of her prolapse. Conclusions Laparoscopic sacral colpopexy or cervicopexy is a safe and effective procedure with excellent results. Gynemesh (Ethicon, Inc.), a wide-pore polypropelene mesh seems to be an excellent graft material with low risk for graft infection (1.4%) or erosion.

Retrovesical haematoma after anterior Prolift® procedure for cystocele correction

Retrovesical haematoma after anterior Prolift procedure was described. Primary conservative treatment was performed with the subsequent transvaginal emptying of the haematoma through the mesh incision without displacement. Prolift is not advocated as an ambulatory procedure.

Pelvic arterial embolization in the setting of acute hemorrhage as a result of the anterior Prolift® procedure

Acute hemorrhage following pelvic reconstructive surgery is a complication requiring immediate evaluation and treatment. Therapeutic options include fluid resuscitation, tamponade techniques, exploratory surgical intervention, and, more recently, pelvic vessel embolization. New approaches to pelvic organ prolapse have been evolving rapidly with little reported on safety and efficacy. We present a 77-year-old female who had a life-threatening acute pelvic hemorrhage from an anterior Prolift procedure successfully treated with pelvic artery embolization.