Reoperation rate and outcomes following the placement of polypropylene mesh by the vaginal route for cystocele: very long-term follow-up.

INTRODUCTION AND HYPOTHESIS: The aim was to evaluate the reoperation rate and outcomes in women who underwent transvaginal non-absorbable monofilament polypropylene mesh placement for the treatment of cystocele. METHODS: The retrospective cohort study included 63 patients who underwent transvaginal surgery using a synthetic polypropylene mesh (Gynemesh™) for cystocele. Patients were evaluated using a clinical examination (POP-Q) and validated questionnaires (PGI-I, PFDI-20, PFIQ-7) at 18 years of follow-up (median 18 years [IQR 16-19]). Cumulative death rate was 13 out of 63 (20%) and rate of total loss to follow-up was 21 out of 50 (42%). Finally, among the 63 women who underwent surgery, 29 completed maximum follow-up and 21 underwent a clinical examination. RESULTS: The cumulative reoperation rate was 35% (22 out of 63). Three patients were reoperated on because of recurrence of pelvic organ prolapse. Among the 63 patients initially operated, vaginal mesh exposure occurred in 16 (25%) during follow-up and 11 women (17%) needed a reintervention for vaginal mesh exposure. One patient was reoperated on for bladder mesh exposure. Among the 29 women who completed follow-up, the overall postoperative improvement rate was 93% after 18 years (PGI-I: 1-3). Mean overall satisfaction rate was 80 out of 100. Functional success rate was 76% (22 out of 29) and anatomical success rate was 62% (13 out of 21). The median score of the POP-DI-6 was 4.1 (IQR: 0-11) and the median score of the PFDI-20 was 30.7 (IQR: 13-60) in the 29 women who completed maximum follow-up. CONCLUSION: At very long-term follow-up, the recurrence rate of cystocele following polypropylene mesh placement by the vaginal route remained low and the satisfaction rate was high. However, we found high cumulative reoperation and mesh exposure rates.

Changes in pelvic organ prolapse mesh mechanical properties following implantation in rats.

BACKGROUND: Pelvic organ prolapse (POP) is a multifactorial disease that manifests as the herniation of the pelvic organs into the vagina. Surgical methods for prolapse repair involve the use of a synthetic polypropylene mesh. The use of this mesh has led to significantly higher anatomical success rates compared with native tissue repairs, and therefore, despite recent warnings by the Food and Drug Administration regarding the use of vaginal mesh, the number of POP mesh surgeries has increased over the last few years. However, mesh implantation is associated with higher postsurgery complications, including pain and erosion, with higher consecutive rates of reoperation when placed vaginally. Little is known on how the mechanical properties of the implanted mesh itself change in vivo. It is assumed that the mechanical properties of these meshes remain unchanged, with any differences in mechanical properties of the formed mesh-tissue complex attributed to the attached tissue alone. It is likely that any changes in mesh mechanical properties that do occur in vivo will have an impact on the biomechanical properties of the formed mesh-tissue complex. OBJECTIVE: The objective of the study was to assess changes in the multiaxial mechanical properties of synthetic clinical prolapse meshes implanted abdominally for up to 90 days, using a rat model. Another objective of the study was to assess the biomechanical properties of the formed mesh-tissue complex following implantation. STUDY DESIGN: Three nondegradable polypropylene clinical synthetic mesh types for prolapse repair (Gynemesh PS, Polyform Lite, and Restorelle) and a partially degradable polypropylene/polyglecaprone mesh (UltraPro) were mechanically assessed before and after implantation (n = 5/ mesh type) in Sprague Dawley rats for 30 (Gynemesh PS, Polyform Lite, and Restorelle) and 90 (UltraPro and Polyform Lite) days. Stiffness and permanent extension following cyclic loading, and breaking load, of the preimplanted mesh types, explanted mesh-tissue complexes, and explanted meshes were assessed using a multi-axial (ball-burst) method. RESULTS: The 4 clinical meshes varied from each other in weight, thickness, porosity, and pore size and showed significant differences in stiffness and breaking load before implantation. Following 30 days of implantation, the mechanical properties of some mesh types altered, with significant decreases in mesh stiffness and breaking load, and increased permanent extension. After 90 days these changes were more obvious, with significant decreases in stiffness and breaking load and increased permanent extension. Similar biomechanical properties of formed mesh-tissue complexes were observed for mesh types of different preimplant stiffness and structure after 90 days implantation. CONCLUSION: This is the first study to report on intrinsic changes in the mechanical properties of implanted meshes and how these changes have an impact on the estimated tissue contribution of the formed mesh-tissue complex. Decreased mesh stiffness, strength, and increased permanent extension following 90 days of implantation increase the biomechanical contribution of the attached tissue of the formed mesh-tissue complex more than previously thought. This needs to be considered when using meshes for prolapse repair.

Transischioanal trans-sacrospinous ligament rectocele repair with polypropylene mesh: a prospective study with assessment of rectoanal function.

INTRODUCTION AND HYPOTHESIS: Despite good anatomical outcomes of pelvic organ prolapse (POP) repair by the vaginal route using synthetic mesh, complications limit their use. Clinical data are needed to generalize prolapse mesh repair by the vaginal route. The current study aims to evaluate midterm rectoanal function and clinical outcomes after transischioanal rectocele repair using a medium weight polypropylene mesh. METHODS: Between March 2003 and June 2004, 230 patients with stage II-IV anterior and/or posterior POP were included in a prospective multicenter study. The current study is based on the analysis of the 116 patients who underwent a rectocele repair via the infracoccygeal route through the sacrospinous ligament. Anatomical cure was defined when rectocele was at stage

Cystocele repair by vaginal route: comparison of three different surgical techniques of mesh placement.

INTRODUCTION AND HYPOTHESIS: Different techniques of mesh placement for cystocele repair are known. Our goal was to compare anatomical and functional outcomes of three different techniques of mesh placement over a 3-year follow-up. METHODS: Between March 2003 and June 2004, 230 patients (stage 2-4 pelvic organ prolapse (POP)) were included in a prospective study. For cystocele repair, mesh was implanted either with two arms into the retropubic space (RP) or with two to four arms into the obturator foramen (TO), or fixed to the arcus tendineous fascia pelvis (FG). RESULTS: Patients' distribution is as follows: 142 TO, 32 RP, and 31 FG. Anatomical success (cystocele < stage 2 in the POP staging system) was clearly poorer after the retropubic free technique, with success rates of 69% (RP), 90.1% (TO), and 96.6% (FG) (p = 0.004). POP distress inventory (p < 0.005) and POP impact questionnaire scores were both significantly poorer after RP. CONCLUSIONS: RP technique is less effective than TO and FG techniques.

Long-term follow-up of persistent vaginal polypropylene mesh exposure for transvaginally placed mesh procedures.

INTRODUCTION AND HYPOTHESIS: The surgical treatment of a cystocele via the vaginal route may require the placement of a synthetic mesh below the bladder. However, the placement of a synthetic mesh via the vaginal route can be associated with specific complications, such as vaginal mesh exposure. There is a lack of data concerning the long-term follow-up of asymptomatic persistent vaginal polypropylene mesh exposure. METHODS: This was a retrospective case series of nine patients presenting with persistent vaginal mesh exposure following the placement of a macroporous monofilament polypropylene mesh for cystocele treatment. Expectant management has been proposed since the patients were asymptomatic. RESULTS: The median follow-up duration was 121 months [interquartile range (IQR) 119-132]. The median surface area of vaginal mesh exposure (1 cm(2); IQR 1-1) did not change significantly during the follow-up. No pelvic or perineal abscess occurred during the follow-up. Only one of them was sexually active; she complained of dyspareunia at the last follow-up, but refused renewed surgery since she had sexual intercourse on only a small number of occasions per year. Clinical examination using the International Continence Society Pelvic Organ Prolapse Quantification system: Ba -3 to -2 (n = 7; 88 %), Ba -1 (n = 1; 12 %), Ba 0 or greater (n = 0). CONCLUSIONS: Persistent asymptomatic vaginal polypropylene mesh exposure is associated with few complications at long-term follow-up.

Basic science and clinical aspects of mesh infection in pelvic floor reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: Bacterial colonization following mesh-augmented pelvic floor reconstructive surgery for pelvic organ prolapse is probably an underestimated consideration. METHODS: Although clinical infections are rare, subclinical contamination of the polypropylene mesh has been systematically demonstrated by bacteriological analyses during mesh implantation and on explanted meshes. RESULTS: A model of subclinical mesh infection does exist and bacterial colonization and mesh shrinkage have recently been correlated experimentally. CONCLUSIONS: New meshes with surface modifications or an antibiotic or antiseptic coating should be explored.

Correlation between shrinkage and infection of implanted synthetic meshes using an animal model of mesh infection.

INTRODUCTION AND HYPOTHESIS: the aim of this study was to evaluate a link between mesh infection and shrinkage. METHODS: twenty-eight Wistar rats were implanted with synthetic meshes that were either non-absorbable (polypropylene (PP), n = 14) or absorbable (poly (D: ,L: -lactic acid) (PLA94), n = 14). A validated animal incisionnal abdominal hernia model of mesh infection was used. Fourteen meshes (n = 7 PLA94 and n = 7 PP meshes) were infected intraoperatively with 10e6 CFU Escherichia coli, and compared with 14 non-infected meshes (n = 7 PLA94 and n = 7 PP meshes) (control groups). Explantations were performed on day 30. Shrinkage was evaluated by a reproducible numerical analysis of mesh area. Infection and histological study were evaluated on day 30. RESULTS: non-infected meshes were less shrunk than infected meshes for both non-absorbable (5.0 ± 1.7% versus 21.6 ± 6.1%, p < 0.05) and absorbable meshes (2.4 ± 0.9% versus 11.0 ± 2.5%, p < 0.05). CONCLUSION: this study highlights a link between infection and shrinkage in the model used.

Preliminary design of a new degradable medical device to prevent the formation and recurrence of intrauterine adhesions.

Intrauterine adhesions lead to partial or complete obliteration of the uterine cavity and have life-changing consequences for women. The leading cause of adhesions is believed to be loss of stroma resulting from trauma to the endometrium after surgery. Adhesions are formed when lost stroma is replaced by fibrous tissue that join the uterine walls. Few effective intrauterine anti-adhesion barriers for gynecological surgery exist. We designed a degradable anti-adhesion medical device prototype to prevent adhesion formation and recurrence and restore uterine morphology. We focused on ideal degradation time for complete uterine re-epithelialization for optimal anti-adhesion effect and clinical usability. We developed a triblock copolymer prototype [poly(lactide) combined with high molecular mass poly(ethylene oxide)]. Comparative pre-clinical studies demonstrated in vivo anti-adhesion efficacy. Ease of introduction and optimal deployment in a human uterus confirmed clinical usability. This article provides preliminary data to develop an intrauterine medical device and conduct a clinical trial.

A new bioabsorbable polymer film to prevent peritoneal adhesions validated in a post-surgical animal model.

BACKGROUND: Peritoneal adhesions are a serious surgical postoperative complication. The aim of this study is to investigate, in a rat model, the anti-adhesive effects of a bioabsorbable film of polymer combining polyethylene glycol and polylactic acid. MATERIALS AND METHODS: Sixty-three animals were randomized into five groups according to the anti-adhesion treatment: Hyalobarrier®, Seprafilm®, Polymer A (PA), Polymer B (PB), and control. The rats were euthanized on days 5 and 12 to evaluate the extent, severity and degree of adhesions and histopathological changes. Three animals were euthanized at day 2 in PA, PB and control groups to observe the in vivo elimination. RESULTS: Macroscopic adhesion formation was significantly lower in the PA group than in the control group at day 5 (median adhesion score 0±0 vs 9.6 ±0.5 p = 0.002) and at day 12 (0±0 vs 7.3±4 p = 0.02). Furthermore, median adhesion score at day 5 was significantly lower in the PA group than in the Seprafilm group (0±0 vs 4.2± 3.9 p = 0.03). Residence time of PA seems longer than PB. CONCLUSION: The PA bioabsorbable film seems efficient in preventing the formation of peritoneal adhesions.

A preclinical evaluation of polypropylene/polylacticacid hybrid meshes for fascial defect repair using a rat abdominal hernia model.

OBJECTIVES: Synthetic mesh surgery for both abdominal and urogenital hernia repair is often unsatisfactory in the long-term due to postoperative complications. We hypothesized that a semi-degradable mesh hybrid may provide more appropriate biocompatibility with comparable mechanical properties. The aim was to compare its in vivo biocompatibility with a commercial polypropylene (PP) mesh. METHODS: 72 rats were randomly allocated to either our new composite mesh (monofilament PP mesh knitted with polylactic-acid-fibers (PLA)) or to a commercially available PP mesh that was used as a control. 15, 90, and 180 days after implantation into the rat abdomen mesh tissue complexes were analysed for erosion, contraction, foreign body reaction, tissue integration and biomechanical properties. RESULTS: No differences were seen in regard to clinical parameters including erosion, contraction or infection rates between the two groups. Biomechanical properties including breaking load, stiffness and deformation did not show any significant differences between the different materials at any timepoint. Macrophage staining did not reveal any significant differences between the two groups or between timepoints either. In regard to collagen I there was significantly less collagen I in the PP group compared to the PP/ PLA group at day 180. Collagen III did not show any significant differences at any timepoint between the two groups. CONCLUSION: A PP/PLA hybrid mesh, leaving a low amount of PP after PLA degradation seems to have comparable biomechanical properties like PP at 180 days due to enhanced collagen production without significant differences in erosion, contraction, herniation or infection rates.

Tolerance and long-term MRI imaging of gadolinium-modified meshes used in soft organ repair.

BACKGROUND: Synthetic meshes are frequently used to reinforce soft tissues. The aim of this translational study is to evaluate tolerance and long-term MRI visibility of two recently developed Gadolinium-modified meshes in a rat animal model. MATERIALS AND METHODS: Gadolinium-poly-ε-caprolactone (Gd-PCL) and Gadolinium-polymethylacrylate (Gd-PMA) modified meshes were implanted in Wistar rats and their tolerance was assessed daily. Inflammation and biocompatibility of the implants were assessed by histology and immunohistochemistry after 30 days post implantation. Implants were visualised by 7T and 3T MRI at day 30 and at day 90. Diffusion of Gadolinium in the tissues of the implanted animals was assessed by Inductively Coupled Plasma Mass Spectrometry. RESULTS: Overall Gd-PMA coated implants were better tolerated as compared to those coated with Gd-PCL. In fact, Gd-PMA implants were characterised by a high ratio collagen I/III and good vascularisation of the integration tissues. High resolution images of the coated mesh were obtained in vivo with experimental 7T as well as 3T clinical MRI. Mass spectrometry analyses showed that levels of Gadolinium in animals implanted with coated mesh were similar to those of the control group. CONCLUSIONS: Meshes coated with Gd-PMA are better tolerated as compared to those coated with Gd-PCL as no signs of erosion or significant inflammation were detected at 30 days post implantation. Also, Gd-PMA coated meshes were clearly visualised with both 7T and 3T MRI devices. This new technique of mesh optimisation may represent a valuable tool in soft tissue repair and management.

Prevention of complications related to the use of prosthetic meshes in prolapse surgery: guidelines for clinical practice.

The objective of the study was to provide guidelines for clinical practice from the French College of Obstetrics and Gynecology (CNGOF), based on the best evidence available, concerning adverse events related to surgical procedures involving the use of prosthetic meshes. French and English-language articles from Medline, PubMed, and the Cochrane Database were searched, using key words (mesh; pelvic organ prolapse; cystocele; rectocele; uterine prolapse; complications; adverse event; sacral colpopexy; extrusion; infection). As with any surgery, recommendations include perioperative smoking cessation (Expert opinion) and compliance with the prevention of nosocomial infections (regulatory recommendation). There is no evidence to recommend routine local or systemic estrogen therapy before or after prolapse surgery using mesh, regardless of the surgical approach (Grade C). Antibiotic prophylaxis is recommended, regardless of the approach (Expert opinion). It is recommended to check for pre-operative urinary tract infection and treat it (Expert opinion). The first procedure should be undertaken under the guidance of a surgeon experienced in the relevant technique (Grade C). It is recommended not to place a non-absorbable synthetic mesh into the rectovaginal septum when a rectal injury occurs (Expert opinion). Placement of a non-absorbable synthetic mesh into the vesicovaginal septum may be considered after suturing of a bladder injury if the suture is considered to be satisfactory (Expert opinion). If a synthetic mesh is placed by vaginal route, it is recommended to use a macroporous polypropylene monofilament mesh (Grade B). It is recommended not to use polyester mesh for vaginal surgery (Grade B). It is permissible to perform hysterectomy associated with the placement of a non-absorbable synthetic mesh placed by the vaginal route but this is not routinely recommended (Expert opinion). It is recommended to minimize the extent of the colpectomy (Expert opinion). The laparoscopic approach is recommended for sacral colpopexy (Expert opinion). It is recommended not to place and suture meshes by the vaginal route when a sacral colpopexy is performed (Grade B). It is recommended not to use silicone-coated polyester, porcine dermis, fascia lata, and polytetrafluoroethylene meshes (Grade B). It is recommended to use polyester (without silicone coating) or polypropylene meshes (Grade C). Suture of the meshes to the promontory can be performed using thread/needle or tacks (Grade C). Peritonization is recommended to cover the meshes (Grade C). If hysterectomy is required, it is recommended to perform a subtotal hysterectomy (Expert opinion). Implementation of this guideline should decrease the prevalence of complications related to surgical procedures involving the use of prosthetic meshes.

New magnetic-resonance-imaging-visible poly(ε-caprolactone)-based polyester for biomedical applications.

A great deal of effort has been made since the 1990s to enlarge the field of magnetic resonance imaging. Better tissue contrast, more biocompatible contrast agents and the absence of any radiation for the patient are some of the many advantages of using magnetic resonance imaging (MRI) rather than X-ray technology. But implantable medical devices cannot be visualized by conventional MRI and a tool therefore needs to be developed to rectify this. The synthesis of a new MRI-visible degradable polymer is described by grafting an MR contrast agent (DTPA-Gd) to a non-water-soluble, biocompatible and degradable poly(ε-caprolactone) (PCL). The substitution degree, calculated by (1)H nuclear magnetic resonance and inductively coupled plasma-mass spectrometry, is close to 0.5% and proves to be sufficient to provide a strong and clear T1 contrast enhancement. This new MRI-visible polymer was coated onto a commercial mesh for tissue reinforcement using an airbrush system and enabled in vitro MR visualization of the mesh for at least 1 year. A stability study of the DTPA-Gd-PCL chelate in phosphate-buffered saline showed that a very low amount of gadolinium was released into the medium over 52 weeks, guaranteeing the safety of the device. This study shows that this new MRI-visible polymer has great potential for the MR visualization of implantable medical devices and therefore the post-operative management of patients.

Is degradable antibiotic coating for synthetic meshes provide protection against experimental animal infection after fascia repair?

The surgical repair of pelvic organ prolapse using synthetic mesh can fail because of slow or partial implant integration due to poor biocompatibility or infection. As systemic antibiotic prophylaxis has only limited success, we have developed a system that coats standard polypropylene mesh with clinically relevant antibiotics. Amoxicillin and ofloxacin are both released from the mesh in vitro at high levels over 3 days, preventing adhesion and biofilm formation by a clinical isolate of E. coli. In an in vivo incisional hernia repair model in rats, the antibiotic-coated mesh results in appropriate tissue integration with adequate vascularization and collagen formation. When implanted animals are infected with virulent E. coli, both antibiotic coatings provide full protection against infection (as assessed both clinically and microbiologically), thus demonstrating their bioavailability. This method is a specific approach for producing a therapeutic coating that could reduce postsurgical infections.

Permanent polymer coating for in vivo MRI visualization of tissue reinforcement prostheses.

The clinical advantage of MRI visualization of prostheses in soft tissue prolapses is very appealing as over 1,000000 MRI-transparent synthetic meshes are implanted annually, and postoperative complications such as mesh shrinkage and migration are frequent. Here, the synthesis of a new material composed of a DTPA-Gd complex grafted onto a backbone of PMA via a covalent bond is described (DTPA-Gd-PMA). This new polymer is sprayed onto meshes and gives an MR signal for a long period without any significant release of Gd. In vitro cytocompatibility tests on fibroblasts show limited cytotoxicity. Microscopic investigations indicate that vital cells rapidly colonize the material. Finally, coated meshes implanted in rats are easily recognizable using an MR imaging system.

Trans-vaginal cystocele repair using a tension-free polypropylene mesh: more than 5 years of follow-up.

OBJECTIVES: Prospective randomized controlled trials, with 2 years' follow-up, seem to lean in favour of anterior repair using synthetic mesh. The goal of this study was to report on long-term (>5 years) follow-up. STUDY DESIGN: Polypropylene mesh was inserted in 63 women (in 1999-2001) from the retropubic space to under the bladder using a tension-free technique. RESULTS: At 79 months' follow-up, 45 women were anatomically cured (76%). Four (7%) were lost to follow-up and 14 (24%) presented with stage 2 or 3 cystocele recurrences. None of them required surgery for cystocele recurrence. Vaginal extrusion was reported in 10 (16%) patients (in four cases after 4 years of follow-up) and all required partial surgical removal of the mesh (n=10, 16%). CONCLUSION: Cystocele repair using tension-free polypropylene mesh is associated with a low long-term rate of repeat surgery for cystocele recurrence.