Use Of Surgical Mesh Research Articles

Restriction of Surgical Options for Pelvic Floor Disorders.

The purpose of this document is to update the 2013 AUGS Position Statement based on subsequent decisions made by the U.S. Food and Drug Administration, published clinical data, and relevant society and national guidelines related to the use of surgical mesh. Urogynecologists specialize in treating pelvic floor disorders, such as pelvic organ prolapse (POP) and urinary incontinence, and have been actively involved and engaged in the national and international discussions and research on the use of surgical mesh in the treatment of POP and stress urinary incontinence. In 2019, the U.S. Food and Drug Administration ordered manufacturers of transvaginally placed mesh kits for prolapse to stop selling and distributing their devices, stating that the data submitted did not provide a reasonable assurance of safety and effectiveness. Evidence supports the use of mesh in synthetic midurethral sling and abdominal sacrocolpopexy. The American Urogynecologic Society (AUGS) remains opposed to any restrictions that ban currently available surgical options performed by qualified and credentialed surgeons on appropriately informed patients with pelvic floor disorders. The AUGS supports the U.S. Food and Drug Administration's recommendations that surgeons thoroughly inform patients seeking treatment for POP about the risks and benefits of all potential treatment options, including nonsurgical options, native tissue vaginal repairs, or abdominally placed mesh. There are certain clinical situations where surgeons may assert that the use and potential benefit of transvaginal mesh for prolapse outweighs the risk of other routes/types of surgery or of not using mesh. The AUGS recommends that surgeons utilize a shared decision-making model in the decision-making process regarding surgical options, including use of transvaginally placed mesh.

Determination of the status of the antioxidant system in rats after implantation of polypropylene surgical mesh with a coating based on tantalum and its derivatives

For the past 10 years, specialists in hernioplasty have noted that there is a problem with the occurrence of an adhesion process after the implantation of surgical meshes. In the future, tantalum-based coatings may become an inhibitor of the development of adhesion and inflammatory processes after surgical mesh implantation. The aim of our study was to determine the state of the antioxidant system by the activity of superoxide dismutase 1 and catalase in the blood of rats after implantation of surgical meshes coated on the basis of tantalum, tantalum oxide and tantalum nitride. After acclimatization, which lasted 21 days, the experimental animals were divided into 6 groups by random sampling: the first (intact) group included 6 rats. The second group included 6 rats that underwent surgery, but without implementation of a surgical mesh. The third group included 7 rats with an implanted surgical mesh coated with tantalum. The fourth group included 7 rats with an implanted surgical mesh covered with tantalum oxide. The fifth group includes 7 rats with an implanted surgical mesh covered with tantalum nitride. The sixth group included 7 rats with an implanted surgical mesh without a coating. To achieve the goal, 40 laboratory rats were implanted with surgical meshes between the abdominal wall and various sections of the large intestine. After 28 days, the activity of SuperOxide Dismutase 1 (SOD 1) and catalase was determined in the blood of the animals. SOD 1 activity was statistically 126.3% higher, and catalase activity was 92.5% higher in the experimental group with surgical mesh without coating. SOD 1 activity was 126.6% higher and catalase activity was 100.0% higher in the experimental group with tantalum nitride coated surgical mesh. In the groups implanted with polypropylene surgical meshes coated with tantalum and tantalum oxide, the activity of SOD 1 was higher by 86.2% and 97.1%, respectively, and the activity of catalase was higher by 70.3% and 67.6%, respectively. As a result of the study, we came to the conclusion that coatings made of tantalum and tantalum oxide demonstrate high biocompatibility in comparison with the results of a group of experimental animals that were implanted with a surgical mesh without a coating. The use of tantalum and tantalum oxide coatings provides a protective effect of the implant against oxidative damage, which indicates their potential to improve the effectiveness of the use of surgical meshes. Keywords: tantalum oxide, superoxide dismutase 1, catalase.

Colporrhaphy using elastic tissue continuous with and obscured behind the fibromuscular layer of the vaginal wall.

Due to the U.S. Food and Drug Administration's order to cease the use of surgical mesh for transvaginal repair, an improvement of the native tissue repair (NTR) of pelvic organ prolapse (POP) could become important as one of the first-line operative methods. This study details the surgical technique of an NTR method we developed, with report of our 5 years of experience. Operative technique: A new fibromuscular layer (FL) was constructed using a thick and elastic tissue continuous with and obscured behind the original FL of the vaginal wall. Between April 2017 and March 2020, we performed our novel repair technique on 87 women with POP of either quantification stage III or IV. We followed up 80 of the 87 women for over 24 months up to 60 months (follow-up rate: 91.2%). POP recurred (defined as stage II or higher) in four patients (5.0%). Operation time was 49-70 min. The bleeding volume was 70-250 g. There were no intra- or postoperative complications that required further treatment. This procedure could potentially become one of the first-line operative methods for repairing POP.

Autologous fascial slings remain viable at long-term follow-up: a post cystectomy case report

BackgroundAutologous fascial slings (AFS) have been used for a very long time in the treatment of female stress urinary incontinence, but the introduction of synthetic mesh slings placed either retropubicallyor trans-obturator has decreased the need to harvest the autologous rectus muscle fascia, thus reducing invasiveness and operative time. However AFS are still indicated in complicated cases and re-interventions, and the FDA has underlined safety concerns over the use of surgical meshes for the transvaginal repair of prolapsed pelvic organs.Case presentationA 76-year-old woman with muscle-invasivebladder cancer underwent radical cystectomy 16 years after retropubic positioning of an autologous rectus muscle fascial sling for SUI, with complete symptom resolution. The sling was easily identified and removed en bloc with the bladder and urethra, providing an opportunity to histologicallyevaluate the autologous fascial graft after its long permanence in the new position. Histopathological examination demonstrated increased fibroblastic proliferation and formation of capillaries. A slight separation and an increased waviness of the connective fibers were both evident. An increased vascularity was also apparent, including transverse vessels, with clusters of vessels. A relative inflammatory reaction was present in over 300 cells/10 HPF. All these characteristics indicated viable connective tissue.ConclusionsAFS remain a valuable surgical option for both primary and recurrent SUI in women, showing high cure rates and low complications in the long-term. The present case, to the best of our knowledge, presents the longest follow-up period of an autologous rectus muscle fascia placed retropubically and its histological evaluation documents characteristics which support its mechanical strength and viability.

Strains induced in the vagina by smooth muscle contractions

The ability of the vagina to contract gives rise to a set of active mechanical properties that contribute to the complex function of this organ in-vivo. Regional differences in the morphology of the vagina have been long recognized, but the large heterogeneous deformations that the vagina experiences during contractions have never been quantified. Furthermore, there is no consensus regarding differences in contractility along the two primary anatomical directions of the vagina: the longitudinal direction (LD) and the circumferential direction (CD). In this study, square vaginal specimens from healthy virgin rats (n=15) were subjected to isometric planar biaxial tests at four equi-biaxial stretches of 1.0, 1.1, 1.2, and 1.3. Contractions were induced at each stretch by a high concentration potassium solution. The digital image correlation method was used to perform full-field strain measurements during contractions. The vagina was found to undergo significantly higher compressive strains, tensile strains, and contractile forces along the LD than along the CD during contractions. Specifically, when computed over all the applied equi-biaxial stretches, mean (± std. dev.) absolute maximum compressive strains were -(13.43 ± 1.56)% along the LD and -(3.19 ± 0.25)% along the CD, mean absolute maximum tensile strains were (10.92 ± 1.73)% along the LD and (3.62 ± 0.57)% along the CD, and mean maximum contractile forces were 6.24 ± 0.55 mN along the LD and 3.35 ± 0.56 mN along the CD. Moreover, the vaginal tissue appeared to undergo compression in the proximal region and tension in the distal region while kept at constant equi-biaxial stretches. The active mechanical properties of the healthy vagina need to be fully investigated so that detrimental alterations in vaginal contractility, such as those caused by pelvic floor disorders and current treatment strategies, can be prevented. Statement of significanceContractile forces of the vagina have been measured by several investigators using uniaxial tensile testing methods. Unlike previous studies, in this study planar-biaxial tests of vaginal specimens were performed while the full-field strains of the vagina, as induced by smooth muscle contraction, were measured. The vagina was found to generate significantly larger contractile strains and forces in the longitudinal direction than in the circumferential direction. Knowledge of the contractile mechanics of the healthy vagina is essential to understand the detrimental effects that pelvic organ prolapse and the use of surgical meshes have on the functionality of smooth muscle in the vagina.

Laparoscopy for the Treatment of Congenital Hernia: Use of Surgical Meshes and Mesenchymal Stem Cells in a Clinically Relevant Animal Model.

More than a century has passed since the first surgical mesh for hernia repair was developed, and, to date, this is still the most widely used method despite the great number of complications it poses. The purpose of this study was to combine stem cell therapy and laparoscopy for the treatment of congenital hernia in a swine animal model. Porcine bone marrow-derived mesenchymal stem cells (MSCs) were seeded on polypropylene surgical meshes using a fibrin sealant solution as a vehicle. Meshes with (cell group) or without (control group) MSCs were implanted through laparoscopy in Large White pigs with congenital abdominal hernia after the approximation of hernia borders (implantation day). A successive laparoscopic biopsy of the mesh and its surrounding tissues was performed a week after implantation, and surgical meshes were excised a month after implantation. Ultrasonography was used to measure hernia sizes. Flow cytometry, histological, and gene expression analyses of the biopsy and necropsy samples were performed. The fibrin sealant solution was easy to prepare and preserved the viability of MSCs in the surgical meshes. Ultrasonography demonstrated a significant reduction in hernia size 1 week after implantation in the cell group relative to that on the day of implantation (p < 0.05). Flow cytometry of the mesh-infiltrated cells showed a non-significant increase of M2 macrophages when the cell group was compared with the control group 1 week after implantation. A significant decrease in the gene expression of VEGF and a significant increase in TNF expression were determined in the cell group 1 month after implantation compared with gene expressions in the control group (p < 0.05). Here, we propose an easy and feasible method to combine stem cell therapy and minimally invasive surgical techniques for hernia repair. In this study, stem cell therapy did not show a great immunomodulatory or regenerative effect in overcoming hernia-related complications. However, our clinically relevant animal model with congenital hernia closely resembles the clinical human condition. Further studies should be focused on this valuable animal model to evaluate stem cell therapies in hernia surgery.

Recurrence after elective incisional hernia repair is more frequent than you think: An international prospective cohort from the French Society of Surgery

BackgroundThe French Society of Surgery has endorsed a cohort aiming to prospectively assess the frequency of recurrence after incisional hernia repair and to identify the risk factors. MethodsConsecutive patients undergoing incisional hernia repair in the participating centers were included in the prospective French Society of Surgery cohort over a 6-month period. Patients were followed up with a computed tomography scan at 1 y and a clinical assessment by the surgeon at 2 years. ResultsA total of 1,075 patients undergoing incisional hernia repair were included in 61 participating centers. The median follow-up was 24.0 months (interquartile range: 14.0–25.3). The follow-up rates were 83.0% and 68.5% at 1 and 2 years, respectively. The recurrence rates were 18.1% at 1 year and 27.7% at 2 years. Recurrence risk factors at 2 years were a history of hernia (odds ratio = 1.57, 95% confidence interval = 1.05–2.35, P = .028), a lateral hernia (odds ratio = 1.84, 95% confidence interval = 1.19–2.86, P = .007), a concomitant digestive operation (odds ratio = 1.97, 95% confidence interval = 1.20–3.22, P = .007), and the occurrence of early surgical site complications (odds ratio = 1,90, 95% confidence interval = 1.06–3.38, P = .030). The use of surgical mesh was strongly associated with a lower risk of recurrence at 2 years (P < .001). ConclusionAfter incisional hernia repair, the 2-year recurrence rate is as high as 27.7%. History of hernia, lateral hernia, concomitant digestive operation, the onset of surgical site complications, and the absence of mesh are strong risk factors for recurrence.

Adhesion Prevention to Polypropylene Meshes Using Combined Icodextrin Four Percent and Dimetindene Maleate

BackgroundThe use of surgical meshes in ventral hernia repair has significantly reduced hernia recurrence rates. However, when placed intraperitoneally prosthetic materials can trigger the development of peritoneal adhesions. The present experimental study evaluated the combined icodextrin 4% and dimetindene maleate treatment in preventing peritoneal adhesion formation to polypropylene and titanium-coated polypropylene meshes. Materials and methodsSixty female white rabbits were divided into four groups. A 2 × 2 cm piece of mesh was fixed to intact peritoneum in all animals through a midline laparotomy. A lightweight polypropylene mesh was implanted in groups 1 and 2 and a titanium-coated polypropylene mesh in groups 3 and 4. Groups 2 and 4 were treated, intraoperatively, with intravenous dimetindene maleate (0.1 mg/kg) and intraperitoneal solution of icodextrin 4% (20 mL/kg) and for the next 6 d with dimetindene maleate intramuscularly. The observation period lasted 15 d. Adhesion scores, percentage of mesh affected surface, tissue hydroxyproline levels, and tissue histopathology were examined. ResultsAll animals in group 1 and 57% of animals in group 3 presented postoperative adhesions. The combination of antiadhesives significantly reduced the extent and severity of adhesions as well as the hydroxyproline levels in groups 2 and 4 compared with groups 1 and 3. On microscopic evaluation, animals in group 1 exhibited higher inflammation scores compared with group 2, whereas animals in groups 2 and 4 had better mesotheliazation compared with groups 1 and 3. ConclusionsThe combined administration of icodextrin 4% and dimetindene maleate reduces the extent and severity of adhesions and may be successfully used to prevent adhesion formation after mesh intraperitoneal placement.

Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months.

Pelvic organ prolapse can significantly reduce quality of life of affected women, with many cases requiring corrective surgery. The rate of recurrence is relatively high after conventional prolapse surgery. In recent years, alloplastic meshes have increasingly been implanted to stabilize the pelvic floor, which has led to considerable improvement of anatomical results. But the potential for mesh-induced risks has led to a controversial discussion on the use of surgical meshes in urogynecology. The impact of cystocele correction and implantation of an alloplastic mesh on patients' quality of life/sexuality and the long-term stability of this approach were investigated. In a large prospective multicenter study, 289 patients with symptomatic cystocele underwent surgery with implantation of a titanized polypropylene mesh (TiLOOP ® Total 6, pfm medical ag) and followed up for 36 months. Both primary procedures and procedures for recurrence were included in the study. Anatomical outcomes were quantified using the POP-Q system. Quality of life including sexuality were assessed using the German version of the validated P-QoL questionnaire. All adverse events were assessed by an independent clinical event committee. Mean patient age was 67 ± 8 years. Quality of life improved significantly over the course of the study in all investigated areas, including sexuality and personal relationships (p < 0.001, Wilcoxon test). The number of adverse events which occurred in the period between 12 and 36 months after surgery was low, with just 22 events reported. The recurrence rate for the anterior compartment was 4.5%. Previous or concomitant hysterectomy increased the risk of recurrence in the posterior compartment 2.8-fold and increased the risk of erosion 2.25-fold. Cystocele correction using a 2nd generation alloplastic mesh achieved good anatomical and functional results in cases requiring stabilization of the pelvic floor and in patients with recurrence. The rate of recurrence was low, the patients' quality of life improved significantly, and the risks were acceptable.

Regulatory Warnings and Use of Surgical Mesh in Pelvic Organ Prolapse.

Regulatory Warnings and Use of Surgical Mesh in Pelvic Organ Prolapse.

Surgical meshes coated with mesenchymal stem cells provide an anti-inflammatory environment by a M2 macrophage polarization

Surgical meshes are widely used in clinics to reinforce soft tissue’s defects, and to give support to prolapsed organs. However, the implantation of surgical meshes is commonly related with an inflammatory response being difficult to eradicate without removing the mesh. Here we hypothesize that the combined use of surgical meshes and mesenchymal stem cells (MSCs) could be a useful tool to reduce the inflammatory reaction secondary to mesh implantation.In vitro determinations of viability, metabolic activity and immunomodulation assays were performed on MSCs-coated meshes. Magnetic resonance imaging, evaluation by laparoscopic optical system and histology were performed for safety assessment. Finally, flow cytometry and qRT-PCR were used to elucidate the mechanism of action of MSCs-coated meshes.Our results demonstrate the feasibility to obtain MSCs-coated surgical meshes and their cryopreservability to be used as an ‘off the shelf’ product. These biological meshes fulfill the safety aspects as non-adverse effects were observed when compared to controls. Moreover, both in vitro and in vivo studies demonstrated that, local immunomodulation of implanted meshes is mediated by a macrophage polarization towards an anti-inflammatory phenotype.In conclusion, the combined usage of surgical meshes with MSCs fulfills the safety requirements for a future clinical application, providing an anti-inflammatory environment that could reduce the inflammatory processes commonly observed after surgical mesh implantation. Statement of SignificanceSurgical meshes are medical devices widely used in clinics to resolve hernias and organs’ prolapses, among other disorders. However, the implantation of surgical meshes is commonly related with an inflammatory response being difficult to eradicate without removing the mesh, causing pain and discomfort in the patient. Previously, the anti-inflammatory, immunomodulatory and pro-regenerative ability of mesenchymal stem cells (MSCs) have been described.To our knowledge, this is the first report where the anti-inflammatory and pro-regenerative ability of MSCs have been successfully applied in combination with surgical meshes, reducing the inflammatory processes commonly observed after mesh implantation. Moreover, our in vitro and in vivo results highlight the safety and efficacy of these bioactive meshes as a ‘ready to use’ medical product.

Use of surgical mesh of different compositions in the correction of the abdominal wall defect in rats.

To analyze the performance of two surgical meshes of different compositions during the defect healing process of the abdominal wall of rats. thirty-three adult Wistar rats were anesthetized and subjected to removal of an area of 1.5 cm x 2 cm of the anterior abdominal wall, except for the skin; 17 animals had the defect corrected by edge-to-edge surgical suture of a mesh made of polypropylene + poliglecaprone (Group U--UltraproTM); 16 animals had the defect corrected with a surgical mesh made of polypropylene + polidioxanone + cellulose (Group P--ProceedTM). Each group was divided into two subgroups, according to the euthanasia moment (seven days or 28 days after the operation). Parameters analyzed were macroscopic (adherence), microscopic (quantification of mature and immature collagen) and tensiometric (maximum tension and maximum rupture strength). there was an increase in collagen type I in the ProceedTM group from seven to 28 days, p = 0.047. Also, there was an increase in the rupture tension on both groups when comparing the two periods. There was a lower rupture tension and tissue deformity with ProceedTM mesh in seven days, becoming equal at day 28. the meshes retain similarities in the final result and more studies with larger numbers of animals must be carried for better assessment.

Complicaciones de la colocación de malla sintética vaginal para la incontinencia urinaria de esfuerzo

BackgroundSurgical mesh has been used for treating urinary incontinence (UI) despite the lack of level i evidence in the literature evaluating its long-term safety and efficacy. Mesh-related complications were responsible for a warning issued by the FDA in 2008 and they stopped being considered rare events. The most common complications are acute urinary retention, bleeding, recurrence or persistence of UI, erosion of the urethra, and mesh infection. AimsTo determine the complications derived from surgical UI treatment with the placement of suburethral mesh in women. Material and methodPatients diagnosed with UI that underwent anti-incontinence surgery with the placement of vaginal mesh within the time frame of 2007 and 2014 were analyzed. Mesh placement complications and the recovery of continence were evaluated. ResultsA synthetic mesh sling was placed in 58 patients with a mean age of 56 years. A total of 51% of the patients had stress urinary incontinence and 49% had mixed urinary incontinence. Early complications were: 4 patients with acute urine retention. Late complications were: urethral or vaginal pain (12.2%), dyspareunia (20%), and mesh extrusion (10%) that was managed through mesh removal; 2 of those patients required surgical procedures. Twelve percent of the patients presented with de novo urgency, 90.2% progressed with no incontinence, 9.7% presented with postoperative UI, and 2 patients had no improvement. DiscussionAlthough small, our case series showed a low long-term complication rate with the use of surgical mesh, compared with the majority of case series that demonstrate a re-operation rate>70%, as well as numerous cases of mesh removal. Thus, it is our experience that suburethral slings continue to be an adequate UI management option. ConclusionsSuburethral slings are a safe and effective option in UI management.

Pelvic organ prolapse surgical management in Portugal and FDA safety communication have an impact on vaginal mesh.

Pelvic organ prolapse (POP) surgery has lately gained importance in gynecological practice. This study aims to characterize the evolution of POP surgical procedures conducted in Portugal in the last decade and the impact of an FDA 2011 safety communication on mesh POP surgeries. Trends in the surgical management of POP were assessed using the Portuguese National Medical Registry. We considered all records of women with diagnosis of genital prolapse from 1 January 2000 to 31 December 2012. Additionally, we also conducted a survey among members of the Portuguese Society of Urogynecology to evaluate current practices in the surgical management of POP. From 2000 to 2012, 46,819 diagnoses of genital prolapse were registered, with a 105 % increase during the study period (2,368 in 2000 to 4,941 in 2012). POP mesh surgery represented only 6 % of total prolapse diagnoses, but mesh use greatly increased up to 2011, when only a slight increase was registered. Among gynecologists who responded to the questionnaire, there was considerable variability on the procedures of choice to treat POP. Fifty-seven per cent of respondents performed vaginal mesh POP surgery, but only 27 % of those actually reported having changed their practice after the FDA 2011 safety communication. Surgical procedures for POP conducted in Portugal greatly increased over the last decade. The use of surgical meshes is still limited, but despite FDA safety communication it has increased over the years, with a slight increase in 2012, which illustrates the need for further analyses in the coming years.

MP6-15 THE UTILIZATION OF MESH IN PROLAPSE AND INCONTINENCE SURGERY BEFORE AND AFTER THE 2008 FDA PUBLIC HEALTH NOTIFICATION IN A PRIVATE INSURER POPULATION

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Practice Patterns, Cost Effectiveness I1 Apr 2014MP6-15 THE UTILIZATION OF MESH IN PROLAPSE AND INCONTINENCE SURGERY BEFORE AND AFTER THE 2008 FDA PUBLIC HEALTH NOTIFICATION IN A PRIVATE INSURER POPULATION Jamal Nabhani and David Ginsberg Jamal NabhaniJamal Nabhani More articles by this author and David GinsbergDavid Ginsberg More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.249AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The FDA public health notification (PHN) on transvaginal surgical mesh in October 2008 and subsequent update in July 2011 has prompted concerns from patient and provider alike about the use of graft material for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). There has been limited investigation into the effect of these warnings on the surgical treatment of POP and SUI in the ensuing time. METHODS Claims from the Humana administrative database (5.2 million patients, 52% female with average age of 48 years, 307 million observed procedures) were queried using current procedural terminology (CPT) and international classification of disease, 9th Revision (ICD-9) codes for POP and/or SUI between January 2007 and November 2012, a time period spanning before, between, and after the PHN and update. RESULTS The query identified 69,786 distinct procedures for SUI and/or POP over the nearly 6 year period, of which 29,946 (42.9%) involved implantation or removal of mesh and 39,840 (57.1%) which did not. In 2008, 46.3% of procedures for POP or SUI involved mesh whereas the use of mesh declined to 35.2% in 2012 (p < 1.8x10-7). The main driver of this change was the decreased rate of POP repair with mesh from 24.1 (cases/month per 100,000 female beneficiaries) in 2008 to 18.9 in 2012 (p=0.001). Over the same period, mesh removal/revision rates increased (2.4 to 5.7, p=4.2x10-5). The rate of sling procedures between 2008 and 2012 did not significantly change (58.2 to 58.9, p=0.46). CONCLUSIONS The FDA PMH has significantly decreased the use of surgical mesh in POP surgery although the overall incidence of surgical treatment for POP and SUI has increased. POP repair with mesh has significantly decreased while mesh removal/revision makes up a larger portion of mesh procedures performed. The rate of sling procedures for SUI has been unchanged over the same period. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e62 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Jamal Nabhani More articles by this author David Ginsberg More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Biocompatibility and tissue integration of a novel shape memory surgical mesh for ventral hernia: In vivo animal studies

Approximately 400,000 ventral hernia repair surgeries are performed each year in the United States. Many of these procedures are performed using laparoscopic minimally invasive techniques and employ the use of surgical mesh. The use of surgical mesh has been shown to reduce recurrence rates compared to standard suture repairs. The placement of surgical mesh in a ventral hernia repair procedure can be challenging, and may even complicate the procedure. Others have attempted to provide commercial solutions to the problems of mesh placement, but these have not been well accepted by the clinical community. In this article, two versions of shape memory polymer (SMP)-modified surgical mesh, and unmodified surgical mesh, were compared by performing laparoscopic manipulation in an acute porcine model. Also, SMP-integrated polyester surgical meshes were implanted in four rats for 30-33 days to evaluate chronic biocompatibility and capacity for tissue integration. Porcine results show that the modified mesh provides a controlled, temperature-activated, automated deployment when compared to an unmodified mesh. In rats, results indicate that implanted SMP-modified meshes exhibit exceptional biocompatibility and excellent integration with surrounding tissue with no noticeable differences from the unmodified counterpart. This article provides further evidence that an SMP-modified surgical mesh promises reduction in surgical placement time and that such a mesh is not substantially different from unmodified meshes in chronic biocompatibility.

Estimating the Early Impact of the FDA Safety Communication on the Use of Surgical Mesh

To estimate the early impact of the July 2011 Food and Drug Administration Safety Communication on the practice patterns of gynecologic surgeons using surgical mesh to manage pelvic organ prolapse (POP) and stress urinary incontinence (SUI). A cross-sectional study was performed by administering a mesh usage questionnaire to physician attendees at the opening session of the American Association of Gynecologic Laparoscopists Global Congress of Minimally Invasive Gynecology in November 2011. Of the 827 physicians attending the opening session of the conference, 281 (34%) completed the questionnaire, 202 (72%) of whom reported performing surgery for POP and/or SUI. The respondents were attending physicians (83.4%) with at least 10 years of experience (65.7%), 136 (71.1%) identifying themselves as General Gynecology, 29 (17.3%) as Urogynecology, 13 (7.1%) as Minimally Invasive Gynecologic Surgery, and 3 (1.8%) as Urology. When compared with generalists, specialists were more likely to use mesh for abdominal (86% vs 56.3%, P < 0.001) and vaginal (65.9% vs 37.2%, P = 0.001) POP repair. Specialists reported using mesh for the anterior compartment (50% vs 28.3%, P = 0.01) and the posterior compartment (36.4% vs 12.5%, P = 0.001), and total vaginal mesh kits (13.6% vs 1.7%, P = 0.005). Respondents reported an increase in mesh use for primary abdominal POP repair (82 vs 92, P = 0.013) and a decrease in mesh use for recurrent vaginal POP repair (99 vs 75, P < 0.001), with more surgeons opting against mesh for recurrent POP (49 vs 74, P < 0.001). For patient counseling, 53.7% reported changing their methods. In a self-selected sample of pelvic surgeons, we noted that the 2011 FDA Safety Communication had an impact, with changes in mesh usage and counseling patterns.

Comprehensive Evaluation of Anterior Elevate System for the Treatment of Anterior and Apical Pelvic Floor Descent: 2-Year Followup

The Elevate® Anterior and Apical Prolapse Repair System is a polypropylene mesh that is anchored through sacrospinous ligament and obturator fascia fixation points. We present a comprehensive evaluation of this prolapse repair system through 2 years with a focus on safety, operative characteristics, and anatomical, subjective and quality of life outcomes. A total of 42 women underwent repair of stage II or greater anterior/apical compartment prolapse using the repair system, of whom 2 were lost to followup. Anatomical outcomes were assessed using POP-Q (Pelvic Organ Prolapse Quantification) staging. Subjective and quality of life outcomes were assessed by the validated ICIQ (International Consultation on Incontinence Questionnaire)-VS (Vaginal Symptoms), ICIQ-FLUTS (Female Lower Urinary Tract Symptoms) and IIQ-7 (Incontinence Impact Questionnaire-7). Additional outcomes included a 3-day bladder diary and cough test with outcomes assessed preoperatively, at 6 weeks, and at 1 and 2 years. Mean ± SD blood loss was 93 ± 55 cc and mean operative time was 58 ± 27 minutes. POP-Q points Aa, Ba and C improved from 0.9, 0.8 and -1.3 preoperatively to -2.1, -2.7 and -6.1 cm at 2 years, respectively (each p <0.05). Four patients experienced anatomical recurrence, which was associated in 2 with symptomatic recurrence on the ICIQ-VS. Statistically significant improvements in the ICIQ-VS, ICIQ-FLUTS and IIQ-7 were seen throughout followup. Adverse events included leg pain, vaginal exposure and urinary retention in 1, 2 and 5 patients, respectively. The Elevate Anterior and Apical Prolapse Repair System was associated with good anatomical restoration and significant improvements in validated symptom and quality of life indexes through 2 years of assessments. Our experience suggests that the system is a safe, effective surgical procedure in appropriately selected patients. Long-term followup is important, given the FDA (Food and Drug Administration) warning regarding the use of surgical mesh in the repair of pelvic organ prolapse.

Integrating a novel shape memory polymer into surgical meshes decreases placement time in laparoscopic surgery: An in vitro and acute in vivo study

About 600,000 hernia repair surgeries are performed each year; recently, the use of laparoscopic minimally invasive techniques has become increasingly popular in these operations. Use of surgical mesh in hernia repair has shown lower recurrence rates compared to other repair methods. However in many procedures, placement of surgical mesh can be challenging and even complicate the procedure, potentially leading to lengthy operating times. Various techniques have been attempted to improve mesh placement, including use of specialized systems to orient the mesh into a specific shape, with limited success and acceptance. In this study, a programmed novel Shape Memory Polymer (SMP) was integrated into commercially available polyester surgical meshes to add automatic unrolling and tissue conforming functionalities, while preserving the intrinsic structural properties of the original surgical mesh. Tensile testing and Dynamic Mechanical Analysis was performed on four different SMP formulas to identify appropriate mechanical properties for surgical mesh integration. In vitro testing involved monitoring the time required for a modified surgical mesh to deploy in a 37°C water bath. An acute porcine model was used to test the in vivo unrolling of SMP integrated surgical meshes. The SMP-integrated surgical meshes produced an automated, temperature activated, controlled deployment of surgical mesh on the order of several seconds, via laparoscopy in the animal model. Results indicate surgical mesh modified with SMP is capable of laparoscopic deployment in vivo, activated by body temperature. This suggests a reduction in surgical operating time and improved mesh placement characteristics is possible with SMP-integrated surgical meshes.

In vitro extracellular matrix model to evaluate stroma cell response to transvaginal mesh

The use of surgical mesh for female pelvic floor reconstruction has increased in recent years. However, there is paucity of information about the biological responses of host stroma cells to different meshes. This study was aimed to establish an in vitro experimental model to study the micro-environment of extracellular matrix (ECM) with embedded mesh and the stroma cell behaviors to different synthetic meshes. Matrigel multi-cellular co-culture system with embedded mesh was used to evaluate the interaction of stroma cells and synthetic mesh in a simulated ECM environment. Human umbilical vein endothelial cells (HUVEC) and NIH3T3 fibroblasts were inoculated in the system. The established multi-cellular Matrigel co-culture system was used to detect stroma cell recruitment and tube formation ability for different synthetic meshes. HUVEC and NIH3T3 cells were recruited into the mesh interstices and organized into tube-like structures in type I mesh material from Perigee, Marlex and Prolift 24 hr after cell inoculation. On the contrary, there was little recruitment of HUVEC and NIH3T3 cells into the type III mesh of intra-vaginal sling (IVS). The Matrigel multi-cellular co-culture system with embedded mesh offers a useful in vitro model to study the biological behaviors of stroma cells in response to different types of synthetic meshes. The system can help to select ideal mesh candidates before actual implantation into the human body.