Mesh Complications Research Articles

Complications of Body Contouring Surgery in Postbariatric Patients: A Systematic Review and Meta-Analysis.

Obesity is a major global health problem. With an increasing number of bariatric surgeries, the need for body-contouring procedures has grown. These procedures are associated with multiple complications because of various patient characteristics and risk factors. In this study, we performed a systematic literature review of all the complications of postbariatric body contouring surgeries, as well as a meta-analysis to estimate the effects of body mass index (BMI) and the weight of the tissue resected during body contouring on the development of complications. We conducted a literature search of the PubMed and Cochrane databases in September 2020, using the MeSH terms plastic surgery, weight loss, and complications. Studies were included if they involved more than 35 postbariatric patients and reported postoperative complication rates and types. In total, 561 articles were initially identified, and 25 studies were included after the final review. The overall weighted rate of postbariatric body contouring surgical complications in all studies was 31.5%. The most frequent complication from all regions of body contouring was seroma (weighted rate 12.7-13.9%). Regarding risk factors, analysis indicated that a BMI < 30 kg/m2 and low mean weight of resected tissue were associated with fewer complications. Body contouring procedures are relatively safe. Although complications after contouring are common, most either resolve spontaneously or require minimal intervention. In body contouring after bariatric surgery, there is a 37% increased risk of developing complications if the BMI is ≥ 30kg/[Formula: see text] before body contouring. A higher weight of resected tissue appears to be linked to a greater risk of complications. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Evaluation of Absorbable Mesh for Prophylactic Mesh Augmentation in High-Risk Patients

Purpose: Hernia prevention following abdominal surgery has become a subject of growing interest in general surgery. Prophylactic mesh augmentation (PMA) is an emerging technique to prevent incisional hernia in high-risk populations. The aim of this study was to determine the efficacy and safety of PMA using an absorbable mesh. Methods: A retrospective review was performed on patients who underwent PMA between July 2014 and March 2020. A prophylactic synthetic absorbable mesh (Phasix™; Becton Dickinson, Franklin Lakes, NJ) was placed at the surgeon’s discretion according to the indication for the primary operation. The primary outcome was the incisional hernia rate. Secondary outcomes included mesh-related or other complications. Results: Fifty patients underwent PMA following cystectomy with ileal conduit, open aortic surgery, or colostomy creation/takedown. Overall, 10 patients (20%) developed hernia at a median follow-up of 2.2 years. Six of these 10 hernias occurred at incisions where mesh was not placed. There were no documented mesh infections. One mesh (2%) in the AAA group was explanted due to an infected endograft, but there was no evidence of mesh complication. Two patients (4%) developed seroma. Two (4%) patients developed superficial surgical site infections (SSI). There were no documented deep-space SSI. Conclusion: PMA is an emerging technique with a low rate of incisional hernia in high-risk patients, such as those undergoing stoma creation or open aortic intervention. The use of an absorbable mesh seems promising, however more and longer-term research is needed.

Surgical Outcomes in Urogynecology—Assessment of Perioperative and Postoperative Complications Relative to Preoperative Hemoglobin A1c—A Fellows Pelvic Research Network Study

Poor control of diabetes mellitus is a known predictor of perioperative and postoperative complications. No literature to date has established a hemoglobin A1c (HbA1c) cutoff for risk stratification in the urogynecology population. We sought to identify an HbA1c threshold predictive of increased risk for perioperative and postoperative complications after pelvic reconstructive surgery. This multicenter retrospective cohort study involving 10 geographically diverse U.S. female pelvic medicine and reconstructive surgery programs identified women with diabetes who underwent prolapse and/or stress urinary incontinence surgery from September 1, 2013, to August 31, 2018. We collected information on demographics, preoperative HbA1c levels, surgery type, complications, and outcomes. Sensitivity analyses identified thresholds of complications stratified by HbA1c. Multivariate logistic regression further evaluated the association between HbA1c and complications after adjustments. Eight hundred seven charts were identified. In this diabetic cohort, the rate of overall complications was 44.1%, and severe complications were 14.9%. Patients with an am HbA1c value of 8% or greater (reference HbA1c, <8%) had an increased rate of both severe (27.1% vs 12.8%, P < 0.001) and overall complications (57.6% vs 41.8%, P = 0.002) that persisted after multivariate logistic regression (odds ratio, 2.618; 95% confidence interval, 1.560-4.393 and odds ratio, 1.931; 95% confidence interval, 1.264-2.949, respectively). Mesh complications occurred in 4.6% of sacrocolpopexies and 1.7% of slings. The average HbA1c in those with mesh exposures was 7.5%. Preoperative HbA1c of 8% or higher was associated with a 2- to 3-fold increased risk of overall and severe complications in diabetic patients undergoing pelvic reconstructive surgery that persisted after adjustments.

Laparoscopic lateral suspension for anterior and apical prolapse: a prospective cohort with standardized technique

Introduction and hypothesisLaparoscopic lateral suspension (LLS) for anterior and apical pelvic organ prolapse (POP) repair is a recent approach. Previous studies used various meshes or sutures. The purpose of this study was to evaluate outcomes of a standardized LLS technique.MethodsFrom January 2010 until December 2014, we performed POP repair by LLS with mesh on 88 women with anterior and apical POP ≥ stage 2. We used a polypropylene titanized mesh fixed to the vesico-vaginal fascia with absorbable sutures and treated posterior compartment defect by vaginal approach with native tissue repair if required. Between July 2013 and December 2018, all women were assessed by gynecological examination including the pelvic organ prolapse quantification (POP-Q) system. Subjective outcome was evaluated by the patient global impression of improvement (PGI-I) questionnaire.ResultsSeventy-nine women (89.8%) were available for follow-up. The mean duration of follow-up was 3.4 years (SD 1.6). Mean age was 59.6 (SD 11.1) years and mean BMI 25.8 (SD 4.0) kg/m2. Ten patients (12.7%) had previous POP surgery. Fifty-two women (65.8%) required posterior colporraphy for associated posterior defect and 21 (26.6%) had associated urinary incontinence (UI) surgery. There were no perioperative complications. The objective cure rate (no prolapse beyond the hymen and no reoperation for POP recurrence) was 87.3%. The reoperation rate for recurrence was 5.1%. The subjective success rate (PGI ≤ 2) was 96.2%. There were no mesh exposures or extrusions.ConclusionsThis standardized LLS is safe and effective with no mesh complications after 3-year follow-up.

Women with advanced pelvic organ prolapse and levator ani muscle avulsion would significantly benefit from mesh repair surgery.

Mesh repair surgery for pelvic organ prolapse (POP) has been suspended in some countries owing to concerns about its associated complications. However, mesh repair has been shown to reduce the risk of prolapse recurrence after surgery. In view of this controversy, our aim was to assess the incidence of subjective and objective recurrence of POP following mesh repair surgery vs native-tissue repair in women with Stage-III or Stage-IV POP. This was a prospective observational study of women who presented with Stage-III or Stage-IV POP and received primary prolapse surgery between 2013 and 2018. Transperineal ultrasound was performed before the operation and volumes were analyzed offline to assess the presence of levator ani muscle (LAM) avulsion. All women were counseled on either mesh repair or native-tissue reconstruction. The mesh-repair group was followed up for up to 5 years and the native-tissue-repair group for up to 2 years after the operation. Prolapse symptoms and POP quantification (POP-Q) staging were assessed at follow-up. Subjective recurrence of POP was defined as symptoms of prolapse (vaginal bulge sensation or dragging sensation) reported by the patient. Objective recurrence was defined as POP-Q ≥ Stage II. The subjective and objective recurrences of prolapse were compared between women with and those without mesh use. Multivariate regression analysis was used to identify risk factors for the recurrence of POP. A total of 154 Chinese women with Stage-III or Stage-IV prolapse were recruited. Of these, 104 (67.5%) underwent mesh repair (transabdominal in 57 women and transvaginal in 47 women) and 50 (32.5%) had native-tissue repair surgery. Ninety-five (61.7%) women had LAM avulsion. Both the subjective POP recurrence rate (4.8% vs 20.0%; P = 0.003) and the objective recurrence rate (20.2% vs 46.0%; P = 0.001) were significantly lower in the mesh-repair group than in the native-tissue-repair group. On multivariate logistic regression analysis, mesh repair was associated significantly with a reduced risk of subjective recurrence (odds ratio (OR), 0.20 (95% CI, 0.07-0.63)) and of objective recurrence (OR, 0.16 (95% CI, 0.07-0.55)) of prolapse. On subgroup analysis of women with LAM avulsion, mesh repair significantly reduced the risk of subjective recurrence (OR, 0.24 (95% CI, 0.07-0.87)) and objective recurrence (OR, 0.23 (95% CI, 0.09-0.57)) of POP. The incidence of mesh-related complications was low, and mesh exposure could be treated conservatively or by minor surgery. Mesh repair surgery, compared with native-tissue repair, was associated with a 5-fold reduction in the risk of subjective recurrence and a 6-fold reduction in the risk of objective recurrence of prolapse in women with Stage-III or Stage-IV POP. In women with concomitant LAM avulsion, mesh repair surgery was associated with a 4-fold reduction in both objective and subjective recurrence of POP. The rate of mesh-related complications was low, and mesh exposure could be treated conservatively or by minor surgery. The benefit of mesh surgery for these high-risk women appears to outweigh the risks of mesh complications, and it could be a treatment option for this group of women. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

The effects of onlay titanium-coated mesh on recurrence, foreign body sensation and chronic pain after ventral hernia repair

Background/objectiveThere are many complications of meshes in hernia repair. The aim of this study was to investigate the effects of onlay titanium-coated meshes (TCM) on recurrence, foreign body sensation and chronic pain in ventral hernia repair. MethodsIn this retrospective study, 160 patients undergone TCM or polypropylene mesh (PM) surgery for onlay repair of ventral hernia were examined between May 2014 and January 2018 at our center. Patient characteristics, type of hernia, defect size, operative time, follow-up time, surgical site occurrence (infection, seroma and hematoma), recurrence, foreign body sensation and chronic pain were analyzed. Patients were divided into two groups according to mesh used: TCM (titanium group) or PM (polypropylene group). ResultsOut of 160 patients, 63 (32.6%) had TCM and 97 (67.4%) had PM. There was no significant difference between groups in terms of recurrence (p = 0.757). Chronic pain and foreign body sensation were low in the titanium group (p = 0.047 and p = 0.029, respectively), a positive correlation was found between surgical site infection and recurrence (p = 0.020). In the polypropylene group, an increase in defect size was significantly associated with foreign body sensation and chronic pain (p < 0.001 for both comparisons). ConclusionIn onlay repair of ventral hernia, TCM led to less foreign body sensation and chronic pain then PM. The surgical site infection was associated with recurrence for these meshes. Additionally, the increase in defect size causes a risk for foreign body sensation and chronic pain in repair using PM.

Assessing pelvic organ prolapse recurrence after minimally invasive sacrocolpopexy: does mesh weight matter?

There has been a trend toward the use of ultra-lightweight mesh types for minimally invasive sacrocolpopexy. We hypothesized that ultra-lightweight mesh would have a greater proportion of composite anatomical pelvic organ prolapse recurrence than lightweight mesh. Retrospective cohort study of minimally invasive sacrocolpopexies at two academic institutions from 2009 to 2016. Our primary outcome was composite anatomical prolapse recurrence, defined as prolapse beyond the hymen or retreatment with pessary or surgery, compared between ultra-lightweight (≤21g/m2 [range 19-21]) and lightweight (>21g/m2 [range 35-50]) mesh types. We assessed time to prolapse recurrence using Kaplan-Meier and Cox regression. The cohort consisted of 1,272 laparoscopic (n = 530, 41.7%) and robotic-assisted sacrocolpopexies (n = 742, 58.4%). Lightweight mesh was used in 745 procedures (58.6%) and ultra-lightweight mesh in 527 (41.4%). The lightweight mesh had longer median follow-up than the ultra-lightweight group (344 [IQR 50-670] vs 143days [IQR 44-379], p < 0.01). There was no difference in composite anatomical prolapse recurrence between lightweight and ultra-lightweight mesh (54 [7.2%] vs 35 [6.6%], p = 0.68). Ultra-lightweight mesh demonstrated a shorter time to prolapse recurrence (p < 0.01), which remained significant on multivariate Cox regression (HR 2.38 [95% CI 1.47-3.87]). The lightweight mesh had significantly more mesh complications (43 [5.8%] vs 7 [1.3%], p < 0.01). Ultra-lightweight mesh for minimally invasive sacrocolpopexy was not associated with a higher proportion of composite anatomical prolapse recurrence; however, it was associated with a shorter time to recurrence. Longer follow-up is needed to assess the clinical importance of this finding, particularly given the trade-off of more complications with lightweight mesh.

Prophylactic Mesh After Midline Laparotomy: Evidence is out There, but why do Surgeons Hesitate?

Incisional hernias have an impact on patients' quality of life and on health care finances. Because of high recurrence rates despite mesh repair, the prevention of incisional hernias with prophylactic mesh reinforcement is currently a topic of interest. But only 15% of surgeons are implementing it, mainly because of fear for mesh complications and disbelief in the benefits. The goal of this systematic review is to evaluate the effectiveness and safety of prophylactic mesh in adult patients after midline laparotomy. An extensive literature search was performed in PubMed, Embase and CENTRAL until 9/5/2020 for RCTs and cohort studies regarding mesh reinforcement versus primary suture closure of a midline laparotomy. The quality of the articles was analyzed using the Scottish Intercollegiate Guidelines Network checklists. Revman 5 was used to perform a meta-analysis. Twenty-three articles were found with a total of 1633 patients in the mesh reinforcement group and 1533 in the primary suture group. An odds ratio for incisional hernia incidence of 0.37 (95% CI = [0.30, 0.46], p < 0.01) with RCTs and of 0.15 (95% CI = [0.09,0.25], p < 0.01) in cohort studies was calculated. Seroma rate shows a significant odds ratio of 2.18 (95% CI = [1.45, 3.29], p < 0.01) in favor of primary suture. No increase was found regarding other complications. The evidence for the use of prophylactic mesh reinforcement is overwhelming with a significant reduction in incisional hernia rate, but implementation in daily clinical practice remains limited. Instead of putting patients at risk for incisional hernia formation and subsequent complications, surgeons should question their arguments why not to use mesh reinforcement, specifically in high-risk patients.

Evaluation of information on the Internet regarding surgical mesh for hernia repair: analysis of websites found through three popular search engines.

Hernia repair remains one of the most common surgical procedures. Surgical mesh usage has been highlighted in the media due to recent lawsuits and recalls. Patients can read potentially biased information on the Internet and this can influence a patient's healthcare decisions. The purpose of this study is to evaluate search engine listings and respective website content of surgical mesh for hernia repair. Websites evaluated were derived from four keyword searches targeting surgical mesh with Google, Yahoo, and Bing. Websites from the first two pages of each search were evaluated for content comprehensiveness. The largest category of websites from search engine results was legal advertisements, accounting for 20% of all results. These websites also held the first position on every results page. Legal advertisements and blog/forum websites were the most skewed toward surgical mesh risks and complications vs. benefits. There was a reduction in advertisements in 2020 vs. 2018. The most comprehensive non-advertisement websites were found more frequently. Overall, only 44% of websites presented references and 50% cited supporting data. Finally, 46% of 'recommended search terms' displayed on the search engine results page had a risk, complication, or legal bias. These results emphasize the challenges of using an Internet search engine to find comprehensive and appropriate information regarding surgical mesh. This manuscript underscores the importance for physicians to direct patients toward specific websites to mitigate their exposure to websites that are biased and not appropriate for patients searching for an accurate and comprehensive overview of surgical mesh.

The comparison of success rate and quality of life due to three types of uterine sparing prolapse surgery

مقدمه: تاکنون درمان پرولاپس رحمی بر پایه هیسترکتومی واژینال و آویزان کردن کاف واژن بنا شده است. اخیرا تمایلی برای حفظ رحم حین جراحی‌های پرولاپس به‌وجود آمده است. مطالعه حاضر با بررسی میزان موفقیت و کیفیت زندگی زنان به‌دنبال یکی از سه نوع روش جراحی پرولاپس با حفظ رحم انجام شد. روش‌کار: این مطالعه گذشته‌نگر در سال 1398 در بیمارستان امام خمینی تهران انجام شد. اطلاعات پرونده 99 بیمار با پرولاپس رحم که در طی 3 سال تحت یکی از سه نوع جراحی پرولاپس با حفظ رحم (منچستر، ساکرواسپاینوس هیستروپکسی، ساکرال هیستروپکسی شکمی) قرار گرفته بودند، بررسی و از نظر موفقیت جراحی و کیفیت زندگی مقایسه شدند. 99 بیمار در فالوآپ 12 ماهه، پرسشنامه معتبر بررسی کیفیت زندگی پس از جراحی پرولاپس (PFDI-20) (شاخص آزردگی‌های کف لگن) را تکمیل کردند. میزان موفقیت بعد از 12 ماه به‌عنوان پیامد اولیه و عوارضی نظیر جراحی مجدد، تعبیه پساری و احساس توده به‌عنوان پیامدهای ثانویه بررسی شدند. تجزیه و تحلیل داده‌ها با استفاده از نرم‌افزار آماری SPSS (نسخه 22) و آزمون‌های آنووا، کروسکال والیس و کای اسکوئر استفاده شد. میزانp کمتر از 05/0 معنی‌دار در نظر گرفته شد. یافته‌ها: میزان موفقیت ساکرال هیستروپکسی از دو گروه دیگر بالاتر بود (حدود 94%). بیشترین عود در ساکرواسپاینوس به‌ترتیب در نقاط Ba (506/0±06/2-) و سپس C (084/1±1/2-) بود (01/0>p). کیفیت زندگی بیماران تحت جراحی منچستر و ساکرال هیستروپکسی مشابه و بالاتر از جراحی ساکرواسپاینوس بود. عوارض زودرس پس از ساکرال هیستروپکسی ایلئوس و اختلال دفع مدفوع بود. نتیجه‌گیری: هر سه روش جراحی پرولاپس با حفظ رحم میزان موفقیت بالای 60% داشتند. هر سه گروه جراحی 12 ماه پس از جراحی کیفیت زندگی خوبی داشتند و از عمل راضی بودند. بالاترین عود پرولاپس در ساکرواسپاینوس و در نقاط Ba و C بود. یافتن عوارض مش به‌دنبال ساکرال هیستروپکسی نیاز به پیگیری طولانی‌مدت دارد.

Prospective International Multicenter Pelvic Floor Study: Short-Term Follow-Up and Clinical Findings for Combined Pectopexy and Native Tissue Repair.

Efforts to use traditional native tissue strategies and reduce the use of meshes have been made in several countries. Combining native tissue repair with sufficient mesh applied apical repair might provide a means of effective treatment. The study group did perform and publish a randomized trial focusing on the combination of traditional native tissue repair with pectopexy or sacrocolpopexy and observed no severe or hitherto unknown risks for patients (Noé G.K. J Endourol 2015;29(2):210–215). The short-term follow-up of this international multicenter study carried out now is presented in this article. Material and Methods: Eleven clinics and 13 surgeons in four European counties participated in the trial. In order to ensure a standardized approach and obtain comparable data, all surgeons were obliged to follow a standardized approach for pectopexy, focusing on the area of fixation and the use of a prefabricated mesh (PVDF PRP 3 × 15 Dynamesh). The mesh was solely used for apical repair. All other clinically relevant defects were treated with native tissue repair. Colposuspension or TVT were used for the treatment of incontinence. Data were collected independently for 14 months on a secured server; 501 surgeries were registered and evaluated. Two hundred and sixty-four patients out of 479 (55.1%) returned for the physical examination and interview after 12–18 months. Main Outcome and Results: The mean duration of follow-up was 15 months. The overall success of apical repair was rated positively by 96.9%, and the satisfaction score was rated positively by 95.5%. A positive general recommendation was expressed by 95.1% of patients. Pelvic pressure was reduced in 95.2%, pain in 98.0%, and urgency in 86.0% of patients. No major complications, mesh exposure, or mesh complication occurred during the follow-up period. Conclusion: In clinical routine, pectopexy and concomitant surgery, mainly using native tissue approaches, resulted in high satisfaction rates and favorable clinical findings. The procedure may also be recommended for use by general urogynecological practitioners with experience in laparoscopy.

Lessons from the vaginal mesh scandal: enhancing the patient-centric approach to informed consent for medical device implantation.

The vaginal mesh scandal, in which thousands of women were irreversibly maimed by polypropylene mesh, revealed multilevel failures in medical device regulation and implantation, demonstrating that patient-centric care has not yet fully transcended from policy into practice. In law, informed consent is considered by a two-stage test: reasonable treatment and patient information disclosure. The standard of reasonable treatment is determined according to what is deemed acceptable in accordance with a body of medical opinion. However, such bodies of medical opinion were vulnerable to external influence from device manufactures. Vaginal mesh manufacturers were found to have had financial links to research, royal colleges, and influential clinicians, which then influenced the basis of the evidence-based practice that often guides such bodies of medical opinion. According to the Independent Medicines and Medical Device Safety Report, patients' mesh complications were also frequently under-reported and patient-based evidence of harm disregarded. Patients were also not sufficiently informed of the material risks or reasonable alternatives to mesh, which is required of the second stage of informed consent pertaining to information disclosure. This paper makes the following recommendations: that conflict of interest disclosure be mandated, that greater value be afforded to patient-based evidence to improve evaluation of treatments, and that information disclosure for informed consent should relate to the risks, benefits, and alternatives to the surgical procedure and medical device. This will ensure that patients can evaluate whether surgeons are offering unbiased treatment options and are also informed of the potential long-term risks associated with device implantation.

Stress urinary incontinence in the mesh complication era: current Australian trends.

To examine available data relating to the surgical management of stress urinary incontinence (SUI) in Australia before, during and after a well-publicized Senate Inquiry into transvaginal mesh use and to consider outcomes in the context of global guideline changes. The annual number of surgical procedures for the management of SUI by procedure type and age group for the years 2008/2009-2017/2018 was obtained from the Australian Government Department of Human Services database using Medicare Benefits Schedule item numbers. The data extracted were limited to women aged 25years and older. These data were used to calculate age-specific and age-standardized rates, so as to accurately analyse trends in the usage of different procedures. Hospital Episode Statistics for mid-urethral sling (MUS) insertions were obtained for England's National Health Service from the Health and Social Care Information Centre for the years 2008/2009-2016/2017. These data were also used to calculate annual age-standardized rates for comparison purposes. Rates declined for most SUI procedures over time (MUS, colposuspension, fascial slings) except for urethral bulking agents. The absolute number of MUSs implanted in 2008/2009 was 5729, which decreased to 3127 in the 2017/2018 financial year. Over the decade, the annual rate for MUS implantation per 100000 population halved from 78 to 36. Over this same period, the rate of usage of bulking agents doubled, although represented a low volume of procedures (overall numbers increased from 304 to 698, representing an increase from four to eight procedures per 100000 population). The age-specific peak rate for MUS and Burch colposuspension changed over the decade from 55-64years to 65-74years, suggesting that women are deferring surgical treatment until later in life. Over the last decade, the total number of surgical procedures performed in Australia to treat SUI has decreased markedly from 6812 to 4279. This represents a decrease in the annual rate per 100000 population from 93 to 49. There are clear changes evident for SUI management in the past decade in Australia, including an overall decline in operative numbers, which correlate with international advisory notifications and local investigations. The results of the Australian Senate inquiry, including removal of single-incision mini-slings, greater availability of patient resources, and greater regulation of SUI procedures, will probably have ongoing effects. Surgeons need to ensure that sufficient training and patient education continue in order to maintain appropriate access to treatment of SUI in the future.

Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up

BackgroundThis study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes. Materials and methodsP4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed at 1, 3, 6,12, 18, 24, and 36 months, with 5-year (60-month) follow-up ongoing. ResultsA total of n = 121 patients were implanted with P4HB mesh (n = 75 (62%) female) with a mean age of 54.7 ± 12.0 years and mean BMI of 32.2 ± 4.5 kg/m2 (±standard deviation). Comorbidities included: obesity (78.5%), active smokers (23.1%), COPD (28.1%), diabetes mellitus (33.1%), immunosuppression (8.3%), coronary artery disease (21.5%), chronic corticosteroid use (5.0%), hypo-albuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernias were repaired via retrorectus (n = 45, 37.2% with myofascial release (MR) or n = 43, 35.5% without MR), onlay (n = 8, 6.6% with MR or n = 24, 19.8% without MR), or not reported (n = 1, 0.8%). 82 patients (67.8%) completed 36-month follow-up. 17 patients (17.9% ± 0.4%) experienced hernia recurrence at 3 years, with n = 9 in the retrorectus group and n = 8 in the onlay group. SSI (n = 11) occurred in 9.3% ± 0.03% of patients. ConclusionsLong-term outcomes following ventral hernia repair with P4HB mesh demonstrate low recurrence rates at 3-year (36-month) postoperative time frame with no patients developing late mesh complications or requiring mesh removal. 5-year (60-month) follow-up is ongoing.

Management of giant omphalocele with a simple and efficient nonsurgical silo

Introduction: Giant omphaloceles can be a challenge for pediatric surgeons and neonatologists worldwide. It is a rare and low-frequency congenital anomaly with no standardized management schemes or treatment protocols. Over the past few decades, we have developed a simple and efficient staged management for giant omphaloceles that allows definitive closure in the neonatal period, the results of which we outline in this report.Material and methods: With IRB approval, a retrospective and multicentric cohort study was carried out between 1994 and 2019 with patients with giant omphalocele defined as an abdominal wall defect greater than 5 cm in diameter and/or that contains more than 50% of the liver within the sac. We included all patients managed with the nonsurgical silo technique. Data on demographics, gestational age, associated malformations, amnion reduction and inversion time, anatomic closure, requirement of a mesh, intra- and post-silo complications, mortality and follow-up were collected. The technique consists of the construction of a silo with an adhesive hydrocolloid dressing (DuodermⓇ) to achieve an omphalocele staged-reduction until complete abdominal reintegration of the liver and bowel preservation of the amnion sac. This also enables the simulation of abdominal closure before definitive surgical closure, being managed in the neonatal intensive care unit (NICU).Results: Forty patients, 21 of whom were female, were managed with this technique. The average weight was 2900 gs (890–3900), and the median gestational age was 38 weeks (28–40). In total, 37.5% of cases had an associated comorbidity. The average silo reduction time was 7.3 days (0–35), the average time of amnion inversion was 5 days (2–9), and the average time to closure was 14.6 days (6–38). Anatomical closure was achieved in 95% of cases. In 4 patients, an absorbable mesh was used to reinforce the anatomical closure, and in 2 patients (5%), a mesh (DualmeshⓇ) was required to achieve an abdominal closure. There was no mortality associated with this nonsurgical silo technique. The average follow-up time was 60 (6 - 288) months.Conclusion: The staged silo management of giant omphalocele in this series is safe and effective and reduces the time to closure and potential morbidity and mortality compared with traditional surgical or medical management.

Developing a Hernia Mesh Tissue Integration Index Using a Porcine Model—A Pilot Study

Introduction: With so many prosthetics available, it can be difficult for surgeons to choose the most appropriate hernia mesh. Successful hernia repair mandates an understanding of how the patient's inflammatory response influences surgical outcomes. Failure to appreciate the importance of the biological aspect of hernia repair can be very costly as emerging evidence supports that biofilm formation and reduction in effective mesh porosity gives rise to long-term mesh complications including fibrosis, chronic mesh infection, and pain. In this pilot study, we utilized a large animal (porcine) model to develop a numerical Mesh Tissue Integration (MTI) Index focused on visible tissue ingrowth, fibrosis, adhesion formation and resorption of mesh. The aim is to help surgeons adopt an evidence-based approach in selecting the most appropriate mesh according to its tissue ingrowth characteristics, matched to the patient to achieve improved surgical outcomes and optimal patient-centered care.Methods: Two forty kg female Landrace pigs were recruited for this pilot study. A total of eight commonly used hernia mesh products and two controls measuring 5 × 5cm were surgically implanted in subrectus and intraperitoneal planes. The pigs were euthanised at 2 and 4 weeks, respectively. The abdominal wall was explanted, and the mesh specimens underwent macroscopic, histologic and biomechanical analysis, with engineering and pathology teams blinded to the mesh.Results: Significant differences between the degrees of MTI were observed at 2 weeks and the distinctions were even more apparent at 4 weeks. One of the interesting incidental findings we observed is that mesh products placed in the subrectus plane displayed greater degrees of adhesion strength and integration than those placed intraperitoneally.Conclusion: This pilot study is one of the first to propose a functional, biological standardized model for comparing hernia mesh products. The results are encouraging and demonstrate that this is a robust and transferrable model for assessing MTI in hernia mesh. The intention for this model is that it will be utilized synergistically with long term mesh/patient outcome registries and databases to inform improved matching of mesh to patient, particularly in the setting of the complex hernia repair and abdominal wall reconstruction.

Mesh Complication Rates Following Pelvic Radiation Therapy in Women With History of Synthetic Midurethral Sling Implantation.

To estimate the risk of mesh complications in women with and without subsequent pelvic and abdominal radiation therapy (RT). We identified women within a large health care organization who underwent mesh-augmented surgery for pelvic floor disorders between 2008 and 2014 and subsequently received RT prior to 2018. We compared them to a randomly selected group of women who underwent similar mesh-augmented pelvic reconstructive surgery without RT in a 1:4 ratio. Mesh complications were identified through chart review corroborated with the ninth and tenth revisions of the International Classification of Diseases and Current Procedural Terminology codes for mesh complications. Mesh complications between groups were compared using survival analysis and Cox proportional hazards models. We identified 36 women with RT and compared them with 144 women without RT. Indications for mesh implantation and concomitant vaginal procedures were similar between the groups. The majority of mesh implants (94.4%) were midurethral slings. Twelve mesh complications (6.7%) were identified, with similar rates in the RT (8.3%) and no-RT (6.2%) groups (P = 0.65). The risk of mesh complications did not differ between groups when compared using the Cox proportional hazards model, controlling for age, body mass index, diabetes, menopausal status, and smoking (hazard ratio, 1.19; 95% confidence interval, 0.802-1.787). There was no difference in the occurrence of mesh-related complications between women with and without RT. Abdominopelvic RT may not substantially increase the risk of mesh complications following placement of a synthetic sling for stress urinary incontinence. The need for future RT may only be a minor factor in counseling patients on the risks of mesh implants for pelvic floor disorders.

Complications of synthetic mesh inserted for stress urinary incontinence.

To provide an update on the literature regarding the management of complications secondary to synthetic mesh placed to treat stress urinary incontinence (SUI). We performed a systematic review of the literature using a multi-database structured search within OVID, the Medical Literature Analysis and Retrieval System Online (MEDLINE), the Excerpta Medica dataBASE (EMBASE) and Cochrane library databases; using the keywords: urology, incontinence, mesh and surgery. Several million synthetic polypropylene meshes have been inserted into women worldwide to manage SUI. Unfortunately, a significant number of women have now reported life-changing complications. We found a paucity of studies, heterogeneity of cohorts, poor long-term follow-up, and lack of evidence on the effective management of mesh-related complications. The contemporary evidence is low-level and often contradictory, which prevents robust recommendations regarding treatment. A prospective registry will be required to generate meaningful outcome data and help in the complex management of patients who have mesh-related complications.

Efficacy of surgical revision of mesh complications in prolapse and urinary incontinence surgery

Introduction and hypothesisWomen with mesh-related complications in prolapse (POP) and stress-urinary incontinence (SUI) surgery may benefit from operative mesh resection to alleviate symptoms. We hypothesized that mesh resection would alleviate symptoms and aimed to evaluate risks and benefits in these women.MethodsWe carried out a cross-sectional study. Primary outcome was improvement specified as better, unchanged or worsened symptoms after mesh revision surgery. Secondary outcomes were health-related quality of life (HrQol) scores of validated questionnaires, surgical characteristics and physical findings at follow-up visits. Descriptive data were reported with mean and medians. Associations were calculated with Spearman correlation coefficient and chi-square test to determine statistical differences between groups.ResultsFifty-nine women who underwent mesh revision surgery between 2009 and 2016 were included. After a median follow-up of 1.7 (IQR: 1.1–2.4) years, 44 women (75%) reported improvement of symptoms. No significant surgical or patient characteristics were identified that could differentiate which patients did or did not experience cure or complications.A trend was observed to better HrQol scores in women who reported overall improvement after mesh revision surgery. Seventeen (29%) women needed a subsequent operation after mesh removal.ConclusionsThis cross-sectional study shows that mesh revision surgery alleviates symptoms in 75% of women with mesh-related complications. Type of revision surgery and individual characteristics did not seem to matter to the individual chance of cure or complications. These data can facilitate the counseling of women considering mesh revision surgery.

Necessary duration of follow-up to assess complications of mesh in hernia surgery: a time-lapse study based on 460 explants.

Risk of complications following hernia repair is the key parameter to assess risk/benefit ratio of a technique. As mesh devices are permanent, their risks are life-long. Too many reports in the past assessed mesh safety prematurely after short follow-ups. We aimed to explore what length of follow up would reveal the full extent of complications. Time lapses between implantation and excision were analyzed in 460 cases of meshes excised for complications after hernia repair. Patterns of percentage growth and time lapses at 50th and 95th percentiles were used to compare groups of different hernia type, age, gender and reason for excision. The 50th and 95th case percentiles in the dataset were at 3.75 and 15.0years between mesh implantation and excision. For hernia types, the longest time lapses were for groin hernias (4.0 and 16.11years at 50th and 95th percentiles). The shortest were for umbilical hernias (2.16 and 9.68years). Males had later excisions than females (4.11 and 16.1 vs. 2.47 and 9.79years). Younger patients (< 45 y.o.) had later excisions than older patients (4.12 and 17.68 vs. 3.37 and 10.0years). Out of all subgroups, the longest time lapses were for groin hernias in younger males (4.77 and 18.89years) and for mesh erosion into organs (4.67 and 17.0years). Follow-up of more than 15yearsis needed to fully assess complications after mesh herniarepair. Especially longer periods are needed to detect mesh erosion into organs and complications in younger males. Presently, short observations and lack of reporting standard in the literature prohibit accurate assessment of complication risks. We propose to use cumulative incidence for standardized risk reporting (y% risk at x years). This will show time-dependent patterns and allow comparisons between different techniques and studies of variable duration. Standardization will also help topredict long-term risks beyond shorter (practical) follow-ups and facilitate real-time monitoring during surveillance.