Use Of Biologic Grafts Research Articles

A multicenter randomized controlled trial comparing short- and medium-term outcomes of novel biologics and lightweight synthetic mesh for laparoscopic inguinal hernia repair.

The use of biological graft in laparoscopic inguinal hernia repair (LIHR) has been controversial, and there is a lack of high-level evidence to confirm the value of biological graft in LIHR. The purpose of this study is to evaluate the effectiveness of a novel composite biologics in LIHR. A multicenter, single-blinded, randomized controlled clinical trial was designed. Fifty patients with unilateral primary inguinal hernia were randomly assigned to the experimental and control group (1:1). The experimental group was repaired with a non-crosslinked composite extracellular matrix from porcine urinary bladder matrix and small intestinal submucosa (UBM/SIS). The control group was repaired with a lightweight, large-pore, synthetic mesh. The primary endpoint was the effectiveness rate of hernia repair. The patients were followed up for four years. No significant difference was found between the experimental group and the control group in the effective rate of hernia repair (24/24[100%] vs 21/22[95.45%], RR, 0.4667; 95%CI, 0.3294-2.304; P = 0.4783). There was no fever, seroma, infection, groin pain, foreign body discomfort or recurrence in the experimental group during the follow-up. In the control group, there were 2 cases of seroma 14days after operation, 1 case of groin discomfort 60days after operation and one case of recurrence 410days after surgery. Compared with the lightweight synthetic mesh, the novel UBM/SIS graft has comparable short-term and medium-term effectiveness in LIHR, and the incidence of postoperative complications such as seroma groin discomfort is lower. Trial registration Clinical Trials Registry: ChiCTR1800020173.

Treatment of Aorto-iliac and Infrainguinal Vascular Infections with a Prefabricated Bovine Pericardial Graft

The use of biological grafts provides acceptable mid- and long-term results in native or prosthetic vascular infections. Several reports describe the successful use of bovine pericardium in case of vascular infections, mainly as a large patch to be sutured as a tubular graft. Recently, a novel prefabricated bovine pericardium graft (Biointegral Surgical No-React® Inc, Mississauga, ON, Canada) has been introduced in clinical practice with promising results. In this study, we report our preliminary experience utilizing Biointegral Surgical graft in case of native and or prosthetic aorto-iliac and infrainguinal infection. We retrospectively analyzed data from 20 patients with native or prosthetic aorto-iliac and infrainguinal infection who underwent in situ reconstruction (ISR) with a Biointegral Surgical No-React bovine pericardium prosthesis between October 2020 and February 2023 at the Vascular Surgery Unit of the Fondazione Policlinico Universitario Gemelli - IRCCS in Rome, Italy. All patients followed a standardized protocol including postoperative anticoagulation and long-term intravenous antibiotics. The indication for surgery was: mycotic aortic aneurysm in 4 patients (20%), graft infection after abdominal aortic repair in 11 patients (55%), peripheral graft infection in 5 patients (25%). Complete excision of the infected aorta or prosthetic graft, surgical debridement and ISR were performed in all patients. Hospital mortality rate was 5% (n=1) and graft-related mortality of 0%. During follow-up (median 13months, range 6-34months), reinfection was 5.2% and primary graft patency 94.7%. The use of prefabricated bovine pericardial grafts represents a promising option for the treatment of native and prosthetic aorto-iliac and infrainguinal infections. The application of this biological graft with a standardized postoperative protocol has been associated with a satisfactory patency and reinfection rate without increased bleeding complications.

Use of biological graft for reconstruction of retrohepatic vena cava: case report in young female

Use of biological graft for reconstruction of retrohepatic vena cava: case report in young female

Urinary basement membrane graft-augmented sacrospinous ligament suspension: a description of technique and short-term outcomes.

Since the discontinuation of manufacture and distribution of surgical mesh for transvaginal prolapse repair, the use of biologic grafts for transvaginal apical suspension has gained renewed attention. However, there is no FDA-approved device and minimal published data describing such an approach. The objective of this video is to describe a technique and to present limited short-term outcomes utilizing a porcine urinary basement membrane (UBM) graft to perform an augmented bilateral sacrospinous ligament suspension (SSLS). We present a step-by-step overview of our technique to perform an augmented SSLS with off-label utilization of a 7- × 10-cm porcine UBM graft. We demonstrate graft shaping and application during transvaginal repair along with data describing perioperative outcomes associated with a series of 25 cases performed at our institution using the technique described. No perioperative complications related to the graft were observed in our cohort. The most common postoperative concern was buttock pain, which spontaneously resolved within 6 months. Two individuals (8%) developed recurrent prolapse within 1 year of surgery. The UBM-augmented apical suspension allows for reinforced transvaginal prolapse repair without the use of permanent mesh material. We have observed good clinical success in our application of this technique, but dedicated research assessing long-term outcomes compared with a native tissue repair is needed.

Clinical Outcomes after Biologic Graft Use for the Creation of Blalock-Taussig Shunt in Critically Ill Patients with Thrombophilia.

The modified systemic to pulmonary artery shunt (mSPS) is an effective palliative procedure in children with cyanotic congenital heart disease (CCHD) who are not suited for total correction. Early graft failure related to hereditary thrombophilic disorder is one cause of mortality. The aim of this study is to compare the clinical outcomes and rate of graft failure after mSPS in cyanotic infants with hereditary thrombophilia using bovine mesenteric venous graft (BMVG) and polytetrafluoroethylene (PTFE). 60 cyanotic patients (28 neonates, mean age 19 ± 11.3 days; range 1 to 27) who had thrombophilic risk factors were divided into 2 groups: BMVG (n = 30) and PTFE (n = 30). Preoperative thrombophilic factors were measured for each patient. The most common thrombophilic factors were protein C and S deficiency and Factor V Leiden mutation. We also investigated D-dimer, positivity of prothrombin G20210A, factor XII and antithrombin III deficiency, and homocysteinemia in both groups. The mean age of patients was 4.6 ± 1.09 months (range 1 day to 6 months) in the BMVG group and 3.9 ± 1.02 months (range 2 days to 9 months) in the PTFE group (P = .67). mSPS procedures were performed via left thoracotomy (n = 19 in the BMVG group and n = 22 in the PTFE group) or right anterior thoracotomy (n = 3 in the BMVG group and n = 3 in the PTFE group). Median sternotomy was performed to create a central shunt in 8 neonates in the BMVG group. In the PTFE group, we performed a central shunt in 5 patients via median sternotomy. Low molecular weight heparin in combination with acetylsalicylic acid (aspirin) were administered after surgery in both groups. The patients received aspirin combined with warfarin (Coumadin) after being discharged from hospital. We performed revision surgery to observe whether any patient had a significant drop in saturation with inaudible mSPS murmur. 7 patients died early after surgery (n = 2 in the BMVG group [6.6%] and n = 5 in the PTFE group [16.5%]; P = .022). 53 patients were discharged home in good clinical condition. Early graft thromboses were observed in 2 patients in the BMVG group (6.6%) and 8 patients in the PTFE group (26.6%) (P = .001). In a case from the BMVG group, the reason for graft thrombosis was entanglement of the graft. Revision surgery was performed successfully without any complication. Cil et collegues has been reported a successful percutaneous balloon angioplasty after an acute thrombosis of BMVG previously [Cil 2010]. In another patient who had acute BMVG thrombosis, we performed transluminal graft angioplasty using successful thrombolytic administration in the catheterization laboratory. There were no complications due to graft materials such as hematoma, seroma, or infection in the BMVG group. Bleeding from the needle hole was seen in 1 patient in the BMVG group. PTFE thrombosis developed in 3 patients within 24 hours (10%). We detected total or partial PTFE graft thrombosis in 5 patients during the follow-up period (20%). Revision surgeries in 3 patients were performed immediately after diagnosis. Transluminal balloon angioplasty combined with thrombolysis was performed in infants with partial or total PTFE occlusion in 5 patients. In the PTFE group, perigraft seroma (n = 5 [16.6%)] and hematoma (n = 2 [6.6%]) were detected. We performed revision surgery because of bleeding from the needle hole in 3 patients in the PTFE group (10%) in the early period after surgery. We detected a graft infection in 1 patient (3.3%) 6 months after surgery in the PTFE group. The rate of overall complications including pseudoaneurysm, seroma formation, graft infection, or partial or total graft occlusion in the early and follow-up periods was 6.6% in the BMVG group and 53.3% in the PTFE group (P = .0001). The rate of freedom from shunt failure was 92.6% ± 2.1% and 76.2% ± 4.8% during follow-up in BMVG and PTFE groups, respectively (P = .034). The rate of shunt-related mortality was 10.7% (n = 3) in the BMVG group and 20% in the PTFE group (P = .01). Regular physical examinations, transcutaneous oxygen saturation, and echocardiographic study were performed for shunt control during follow-up. Shunt occlusion or thrombosis was not seen in the BMVG group; 5 patients in the PTFE group (20%) had shunt occlusion during follow-up (P = .001). Our study shows that BMVG, as a biological material, may be used as an alternative material for creating mSPS. It decreases postoperative life-threatening complications after shunt procedures, including graft thrombosis, bleeding from the needle hole, perigraft hematoma, and seroma in patients with hereditary thrombophilia. To our knowledge, we report the first clinical comparison of the 2 grafts in our case series with thrombophilic risk factors.

Composite Outcomes After Posterior Colporrhaphy With and Without Biologic Graft Augmentation.

To compare subjective and objective failure after posterior colporrhaphy with and without biologic graft augmentation. We conducted a retrospective chart review and telephone survey of patients who underwent a posterior colporrhaphy with and without biologic graft augmentation from 2005 to 2019. Patients who underwent a sacrocolpopexy, uterosacral ligament suspensions, or anterior sacrospinous ligament fixation were excluded. We determined objective, subjective, and composite failure rates. Although 137 patients met eligibility criteria, 56 did not have valid contact information and, therefore, were excluded from the study. Of the 81 with valid contact information, 67 (83%) agreed to participate. There were 24 (36%) who had a native tissue repair and 43 (64%) who had biologic graft augmentation. Median telephone follow-up was 73 months (interquartile range [IQR], 36-117). Objective failure was similar for the biologic graft (37%) and the native tissue (42%) groups (P = 0.72). Subjective failure was twice as likely among the biologic graft group (60%) compared with the native tissue group (33%, P = 0.03). Patients with a biologic graft reported a median Pelvic Floor Distress Inventory-Short Form 20 improvement of 31 (IQR, 8-33), while those with a native tissue repair reported a median improvement of 45 (IQR, 4-46). Overall, 78% were satisfied, 85% would recommend the procedure, and 84% reported symptomatic improvement. Reoperation occurred for 15% of patients. Although biologic graft-augmented posterior colporrhaphy may be a safe and effective treatment option, the use of biologic grafts in the posterior compartment does not appear to confer a significant long-term benefit to traditional posterior colporrhaphy.

Primary paediatric chest wall tumours necessitating surgical management.

Limited literature exists on oncological chest wall reconstruction in the paediatric population, with the field still largely undecided on the best surgical reconstructive techniques to employ. The use of biological grafts/meshes is gaining popularity in certain adult surgical procedures but their use in paediatric procedures is rarely reported in the literature. We present the outcomes of our institution's multidisciplinary approach to managing paediatric chest wall tumours as well as our experience with the use of biological grafts for chest wall reconstruction following oncological resections. Data were analysed retrospectively from eight paediatric patients who were treated for primary chest wall tumours between 2010 and 2018. The tumours comprised two lipoblastomas, three Ewing's sarcomas, an undifferentiated sarcoma with osteosarcomatous differentiation, a high grade undifferentiated sarcoma and a myofibroma. Seven of the eight patients underwent chest wall reconstruction with a biological graft. There were no postoperative mortalities and no evidence of recurrence in any of the patients in the series. No further chest wall operations were required and there were no postoperative infection related complications. We support the use of biological grafts for chest wall reconstruction after oncological resections and maintain that a multidisciplinary approach is essential for the management of paediatric chest wall tumours.

Biologics for Rotator Cuff Repair: A Critical Analysis Review.

* The complexity of tendon to bone healing in a rotator cuff surgical procedure has led to the investigation of biologic augmentation such as platelet-rich plasma, stem cells, and biomaterials to enhance the healing environment and to decrease the prevalence of failure.* Among the many types of biologic augmentation, there is considerable heterogeneity of the content, quality, and quantity of growth factors used in platelet-rich plasma and bone marrow aspirate concentrate, and conclusions from individual studies may not necessarily be generalizable to other formulations within the group.* Current Level-I evidence suggests that universal use of platelet-rich plasma provides no significant clinical benefit in rotator cuff repair.* Although some evidence exists for the use of stem cells from bone marrow aspirate concentrate and the use of biologic grafts, results from Level-I studies are lacking.* Level-I trials focused on the evaluation of clinical outcomes (i.e., American Shoulder and Elbow Surgeons [ASES] score, University of California at Los Angeles [UCLA] shoulder score, Constant score, Simple Shoulder Test) should be performed to help to determine the appropriate use of biologic augmentation in rotator cuff surgical procedures.

Long-Term Outcomes After Ventral Rectopexy With Sacrocolpo- or Hysteropexy for the Treatment of Concurrent Rectal and Pelvic Organ Prolapse.

The primary objective is to describe the long-term anatomic and subjective outcomes in women undergoing ventral rectopexy with sacrocolpo- or hysteropexy. The secondary objective is to describe the perioperative adverse events. This is a retrospective cohort of women who underwent ventral rectopexy with either concurrent sacrocolpo- or hysteropexy at a tertiary care center between 2009 and 2015. A composite outcome for recurrent pelvic organ prolapse and rectal prolapse was defined as subjective failure (vaginal or rectal prolapse symptoms), objective failure (prolapse to or beyond the hymen or full thickness rectal prolapse), or any retreatment for prolapse. Patient's Global Impression of Change was recorded at baseline and at all follow-up visits. Perioperative adverse events were defined a priori and collected up to 6 weeks after surgery. A total of 59 patients underwent a ventral rectopexy, either a sacrocolpopexy (48/59, 81.3%) or sacrohysteropexy (11/59, 18.6%). The median follow-up after surgery for all patients was 17 months (range, 1-76) with a composite success rate for both pelvic organ prolapse and rectal prolapse (estimated by Kaplan-Meier method) of 57.4%. Forty (91%) of 44 patients reported a Patient's Global Impression of Change score of 6 or 7, indicating significant improvement after surgery. Of the patients, 15 (25.4%) experienced a perioperative adverse event. Use of biologic graft was associated with a higher rate of adverse event (40.0% [95% confidence interval, 24.6-57.5] vs 10.3% [95% confidence interval, 3.6-26.3]; P < 0.01). Ventral rectopexy with sacrocolpo- or hysteropexy is associated with significant improvement in anatomic and subjective outcomes. One in 4 women experienced a perioperative adverse event.

Anterior compartment prolapse: what's new?

The purpose of this review is to summarize the treatment options for anterior compartment prolapse, describe the role that apical suspension plays in the correction of anterior vaginal wall prolapse, and assess the risks and benefits of biologic and synthetic graft use in anterior compartment repair. In 2016, The Cochrane Review published a review of 37 trials including 4023 participants finding that compared to native tissue repair, the use of synthetic mesh resulted in reduced symptomatic prolapse recurrence, anatomic recurrence, and repeat prolapse surgery. There was insufficient evidence regarding quality of life improvement or the use of biologic grafts. Of note the differences between native tissue and mesh kit repairs were not large. A strong consideration should be on the correction of apical prolapse when present; isolated anterior wall repairs should be pursued with caution. The surgeon may consider the use of augmenting materials in their repair of anterior vaginal wall prolapse, although the available evidence is not strongly supportive of their use given potential risks.

Platelet rich plasma as a minimally invasive approach to uterine prolapse

Pelvic organ prolapse (POP) is a major health problem that affects many women with potentially severe physical and psychological impact as well as impact on their daily activities, and quality of life. Several surgical techniques have been proposed for the treatment of POP. The FDA has published documents that refer to concerns about the use of synthetic meshes for the treatment of prolapse, in view of the severe complications that may occur. These led to hesitancy in use of these meshes and partial increase in use of other biological grafts such as allografts and xenografts. Although there seems to be an increasing tendency to use grafts in pelvic floor reconstructive procedures due to lower risks of erosion than synthetic meshes, there are inconclusive data to support the routine use of biological grafts in pelvic organ prolapse treatment.In light of these observations new strategies are needed for the treatment of prolapse. Platelet rich plasma (PRP) is extremely rich in growth factors and cytokines, which regulate tissue reconstruction and has been previously used in orthopaedics and plastic surgery. To date, however, it has never been used in urogynaecology and there is no evidence to support or oppose its use in women who suffer from POP, due to uterine ligament defects. PRP is a relatively inexpensive biological material and easily produced directly from patients’ blood and is, thus, superior to synthetic materials in terms of potential adverse effects such as foreign body reaction. In the present article we summarize the existing evidence, which supports the conduct of animal experimental and clinical studies to elucidate the potential role of PRP in treating POP by restoring the anatomy and function of ligament support.

Risk Factors for Recurrence After Laparoscopic Ventral Rectopexy.

Laparoscopic ventral rectopexy effectively treats posterior compartment prolapse. However, recurrence after laparoscopic ventral rectopexy is poorly understood. This study aimed to evaluate factors contributing to recurrence after laparoscopic ventral rectopexy. A retrospective cohort analysis was performed of patients who underwent laparoscopic ventral rectopexy between June 2008 and June 2014. Patients presenting with full-thickness rectal prolapse were compared against the rest. Cox proportional hazards regression was used to determine predictors for recurrence. Operative findings of redo cases were evaluated. This study was conducted under the supervision of a single pelvic floor surgeon. A total of 231 patients with a median follow-up of 47 months were included. Clinicopathological risk factors and technical failures contributing to recurrence were analyzed. The overall recurrence rate was 11.7% (n = 27). Twenty-five recurrences occurred in patients with full-thickness rectal prolapse, of which 16 were full-thickness recurrences (14.2% (16/113)). Multivariate analyses showed predictors for recurrence to be prolonged pudendal nerve terminal motor latency (HR = 5.57 (95% CI, 1.13 - 27.42); p = 0.04) and the use of synthetic mesh as compared with biologic grafts (HR = 4.24 (95% CI, 1.27-14.20); p = 0.02). Age >70 years and poorer preoperative continence were also associated with recurrence on univariate analysis. Technical failures contributing to recurrence included mesh detachment from the sacral promontory and inadequate midrectal mesh fixation. Modifications to the operative technique were made throughout the study period. A postoperative defecating proctogram was not routinely performed. Recurrence after laparoscopic ventral rectopexy is multifactorial, and risk factors are both clinical and technical. The use of biologic grafts was associated with lower recurrence as compared with synthetic mesh. Patients with full-thickness rectal prolapse who are elderly, have poorer baseline continence, and have prolonged pudendal nerve terminal motor latency are at increased risk of recurrence.

Biological substitutes/extenders for spinal arthrodesis: which agents are cost-effective?

Systematic review. To evaluate the cost-effectiveness of lumbar or cervical spinal arthrodesis using biological substitutes and extenders compared with iliac crest autograft for the treatment of degenerative spinal conditions. The cost-effectiveness of using bone graft substitutes and extenders for spinal fusion compared with using iliac crest autograft is not yet well established. A systematic search of PubMed/MEDLINE, the Cochrane Collaboration Library, EMBASE, the CRD (Centre for Reviews and Dissemination) database, and Tuft's CEA registry for literature published through December 2013 was performed to identify full formal economic analyses comparing the use of biological grafts with iliac crest bone graft in spinal fusion for thoracolumbar or cervical degenerative, deformity, and traumatic spinal conditions. Economic outcomes such as cost per improved outcome or cost per quality-adjusted life year were reported in the context of the model type, analytic perspective clinical comparisons, and sensitivity analyses employed. The search strategy yielded 88 citations, and 6 full economic analyses ultimately met our inclusion criteria. For the comparison of recombinant human bone morphogenetic protein-2 to iliac crest bone graft in the lumbar spine, data from 4 cost-effectiveness studies and 1 cost-utility study provided discordant conclusions that varied with type of data used, cost-measurement methods, and study design. In the cervical spine, one study suggested that from a societal perspective, anterior cervical discectomy and fusion (ACDF) with allograft is similarly cost-effective as ACDF with autograft. The results suggest that compared with use of iliac crest bone graft in lumbar spinal fusion, use of recombinant human bone morphogenetic protein is not cost-effective from a payer perspective with higher upfront costs, but it may be cost-effective from a societal perspective due to a decrease in lost productivity. The data in this study also suggest that from a societal perspective, ACDF with allograft is similarly cost-effective to ACDF with autograft. 3.

Practice patterns in complex ventral hernia repair and place of biological grafts: A national survey among French digestive academic surgeons

Despite the prevalence of complex ventral hernias, there is little agreement on the most appropriate technique or prosthetic to repair these defects, especially in contaminated fields. Our objective was to determine French surgical practice patterns among academic surgeons in complex ventral hernia repair (CVHR) with regard to indications, most appropriate techniques, choice of prosthesis, and experience with complications. A survey consisting of 21 questions and 6 case-scenarios was e-mailed to French practicing academic surgeons performing CVHR, representing all French University Hospitals. Forty over 54 surgeons (74%) responded to the survey, representing 29 French University Hospitals. Regarding the techniques used for CVHR, primary closure without reinforcement was provided in 31.6% of cases, primary closure using the component separation technique without mesh use in 43.7% of cases, mesh positioned as a bridge in 16.5% of cases, size reduction of the defect by using aponeurotomy incisions without mesh use in 8.2% of cases. Among the 40 respondents, 36 had experience with biologic mesh. There was a strong consensus among surveyed surgeons for not using synthetic mesh in contaminated or dirty fields (100%), but for using it in clean settings (100%). There was also a strong consensus between respondents for using biologic mesh in contaminated (82.5%) or infected (77.5%) fields and for not using it in clean setting (95%). In clean-contaminated surgery, there was no consensus for defining the optimal therapeutic strategy in CVHR. Infection was the most common complication reported after biologic mesh used (58%). The most commonly reported influences for the use of biologic grafts included literature, conferences and discussion with colleagues (85.0%), personal experience (45.0%) and cost (40.0%). Despite a lack of level I evidence, biologic meshes are being used by 90% of surveyed surgeons for CVHR. Importantly, there was a strong consensus for using them in contaminated or infected fields and for not using them in clean setting. To better guide surgeons, prospective, randomized trials should be undertaken to evaluate the short- and long-term outcomes associated with these materials in various surgical wound classifications.

The use of biological grafts for reconstruction of the inferior vena cava is a safe and valid alternative: results in 32 patients in a single institution

BackgroundResection and reconstruction of the inferior vena cava (IVC) is occasionally required in the surgical treatment of intra‐abdominal tumours. IVC reconstruction can be performed with biological or synthetic graft material, with most centres preferring synthetic grafts. In spite of the potential advantages of biological grafts in terms of handling characteristics, and safety, very limited data are available about their use in patients requiring an IVC resection. MethodsMedical records of 32 patients who underwent an IVC resection and reconstruction from 1990 and 2011 with autogenous peritoneo‐fascial (N = 22) and bovine pericardial (N = 10) grafts were reviewed. ResultsA tangential resection with patch repair was performed in 10 patients, whereas in the remaining 22 it was necessary to resect and replace a segment or all of the retrohepatic IVC. A concomitant liver resection was performed in 14 patients, nephrectomy in 10 and pancreaticoduodenectomy in 2 patients. There were no acute or late complications related to graft thrombosis or infection. Three patients died as a consequence of multi‐organ failure. Overall survival at 1 and 5 years was 78% and 48%, respectively. ConclusionsThe preferential use of synthetic grafts in IVC replacement is not evidence based. Selection of an appropriate prosthetic graft for IVC reconstruction should be based on the safety and its handling features. The use of biological grafts for IVC repair is a valid alternative to current synthetic materials and may in fact be superior in terms of biocompatability, ease of handling, reduced rate of infection and improved long‐term patency without permanent anticoagulation.

Impact of the 2011 FDA Transvaginal Mesh Safety Update on AUGS Members’ Use of Synthetic Mesh and Biologic Grafts in Pelvic Reconstructive Surgery

To describe the frequency of use and recent change in use of synthetic mesh and biologic grafts in pelvic organ prolapse (POP) and stress urinary incontinence surgery by American Urogynecology Society (AUGS) members. An electronic survey of AUGS members was conducted between December 2011 and January 2012. Frequency of graft use in POP (overall and by transvaginal and transabdominal approaches) and stress urinary incontinence surgery was queried relative to the timing of the 2011 Food and Drug Administration (FDA) safety update. Rates of materials' use before and after the statement were compared using Wilcoxon signed rank test. Fifty-three percent (507/962) of AUGS members responded and were included in analysis; 79% were urogynecologists. Before the FDA warning, in POP surgery, most (90%) used synthetic mesh and fewer (34%) used biologic grafts; 99% used synthetic mesh slings. After the FDA statement, respondents reported an overall decrease in the percent of POP cases in which they used synthetic mesh (P < 0.001) but no change in biologic graft use for POP (P = 0.37) or synthetic mesh sling use (P = 0.10). Specifically, transvaginal mesh use decreased: 40% reported decreased use and 12% stopped use. However, transvaginal mesh was still used by 61% of respondents in at least some cases. No change (62%) or increased use (12%) of mesh was reported for transabdominal POP procedures. Synthetic mesh use in transvaginal POP surgery decreased after the 2011 FDA safety update, but synthetic mesh use for transabdominal POP repair and sling procedures and overall biologic graft use in POP surgery did not decrease.

Biologic mesh use practice patterns in abdominal wall reconstruction: a lack of consensus among surgeons

Despite the prevalence of ventral hernias, there is little agreement as to the most appropriate technique or prosthetic to repair these defects. Our objective was to determine biologic mesh practice patterns of reconstructive surgeons with regard to indications, most appropriate technique, choice of prosthetic, and experience with complications. A survey was mailed to 2,000 practicing surgeons. Main outcome measures included surgeon experience with biologic mesh and associated complications. Two hundred and forty (12 %) surgeons responded to the survey. Ten were excluded, as surgeons completing the survey indicated they did not perform ventral hernia repairs or left multiple questions unanswered. Of the 230 included, 93.5 % (n = 215) of responders had experience using biologic mesh. Frequency of biologic graft use in the last year was as follows: low-volume users (<5 times in the last year) 50.7 %; medium-volume users (5-20 times in the last year) 37.3 %; high-volume users (>20 times in the last year) 11.9 %. Indications for biologic mesh use based on wound classifications (clean, clean contaminated, contaminated or dirty) were quite varied and lacked consensus among surgeons (p value < 0.05). The most commonly reported influences for use included personal experience (45 %), literature (28.3 %), and availability (17.2 %). Despite a lack of level 1 evidence, biologic meshes are being used under various wound classifications. Importantly, use in clean and dirty-infected settings may reflect an inappropriate overuse of these expensive materials. To better guide surgeons, prospective, randomized trials should be undertaken to evaluate the short- and long-term outcomes associated with these materials under the various surgical wound classifications.

Use and Indications of Human Acellular Dermis in Ventral Hernia Repair at a Community Hospital

Background. To evaluate the use, indications, and short-term outcomes for human acellular dermis. Methods. We retrospectively reviewed patients having human acellular dermis placed for ventral hernia repair from January 2008 through October 2009. Demographic information, operative details, and outcomes of patients with and without recurrences were compared; a P value <0.05 was considered significant. Results. 115 patients met inclusion criteria. The average age was 60 years (range, 24–89). The technique of repair included primary repair with overlay of mesh in 76%, bridge repair in 13%, and underlay in 11%. Average cost of mesh per operation was $3,709 (range $191–10,630). Open repairs were performed in 90% of patients with addition of component separation in 12%. At an average of 13 months, 58 patients were available for followup (50%), with a 47% recurrence rate. The morbidity rate was 48% and the mortality rate was 2%. Technique of repair was the only significant risk factor for recurrence with bridge repairs associated with a higher rate of recurrence (P < 0.05). Conclusions. The use of biologic grafts for ventral hernia repair is becoming more popular especially in clean cases. Although followup is limited, there remains a high recurrence rate associated with the use of human acellular dermis.

The Use of Biologic Graft for Posterior Colporrhaphy in Women with Poor Rectovaginal Fascia

The Use of Biologic Graft for Posterior Colporrhaphy in Women with Poor Rectovaginal Fascia

Immediate effects of the initial FDA notification on the use of surgical mesh for pelvic organ prolapse surgery in medicare beneficiaries

Prompted by increased reports of complications with the use of mesh for pelvic organ prolapse (POP) surgery, the FDA issued an initial public health notification (PHN) in 2008. We proposed to determine if the numbers of POP cases augmented with surgical mesh performed in U.S. Medicare beneficiaries changed relative to this PHN. Using administrative healthcare claims for beneficiaries enrolled in the U.S. Medicare program from 2008 to 2009, we identified women who underwent POP surgery with and without surgical mesh by procedural and diagnosis coding. In addition to comparing cases with and without mesh, we also calculated rates (number of cases per 100,000 female beneficiaries) and compared these relative to the timing of the PHN. We identified 104,185 POP procedures, of which 27,839 (26.7%) included mesh material and 76,346 (73.3%) did not. Between the last three quarters of 2008 and the first three of 2009, the rates of mesh cases increased (40.3-42.1, P < 0.001) and those without mesh decreased (115.5-111.4, P < 0.001). Inpatient procedures decreased and outpatient procedures increased for both those with and without mesh augmentation. For inpatient procedures, the relative use of biologic graft and synthetic mesh material did not vary over the study period. A substantial number of Medicare beneficiaries underwent mesh POP procedures in 2008-2009. However, despite the PHN cautioning about potential mesh complications, the numbers of mesh cases continued to rise in the immediate period after the PHN.