Graft-versus-host disease following transobturator tape procedure with small intestinal submucosa (Surgisis): a case report

Transobturator tape procedure using small intestinal submucosa (SIS) is designed for the diminishment of the complications of tension-free vaginal tape procedures, and SIS can lower the erosion rate of mesh. However, we here report a case which developed graft-versus-host disease following the use of SIS for the transobturator procedure.     

Short-term outcomes with small intestinal submucosa for ventral abdominal hernia

HYPOTHESIS: A bioabsorbable tissue scaffold of porcine submucosal small intestine extracellular matrix (Surgisis Gold [SIS]; Cook Biotech Inc, West Lafayette, Ind) mesh is safe and effective for ventral hernia repair. DESIGN: Retrospective case series at a university teaching hospital. PATIENTS: Fifty-three consecutive patients having 8-ply SIS mesh repair of ventral abdominal hernias. MAIN OUTCOME MEASURES: Early complications, reoperation, hernia recurrence, mesh or wound infection, or reaction. Outcomes reported and compared on an intention-to-treat basis. RESULTS: Patients were stratified by wound class: clean, clean-contaminated and contaminated, or dirty. Median follow-up was 14 months (range, 2-29 months) during which there were 22 complications (41%), 17 early reoperations (32%), 13 partial dehiscences (21%), 6 mesh reactions (11%), and 9 recurrent hernias (17%). Seven recurrent hernias (78%) in critically ill, patients with dirty wounds had the SIS mesh removed owing to infection or reoperation. In patients without SIS mesh removal or debridement, 1 (2.2%) of 44 developed a recurrent hernia at 6 months. Patients with dirty wounds were more likely to need early reoperation (P<.001), develop a complication (P<.01), partial wound dehiscence (P<.05), or recurrent hernia (P<.01) compared with patients with clean wounds. Critically ill patients were more likely to have hernia recurrence (P<.05), early reoperation (P<.001), and postoperative complications (P<.05). CONCLUSIONS: Eight-ply SIS mesh is safe in clean and clean-contaminated hernia repair with satisfactory short-term outcomes. However, delayed wound infection, repeated operation, and mesh debridement warrant cautious use of SIS mesh in critically ill patients and those with dirty wounds.     

Minimally Invasive Sacrocolpopexy: How to Avoid Short- and Long-Term Complications

Sacrocolpopexy remains the “gold standard” procedure for management of posthysterectomy vaginal vault prolapse with improved anatomic outcomes compared to native tissue vaginal repair. Despite absence of clinical data, sacrocolpopexy is increasingly being offered to women as a primary treatment intervention for uterine prolapse. While reoperation rates remain low, recurrent prolapse and vaginal mesh exposure appear to increase over time. The potential morbidity associated with sacrocolpopexy is higher than for native tissue vaginal repair with complications including sacral hemorrhage, discitis, small bowel obstruction, port site herniation, and mesh erosion. Complications are more common during the learning curve of minimally invasive sacrocolpopexy. Appropriate case selection is paramount to balancing the potential for prolapse recurrence with the risk of surgical complications. Use of ultra-lightweight polypropylene mesh and vaginal mesh attachment with delayed absorbable suture may reduce the risks of vaginal mesh exposure.     

Long-term outcomes of vaginal mesh versus native tissue repair for anterior vaginal wall prolapse

Introduction and hypothesis

To estimate the risk of repeat surgery for recurrent prolapse or mesh removal after vaginal mesh versus native tissue repair for anterior vaginal wall prolapse.

Methods

We utilized longitudinal, adjudicated, healthcare claims from 2005 to 2010 to identify women ≥18 years who underwent an anterior colporrhaphy (CPT 57420) with or without concurrent vaginal mesh (CPT 57267). The primary outcome was repeat surgery for anterior or apical prolapse or for mesh removal/revision; these outcomes were also analyzed separately. We utilized Kaplan–Meier curves to estimate the cumulative risk of each outcome after vaginal mesh versus native tissue repair. Cox proportional hazards models were used to estimate the hazard ratio (HR) for vaginal mesh versus native tissue repair, adjusted for age, concurrent hysterectomy, and concurrent or recent sling.

Results

We identified 27,809 anterior prolapse surgeries with 49,658 person-years of follow-up. Of those, 6,871 (24.7%) included vaginal mesh. The 5-year cumulative risk of any repeat surgery was significantly higher for vaginal mesh versus native tissue (15.2 % vs 9.8 %, p?<0.0001) with a 5-year risk of mesh revision/removal of 5.9%. The 5-year risk of surgery for recurrent prolapse was similar between vaginal mesh and native tissue groups (10.4 % vs 9.3 %, p?=?0.70. The results of the adjusted Cox model were similar (HR 0.93, 95%CI: 0.83, 1.05).

Conclusions

The use of mesh for anterior prolapse was associated with an increased risk of any repeat surgery, which was driven by surgery for mesh removal. Native tissue and vaginal mesh surgery had similar 5-year risks for surgery for recurrent prolapse.     

Tension-free vaginal mesh repair for anterior vaginal wall prolapse

OBJECTIVES: We determined the efficacy of the use of a tension free prolene mesh to correct a grade III anterior vaginal wall prolapse recurrence. METHODS: Twelve women (mean age 65.6 years) with stress urinary incontinence (SUI) (4 type II and 1 type III) and bladder prolapse entered the study. After vaginal incision a pretailored polypropylene mesh was fixed to its four angles by absorbable sutures to the urethropelvic ligaments and pubocervical fascia anteriorly and to the cardinal ligaments and pubocervical fascia posteriorly. When present, a posterior descensus was corrected during the same procedure. SUI was treated with the tension-free vaginal tape procedure (TVT) through a separate vaginal incision over the mid-urethra. RESULTS: All patients were available for postoperative pelvic examination at 3-month intervals, for a mean follow-up of 20.5 months (range 15-32). Nine patients were considered cured (no cystocele recurrence) while in 3 patients a grade 1 asymptomatic cystocele was present postoperatively (asymptomatic). No significant postoperative pain was reported by the patients. CONCLUSIONS: This study confirms that in patients with moderate cystocele a tension-free mesh to support bladder base and neck effectively treats the cystocele. It is particularly recommended in the treatment of previous failure with traditional techniques and when the quality of suspending tissue is poor or defective. A long-term study on a large number of patients is still warranted to confirm and validate its clinical use.     

国产生物补片与聚丙烯补片在日间腹股沟斜疝Lichtenstein修补术中的疗效对比

目的探讨猪小肠黏膜下层生物补片在腹股沟疝日间手术中的应用价值。 方法回顾分析2019年1月至2020年12月武汉大学中南医院疝病诊疗中心100例接受日间Lichtenstein手术的腹股沟疝患者。根据使用补片的不同分为试验组（SIS补片）和对照组（聚丙烯补片），记录2组患者的临床参数和术后并发症发生情况，对比数据进行统计学分析。 结果2组手术时间，差异无统计学意义（P>0.05）。术后1周，试验组患者术后发热、切口血清肿多于对照组（P<0.05）；而试验组术后切口感染和疼痛发生率均低于对照组（P<0.05）。术后1年，试验组慢性疼痛、异物感发生率均低于对照组（P<0.05）；2组复发率比较，差异无统计学意义（P>0.05）。 结论在开放腹股沟疝手术中，SIS补片术后早期发热及血清肿发生率高于聚丙烯补片，但在早期切口感染及疼痛方面优于聚丙烯补片；在远期慢性疼痛和异物感方面，SIS补片也优于聚丙烯补片，临床应用应遵循个体化原则。     

Basic procedures in tension‐free vaginal mesh operation for pelvic organ prolapse

A variety of tension‐free vaginal mesh (TVM) systems are available for surgical treatment of pelvic organ prolapse (POP). These include Prolift, Apogee/Perigee and Avaulta, all of which vary in terms of mesh size, shape and surgical technique to such an extent that they cannot truly be considered the same operation for the purpose of evaluating results. I began carrying out self‐made mesh cut out from Gynemesh PS in 2005. This system has four main characteristics: (i) the mesh is intended as a replacement for defective visceral pelvic fascia; (ii) it bridges between the left and right arcus tendineus fascia pelvis (white line, or ATFP); (iii) large‐size mesh is held in place by passing cannulas through the obturator fascia (anterior wall) or the sacrospinous ligament (SSL) to attach the arms of the mesh graft; and (iv) the bladder neck is preserved. The mesh that I have used since then has been essentially similar to the Prolift System, developed by a French TVM group, in terms of size and shape of its central portion. Mesh grafts used for the anterior wall are quite large, so skillful execution will provide sufficient room between the left and right ATFP in almost all cases. This video discusses the fundamental techniques necessary for skillful execution of the tension‐free vaginal mesh (TVM) procedure using the Prolift System, focusing on the following points: (i) surgical separation of the correct layers of the vaginal wall, and the area separated, and effective hemostasis; (ii) precise puncture technique, especially the second puncture for the anterior TVM (TVM‐A) procedure and the sacrospinous ligament (SSL) puncture in the posterior TVM (TVM‐P) procedure; (iii) firmly securing the mesh to the vaginal wall or cervical canal; and (iv) careful mesh placement and formation of a bridge between the left and right arcus tendineus fascia pelvis (ATFP). Proper separation of the vaginal wall layers, in particular, is crucial for preventing unnecessary blood loss and mesh erosion. The second puncture in the TVM‐A is the most important of the puncture maneuvers for the procedure. Penetrating the tough tissue near the ischial spine represents a significant challenge, and the SSL penetration in the TVM‐P procedure is unexpectedly difficult for those without sufficient experience. In order to become proficient, the surgeon must have hands‐on experience under the supervision of experts. Finally, TVM is a relatively new procedure, so one must master the fundamentals before gaining true proficiency. The technique does not call for virtuosity on the part of the surgeon, but key points must be mastered to reduce the risk of complications and recurrences. With repeated hands‐on training, surgical skills will gradually improve to the requisite level. This is a translated section of a video article originally published in Japanese as a DVD in the Audio‐Visual Journal Vol.15 No.15. 2009 by The Japanese Urological Association.     

Where to for pelvic organ prolapse treatment after the FDA pronouncements?

Introduction

With the publication of the updated US Food and Drug Administration (FDA) communication in 2011 on the use of transvaginal placement of mesh for pelvic organ prolapse (POP) it is appropriate to now review recent studies of good quality on POP to assess the safety and effectiveness of treatment options and determine their place in management.

Methods

A systematic search for studies on the conservative and surgical management of POP published in the English literature between January 2002 and October 2012 was performed. Studies included were review articles, randomized controlled trials, prospective and relevant retrospective studies as well as conference abstracts. Selected articles were appraised by the authors regarding clinical relevance.

Results

Prospective comparative studies show that vaginal pessaries constitute an effective and safe treatment for POP and should be offered as first treatment of choice in women with symptomatic POP. However, a pessary will have to be used for the patient’s lifetime. Abdominal sacral colpopexy is effective in treating apical prolapse with an acceptable benefit-risk ratio. This procedure should be balanced against the low but non-negligible risk of serious complications. The results of native tissue vaginal POP repair are better than previously thought with high patient satisfaction and acceptable reoperation rates. The insertion of mesh at the time of anterior vaginal wall repair reduces the awareness of prolapse as well as the risk of recurrent anterior prolapse. There is no difference in anatomic and subjective outcome when native tissue vaginal repairs are compared with multicompartment vaginal mesh. Mesh exposure is still a significant problem requiring surgical excision in approximately ≥10 % of cases. The ideal mesh has not yet been found necessitating more basic research into mesh properties and host response. Several studies indicate that greater surgical experience is correlated with fewer mesh complications. In women with uterovaginal prolapse uterine preservation is a feasible option which women should be offered. Randomized studies with long-term follow-up are advisable to establish the place of uterine preservation in POP surgery.

Conclusion

Over the last decade treatment of POP has been dominated by the use of mesh. Conservative treatment is the first option in women with POP. Surgical repair with or without mesh generally results in good short-term objective and functional outcomes. However, basic research into mesh properties with host response and comparative studies with long-term follow-up are urgently needed.     

Laparoscopic herniorrhaphy with porcine small intestinal submucosa: a preliminary study.

INTRODUCTION: Using mesh or a synthetic prosthesis during the laparoscopic repair of inguinal hernias has been demonstrated to be safe and effective. A new material, porcine small intestinal submucosa (SIS mesh), has been successfully used in canine and rodent animal models with excellent results. This mesh is degradable and resorbable with a marked decrease in the possibility of becoming infected. However, the amount of fibroblast ingrowth is equal to that with polypropylene mesh. METHODS: A comparison was made between this new SIS mesh to repair 15 inguinal hernias in 12 patients and polypropylene mesh used in 12 similar patients. A preperitoneal approach with balloon dissection was used in all patients. RESULTS: Demographics were similar in both groups. The results were excellent and compared equally. Complications (seroma, discomfort) were minimal in both groups and were similar. CONCLUSIONS: Porcine small intestinal submucosa, SIS mesh, can be used for laparoscopic repair of inguinal hernias. Long-term follow-up will be necessary to confirm these preliminary results.     

Diagnosis, management and prognosis of vaginal erosion after transobturator suburethral tape procedure using a nonwoven thermally bonded polypropylene mesh

PURPOSE: We studied the diagnosis, management and prognosis of vaginal mesh erosion using a thermally bonded nonwoven polypropylene mesh in a transobturator suburethral tape procedure for the surgical treatment of stress urinary incontinence in women. MATERIALS AND METHODS: A total of 65 patients diagnosed with stress urinary incontinence underwent a transobturator suburethral tape procedure with a fusion welded, nonwoven, nonknitted polypropylene mesh, with or without a central silicone coated section, at our institution. All women were followed and if vaginal erosion was diagnosed, cystoscopy and vaginoscopy were performed, the mesh was partially or completely removed and, if necessary, posterior cough test and urodynamic study were performed. RESULTS: Of the 65 patients 9 (13.8%) were diagnosed with vaginal erosion at the vaginal incision during a relatively long postoperative period (mean 290 days). All presented with vaginal discharge and 1 had a severe complication (obturator abscess). Complete mesh removal was necessary in 8 patients and only 2 (22%) had recurrent stress urinary incontinence. CONCLUSIONS: A 13.8% rate of vaginal mesh erosion using a nonwoven thermally bonded polypropylene mesh was reported. This complication was probably due to the characteristics of the mesh and not to the transobturator approach. Complete removal of the tape is recommended and the continence status prognosis is good (78%).     

Small Intestinal Submucosa (SIS) in the Repair of a Cecal Wound in Unprepared Bowel in Rats

Purpose Porcine-derived small intestinal submucosa (SIS) has been accepted as an acellular matrix for tissue regeneration. However, its use for remodeling gastrointestinal defects has been poorly investigated. Our previous study of the rodent stomach has demonstrated that the SIS stimulates regeneration of native tissue under acidic conditions. The purpose of this paper was to investigate the feasibility of using SIS as a bioscaffold for a colonic defect in unprepared bowel. Methods A 1 × 1-cm whole layer was excised on the anterior wall of the cecum in 24 rats, followed by onlay repair with SIS. Measurement outcomes included animal survival, mesh stability in situ, and histologic evaluation at 3 weeks and 6 months. Results Rats showed a significant weight gain and had no evidence of postoperative leakage. All wounds were secured and associated with either omental or other fatty adhesions. Histological findings revealed that intact mucosa covered the area of the graft in all cases 6 months after surgery and that the defect was completely replaced by the normal constituents (mucosa, muscle, and nerve cells) of the bowel wall. Conclusions SIS was largely successful in promoting healing in a cecal wound in unprepared bowel and serving as a bioscaffold for regeneration of the native colonic tissue. Small intestinal submucosa may be useful in surgical anastomoses to promote healing and presumably prevent leakage.     

The use of small intestine submucosa in the repair of paraesophageal hernias: initial observations of a new technique

BACKGROUND: Recent reports suggest that when laparoscopy is used to repair paraesophageal hernias recurrence rates reach 20% to 40%. Tension-free hernia closure with synthetic mesh reduces recurrence but occasionally results in esophageal injury. We hypothesized that reinforcement of the hiatal closure with small intestine submucosa (SIS) mesh, in some unusually large hernias, might reduce recurrence rates without causing injury to the esophagus. METHODS: From January 2001 to March 2002 we treated 18 large paraesophageal hernias via a laparoscopic approach. In 9 of the largest hernias (one type II and 8 type III, of which 1 was recurrent) the repair was reinforced with SIS mesh (Surgisis, Cook Surgical) and represent the subjects of this study. Nissen fundoplication with gastropexy was performed in all patients. Clinical follow-up ranged from 3 to 16 months (median 8). Every patient was evaluated with barium esophagram or endoscopy or both 1 to 8 months (median 2) postoperatively. RESULTS: The presenting symptoms were postprandial pain/fullness (9 of 9), heartburn (4 of 9), anemia (4 of 9), dysphagia (3 of 9), regurgitation (3 of 9), and chest pain (3 of 9). One patient died of a hemorrhagic stroke within 30 days of the operation. Postoperatively, presenting symptoms resolved (83%) or improved (17%) in each of the remaining 8 patients. One patient required endoscopic dilation for mild dysphagia. Seven of 8 patients had a normal barium esophagram without evidence of hernia. One morbidly obese (body mass index = 47) patient had a small (2 cm) sliding hiatal hernia postoperatively. There were no other complications, and specifically no perforations or mesh erosions. CONCLUSIONS: These observations suggest that the use of SIS in the repair of paraesophageal hernias is safe and may reduce recurrence. Longer follow-up and a randomized study are needed to validate these results.     

Antimicrobial mesh versus vaginal wall sling: a comparative outcomes analysis

PURPOSE: We prospectively compared transvaginal antimicrobial mesh (MycroMesh*) and anterior vaginal wall slings using an outcomes analysis. MATERIALS AND METHODS: Between August 1997 and November 1998 we implanted transvaginal slings in 40 consecutive women randomized to a synthetic mesh (20) or vaginal wall (20) group. All patients had documented stress urinary incontinence on preoperative urodynamics. We prospectively compared postoperative outcomes data obtained from pelvic examinations, cough stress test, cotton swab test and validated patient questionnaires using a visual analog scale. RESULTS: Complete followup was available in all patients. Mean followup was 22 months (range 12 to 27). Stress incontinence was cured in 95% of the mesh and 70% of the vaginal wall group, and pelvic prolapse was cured in 100% and 95%, respectively. Transient de novo urge incontinence was noted in 12.5% of the mesh and 14.3% of the vaginal wall group. Mean postoperative cotton swab angle during Valsalva's maneuver was 20 and 45 degrees for the mesh and vaginal wall groups, respectively. The incidence of urinary retention and tissue erosion was 0% for both groups. The satisfaction rate was 100% and 80% for the mesh and vaginal wall groups, respectively. CONCLUSIONS: The antimicrobial MycroMesh sling was superior to the vaginal wall sling for correction of stress incontinence and pelvic prolapse with comparatively low morbidity.     

Failure of Expectations in Vaginal Surgery: Lack of Appropriate Consent,Goals and Expectations of Surgery

Introduction and Background

Vaginal surgery for the treatment of urinary stress incontinence (USI) and pelvic organ prolapse (POP) using a synthetic polypropylene mesh is going through a time of unprecedented turmoil and debate. This review focuses on vaginal surgery for vaginal prolapse and looks at the current scientific literature on issues surrounding surgery including consent and expectations.

Safety and Effectiveness of Surgical Options

Synthetic mesh has been used both abdominally and vaginally to improve the effectiveness of POP surgery. The relatively high incidence of mesh complications particularly with vaginal surgery has lead to repeat surgery, disappointment and litigation in some women. The benefits and risks of the various POP procedures are reviewed including native tissue repair, uterine conservation and obliterative vaginal surgery.

Conclusion

Women with symptomatic pelvic organ prolapse and their doctors have many treatment options. The benefits and risks should be discussed as part of shared decision making.

     

Changes in prolapse surgery trends relative to FDA notifications regarding vaginal mesh

Introduction and hypothesis

In 2008 and 2011, the US Food and Drug Administration (FDA) released notifications regarding vaginal mesh. In describing prolapse surgery trends over time, we predicted vaginal mesh use would decrease and native tissue repairs would increase.

Methods

Operative reports were reviewed for all prolapse repairs performed from 2008 to 2011 at our large regional hospital system. The number of each type of prolapse repair was determined per quarter year and expressed as a percentage of all repairs. Surgical trends were examined focusing on changes with respect to the release of two FDA notifications. We used linear regression to analyze surgical trends and chi-square for demographic comparisons.

Results

One thousand two hundred and eleven women underwent 1,385 prolapse procedures. Mean age was 64?±?12, and 70 % had stage III prolapse. Vaginal mesh procedures declined over time (p?=?0.001), comprising 27 % of repairs in early 2008, 15 % at the first FDA notification, 5 % by the second FDA notification, and 2 % at the end of 2011. The percentage of native tissue anterior/posterior repairs (p?<?0.001) and apical suspensions (p?=?0.007) increased, whereas colpocleisis remained constant (p?=?0.475). Despite an overall decrease in open sacral colpopexies (p?<?0.001), an initial increase was seen around the first FDA notification. We adopted laparoscopic/robotic techniques around this time, and the percentage of minimally invasive sacral colpopexies steadily increased thereafter (p?<?0.001). All sacral colpopexies combined as a group declined over time (p?=?0.011).

Conclusions

Surgical treatment of prolapse continues to evolve. Over a 4-year period encompassing two FDA notifications regarding vaginal mesh and the introduction of laparoscopic/robotic techniques, we performed fewer vaginal mesh procedures and more native tissue repairs and minimally invasive sacral colpopexies.     

Surgical management of vaginal wound healing defects after tension-free vaginal tape placement

The use of tension-free vaginal tape (TVT) made of polypropylene mesh carries the risk of causing vaginal wound healing defects, which are usually detected within 4 weeks of operation. We present three cases of vaginal wound healing defects after TVT procedures. These defects were managed using surgical techniques aimed at preserving the mesh, but all failed. There are many options for dealing with the problems of vaginal wounds following TVT. These include further observation, mesh removal, suturing the wound, or using tissue flaps to cover it. However, the latter two options cannot be recommended as they usually fail.     

Six-month magnetic resonance imaging follow-up of large and massive rotator cuff repairs reinforced with porcine small intestinal submucosa

Small intestinal submucosa (SIS) has been used for reinforcement of other tissues in the body with success and has been shown to act as a bioabsorbable tissue scaffold that promotes and assists healing. The effectiveness of using porcine SIS as a tissue scaffold for reinforcement of rotator cuff repair is unclear. This study evaluates both clinical and magnetic resonance imaging (MRI) follow-up at 6 months in patients with large and massive rotator cuff tears treated with open repair and SIS reinforcement or interpositional grafting. Eleven consecutive patients who underwent open rotator cuff repair with SIS augmentation for large or massive tears were selected retrospectively, and their charts were reviewed. Magnetic resonance images were then obtained at least 6 months after the index procedure. Patients were evaluated clinically and with a questionnaire, and an American Shoulder and Elbow Surgeons shoulder score was calculated. Results showed retear on MRI in 10 of 11 patients with recurrence of large, retracted tears. One repair remained intact by MRI evaluation at 10 months. Clinically, there was no statistically significant difference between preoperative and postoperative shoulder scores by use of a paired t test analysis (P =.70). Five patients had worse scores postoperatively. We concluded that, though SIS xenografting may be effective in other areas of the body for tendon healing, its use in reinforcement of large and massive rotator cuff repairs seems to be ineffective and does not improve clinical outcome.     

Anterior vaginal wall prolapse: a randomized controlled trial of SIS graft versus traditional colporrhaphy

Introduction and hypothesis  

This study seeks to compare the small intestine submucosa (SIS) graft with traditional colporrhaphy (TC) for surgical treatment of anterior vaginal prolapse.