Not all biologics are equal!

Shah, Bhavin C.; Tiwari, Manish; Goede, Matthew R.; Eichler, Markus; Hollins, Ronald R.; McBride, Corrigan L.; Thompson, Jon S.; Oleynikov, Dmitry

doi:10.1007/s10029-010-0768-7

Cited by 105 publications

(80 citation statements)

References 39 publications

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“…From these eligible articles were found to have partial or complete data available for the population of interest and were used for the synthesis of results (Table 4). [14][15][16][17][18][19][20][21][22][23][24] These articles provided data regarding the following biologic mesh products: AlloDerm (n ¼ 7); Surgisis (n ¼ 2); CollaMend (n ¼ 2); Permacol (n ¼ 2); Strattice (n ¼ 1); and Veritas (n ¼ 1) (see Table 4 footnotes for manufacturers). None provided data on surgical repair procedures conducted using synthetic mesh or no mesh.…”

Section: Study Selection and Synthesis Of Resultsmentioning

confidence: 99%

“…15 Shah et al reported a 25% (1 of 4) rate of recurrence with CollaMend or another porcine cross-linked acellular dermal matrix, Permacol. 24 In the study from Parker et al, 22 it was not possible to determine the rate of hernia recurrence in the target population, although only 1 patient experienced hernia recurrence during an average of 18. 24 which included 5 types of biologic mesh, the lowest infection rates were observed in patients treated with AlloDerm (39.3% versus 75% with cross-linked porcine Permacol/CollaMend and 64.7% with non-cross-linked porcine Surgisis/Strattice).…”

Section: Hernia Recurrencementioning

confidence: 99%

“…Among patients who underwent ventral hernia repair in the setting of a compromised surgical field, the most commonly reported reasons for a secondary surgical procedure included repair of recurrent hernia, mesh removal, drainage of seroma, and drainage of surgical site abscess. 16,18,22,24 Some authors highlighted the management of surgical site infection with antibiotics and wound care without mesh removal as a benefit of using biologic mesh. 14,16 Interpretative challenges…”

Section: Subsequent Surgeriesmentioning

confidence: 99%

“…The 3 largest studies examined outcomes among patients (N ¼ 459) with a contaminated surgical field who underwent repair of ventral hernia (primary or recurrent) or abdominal wall repair for other indications using acellular human dermal matrix (AlloDerm). 16,17,21 Two other larger studies (N ¼ 53 18 and N ¼ 58 24 ) retrospectively reviewed outcomes following ventral hernia repair with a porcine submucosa-derived mesh [Surgisis Gold (SIS)] 18 or a variety of biologic mesh products 24 in the setting of a contaminated field. Across the 11 studies, 84 repairs were performed using components separation, and 17 involved laparoscopic repair.…”

mentioning

confidence: 99%

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A Systematic Review of Outcomes Following Repair of Complex Ventral Incisional Hernias With Biologic Mesh

Ferzoco¹

2013

International Surgery

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Repair of contaminated/infected ventral incisional hernias is marked by high rates of recurrence, complications, and/or explantation of synthetic mesh. Biologic mesh products are recommended for repair to permit reconstruction and reduce complications. A systematic review of PubMed, EMBASE, and Cochrane databases identified Englishlanguage articles reporting postoperative outcomes (e.g., hernia recurrence, infection, mesh explantation) in patients undergoing contaminated/infected ventral incisional herniorrhaphy. Eleven studies met inclusion criteria and contained quantitative outcome data. All were retrospective chart reviews of biologic mesh use (mostly human acellular dermal matrix). Hernia recurrence and wound infection rates were highly variable and inconsistently reported across studies. Mesh explantation was rarely reported. Outcome variability is likely owing to heterogenous patient populations, surgical technique variations, and follow-up duration. Biologic mesh use in contaminated/infected herniorrhaphy was marked by low reported rates of secondary surgeries for infected mesh removal. Data from large, well-controlled, prospective trials with biologic mesh products are needed.

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Section: Study Selection and Synthesis Of Resultsmentioning

confidence: 99%

Section: Hernia Recurrencementioning

confidence: 99%

Section: Subsequent Surgeriesmentioning

confidence: 99%

mentioning

confidence: 99%

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A Systematic Review of Outcomes Following Repair of Complex Ventral Incisional Hernias With Biologic Mesh

Ferzoco¹

2013

International Surgery

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“…22 Clinical studies have shown the utility of PADM in several surgical procedures, including chest wall reconstruction, 23 breast reconstruction surgery, 24 and ventral herniorrhaphy. 25 To date, limited data have been reported about biologic matrix use in laparoscopic inguinal herniorrhaphy. [26][27][28] To the author's knowledge, results from studies assessing the use of PADM in laparoscopic inguinal hernia repair have not been previously reported.…”

mentioning

confidence: 99%

Placement of a Non–Cross-Linked Porcine-Derived Acellular Dermal Matrix During Preperitoneal Laparoscopic Inguinal Hernia Repair

Alshkaki

2013

International Surgery

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This retrospective chart review evaluated outcomes following laparoscopic inguinal herniorrhaphies with non-cross-linked intact porcine-derived acellular dermal matrix (PADM) by one surgeon in a community teaching facility hospital. Mesh was sutured and/or tacked in the preperitoneal space. Postoperative visits were scheduled at 2 weeks, 3 months, and 6 months, and then at 6-month intervals up to 2 years. PADM was placed in 14 male patients (mean age, 41.1 years). Seven patients had bilateral hernias. One patient required intraoperative conversion to open herniorrhaphy based on diagnostic laparoscopy findings. PADM sizes were 6 3 10 to 12 3 16 cm; mean operative time was 102 minutes. All patients were discharged on the day of surgery and resumed full activity. This treatment approach was effective, with no recurrence or complications during a median follow-up period of 18 months (range, 13-25 months). Synthetic mesh is often used in conjunction with both open and laparoscopic inguinal herniorrhaphy and has been shown to significantly reduce the risk of hernia recurrence compared with primary repair without mesh.9 However, synthetic mesh has been associated with postoperative complications such as infection, which can occur during the acute or longterm postsurgical period, [13][14][15] and longer-term complications such as chronic pain, fistula formation, and extrusion. [16][17][18][19] Infection following synthetic mesh insertion 19,20 often leads to explantation of the mesh, which may result in increased patient morbidity and use of health care resources. 20,21 Biologic matrices support tissue revascularization and are thought to resist infection better than synthetic meshes.13 Several biologic alternatives to synthetic mesh have been developed, including a non-cross-linked intact porcine-derived acellular dermal matrix (PADM; Strattice Reconstructive Tissue Matrix, LifeCell Corporation, Branchburg, New Jersey). The structure of PADM is strong and biocompatible, and it allows for cellular infiltration, vascularization, and tissue remodeling. 22 Clinical studies have shown the utility of PADM in several surgical procedures, including chest wall reconstruction, 23 breast reconstruction surgery, 24 and ventral herniorrhaphy. 25 To date, limited data have been reported about biologic matrix use in laparoscopic inguinal herniorrhaphy. [26][27][28] To the author's knowledge, results from studies assessing the use of PADM in laparoscopic inguinal hernia repair have not been previously reported. This retrospective chart review evaluated the results of laparoscopic inguinal herniorrhaphy in 14 patients using a totally extraperitoneal (TEP) approach with placement of PADM. Postoperative recurrence and complication rates associated with this procedure were evaluated for a median follow-up period of 18 months (range, 13-25 months). Patients and MethodsA retrospective chart review was conducted to identify patients who underwent elective laparoscopic inguinal herniorrhaphy with use of PADM performed by the author in a commu...

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Systematic review of the stage of innovation of biological mesh for complex or contaminated abdominal wall closure

et al. 2018

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BackgroundAchieving stable closure of complex or contaminated abdominal wall incisions remains challenging. This study aimed to characterize the stage of innovation for biological mesh devices used during complex abdominal wall reconstruction and to evaluate the quality of current evidence.MethodsA systematic review was performed of published and ongoing studies between January 2000 and September 2017. Eligible studies were those where a biological mesh was used to support fascial closure, either prophylactically after midline laparotomy, or for reinforcement after repair of incisional hernia with midline incision. The primary outcome measure was the IDEAL framework stage of innovation. The key secondary outcome measure was the GRADE criteria for study quality.ResultsThirty‐five studies including 2681 patients were included. Four studies considered mesh prophylaxis, 23 considered hernia repair, and eight reported on both. There was one published randomized trial (IDEAL stage 3), none of which was of high quality; the others were non‐randomized studies (IDEAL stage 2a). A detailed description of surgical technique was provided in most studies (27 of 35); however, no study reported outcomes according to the European Hernia Society consensus statement and only two described quality control of surgical technique during the study. From 21 ongoing randomized trials and observational studies, 11 considered repair of incisional hernia and 10 considered prophylaxis (seven in elective settings).ConclusionThe evidence base for biological mesh is limited, and better reporting and quality control of surgical techniques are needed. Although results of ongoing trials over the next decade will improve the evidence base, further study is required in the emergency and contaminated settings.

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Not all biologics are equal!

Cited by 105 publications

References 39 publications

A Systematic Review of Outcomes Following Repair of Complex Ventral Incisional Hernias With Biologic Mesh

A Systematic Review of Outcomes Following Repair of Complex Ventral Incisional Hernias With Biologic Mesh

Placement of a Non–Cross-Linked Porcine-Derived Acellular Dermal Matrix During Preperitoneal Laparoscopic Inguinal Hernia Repair

Systematic review of the stage of innovation of biological mesh for complex or contaminated abdominal wall closure

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