For those publications discussing use of Galatea surgical scaffolds (GalaFLEX®, GalaFLEX 3D™ or GalaFLEX 3DR™), the FDA does not consider the use of these products as described in the publications to be within the cleared indications for use for each device. Significant safety risks or safety concerns associated with the use of Galatea scaffolds known to the manufacturer are described in the Instructions for Use for each of those devices.  

Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up.

Category: Clinical
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John Scott Roth, Gary J. Anthone, Don J. Selzer, Benjamin K. Poulose, James G. Bittner, William W. Hope, Raymond M. Dunn, Robert G. Martindale, Matthew I. Goldblatt, David B. Earle, John. R. Romanelli, Gregory J. Mancini, Jacob A. Greenberg, John G. Linn, Eduardo Parra-Davila

Surgical Endoscopy 32(4):1929–1936.2018

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/29063307

ABSTRACT

 

BACKGROUND:

Long-term resorbable mesh represents a promising technology for complex ventral and incisional hernia repair (VIHR). Preclinical studies indicate that poly-4-hydroxybutyrate (P4HB) resorbable mesh supports strength restoration of the abdominal wall. This study evaluated outcomes of high-risk subjects undergoing VIHR with P4HB mesh.

METHODS:

This was a prospective, multi-institutional study of subjects undergoing retrorectus or onlay VIHR. Inclusion criteria were CDC Class I, defect 10-350 cm2, ≤ 3 prior repairs, and ≥ 1 high-risk criteria (obesity (BMI: 30-40 kg/m2), active smoker, COPD, diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, hypoalbuminemia, advanced age, and renal insufficiency). Physical exam and/or quality of life surveys were performed at regular intervals through 18 months (to date) with longer-term, 36-month follow-up ongoing.

RESULTS:

One hundred and twenty-one subjects (46M, 75F) with an age of 54.7 ± 12.0 years and BMI of 32.2 ± 4.5 kg/m2 (mean ± SD), underwent VIHR. Comorbidities included the following: obesity (n = 95, 78.5%), hypertension (n = 72, 59.5%), cardiovascular disease (n = 42, 34.7%), diabetes (n = 40, 33.1%), COPD (n = 34, 28.1%), malignancy (n = 30, 24.8%), active smoker (n = 28, 23.1%), immunosuppression (n = 10, 8.3%), chronic corticosteroid use (n = 6, 5.0%), advanced age (n = 6, 5.0%), hypoalbuminemia (n = 3, 2.5%), and renal insufficiency (n = 1, 0.8%). Hernia types included the following: primary ventral (n = 17, 14%), primary incisional (n = 54, 45%), recurrent ventral (n = 15, 12%), and recurrent incisional hernia (n = 35, 29%). Defect and mesh size were 115.7 ± 80.6 and 580.9 ± 216.1 cm2 (mean ± SD), respectively. Repair types included the following: retrorectus (n = 43, 36%), retrorectus with additional myofascial release (n = 45, 37%), onlay (n = 24, 20%), and onlay with additional myofascial release (n = 8, 7%). 95 (79%) subjects completed 18-month follow-up to date. Postoperative wound infection, seroma requiring intervention, and hernia recurrence occurred in 11 (9%), 7 (6%), and 11 (9%) subjects, respectively.

CONCLUSIONS:

High-risk VIHR with P4HB mesh demonstrated positive outcomes and low incidence of hernia recurrence at 18 months. Longer-term 36-month follow-up is ongoing.

Ventral hernia repair with poly-4-hydroxybutyrate mesh.

Category: Clinical
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Margaret A. Plymale, Daniel L. Davenport, Adam Dugan, Amanda Zachem, John Scott Roth

Surgical Endoscopy 32(4):1689–1694.2018

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/28916979

ABSTRACT

BACKGROUND:

Biomaterial research has made available a biologically derived fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for use in ventral and incisional hernia repair (VIHR). This study evaluates outcomes of patients undergoing VIHR with P4HB mesh.

METHODS:

An IRB-approved prospective pilot study was conducted to assess clinical and quality of life (QOL) outcomes for patients undergoing VIHR with P4HB mesh. Perioperative characteristics were defined. Clinical outcomes, employment status, QOL using 12-item short form survey (SF-12), and pain assessments were followed for 24 months postoperatively.

RESULTS:

31 patients underwent VIHR with bioresorbable mesh via a Rives-Stoppa approach with retrorectus mesh placement. The median patient age was 52 years, median body mass index was 33 kg/m2, and just over half of the patients were female. Surgical site occurrences occurred in 19% of patients, most of which were seroma. Hernia recurrence rate was 0% (median follow-up = 414 days). Patients had significantly improved QOL at 24 months compared to baseline for SF-12 physical component summary and role emotional (p < 0.05).

CONCLUSIONS:

Ventral hernia repair with P4HB bioresorbable mesh results in favorable outcomes. Early hernia recurrence was not identified among the patient cohort. Quality of life improvements were noted at 24 months versus baseline for this cohort of patients with bioresorbable mesh. Use of P4HB mesh for ventral hernia repair was found to be feasible in this patient population. (ClinicalTrials.gov Identifier: NCT01863030).

Comparison of Phasix, polypropylene, and primary closure of the abdominal donor site after bilateral free flap breast reconstruction: Long‐term evaluation of abdominal hernia and bulge formation

Category: Clinical
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Deborah Yu MD, Anika T. Patel, Kristie Rossi BA, Neil S. Topham MD, Eric I. Chang MD

Microsurgery. 2019

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/31815314

ABSTRACT

Background: Abdominal free flap harvest for breast reconstruction may result in significant morbidity in terms of hernias and bulges. Reinforcement of the donor site with mesh has been recommended to minimize the risk of hernias and bulges, but no studies exist evaluating the optimal type of mesh. Polypropylene has traditionally been used but the development of Phasix restorable mesh may be a reasonable alternative. Here, we compared the use of Phasix to polypropylene and primary closure and hypothesize that the former has lower rates of abdominal morbidity in the long term.

Patients and Methods: A retrospective review of all patients undergoing bilateral free flap breast reconstruction from the abdomen was performed while patients with pedicle flaps or alternative donor sites were excluded. Patient demographics, medical/surgical history, cancer treatments, and flap type were analyzed. All patients were monitored for a minimum of 2 years for early donor site complications as well as hernia/bulges.

Results: Sixty-six consecutive patients were included (40 patients with Phasix, 20 patients with polypropylene, and 6 patients with primary closure). Use of Phasix mesh resulted in higher initial operative costs ($2,750 vs. $72 vs. $0). Two patients with polypropylene mesh and one patient undergoing primary closure developed an abdominal bulge in an average follow-up of 25.2 months (11.5% vs. 0%, p = .04).

Conclusions: Mesh placement for abdominal wall reinforcement after bilateral free flap breast reconstruction minimizes the risk of hernias and bulges. Although Phasix results in increased initial costs, abdominal morbidity is significantly decreased after follow-up beyond 2 years.

Combination of Surgical Technique and Bioresorbable Mesh Reinforcement of the Crural Repair Leads to Low Early Hernia Recurrence Rates with Laparoscopic Paraesophageal Hernia Repair

Category: Clinical
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Walaa F. Abdelmoaty, Christy M. Dunst, Filippo Filicori, Ahmed M. Zihni, Daniel Davila-Bradley, Kevin M. Reavis

Lee L. Swanstrom, Steven R. DeMeester

Journal of Gastrointestinal Surgery 2019

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/31468330

Abstract

Introduction:

Laparoscopic paraesophageal hernia (PEH) is associated with a low morbidity and mortality but an objective hernia recurrence rate in excess of 50% at 5 years. Biologic mesh has not been shown to reduce hernia recurrence rates. Recently, a new bioresorbable mesh made with poly-4-hydroxybutyrate with a Sepra-Technology coating on one side (Phasix-ST mesh) has become available. The aim of this study was to evaluate the feasibility, safety, and short-term efficacy of Phasix-ST mesh for reinforcement of the primary crural closure in patients undergoing elective, laparoscopic PEH repair.

Methods:

A prospective database was initiated and maintained for all patients undergoing PEH repair with the use of Phasix-ST mesh. We retrospectively reviewed the records of consecutive patients who had an elective, first-time laparoscopic PEH repair with Phasix-ST mesh and who completed their 1-year objective follow-up study. Patients having a reoperation, non-laparoscopic repair, or who failed to comply with the objective follow-up were excluded.

Results:

To achieve the desired 50 patients with 1-year objective follow-up, we reviewed the records of 90 consecutive PEH patients. In the final cohort of 50 patients, there were 32 females (64%) and 18 males. The median age of the patients at surgery was 67 years (range 44–84). The operation was PEH repair with fundoplication alone in 29 patients (58%) and PEH repair with Collis gastroplasty and fundoplication in 21 patients (42%). Phasix-ST mesh was used for crural reinforcement in all patients, and there were no intraoperative issues with the mesh or any difficulty placing or fixating the mesh at the hiatus. A diaphragm relaxing incision was performed in 2 patients (4%). The mean length of hospital stay was 2.8 days, and there was no major morbidity or mortality. On the 1-year objective follow-up study (median 12 months) a recurrent hernia was found in 4 patients (8%). No patient that had a Collis gastroplasty or a relaxing incision had a recurrent hernia. No patient had a reoperation. No patient had a mesh infection or mesh erosion.

Conclusions:

Phasix-ST mesh reinforcement of the crural closure during laparoscopic primary, elective PEH repair was associated with no adverse mesh-related events such as infection or erosion. Phasix-ST crural reinforcement in combination with tension-reduction techniques when necessary resulted in a very low (8%) objective hernia recurrence rate at a median follow-up of 1 year. These results demonstrate the safety of Phasix-ST mesh for use at the hiatus for crural reinforcement. This safety, along with the encouraging short-term efficacy for reducing hernia recurrence, should encourage further studies using the combination of resorbable biosynthetic mesh crural reinforcement and tension-reducing techniques during repair of paraesophageal hernias.

Initial Experience With Biologic Polymer Scaffold (Poly-4-hydroxybuturate) in Complex Abdominal Wall Reconstruction

Category: Clinical
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Joseph Buell; David Sigmon; Christopher Ducoin; Max Shapiro; Nikhil Teja; Emmett Wynter; Mary Hanisee; Geoffrey Parker; Emad Kandil; Michael Darden;

Annals of Surgery. 266(1):185–188. 2017

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/28594679

ABSTRACT

Objective: To evaluate the use of the new absorbable polymer scaffold poly-4-hydroxybutyrate (P4HB) in complex abdominal wall reconstruction.

Background: Complex abdominal wall reconstruction has witnessed tremendous success in the last decade after the introduction of cadaveric biologic scaffolds. However, the use of cadaveric biologic mesh has been expensive and plagued by complications such as seroma, infection, and recurrent hernia. Despite widespread application of cadaveric biologic mesh, little data exist on the superiority of these materials in the setting of high-risk wounds in patients. P4HB, an absorbable polymer scaffold, may present a new alternative to these cadaveric biologic grafts.

Methods: A retrospective analysis of our initial experience with the absorbable polymer scaffold P4HB compared with a consecutive contiguous group treated with porcine cadaveric mesh for complex abdominal wall reconstructions. Our analysis was performed using SAS 9.3 and Stata 12.

Results:
The P4HBgroup (n¼31) experienced shorter drain time(10.0 vs 14.3 d; P < 0.002), fewer complications (22.6% vs 40.5%; P < 0.046), and reherniation (6.5% vs 23.8%; P < 0.049) than the porcine cadaveric mesh group (n¼ 42). Multivariate analysis for infection identified: porcine cadaveric mesh odds ratio 2.82, length of stay odds ratio 1.11; complications: drinker odds ratio 6.52, porcine cadaveric mesh odds ratio 4.03, African American odds ratio 3.08, length of stay odds ratio 1.11; and hernia recurrence: porcine cadaveric mesh odds ratio 5.18, drinker odds ratio 3.62, African American odds ratio 0.24. Cost analysis identified that P4HB had a $7328.91 financial advantage in initial hospitalization and $2241.17 in the 90-day post discharge global period resulting in $9570.07 per case advantage over porcine cadaveric mesh.

Conclusions: In our early clinical experience with the absorbable polymer matrix scaffold P4HB, it seemed to provide superior clinical performance and value-based benefit compared with porcine cadaveric biologic mesh.

Reducing Postoperative Abdominal Bulge Following Deep Inferior Epigastric Perforator Flap Breast Reconstruction with Onlay Monofilament Poly-4-Hydroxybutyrate Biosynthetic Mesh

Category: Clinical
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Blair A. Wormer, MD; Nicholas W. Calvin, MD; Jean-Francois Lefaivre, MD; Jason M. Korn, MD; Edward Teng, MD; Anthony S. Aukskalnis, BA; J. Michael Robinson, MD

Division of Plastic Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina

Journal of Reconstructive Microsurgery

September 5, 2016


Full Article

ABSTRACT

The purpose of this study was to evaluate the use of a biosynthetic mesh onlay on reducing postoperative abdominal bulge following deep inferior epigastric perforator (DIEP) flap breast reconstruction.

Methods: All patients undergoing DIEP reconstructions from January, 2010 to January, 2014 at a tertiary center were reviewed. Patients were divided into two groups for comparison based on whether a biosynthetic mesh onlay (Phasix [monofilament poly-4-hydroxybutyrate], Bard Inc., Warwick, RI) was used for reinforcement of the anterior rectus fascia. Rates of postoperative abdominal bulge were compared between the groups utilizing standard statistical methods.

Results: During the study period, 319 patients underwent 553 DIEP reconstructions, 160 (50.2%) used mesh and 159 (49.8%) did not (nonmesh). The mean follow-up was 16.4 ± 11.1 months. There was no difference in age (49 ± 9.3 years), current tobacco use, diabetes, or mean body mass index (BMI, 29.4 ± 4.4) between the mesh and nonmesh groups (p > 0.05); however, there was a higher proportion of obese patients (BMI > 30) in the mesh group (45.0 vs. 33.3%; p = 0.03). Abdominal bulge rate following DIEP with mesh was lower than the nonmesh group (0 vs. 5.0%; p = 0.004). In the entire sample, 234 (73.4%) underwent bilateral DIEP and 85 (26.6%) underwent unilateral DIEP. In unilateral DIEP patients, the bulge rate was similar between the mesh and nonmesh groups (0 vs. 4.4%; p > 0.05); however, in bilateral DIEP patients, the bulge rate was lower in the mesh group compared with a nonmesh group (0 vs. 5.5%; p = 0.008).

Conclusion: Reinforcement of the anterior rectus with an onlay monofilament poly-4-hydroxybutyrate biosynthetic mesh may reduce the risk of postoperative bulge rate in patients undergoing DIEP reconstruction.

 

DISCLOSURES

None

Indications for Use

GalaFLEX, GalaFLEX 3D and GalaFLEX 3DR scaffolds are indicated for use as bioresorbable scaffolds for soft tissue support and to repair, elevate, and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. These products, referred to as Galatea scaffolds, are also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Important Safety Information

Possible complications following implantation of Galatea scaffolds include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. The safety and product use of Galatea scaffolds for patients with hypersensitivities to the antibiotics kanamycin sulfate and tetracycline hydrochloride is unknown. Galatea scaffolds have not been studied for use in breast reconstructive surgeries. The safety and effectiveness of Galatea scaffolds in neural tissue and in cardiovascular tissue has not been established. The safety and effectiveness of Galatea scaffolds in pediatric use has not been established. Consult the specific Galatea scaffold Instructions for Use for complete prescribing information, including its indications for use, warnings and precautions.