Viewpoints A 12-month Survey of Early Use and Surgeon Satisfaction with a New Highly Purified Silk Matrix: SERI Surgical Scaffold Bradley Bengtson, MD, FACS Bengtson Center for Aesthetics & Plastic Surgery Women’s Health Center Grand Rapids, Mich. Richard A. Baxter, MD Plastic Surgery Clinic Mountlake Terrace, Wash. Mark W. Clemens, MD Department of Plastic Surgery MD Anderson Cancer Center Houston, Tex. Damien Bates, MD, PhD, FRACS Allergan, Inc. Irvine, Calif.
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ERI Surgical Scaffold (Allergan, Inc., Irvine, Calif.) is a silk-derived, bioresorbable scaffold approved in the United States for use as a transitory scaffold for soft-tissue support and repair to reinforce deficiencies where weakness or voids exist, including use in plastic and reconstructive surgery and general soft-tissue reconstruction. Its biomechanical properties are similar to those of host tissue, with good biocompatibility and evidence of a mild, self-limiting foreign body response.1,2 SERI provides strong but pliable postoperative soft-tissue support with gradual enzymatic resorption,3 permits progressive ingrowth and replacement of SERI by host tissue that is 2–3 times that of the initial SERI thickness, and is stronger than native ovine fascia.1–3 The SERI Product Evaluation Program gathers feedback from surgeons who use this device. This report describes the first 12 months of surgeons’ ease of use and satisfaction with SERI. Fifty plastic surgeons were invited to participate in the SERI Product Evaluation Program. Participants provided reports on patients for whom they used Copyright © 2014 The Authors. Published by Lippincott Williams & Wilkins on behalf of The American Society of Plastic Surgeons. PRS Global Open is a publication of the American Society of Plastic Surgeons. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. Plast Reconstr Surg Glob Open 2014;2:e182; doi:10.1097/ GOX.0000000000000139; Published online 18 July 2014.
SERI and completed a survey assessing SERI ease of use and postoperative satisfaction for each procedure. Four separate ease-of-use items were rated on a 4-point Likert scale (0–3). SERI use satisfaction items were rated on an 11-point Likert scale (0–10). Participants also reported postoperative repair-related adverse events (AEs). After 12 months of SERI use, 28 surgeons provided responses based on 141 patients undergoing 16 procedure types (Table 1). Mean ease-of-use scores exceeded 2.75 (Table 2). Ratings showed minimal variability between procedure types (mean ranges: preparation, 2.85–3.0; cutting/shaping, 2.87–3.0; position/draping, 2.50–3.0; suturing, 2.50–3.0). Mean satisfaction scores exceeded 9.2 for each item (Table 2). As with ease-of-use ratings, mean satisfaction scores showed low variability among procedure types (ranges: meeting expectations, 8.0–9.89; aesthetic result, 8.58–9.85; feel, 8.50–10.0; shape, 8.50–9.82). Lower scores within these ranges were associated with neck procedures, which comprised a small proportion of surgeries performed (Table 1). Over 12 months, overall satisfaction scores showed little variation (9.0−9.67), with no single procedure associated with clear trends or shifts over time. Potential device-related AEs included irritation/ inflammation (n = 1; midface lift), visibility/palpability (n = 1; breast augmentation-revision), and Table 1. Procedures for Which SERI Was Used over 12 Months Type of Procedure Revision of breast augmentation Revision of breast reconstruction Mastopexy augmentation Mastopexy augmentation-revision Hernia repair Transverse rectus abdominus myocutaneous flap donor-site repair Abdominal wall repair Reduction mammaplasty Diastasis recti repair/ abdominoplasty Deep inferior epigastric perforator flap donor-site repair Platysmaplasty Blepharoplasty Midface lift Brow lift Rhinoplasty Pelvic floor repair
Patients (n = 141)
Sheets (n = 174)
40 24 20 16 11 10
49 25 29 23 13 11
5 3 3
5 6 3
2
2
2 1 1 1 1 1
2 2 1 1 1 1
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PRS GO • 2014 Table 2. Ease-of-Use and Postoperative Satisfaction Scores Parameter Ease of use (0–3) Preoperative handling and preparation Cutting and shaping of SERI Drapability and positioning of SERI Suturing/tension/stretch Satisfaction (0–10) Meeting expectations Aesthetic results Feel of the repaired area Shape/anatomical profile
Mean Score 2.92 2.93 2.77 2.83 9.37 9.25 9.33 9.28
Ease-of-use items were rated on a 4-point Likert scale (0 = unacceptable/cannot be used; 1 = significantly increases surgical time or is difficult to use; 2 = acceptable; 3 = easy to use and handle, redrapes well, fast preparation), and postoperative satisfaction items were rated on an 11-point Likert scale (from 0 = very dissatisfied to 10 = very satisfied).
induration (n = 1; blepharoplasty). However, AE reporting was voluntary and may be underreported. Non–device-related complications include 1 case of wound dehiscence at the inverted “T” incision. The patient (breast reduction) had SERI exposure and healed following minimal debridement. Other non– device-related AEs were seroma (breast revision-reconstruction), necrosis (abdominal wall repair), and erythema (breast revision-augmentation). Among cases with potentially device-related AEs, postoperative satisfaction ratings remained high and were similar to the overall case sample. In conclusion, surgeons who used SERI in procedures for soft-tissue support and repair reported consistently high levels of pre- and intraoperative ease of use and satisfaction with postoperative results. Few device-related AEs were reported, suggesting a positive safety profile with SERI use. Multiple prospective surgical procedures in breast, abdominal wall, and other sites are under way. Product performance evaluation data gathered at program completion will broaden our understanding of surgeons’ perceptions of SERI and whether patterns of SERI use and satisfaction change over time.
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Correspondence to Dr. Bengtson Bengtson Center for Aesthetics & Plastic Surgery Women’s Health Center 555 MidTowne Street NE Suite 110 Grand Rapids, MI 49503
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DISCLOSURE: This survey was sponsored by Allergan, Inc., Irvine, Calif. Writing and editorial assistance was provided to the authors by Karen Dougherty, PhD, and Linda Romagnano, PhD, of Peloton Advantage, Parsippany, N.J., and was funded by Allergan, Inc. Neither honoraria nor payments were made for authorship. Dr. Bengtson serves as a consultant to Allergan, Inc., and to LifeCell Corporation, Branchburg, N.J. Drs. Baxter and Clemens serve as consultants to Allergan, Inc. Dr. Bates was an employee of Allergan, Inc., at the time these data were collected. The Article Processing Charge was paid by Allergan, Inc. (Irvine, Calif.). The authors had full control of the content of this manuscript and the final decision to submit for publication. The views, opinions, and conclusions expressed in this Viewpoint represent the personal opinions of the authors and not those of the publisher, the Editorial Board, or the sponsors of PRS GO. Any stated views, opinions, and conclusions do not reflect the policy of any of the institutions with which the authors are affiliated, and the publisher and the Editorial Board assume no responsibility for the content.Current address for Damien Bates, MD, PhD, FRACS: DNA Surgical, LLC, Corona Del Mar, Calif. REFERENCES
1. Horan RL, Bramono DS, Stanley JR, et al. Biological and biomechanical assessment of a long-term bioresorbable silk-derived surgical mesh in an abdominal body wall defect model. Hernia. 2009;13:189–199. 2. Horan RL, Toponarski I, Boepple HE, et al. Design and characterization of a scaffold for anterior cruciate ligament engineering. J Knee Surg. 2009;22:82–92. 3. Horan RL, Antle K, Collette AL, et al. In vitro degradation of silk fibroin. Biomaterials. 2005;26:3385–3393.
