SERI Surgical Scaffold, Prospective Clinical Trial of a Silk-Derived Biological Scaffold in Two-Stage Breast Reconstruction

Fine, Neil A.; Lehfeldt, Max R.; Gross, John E.; Downey, Susan E.; Kind, Gabriel M.; Duda, Gloria; Kulber, David A.; Horan, Rebecca L.; Ippolito, Jeff; Jewell, Mark L.

doi:10.1097/prs.0000000000000987

Cited by 46 publications

(35 citation statements)

References 17 publications

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“…As the number of mastectomies and subsequent reconstructions continue to increase, and with the evolving nature of the reimbursement in healthcare, cost may become a significant limiting factor. Other options include utilizing ADM as an anterior sling, in which only the entire anterior aspect of the prosthesis is covered by ADM. 34 In addition, synthetic mesh products, including vicryl, 7,34 silk, 50 and titanium 24,41,51 derivatives, among others, may be a less expensive alternative, and have shown promising results. Mesh was less commonly utilized in the studies in this review, likely because of its more recent introduction in implant-based breast reconstruction.…”

Section: Discussionmentioning

confidence: 99%

Subcutaneous Implant-based Breast Reconstruction with Acellular Dermal Matrix/Mesh: A Systematic Review

Salibian

Frey

Choi

et al. 2016

Plastic and Reconstructive Surgery - Global Open

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Background:The availability of acellular dermal matrix (ADM) and synthetic mesh products has prompted plastic surgeons to revisit subcutaneous implant-based breast reconstruction. The literature is limited, however, with regards to evidence on patient selection, techniques, and outcomes.Methods:A systematic review of the Medline and Cochrane databases was performed for original studies reporting breast reconstruction with ADM or mesh, and subcutaneous implant placement. Studies were analyzed for level of evidence, inclusion/exclusion criteria for subcutaneous reconstruction, reconstruction characteristics, and outcomes.Results:Six studies (186 reconstructions) were identified for review. The majority of studies (66.7%) were level IV evidence case series. Eighty percent of studies had contraindications for subcutaneous reconstruction, most commonly preoperative radiation, high body mass index, and active smoking. Forty percent of studies commenting on patient selection assessed mastectomy flap perfusion for subcutaneous reconstruction. Forty-five percent of reconstructions were direct-to-implant, 33.3% 2-stage, and 21.5% single-stage adjustable implant, with ADM utilized in 60.2% of reconstructions versus mesh. Pooled complication rates included: major infection 1.2%, seroma 2.9%, hematoma 2.3%, full nipple-areola complex necrosis 1.1%, partial nipple-areola complex necrosis 4.5%, major flap necrosis 1.8%, wound healing complication 2.3%, explantation 4.1%, and grade III/IV capsular contracture 1.2%.Conclusions:Pooled short-term complication rates in subcutaneous alloplastic breast reconstruction with ADM or mesh are low in preliminary studies with selective patient populations, though techniques and outcomes are variable across studies. Larger comparative studies and better-defined selection criteria and outcomes reporting are needed to develop appropriate indications for performing subcutaneous implant-based reconstruction.

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Section: Discussionmentioning

confidence: 99%

Subcutaneous Implant-based Breast Reconstruction with Acellular Dermal Matrix/Mesh: A Systematic Review

Salibian

Frey

Choi

et al. 2016

Plastic and Reconstructive Surgery - Global Open

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“…Thirty-six of 139 subjects were excluded from the PP population, 28 of whom received unplanned radiation therapy after implantation. 8 The other 8 subjects were excluded for various reasons, including not receiving a breast implant, having another support device implanted, being involved in another clinical trial, and not meeting eligibility criteria. All satisfaction, effectiveness, and safety analyses were performed on the PP population, which included 103 subjects (161 breasts).…”

Section: Resultsmentioning

confidence: 99%

“…Study design and eligibility criteria were previously reported. 8 Briefly, this prospective, multicenter, single-arm study enrolled women who received SERI during stage 1 of 2-stage breast reconstruction. Subjects included women undergoing breast reconstruction with subpectoral placement of a tissue expander (Natrelle Style 133V; Allergan plc, Dublin, Ireland) followed by exchange with a breast implant.…”

Section: Methodsmentioning

confidence: 99%

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SERI Surgical Scaffold in 2-Stage Breast Reconstruction: 2-Year Data from a Prospective, Multicenter Trial

Karp

Choi

Kulber

et al. 2017

Plastic and Reconstructive Surgery - Global Open

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Background:Soft-tissue support devices are used during breast reconstruction. This study investigated long-term clinical data following SERI Surgical Scaffold (SERI) implantation, a bioresorbable, silk-derived scaffold for soft-tissue support.Methods:This was a prospective, multicenter study in 103 subjects who received SERI during stage 1 of 2-stage breast reconstruction with subpectoral tissue expander placement (Natrelle Style 133V; Allergan plc, Dublin, Ireland) followed by subpectoral breast implant placement. Investigator satisfaction (11-point scale: 0, very dissatisfied and 10, very satisfied) at 6 months was the primary endpoint. Ease of use, satisfaction, scaffold palpability/visibility, breast anatomy measurements via 3D images, SERI integration, histology, and safety were also assessed through 2 years after stage 1 surgery.Results:Analyses were performed on the per-protocol population (103 subjects; 161 breasts) with no protocol deviations that could affect outcomes. Ease of use and subject and investigator satisfaction with SERI were high throughout 2 years. Breast anatomy measurements with 3D images demonstrated long-term soft-tissue stability of the lower breast mound. Key complication rates per breast were tissue/skin necrosis and wrinkling/rippling (8.1% each) and seroma, wound dehiscence, and breast redness (5.0% each). Over 2 years, 4 breasts in 4 subjects underwent reoperation with explantation of any device; 2 breasts required SERI explantation. SERI was retained in 98.8% of breasts (159/161) at 2 years.Conclusions:SERI was associated with high and consistent levels of investigator and subject satisfaction and demonstrated soft-tissue stability in the lower breast through 2 years. SERI provides a safe, long-term benefit for soft-tissue support in 2-stage breast reconstruction.

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“…According to a protocol described in recent publications (24,25) we are making pockets with pectoralis major on the inner upper region of the breast, sutured to a mesh silk (SERI™ Surgical Scafffold, Allergan, California, USA) in the outer lower region achieving full coverage of the expander and evaluate whether this technique provides the same results in terms of complications and aesthetics, which completely muscular pocket ( Figure 10). The patient's smoking status must also be assessed with regard to the reduction of necrosis.…”

Section: Complicationsmentioning

confidence: 99%

Skin-Sparing Mastectomy

Chan

Azlan²,

et al.

Encyclopedia of Cancer

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The surgical treatment of breast cancer has evolved rapidly in recent decades. Conservative treatment was adopted in the late 1970s, with rates above 70%, and this was followed by a period during which the indications for surgical intervention were expanded to those patients at high risk for BRCA1, BRCA2 mutations, and also due to new staging standards and use of nuclear magnetic resonance. This increase in the indications for mastectomy coincided with the availability of immediate breast reconstruction as an oncologically safe and important surgical procedure for prevention of sequelae. Immediate reconstruction was first aimed at correcting the consequences of treatment, and almost immediately, the challenge of the technique became the achievement of a satisfactory breast appearance and shape, as well as normal consistency. The skin-sparing mastectomy (SSM) in conservation first and nipple-areola complex (NAC) later was a result of this shift that occurred from the early 1990s to the present. The objective of this review is to present all these developments specifically in relation to SSM and analyze our personal experience as well as the experience of surgeons worldwide with an emphasis on the fundamental aspects, indications, surgical technique, complications, oncological safety, and cosmetic results of this procedure.

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SERI Surgical Scaffold, Prospective Clinical Trial of a Silk-Derived Biological Scaffold in Two-Stage Breast Reconstruction

Abstract: Therapeutic, IV.

Cited by 46 publications

References 17 publications

Subcutaneous Implant-based Breast Reconstruction with Acellular Dermal Matrix/Mesh: A Systematic Review

Subcutaneous Implant-based Breast Reconstruction with Acellular Dermal Matrix/Mesh: A Systematic Review

SERI Surgical Scaffold in 2-Stage Breast Reconstruction: 2-Year Data from a Prospective, Multicenter Trial

Skin-Sparing Mastectomy

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