Macrotextured Breast Implants with Defined Steps to Minimize Bacterial Contamination around the Device: Experience in 42,000 Implants

Adams, William P.; Culbertson, Eric J.; Deva, Anand K.; Magnusson, Mark; Layt, Craig; Jewell, Mark L.; Mallucci, Patrick; Hedén, Per

doi:10.1097/prs.0000000000003575

Cited by 177 publications

(149 citation statements)

References 17 publications

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“…The reduction of capsular contracture and ALCL using steps to reduce the introduction of bacteria during surgery provided indirect evidence of the role of bacteria in these conditions [7]. Due to their increased surface area, implants with highly textured surfaces may harbor greater biofilm loads than those with smooth surfaces.…”

Section: Introductionmentioning

confidence: 99%

Bacterial Adhesion and Biofilm Formation on Textured Breast Implant Shell Materials

James

Boegli

Hancock³

et al. 2018

Aesth Plast Surg

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BackgroundBacterial biofilms have been implicated with breast implant complications including capsular contracture and anaplastic large-cell lymphoma. The actual mechanisms for either are still under active investigation and are not clear. Due to their increased surface area, implants with textured surfaces may harbor greater biofilm loads than those with smooth surfaces.MethodsBiofilm formation on the outer surface material was compared using implants with various surface areas and roughness, including Natrelle® (Smooth), SmoothSilk®/SilkSurface® (Silk), VelvetSurface ® (Velvet), Siltex®, and Biocell®. The roughness and surface area of each material were assessed using non-contact profilometry. Bacterial attachment (2 h) and biofilm formation (24 h) were evaluated for Staphylococcus epidermidis, Pseudomonas aeruginosa, and Ralstonia pickettii over nine independent experiments using a CDC biofilm reactor and viable plate counts (VPCs) as well as confocal scanning laser microscopy. VPCs of the textured implants were compared relative to the Smooth implant.ResultsSurface areas increased with roughness and were similar among the three least rough implants (Smooth, Silk, and Velvet) and among the roughest implants (Siltex and Biocell). Overall, VPC indicated there was significantly more bacterial attachment and biofilm formation on the Siltex and Biocell implants than the Silk or Velvet implants, although there were differences between species and time points. CSLM confirmed the formation of thicker biofilms on the implants with rougher surface textures.ConclusionThis in vitro study confirmed that implant surfaces with rougher texture, resulting in more surface area, harbored greater biofilm loads than those with smoother surfaces.No Level AssignedThis journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

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Section: Introductionmentioning

confidence: 99%

Bacterial Adhesion and Biofilm Formation on Textured Breast Implant Shell Materials

James

Boegli

Hancock³

et al. 2018

Aesth Plast Surg

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“…The expected number of the incidence of breast implant-associated ALCL in this study using only macrotextured breast implants would be between eight and nine diagnoses. However, there were no cases at all [17]. One may logically suspect that the operative technique is an important factor in the use of breast implants, especially those with the highest risk.…”

Section: Etiology and Prevalencementioning

confidence: 98%

“…In the case of capsular contracture, this has been achieved through the "14-point effect" [15,16]. The Surgical 14-Point Plan for Breast Implant Placement proposed by Adams et al is presented in detail in Table I [17].…”

Section: Etiology and Prevalencementioning

confidence: 99%

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) — How to diagnose and treat?

Pieszko¹,

Kuczyński²,

Murawa³

2018

Nowotwory. Journal of Oncology

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Breast implant-associated anaplastic large cell lymphoma (ALCL) is a rare type of T-cell non-Hodgkin lymphoma arising around the capsule of breast implants. It has been diagnosed in an extremely small group of women with breast implants for breast reconstruction and augmentation. The pathogenesis of this disease is currently poorly understood, but it appears to be related to textured implants. The aim of this article is to provide patients, radiologists, pathologists, surgical oncologists and plastic surgeons with an evidence-based overview of the incidence, diagnosis, and management of BIA-ALCL according to real-world experience, because although it is very rare, early recognition and surgical resection is usually crucial and curative. NOWOTWORY J Oncol 2018; 68, 1: 15-21

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“…Although the pathogenic mechanism of BIA-ALCL has not been determined, some regulatory bodies, plastic surgery societies, plastic surgeons and patients are advising against the use of textured breast implants and in some cases specifically textured breast implants using the salt loss process. Some surgeons advocate for the use of a multi-point plan designed to reduce biofilm formation (Adams et al, 2017).…”

Section: Description Of Approved Breast Implantsmentioning

confidence: 99%

“…The findings generally support MRI as the gold standard imaging modality for assessing silicone implant integrity. However, several reports have challenged the role of MRI as a screening tool for the evaluation of silent rupture citing concerns related to compliance, cost and reimbursement (Adams et al, 2017;Bengtson & Eaves, 2012;Juanpere et al, 2011;Lindenblatt et al, 2014;Lourenco et al, 2018;C. M. McCarthy et al, 2008;Paetau et al, 2010;Sardanelli et al, 2010;Song et al, 2011).…”

Section: Breast Implant Rupturementioning

confidence: 99%

Acellular Dermal Matrix, the Breast, and the FDA

Nahabedian

2020

Plastic &Amp; Reconstructive Surgery

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Macrotextured Breast Implants with Defined Steps to Minimize Bacterial Contamination around the Device: Experience in 42,000 Implants

Abstract: Therapeutic, IV.

Cited by 177 publications

References 17 publications

Bacterial Adhesion and Biofilm Formation on Textured Breast Implant Shell Materials

Bacterial Adhesion and Biofilm Formation on Textured Breast Implant Shell Materials

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) — How to diagnose and treat?

Acellular Dermal Matrix, the Breast, and the FDA

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