“Plasma, the fourth state of matter, is a distinct processing medium for the treatment and modification of surfaces.”1 Modern approaches to biomaterials aim to alter or elicit specific tissue responses from the host. An implant’s surface can be manipulated by altering the materials, the surface texture and topography, and the electrical charge, each with the eventual goal of biocompatibility. The earliest breast implants were designed with smooth silicone surfaces and were filled with either silicone gel or saline. Because of persistent issues with rapid capsular contracture, polyurethane-covered implants were developed as a new alternative. Early results with these textured surfaces were promising, but due to legal, regulatory, and safety concerns, they were taken off the US market in 1991.2 Soon, textured, silicone shells became available, demonstrating the promise of lower capsular contracture rates. For the last three decades, studies have endeavored to define the etiologies of capsular contracture. Attempts to reduce this leading driver of revisional surgery focused on several goals: first, to alter the implant surface texture and manipulate the surrounding fibroblast response; second, to alter the pocket location, thereby affecting vascularity and soft tissue coverage;3 and third, to reduce bacterial contamination by altering either incision location4,5 or adding pocket irrigation.6,7 Recent studies suggest a potential benefit of the treatment of an existing capsular contracture with various immune modulators such as such as Leukotriene inhibitors or TGF-beta1 inhibitors.8 Unlike studies that focus on the modification of the mechanical properties of implant surfaces and their effect on capsular contracture, the authors of this paper are presenting an alternative method of surface manipulation; studying the potential effects of altering the electrical forces on the implant surface.9 They describe the significance of hydrophobic (water repelling) and hydrophilic (water absorbing) surface properties and their possible role in the prevention of capsular contracture. The concept of altering the wettability of the surface of an implantable device is not new and previous studies have looked at the agents that cause surfaces to be hydrophilic or conversely, hydrophobic.10 Cell adhesion to artificial materials is affected by multiple factors, such as water contact angles, temperature variations, and chemical agents that may alter surface charges.11 The authors also acknowledge that previously published studies have demonstrated that bacterial contamination on the implant surface plays a significant role in capsular contracture and implant infection. Further, they describe current implant surfaces as hydrophobic, and therefore propose that the prevailing recommendations regarding pocket irrigation techniques may be less than optimal, because the time that selected irrigants remain on the implant surface may be less than ideal in the prevention of bacterial colonization. They suggest that altering the electrical forces on an implant surface will change its polarity and enhance its “wetting” properties. They go on to suggest that this factor may potentially improve the contact time between the antibacterial irrigants and the implant surface. The method the authors employed to alter the surface properties of the shell was plasma activation (Active-SiTM device, Nova Plasma, Megiddo, Israel). This technique works by applying energized argon gas onto the surface of an implant. Plasma activation alters the closed polymer matrix of the implant shell allowing –OH to bind, thus converting a hydrophobic implant surface to a hydrophilic surface. The authors studied only one commercially available breast implant shell, Mentor Siltex (Mentor, Dallas TX). Shell discs were divided into groups and either plasma activated or non-activated, and further divided into subgroups with and without single or combination irrigants, 10% Povodine-iodine plus Cefazolin (Teva Pharmaceutical Industries, Israel) or Gentamicin (Teva Pharmaceutical Industries, Israel). The discs were then contaminated with Staphylococcus aureus and Pseudomonas aeruginosa cultured from infected breast implants. They then compared colony counts in the plasma activated and non-plasma activated silicone shell discs, with and without irrigants over a 14-day period. The results of the study demonstrated no bacterial growth on plasma activated discs in combination with 10% Povodine-Iodine, or Cefazolin for gram-positive bacteria, and Gentamicin for the gram-negative bacteria. A limitation of this study not addressed by the authors was the 5-second contact time between the shell discs and the irrigants, which is an extremely short contact time. Ideal contact times for irrigants have been described ranging from 2 minutes up to 30 minutes.12 To be clear, this study was designed to eliminate just two specific organisms in vitro, and surgeons should not assume that single agent irrigation is sufficient for normal breast flora.13,14 The bacteria not tested in this study was Ralstonia pickettii, the primary gram-negative organism that has been associated with the pathogenesis of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).15 With more evidence pointing towards the role of bacteria and biofilms in both capsular contracture and BIA-ALCL, a significant number of studies are now focusing on whether electrically and chemically altering the surface charges of an implant will affect what sticks to the implant surface, and what does not. From the start of the 21st century, the definition of biocompatibility has evolved from simply developing materials that did not produce a toxic effect, to a new generation of materials that can bring about deliberate and controlled protein absorption and cell response.16 To understand why we might want to alter an implant’s surface topography or chemistry, we need to understand what is happening on the surface of an implant as soon as it is implanted. The first cellular material to reach the surface of a breast implant is usually blood, even in the driest of pockets. Proteins, macrophages, and neutrophils, all attempt to phagocytose foreign material, recruiting fibroblasts. Fibroblast growth on breast implant surfaces has been reviewed for over two decades as studies attempt to elucidate a potential relationship between wound healing and implant surface topography.17 Fibroblast growth was found to decrease with increasing surface roughness. Further, the contact angles of various surfaces have also been studied and greater water contact angles, (>130°), and greater surface roughness are related to greater rates of attachment of fibroblasts and bacteria.18 Biomechanical studies looking at cell attachment to an implant surface indicate that surface characteristics play an essential role in early cell attachment.19,20 While this paper postulates that the plasma activation of an implant surface will allow adherence of the precise irrigants that may prevent initial colonization of the surface with gram-negative and gram-positive bacteria, there remain many unanswered questions. First, are the findings of this study using a single textured surface device reproducible with other currently available implant surfaces and in other laboratories? Secondly, while it is likely that the attachability of bacteria to a surface are affected by temperature, contact angles, and factors other than just the hydrophobic or hydrophilic nature of an implant surface, it is also known that some bacteria prefer a hydrophilic surface and attach more readily.10 Will plasma activation increase surface attachment of certain bacteria naturally present in the breast microbiome? Finally, the question arises, what is the most significant barrier to the breast implant industry modulating silicone implant shells and embracing new technologies? The authors acknowledge that the plasma activated discs appeared more “sticky” and felt that there was a need to further evaluate the effect of plasma activation on the shell beyond its wetting properties. It is extremely likely that the Federal Food and Drug Administration (FDA) will be asking the exact same questions. Even if plasma activation is eventually proven effective, the FDA will require validation of the safety of this surface change. A sufficient case would need to be presented that plasma activated implants are not a new product, but a beneficial alteration to an existing product. There would need to be compelling evidence that this is the case, and that the benefits of altering the surface outweigh potential short or long-term risks. To be sure, the FDA will certainly require manufacturers to provide data on the chemistry, toxicology, bleed testing, shelf life, and shell stability produced by even a temporary transformation of the elastomeric shell of an implant.21 Disclosures The author is a Consultant for the Allergan Innovative Council (Irvine, CA); and is Medical Director for the Motiva Breast Implant Clinical Trial (Establishment Labs, Alajuela, Costa Rica). Funding The author received no financial support for the research, authorship, and publication of this article. REFERENCES 1. Overview | Harrick Plasma. http://harrickplasma.com/plasma/overview. Accessed March 1, 2018. 2. Spear SL, Elmaraghy M, Hess C. Textured-surface saline-filled silicone breast implants for augmentation mammaplasty. Plast Reconstr Surg . 2000; 105( 4): 1542- 1552; discussion 1553. Google Scholar CrossRef Search ADS PubMed 3. Stevens WG, Nahabedian MY, Calobrace MBet al. Risk factor analysis for capsular contracture: a 5-year Sientra study analysis using round, smooth, and textured implants for breast augmentation. Plast Reconstr Surg . 2013; 132( 5): 1115- 1123. Google Scholar CrossRef Search ADS PubMed 4. Jacobson JM, Gatti ME, Schaffner AD, Hill LM, Spear SL. Effect of incision choice on outcomes in primary breast augmentation. Aesthet Surg J . 2012; 32( 4): 456- 462. Google Scholar CrossRef Search ADS PubMed 5. Wiener TC. Relationship of incision choice to capsular contracture. Aesthetic Plast Surg . 2008; 32( 2): 303- 306. Google Scholar CrossRef Search ADS PubMed 6. Adams WPJr. Capsular contracture: what is it? What causes it? How can it be prevented and managed? Clin Plast Surg . 2009; 36( 1): 119- 126, vii. Google Scholar CrossRef Search ADS PubMed 7. Adams WPJr, Rios JL, Smith SJ. Enhancing patient outcomes in aesthetic and reconstructive breast surgery using triple antibiotic breast irrigation: six-year prospective clinical study. Plast Reconstr Surg . 2006; 117( 1): 30- 36. Google Scholar PubMed 8. Ruiz-de-Erenchun R, Dotor de las Herrerías J, Hontanilla B. Use of the transforming growth factor-beta1 inhibitor peptide in periprosthetic capsular fibrosis: experimental model with tetraglycerol dipalmitate. Plast Reconstr Surg . 2005; 116( 5): 1370- 1378. Google Scholar CrossRef Search ADS PubMed 9. Barnea Y, Hammond DC, Geffen Y, Navon-Venezia S, Goldberg K. Plasma activation of a breast implant shell in conjunction with antibacterial irrigants enhances antibacterial activity. Aesthet Surg J . 2018. doi: 10.1093/asj/sjy020. 10. Ista LK, Mendez S, Lopez GP. Attachment and detachment of bacteria on surfaces with tunable and switchable wettability. Biofouling . 2010; 26( 1): 111- 118. Google Scholar CrossRef Search ADS PubMed 11. Arima Y, Iwata H. Effect of wettability and surface functional groups on protein adsorption and cell adhesion using well-defined mixed self-assembled monolayers. Biomaterials . 2007; 28( 20): 3074- 3082. Google Scholar CrossRef Search ADS PubMed 12. Zhadan O, Becker H. Surgical site irrigation in plastic surgery. Aesthet Surg J . 2018; 38( 3): 265- 273. Google Scholar CrossRef Search ADS PubMed 13. Weiner TC. The role of betadine irrigation in breast augmentation. Plast Reconstr Surg . 2007; 119( 1): 12- 15; discussion 16-7. Google Scholar CrossRef Search ADS PubMed 14. Adams WPJr. Commentary on: surgical site irrigation in plastic surgery: what is essential? Aesthet Surg J . 2018; 38( 3): 276- 278. Google Scholar CrossRef Search ADS PubMed 15. Adams WPJr. Discussion: bacterial biofilm infection detected in breast implant-associated anaplastic large-cell lymphoma. Plast Reconstr Surg . 2016; 137( 6): 1670- 1672. Google Scholar CrossRef Search ADS PubMed 16. Castner DG, Ratner BD. Biomedical surface science: foundations to frontiers. Surf Sci . 2002; 500( 1–3): 28- 60. Google Scholar CrossRef Search ADS 17. Harvey AG, Hill EW, Bayat A. Designing implant surface topography for improved biocompatibility. Expert Rev Med Devices . 2013; 10( 2): 257- 267. Google Scholar CrossRef Search ADS PubMed 18. Jacombs A, Tahir S, Hu Het al. In vitro and in vivo investigation of the influence of implant surface on the formation of bacterial biofilm in mammary implants. Plast Reconstr Surg . 2014; 133( 4): 471e- 480e. Google Scholar CrossRef Search ADS PubMed 19. Valencia-Lazcano AA, Alonso-Rasgado T, Bayat A. Characterisation of breast implant surfaces and correlation with fibroblast adhesion. J Mech Behav Biomed Mater . 2013; 21: 133- 148. Google Scholar CrossRef Search ADS PubMed 20. Barr S, Hill E, Bayat A. Patterning of novel breast implant surfaces by enhancing silicone biocompatibility, using biomimetic topographies. Eplasty . 2010; 10: e31. Google Scholar PubMed 21. Guidance for Industry and FDA Staff: Saline, Silicone Gel, and Alternative Breast Implants . https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071233.pdf. Accessed March 1, 2018. © 2018 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: email@example.com
Aesthetic Surgery Journal – Oxford University Press
Published: Mar 26, 2018
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