Baker Grade IV Capsular Contracture Is Correlated with an Increased Amount of Silicone Material: An Intrapatient Study.
Journal
Plastic and reconstructive surgery
ISSN: 1529-4242
Titre abrégé: Plast Reconstr Surg
Pays: United States
ID NLM: 1306050
Informations de publication
Date de publication:
01 12 2023
01 12 2023
Historique:
medline:
30
11
2023
pubmed:
7
3
2023
entrez:
6
3
2023
Statut:
ppublish
Résumé
Breast implant surgery is one of the most frequently performed procedures by plastic surgeons worldwide. However, the relationship between silicone leakage and the most common complication, capsular contracture, is far from understood. This study aimed to compare Baker grade I with Baker grade IV capsules regarding their silicone content in an intradonor setting, using two previously validated imaging techniques. Twenty-two donor-matched capsules from 11 patients experiencing unilateral complaints were included after bilateral explantation surgery. All capsules were examined using both stimulated Raman scattering (SRS) imaging and staining with modified oil red O (MORO). Evaluation was done visually for qualitative and semiquantitative assessment and automated for quantitative analysis. Using both SRS and MORO techniques, silicone was found in more Baker grade IV capsules (eight of 11 and 11 of 11, respectively) than in Baker grade I capsules (three of 11 and five of 11, respectively). Baker grade IV capsules also showed significantly more silicone content compared with the Baker grade I capsules. This was true for semiquantitative assessment for both SRS and MORO techniques ( P = 0.019 and P = 0.006, respectively), whereas quantitative analysis proved to be significant for MORO alone ( P = 0.026 versus P = 0.248 for SRS, respectively). In this study, a significant correlation between capsule silicone content and capsular contracture is shown. An extensive and continued foreign body response to silicone particles is likely to be responsible. Considering the widespread use of silicone breast implants, these results affect many women worldwide and warrant a more focused research effort. Risk, III.
Sections du résumé
BACKGROUND
Breast implant surgery is one of the most frequently performed procedures by plastic surgeons worldwide. However, the relationship between silicone leakage and the most common complication, capsular contracture, is far from understood. This study aimed to compare Baker grade I with Baker grade IV capsules regarding their silicone content in an intradonor setting, using two previously validated imaging techniques.
METHODS
Twenty-two donor-matched capsules from 11 patients experiencing unilateral complaints were included after bilateral explantation surgery. All capsules were examined using both stimulated Raman scattering (SRS) imaging and staining with modified oil red O (MORO). Evaluation was done visually for qualitative and semiquantitative assessment and automated for quantitative analysis.
RESULTS
Using both SRS and MORO techniques, silicone was found in more Baker grade IV capsules (eight of 11 and 11 of 11, respectively) than in Baker grade I capsules (three of 11 and five of 11, respectively). Baker grade IV capsules also showed significantly more silicone content compared with the Baker grade I capsules. This was true for semiquantitative assessment for both SRS and MORO techniques ( P = 0.019 and P = 0.006, respectively), whereas quantitative analysis proved to be significant for MORO alone ( P = 0.026 versus P = 0.248 for SRS, respectively).
CONCLUSIONS
In this study, a significant correlation between capsule silicone content and capsular contracture is shown. An extensive and continued foreign body response to silicone particles is likely to be responsible. Considering the widespread use of silicone breast implants, these results affect many women worldwide and warrant a more focused research effort.
CLINICAL QUESTION/LEVEL OF EVIDENCE
Risk, III.
Identifiants
pubmed: 36877628
doi: 10.1097/PRS.0000000000010359
pii: 00006534-990000000-01626
pmc: PMC10666937
doi:
Substances chimiques
Silicones
0
Silicone Gels
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1191-1200Informations de copyright
Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons.
Références
International Society of Aesthetic Plastic Surgery. ISAPS international survey on aesthetic/cosmetic procedures. 2018. Hanover, NH: ISAPS. Available at: https://www.isaps.org/media/wifiy3oo/isaps-global-survey-results-2018-1.pdf . Accessed March 27, 2020.
Becherer BE. Dutch Breast Implant Registry (DBIR) annual report 2015–2017. Available at: https://dica.nl/media/2165/DBIR%20Annual%20report%20(2015-2017).pdf . Accessed June 24, 2019.
Rohrich RJ, Kaplan J, Dayan E. Silicone implant illness: science versus myth? Plast Reconstr Surg. 2019;144:98–109.
Cohen Tervaert JW, Kappel RM. Silicone implant incompatibility syndrome (SIIS): a frequent cause of ASIA (Shoenfeld’s syndrome). Immunol Res. 2013;56:293–298.
Watad A, Rosenberg V, Tiosano S, et al. Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis. Int J Epidemiol. 2018;47:1846–1854.
Mojsiewicz-Pienkowska K, Jamrógiewicz M, Szymkowska K, Krenczkowska D. Direct human contact with siloxanes (silicones)—safety or risk part 1. Characteristics of siloxanes (silicones). Front Pharmacol. 2016;7:132.
Katzin WE, Feng LJ, Abbuhl M, Klein MA. Phenotype of lymphocytes associated with the inflammatory reaction to silicone gel breast implants. Clin Diagn Lab Immunol. 1996;3:156–161.
Lykissa E, Maharaj S. Platinum concentration and platinum oxidation states in body fluids, tissue, and explants from women exposed to silicone and saline breast implants. J Long Term Eff Med Implants 2006;16:435–439.
Lykissa ED, Kala SV, Hurley JB, Lebovitz RM. Release of low molecular weight silicones and platinum from silicone breast implants. Anal Chem. 1997;69:4912–4916.
Wang DG, Norwood W, Alaee M, Byer JD, Brimble S. Review of recent advances in research on the toxicity, detection, occurrence and fate of cyclic volatile methyl siloxanes in the environment. Chemosphere 2013;93:711–725.
Nanayakkara PWB, De Blok CJM. Silicone gel breast implants: what we know about safety after all these years. Ann Intern Med. 2016;164:199–200.
Levy Y, Ruhrman-Shahar N. The ongoing debate regarding long-term safety of silicone breast augmentation rages. Isr Med Assoc J. 2016;18:754–755.
de Boer M, van Leeuwen FE, Hauptmann M, et al. Breast implants and the risk of anaplastic large-cell lymphoma in the breast. JAMA Oncol. 2018;4:335–341.
Maijers MC, de Blok CJM, Niessen FB, et al. Women with silicone breast implants and unexplained systemic symptoms: a descriptive cohort study. Neth J Med. 2013;71:534–540.
Bachour Y, Verweij SP, Gibbs S, et al. The aetiopathogenesis of capsular contracture: a systematic review of the literature. J Plast Reconstr Aesthet Surg. 2017;71:307–317.
Coroneos CJ, Selber JC, Offodile AC, Butler CE, Clemens MW. US FDA breast implant postapproval studies: long-term outcomes in 99,993 patients. Ann Surg. 2019;269:30–36.
Spear SL, Murphy DK; Allergan Silicone Breast Implant U.S. Core Clinical Study Group. Natrelle round silicone breast implants. Plast Reconstr Surg. 2014;133:1354–1361.
Cunningham B. The Mentor core study on silicone MemoryGel breast implants. Plast Reconstr Surg. 2007;120(Suppl 1):19S–29S.
Bachour Y, Bargon CA, de Blok CJM, Ket JCF, Ritt MJPF, Niessen FB. Risk factors for developing capsular contracture in women after breast implant surgery: a systematic review of the literature. J Plast Reconstr Aesthet Surg. 2018;71:e29–e48.
Benediktsson K, Perbeck L. Capsular contracture around saline-filled and textured subcutaneously-placed implants in irradiated and non-irradiated breast cancer patients: five years of monitoring of a prospective trial. J Plast Reconstr Aesthet Surg. 2006;59:27–34.
Hillard C, Fowler JD, Barta R, Cunningham B. Silicone breast implant rupture: a review. Gland Surg. 2017;6:163–168.
Berry MG, Cucchiara V, Davies DM. Breast augmentation: part II—adverse capsular contracture. J Plast Reconstr Aesthet Surg. 2010;63:2098–2107.
Araco A, Caruso R, Araco F, Overton J, Gravante G. Capsular contractures: a systematic review. Plast Reconstr Surg. 2009;124:1808–1819.
Caffee HH. The influence of silicone bleed on capsule contracture. Ann Plast Surg. 1986;17:284–287.
Siggelkow W, Faridi A, Spiritus K, Klinge U, Rath W, Klosterhalfen B. Histological analysis of silicone breast implant capsules and correlation with capsular contracture. Biomaterials 2003;24:1101–1109.
Haasterecht L, Zada L, Schmidt RW, et al. Label-free stimulated Raman scattering imaging reveals silicone breast implant material in tissue. J Biophotonics 2020;13:e20196019.
Kappel R, Boer LL, Dijkman H. Gel bleed and rupture of silicone breast implants investigated by light-, electron microscopy and energy dispersive x-ray analysis of internal organs and nervous tissue. Clin Med Rev Case Rep. 2016;3:087.
de Bakker E, van den Broek LJ, Ritt MJPF, Gibbs S, Niessen FB. The histological composition of capsular contracture focussed on the inner layer of the capsule: an intra-donor Baker-I versus Baker-IV comparison. Aesthetic Plast Surg. 2018;42:1485–1491.
Lee JM, Kim YJ. Foreign body granulomas after the use of dermal fillers: pathophysiology, clinical appearance, histologic features, and treatment. Arch Plast Surg. 2015;42:232–239.
Committee for Guidelines in Research (COREON). Human tissue and medical research: code of conduct for responsible use. Federation of Dutch Medical Scientific Societies (FEDERA). 2015. Available at: https://www.coreon.org/wp-content/uploads/2020/04/coreon-code-of-conduct-english.pdf . Accessed March 28, 2020.
Moester MJ, Ariese F, De Boer JF. Optimized signal-to-noise ratio with shot noise limited detection in stimulated Raman scattering microscopy. J Eur Opt Soc. 2015;10:15022.
Peng T, Thorn K, Schroeder T, et al. A BaSiC tool for background and shading correction of optical microscopy images. Nat Commun. 2017;8:1–7.
Bankhead P, Loughrey MB, Fernández JA, et al. QuPath: open source software for digital pathology image analysis. Sci Rep. 2017;7:16878.
Fowler MR, Nathan CAO, Abreo F. Synovial metaplasia, a specialized form of repair: a case report and review of the literature. Arch Pathol Lab Med. 2002;126:727–730.
Moyer HR, Ghazi BH, Losken A. The effect of silicone gel bleed on capsular contracture: a generational study. Plast Reconstr Surg. 2012;130:793–800.
Hölmich LR, Vejborg IM, Conrad C, et al. Untreated silicone breast implant rupture. Plast Reconstr Surg. 2004;114:204–214; discussion 215–216.
Joseph J, Mohanty M, Mohanan PV. Role of immune cells and inflammatory cytokines in regulation of fibrosis around silicone expander implants. J Mater Sci Mater Med. 2010;21:1665–1676.
Potter EH, Rohrich RJ, Bolden KM. The role of silicone granulomas in recurrent capsular contracture. Plast Reconstr Surg. 2013;131:888e–895e.
Kamel M, Protzner K, Fornasier V, Peters W, Smith D, Ibanez D. The peri-implant breast capsule: an immunophenotypic study of capsules taken at explantation surgery. J Biomed Mater Res. 2001;58:88–96.
Bui JM, Perry T, Ren CD, Nofrey B, Teitelbaum S, Van Epps DE. Histological characterization of human breast implant capsules. Aesthetic Plast Surg. 2015;39:306–315.
Luke JL, Kalasinsky VF, Turnicky RP, Centeno JA, Johnson FB, Mullick FG. Pathological and biophysical findings associated with silicone breast implants: a study of capsular tissues from 86 cases. Plast Reconstr Surg. 1997;100:1558–1565.
Prantl L, Schreml S, Fichtner-Feigl S, et al. Clinical and morphological conditions in capsular contracture formed around silicone breast implants. Plast Reconstr Surg. 2007;120:275–284.
Kastellorizios M, Tipnis N, Burgess DJ. Foreign body reaction to subcutaneous implants. Adv Exp Med Biol. 2015;865:93–108.
de Bakker E, Rots M, Buncamper ME, et al. The Baker classification for capsular contracture in breast implant surgery is unreliable as a diagnostic tool. Plast Reconstr Surg. 2020;146:956–962.
O’Toole M, Caskey CI. Imaging spectrum of breast implant complications: mammography, ultrasound, and magnetic resonance imaging. Semin Ultrasound CT MR 2000;21:351–361.
Zahavi A, Sklair ML, Ad-El DD. Capsular contracture of the breast: working towards a better classification using clinical and radiologic assessment. Ann Plast Surg. 2006;57:248–251.
American Society of Plastic Surgeons. Breast implant removal. Available at: https://www.plasticsurgery.org/cosmetic-procedures/breast-implant-removal . Accessed October 18, 2020.
Headon H, Kasem A, Mokbel K. Capsular contracture after breast augmentation: an update for clinical practice. Arch Plast Surg. 2015;42:532–543.
Schnur PL, Weinzweig J, Harris JB, et al. Silicon analysis of breast and periprosthetic capsular tissue from patients with saline or silicone gel breast implants. Plast Reconstr Surg. 1996;98:798–803.