Heavy Metals in Breast Implant Capsules and Breast Tissue: Findings from the Systemic Symptoms in Women-Biospecimen Analysis Study: Part 2
- PMID: 35474526
- PMCID: PMC9400612
- DOI: 10.1093/asj/sjac106
Heavy Metals in Breast Implant Capsules and Breast Tissue: Findings from the Systemic Symptoms in Women-Biospecimen Analysis Study: Part 2
Abstract
Background: Breast Implant Illness (BII), as described in recent medical literature and by social media, describes a range of symptoms in patients with breast implants for which there are no physical findings or laboratory results that explain their symptoms.
Objectives: Part 2 of this study aims to determine whether heavy metals are present in the capsules around saline and silicone implants and if there are statistical differences in the type or level of these metals between women with or without symptoms. Demographic data was collected to investigate potential alternate sources of metals: inhaled, absorbed, or ingested.
Methods: A prospective, blinded study enrolled 150 consecutive subjects divided equally into in three cohorts: (A) women with systemic symptoms they attribute to their implants who requested implant removal, (B) women with breast implants requesting removal or exchange who do not have symptoms they attribute to their implants, and (C) women undergoing cosmetic mastopexy who have never had any implanted medical device. Capsule tissue was removed from Cohort A and B for analysis of 22 heavy metals. Additionally, breast tissue was obtained from a control group with no previous exposure to any implanted medical device.
Results: The study was performed between 2019-2021. Heavy metal content was compared between the capsule tissue from Cohort A and B. The only statistically significant differences identified in Cohort A were higher levels of arsenic and zinc, and lower levels of cobalt, manganese, silver, and tin. There were no elevated levels or statistically significant differences in the other metals tested between Cohorts A and B.
Conclusions: This study analyzes the metal content in capsules surrounding both saline and silicone breast implants. Heavy metals were also detected in the non-implant control group breast tissue, with some metals at numerically higher levels than either breast implant cohort. Smoking, gluten free diets, dietary supplements, and the presence of tattoos were all identified as statistically significant sources of arsenic and zinc in Cohort A. The risk of heavy metal toxicity should not be used as an indication for total capsulectomy if patients elect to remove their breast implants.
© 2022 The Aesthetic Society.
Comment in
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Commentary on: Heavy Metals in Breast Implant Capsules and Breast Tissue: Findings from the Systemic Symptoms in Women-Biospecimen Analysis Study: Part 2.Aesthet Surg J. 2022 Aug 24;42(9):1080-1082. doi: 10.1093/asj/sjac128. Aesthet Surg J. 2022. PMID: 35596729 No abstract available.
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Commentary on: Heavy Metals in Breast Implant Capsules and Breast Tissue: Findings From the Systemic Symptoms in Women-Biospecimen Analysis Study: Part 2.Aesthet Surg J. 2022 Aug 24;42(9):1077-1079. doi: 10.1093/asj/sjac124. Aesthet Surg J. 2022. PMID: 35751870 No abstract available.
References
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- National Academy of Sciences, Institute of Medicine. Safety of Silicone Breast Implants. National Academy Press; 1999.
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- US Food and Drug Administration. FDA Backgrounder on Platinum in Silicone Breast Implants. Published January 18, 2018. Accessed January 10, 2022. https://www.fda.gov/medical-devices/breast-implants/fda-backgrounder-pla...
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- US Food and Drug Administration. Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and Food and Drug Administration Staff. Heavy Metals, p. 7. Published September 29, 2020. Accessed February 19, 2022. https://www.fda.gov/media/71081/download
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