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. The Aesthetic Surgery Education and Research Foundation (ASERF) Biospecimen study utilized a convergent design to prospectively study both qualitative systemic symptom data and quantitative heavy metals analysis of tissue obtained in surgery. Objectives Part two of this study aims to determine whether heavy metals are present in the capsules around both saline and silicone implants and if there is a statistical difference in the type or level of these metals between women with or without symptoms. Further, data was collected to understand whether the potential source of metals might be from breast implants or from alternate sources such as smoking, diet, nutritional supplements, tattoos, or environmental exposure. This study was entirely funded by ASERF. Methods As previously described, a prospective, blinded study enrolled 150 consecutive subjects divided equally into 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 and sent to Eurofins 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 150 patients were enrolled between 2019-2021. Follow-up at 3-6 weeks for all three cohorts was between 98-100%, at 6-months was 84-98%, and at one year is currently at 66-90%. 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 was no detectable beryllium, thallium, or uranium detected in any capsule tissue. There were no statistically significant differences in aluminum, antimony, barium, cadmium, chromium, copper, iron, lead, lithium, mercury, molybdenum, nickel, platinum, selenium, titanium, or vanadium in Cohort A. Platinum was detected in only one of 50 patients in Cohort A and one of 50 patients in Cohort B. Conclusions This study provides an in-depth analysis of the metal content in breast implant capsules surrounding both saline and silicone breast implants. The data reveal patients in Cohort A had a statistically significant increase in only two of the twenty-two metals tested, arsenic and zinc. Heavy metals were also detected in the non-implant control group breast tissue, with some metals (arsenic, lithium, molybdenum) at numerically higher levels than either breast implant cohort. Confounding variables such as cigarette smoking, gluten free diets, dietary supplements, and the presence of tattoos were all identified as statistically significant potential contributory sources of arsenic and zinc in Cohort A.

Self-Reported Breast Implant Illness: The Contribution of Systemic Illnesses and Other Factors to Patient Symptoms

“…Wixtrom et al noted a higher incidence of marijuana use in females self-reporting BII symptoms compared to controls as well as the fact that more females with BII symptoms smoked cigarettes than controls. 45 Cigarette smoking is known to be associated with increased rates of fatigue and depression 46 and is known to increase the risk of joint pain and cartilage loss within joint structures. 47 Marijuana use has been shown to produce “brain fog,” cognitive decline, anxiety, depression, fatigue, and hair loss with regular use.…”

“…Gluten sensitivity and wheat allergy were found to be statistically higher in patients with self-reported BII symptoms compared to patients undergoing silicone implant exchange or mastopexy in a recent prospective study. 45 Nonceliac gluten sensitivity can present with many of the symptoms of autoimmune celiac disease, although the mechanism of this condition is unclear. 51 It is more common in females, typically in the fourth decade of life, with prevalence varying from 1% up to 13% of the general population.…”

Breast implant illness: we must counter misinformation around this mysterious condition

“…Implant capsules and breast tissue were analysed histologically and microbiologically and for heavy metals, and blood analyses were undertaken. Key findings included that the type of capsulectomy undertaken (intact total, total, or partial) did not alter symptom improvement10 heavy metal levels were not significantly higher or at toxic levels in the breast implant illness cohort11 and no significant differences in biospecimen analysis were seen 12. At one year, 88% of patients with symptoms showed at least partial improvement of systemic symptoms regardless of the type of capsulectomy performed 13…”

“…Considerable progress has been made in research on breast implant illness, including a substantial series of publications 10111213. These studies looked prospectively at cohorts of women undergoing surgery with implants for breast implant illness related and unrelated reasons and women undergoing breast surgery without implants.…”

Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women–Biospecimen Analysis Study: Part 3

“…The previously published Part 2 of the Systemic Symptoms Biospecimen Analysis Study showed that heavy metals contained within implant capsules are well below what are considered safe levels of exposure, and those that were higher in the symptomatic cohort could be attributed to lifestyle differences and potential environmental exposures and are unlikely to be a cause of symptoms. 1 …”