Longevity of Post-Explantation Systemic Symptom Improvement and Potential Etiologies: Findings From the ASERF Systemic Symptoms in Women–Biospecimen Analysis Study: Part 4

Abstract

Background Breast Implant Illness (BII) describes a variety of symptoms reported by patients with breast implants. Biospecimens data revealed minimal statistical differences between BII and Non-BII cohorts. Baseline analysis of PROMIS data demonstrated significant differences between the BII Cohort and the two control cohorts. Objectives This study was designed to determine if subjects in the BII Cohort obtained any symptom improvement after explantation, whether symptom improvement was related to the type of capsulectomy, and which symptoms improved. Methods A prospective blinded study enrolled 150 consecutive subjects divided equally into three cohorts. Baseline demographic data and a systemic symptoms survey, including PROMIS validated questionnaires, was obtained at baseline, 3-6 weeks, 6 months, and one year. Results 150 patients were enrolled between 2019-2021. Follow-up at one year is 94% of BII Cohort and 77% of Non-BII and Mastopexy Cohorts. At one year, 88% of patients showed at least partial symptom improvement with a reduction of 2-20 symptoms. The PROMIS score in the BII Cohort decreased at one year for anxiety, sleep disturbances, and fatigue. Systemic symptom improvement was noted out to one year in the BII Cohort regardless of the type of capsulectomy performed. Conclusions Parts 1-3 in this series concluded there were no consistent differences in biospecimen results between the cohorts. Unlike the data observed in the biospecimen analysis, BII subjects had heightened symptoms and poorer PROMIS scores at baseline compared to the control cohorts. The reduction of negative expectations and a potential nocebo effect could contribute to this improvement.

Self-reported systemic symptoms among women with breast implants

“…Alle patienterne med brystimplantater angav bedring af symptomer uagtet typen af kapsulektomi. Ved baseline var der i BII-kohorten højere rapportering af angst, traethed og søvnforstyrrelser end i de øvrige kohorter [28].…”

“…I et andet studie, baseret på de samme kohorter som i ovennaevnte studie, undersøgte man forekomsten af tungmetaller i bindevaevskapslen omkring brystimplantaterne [8,28,29]…”

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

“…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.…”

Biofilm-derived oxylipin 10-HOME–mediated immune response in women with breast implants

“…A subset of women with breast implants have reported a myriad of nonspecific systemic symptoms (5,6). The symptoms described include fever, myalgias, chronic fatigue, arthralgias, and other manifestations often associated with autoimmune ill-nesses (7)(8)(9)(10)(11)(12)(13)(14)(15). This constellation of symptoms related to implants has been named breast implant illness (BII) or systemic symptoms associated with breast implants (SSBI).…”