Abstract
BACKGROUND: Breast Implant Illness (BII) is a controversial condition characterized by a broad spectrum of systemic symptoms reported by patients with breast implants, leading to an increase in explantation procedures. Its mechanisms remain unclear, with hypotheses including immune responses, microbial colonization, and psychological factors. This study analyzes potential causes, common symptoms, and the impact of explantation on symptom resolution. METHODS: A systematic review following PRISMA guidelines was conducted using PubMed, Web of Science, and Scopus databases. Studies on BII symptoms and outcomes were screened based on predefined criteria. Data on demographics, implant characteristics, symptoms, explantation outcomes and potencial etiologies were extracted. Meta-analyses were performed on symptom reduction, fibromyalgia and antinuclear antibodies (ANA) positivity prevalence. RESULTS: From 4612 identified articles, 33 met the inclusion criteria, encompassing 6048 women with an average age of 46.0 years. Symptoms appeared 6.4 years post-implantation, with explantation after 12.3 years. 81.9% of patients reported symptom improvement post-explantation, with fatigue (58.3%), joint pain (51%), and muscle pain (44%) being the most common symptoms. The prevalence of psychiatric illness, autoimmune conditions and fibromyalgia was 16.5%, 20.7% and 12%, respectively. Microbial analysis was positive on 35.2% of BII patients. ANA positivity prevalence was estimated at 24% and capsular inflammation at 58.4%. Implant rupture and capsular contracture rates were 21.4% and 44.4%, respectively. CONCLUSION: This review supports BII as a real, multifactorial clinical entity involving immune dysregulation, chronic inflammation, and microbial biofilms. These findings underscore the importance of individualized assessment, screening for autoimmune and psychiatric conditions, informed consent and adherence to surgical protocols such as the 14-Point Plan and antimicrobial irrigation to reduce complications. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .