LAUSR

INTRODUCTION There is growing recognition of a condition known as Breast Implant Illness (BII). Very little information exists about the diagnosis and natural history of BII. To better understand the patient experience, we surveyed the FDA's MAUDE database for narratives describing symptoms of BII. METHODS The Manufacturer and User Facility Device Experience Database (MAUDE) was queried for all reports that included Breast Implant Illness within the patient narrative between 2010 and 2020. A review of narratives was used to identify and summarize 36 symptoms over 9 symptom classes. Event year and reporting year were summarized. Hierarchical clustering analysis using centroid components was conducted on all reported BII symptoms and a dendrogram was created to visualize clustering. RESULTS During the study period from 2010 to 2020, there were 751 captured adverse event reports in the FDA's MAUDE database that referenced Breast Implant Illness with the first report submission in 2014. Of those reports, 60.6% were for silicone implants and 39.4% were for saline implants. The three most commonly reported symptom categories were neurological (N=544, 72.4%), followed by musculoskeletal (N=418, 55.7%), and dermatological (N=273, 36.4%). The top ten symptoms, irrespective of category, include fatigue/weakness, numbness/tingling, brain fog, depression/anxiety, arthralgia, myalgia, headache, hair loss, gastrointestinal issues, and weight change. A hierarchical clustering analysis demonstrated that symptoms reported by patients clustered into 2 major groups. CONCLUSION This study demonstrates the utility of public facing databases like MAUDE in understanding the patient experience as it relates to the term Breast Implant Illness.