This study was conducted after receiving approval from the hospital institutional review board at Abington Hospital-Jefferson Health with a waiver of the need for individual consent (IRB#19-039). We retrospectively reviewed the medical records of all women 18 years of age and older who presented to the senior author from 2016 to 2020 with systemic symptoms that patients ascribed to their breast implants and subsequently underwent total capsulectomy and implant removal after appropriately balanced discussion of expectations, risks, and the current scientific evidence.
Patients underwent explantation via previous inframammary, mastectomy, or periareolar incisions when possible, or through concurrent mastopexy if being performed. Bilateral capsulectomies were performed and cultures were routinely obtained intraoperatively through a capsulotomy made to access the implant pocket. A portion of the capsule was divided and submitted for permanent pathology.
Data obtained from medical records included demographics, indication for initial placement of implants (reconstruction versus cosmetic), medical history, physical examination findings, presenting symptoms, results of any laboratory tests obtained, operative findings at time of surgery, simultaneous procedures, and postoperative follow-up. The senior author obtained cultures from all implant pockets before excision of the capsule. The first four postoperative visit notes were reviewed to determine each patient's level of satisfaction with the results of the procedure and specific postoperative symptoms when available, with a mean follow-up of 6 months.
Statistical analysis was performed using SAS 9.4 (SAS Institute, Cary, N.C.). Chi-squared analysis was utilized for independent variables, and logistic regression analysis was used to evaluate implant characteristics associated with findings of inflammation on pathology, which was defined as calcification or microcalcifications, histiocytic reaction or abundance of histiocytes, macrophages, or giant cells, presence of sclerosis, lymphoid or lymphocytic infiltration, or the term inflammation otherwise contained in the final pathology report with reference to the capsule.
Plast Reconstr Surg Glob Open. 2021;9(9):e3813 © 2021 Lippincott Williams & Wilkins