Explantation of silicone breast implants

Silicone gel-filled breast implants have been employed clinically for decades for aesthetic augmentation or postmastectomy reconstruction. Most patients and surgeons attest to the efficacy and safety of these devices. However, more recently in the medical literature and popular media, silicone gel-filled breast implants have been claimed to incite an array of clinical sequelae such as capsular formation, granulomatous disease, arthritis, arthralgia, fibromyalgia, autoimmune collagen vascular disease, human adjuvant disease, siliconosis, silicone-related disease, and silicone implant-associated syndrome. During a recent 24-month period, 25 referred patients underwent explantation of bilateral silicone gel-filled prostheses at the University of South Alabama. Patient-reported symptoms and signs included mastodynia, arthralgia, fibromyalgia, xerophthalmia, xerostomia, hypesthesia, and amblyopia. Clinical examination and mammography were reliable in diagnosing implant rupture, but only re-exploration reliably detected implant leakage. Most patients underwent concurrent replacement with saline-filled devices. Histopathologic analyses of all tissue samples revealed chronic inflammation. Subjective improvement of patient-reported symptoms and signs occurred over the course of months postoperatively. There was no mortality associated with explantation, with or without replacement, but an overall morbidity incidence of 20 per cent (5 of 25) was observed. Predicated upon review of the available scientific literature and analysis of this modest number of patients, the following perspectives are germane. 1) A small cohort of patients of status postimplantation of silicone gel-filled devices will manifest chronic morbidity. Identifying such patients prospectively remains problematic. 2) Whether or not silicone gel incites adverse systemic phenomena is unproven, although it has been implicated. 3) Symptomatic patients with silicone gel-filled implants in place should be considered for removal, with full knowledge of the morbidity associated with revisional procedures. 4) Patients currently undergoing breast augmentation or reconstruction employing prosthetics are perhaps best served by insertion of saline-filled devices. 5) Patient-physician dialogue regarding the risk-benefit analysis of prosthetic implantation is imperative. Patients consenting to such procedures must be willing to assume risks.