Silicone gel-filled breast implants have been employed clinically for
decades for aesthetic augmentation or postmastectomy reconstruction. M
ost patients and surgeons attest to the efficacy and safety of these d
evices. However, more recently in the medical literature and popular m
edia, silicone gel-filled breast implants have been claimed to incite
an array of clinical sequelae such as capsular formation, granulomatou
s disease, arthritis, arthralgia, fibromyalgia, autoimmune collagen va
scular 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. Pa
tient-reported symptoms and signs included mastodynia, arthralgia, fib
romyalgia, xerophthalmia, xerostomia, hypesthesia, and amblyopia. Clin
ical examination and mammography were reliable in diagnosing implant r
upture, but only re-exploration reliably detected implant leakage. Mos
t patients underwent concurrent replacement with saline-filled devices
. Histopathologic analyses of all tissue samples revealed chronic infl
ammation. Subjective improvement of patient-reported symptoms and sign
s occurred over the course of months postoperatively. There was no mor
tality 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 anal
ysis 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. Identifyi
ng 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-fill
ed implants in place should be considered for removal, with full knowl
edge of the morbidity associated with revisional procedures. 4) Patien
ts currently undergoing breast augmentation or reconstruction employin
g prosthetics are perhaps best served by insertion of saline-filled de
vices. 5) Patient-physician dialogue regarding the risk-benefit analys
is of prosthetic implantation is imperative. Patients consenting to su
ch procedures must be willing to assume risks.