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Explantation of silicone breast implants

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By Thomas WO 3rd, Harper LL, Wong SW, Michalski JP, Harris CN, Moore JT, Rodning CB • www.ProHealth.com • May 21, 1997


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.




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