Ethylene oxide burns from improperly sterilized mammary implants

Sixteen patients are presented who suffered from substantial tissue burn subsequent to the insertion of textured silicone gel breast implants for cosmetic purposes. The injuries may have been caused by ethylene oxide (ETO) residues in the implants used for the surgical procedure. The manufacturer apparently used ETO to sterilize the implants. If the implants were not adequately ventilated, that likely would allow toxic residues to persist and affect organic tissue. The clinical condition appeared during the first 4 weeks following surgery, and consisted mainly of the exudation of noninfectious liquid, rash, edema, pain, and in some patients severe cutaneous necrosis. In none of the patients did the clinical condition yield to conservative treatment, so it was thought necessary to remove the implant to clear up the problem definitively. A new implant was inserted in the majority of the patients several months later. It is important to recognize the potential implications of improper ETO sterilization, and to act quickly if the condition is suspected because a conservative, time-consuming treatment will cause greater tissue damage than if the implant was removed immediately.