Abstract. Thirty-eight patients underwent surgical removal of their smooth silicone gel breast implants. In 22 cases the implants had been inserted for aesthetic augmentation, and in 16 for reconstruction. Twelve of the reconstructed patients had a simple mastectomy, four had a modified radical mastectomy with latissimus dorsi flap reconstruction. The time between implantation and removal was from three months to 18 years, with a mean of 8.75. Sixty-two implants were removed of which 33 were intact, 17 leaking, and 12 ruptured. Fifteen intact implants were removed in the first five years and 18 from five to ten years; no implant had been in place for more than ten years. In those implants where there was leakage (n=17), two were removed in the first five years, four from five to ten years, and 11 after ten years. None of the implants removed during the first five years of implantation were ruptured. Nevertheless, rupture was detected in three implants removed from five to ten years, and in nine removed after ten years. Thus, the 20 implants removed after 10 or more years of implantation showed some form of damage to their outer shell. These findings suggest that a thorough follow-up is mandatory in patients having silicone gel breast implants for more than five years.
Key words: Silicone elastomers -Breast reconstruction -Breast -Plastic surgery -ImplantsThe moratorium on silicone gel breast implants put in effect by the FDA on November 1991 raised considerable controversy, in which the main concern was that it had been too hasty a decision. It was based upon reports of asymptomatic rupture and diagnosis of immunological diseases related to silicone implantation [8]. After only a few years, a growing number of reports have appeared in the literature describing complications related Since then a large number of patients have undergone removal or substitution of their implants. The concern that drives these patients is shared by their physicians and that has led to more detailed observations and documentation of operative findings. It is 30 years since augmentation was begun, thus the long-term outcome of such procedures can now be evaluated [4,6].The present study is a retrospective analysis of patients who had implants removed, the structural changes of these implants to the length of their implantation time. In this series all implants in place for more than ten years had structural damage.
Material and methodsThirty-eight patients had 62 smooth removed and exchanged silicone gel implants between 1979 and 1993. The patients were 28 to 69 years old, with a mean of 46 years. Fifty-eight percent (22/38) were for augmentation and 42% (16/38) for reconstruction. The patients presented with the complaint of capsular contracture, pain, spontaneous change in breast shape, desire to improve the breast shape, or to increase size (Table 1). There were no systemic symptoms of complaints such as arthritis, myalgia, asthenia, thyroid or liver disorders. The time elapsed from implantation varied from three months to 18 years. ...