Experience with Soybean Oil-filled Breast Implants in a Swedish Surgical Practice

Abstract

Restrictions ordered by the U.S. Food and Drug Administration on the use of silicone gel-filled breast implants, as well as patient and surgeon dissatisfaction with the aesthetic results sometimes attained with saline solution-filled implants, have prompted new interest in developing alternative implant filler materials, including triglycerides. Soybean oil-filled breast implants are now in various stages of testing and use in the United States, Europe, and Canada. This article reports on experience with Trilucent ® breast implants (prefilled with soybean oil) by one plastic surgeon in Sweden. A total of 96 patients (191 implants) underwent primary augmentation or replacement augmentation mammaplasty between October 1995 and June 1997. Data have been analyzed for all 96 patients with a mean follow-up period of 15 months and for 67 patients (133 implants) with a mean follow-up of 18 months. The significant findings of the study include the absence of systemic reactions or unusual local complications, the low incidence (2.3%) of symptomatic capsular contracture (grades III and IV) among the 67 patients at the 18-month postoperative time point, and high patient satisfaction with the aesthetic results. The mammographic radiolucency of soybean oil-filled implants was also demonstrated. At the 18-month follow-up point, the only negative observations were the presence of skin wrinkling in 3% of the breasts and implant palpability in 46% of the breasts. These findings are in general agreement with preliminary data from the European clinical trials of Trilucent ® breast implants.