Experience with soybean oil-filled breast implants in a Swedish surgical practice.

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.