Secondary surgery and silicone implants: one center's experience before and after the food and drug administration hearings of 1991 and 1992.

Abstract

The reader is presumed to have a broad understanding of plastic surgical procedures and concepts. After studying this article, the participant should be able to: Physicians may earn 1 hour of Category 1 CME credit by successfully completing the examination based on material covered in this article. The examination begins on page 175. A retrospective study was performed to compare reoperative breast implantation surgery before and after the Food and Drug Administration (FDA) hearings in 1991 and 1992 on silicone breast implants. The two groups were compared regarding the motivation, findings, and procedures associated with the operations. One hundred seventy-one patient records were reviewed covering the years 1989 to 1994, evenly straddling 1991; of those, 146 charts had sufficient data to be included in the study. Each implant and each implantation operation were counted as a separate event. Before November 1991, 64% of reoperations were performed on the senior author's own original patients, whereas after 1991, only 33% were. Fifty-seven percent of the reoperations performed before November 1991 were performed on patients requiring augmentation in contrast to those patients requiring reconstruction; after 1991, 78% of the reoperations were augmentation mammaplasties. In the early period, reoperation was primarily performed to correct asymmetry (47%) or capsular contracture (47%); it was rarely performed for rupture (3%) or infection (3%) and never for anxiety or pain. In the later period, contracture (44%) and asymmetry (18%) remained as common causes, but anxiety (11%) and pain (8%) appeared as new factors, and rupture was suspected more often (21%). One of the most dramatic, if not surprising, findings was the choice for replacement implant. In the earlier period, saline solution-filled implants were used 12% of the time, whereas in the later period, they were used 80% of the time. Finally, implants removed that were more than 15 years old had ruptured nearly 50% of the time.