Silent Rupture of Silicone Gel Breast Implants: High-Resolution Ultrasound Scans and Surveys of 584 Women

Abstract

Background: Patient compliance has been low for U.S. Food and Drug Administration-recommended magnetic resonance imaging scans to screen silicone gel breast implants for silent rupture. High-resolution ultrasound scans are a convenient, in-office alternative that may improve screening compliance; however, women's attitudes and feelings about silent rupture and their desire for rupture screening are unknown. Methods: Plastic surgeons and staff in nine private practices received 1-day training in high-resolution ultrasound scanning, then screened women with silicone gel implants implanted since 2000. Suspect scans were reviewed by a high-resolution ultrasound-experienced plastic surgeon to determine if they showed ruptures. Surgical and scan findings were correlated. To learn attitudes and feelings about silent rupture, women took surveys before and after the scan. Results: Of 584 women screened, 82 (14.0 percent) had scans showing ruptures; of 1153 implants, 92 (8.0 percent) showed ruptures. Forty women with scans showing ruptures underwent surgery, of which 30 (75 percent) had their ruptures confirmed. Surveys found 99.5 percent of women want to know if they have a rupture and 95.2 percent want the ruptured implant removed. If the scan showed no rupture, women felt relieved and 95.5 percent would get future high-resolution ultrasound screening for silent rupture. If a rupture was found, women expressed various concerns and 87.8 percent would remove the ruptured implant within 12 months. Conclusions: Surveys show that women with silicone gel implants have concerns and feel anxious about possible silent rupture. Based on 14 percent of women showing a ruptured implant on high-resolution ultrasound scans and 75 percent of ruptures on high-resolution ultrasound scans surgically confirmed, 10.6 percent of women in this study have a silent rupture. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, IV.