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

 

by Salzman, Marc J. 

 

Plastic and Reconstructive Surgery: January 2022 - Volume 149 - Issue 1 - p 7-14

 

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.

 

 

Five-Year Safety Data for More than 55,000 Subjects following Breast Implantation: Comparison of Rare Adverse Event Rates with Silicone Implants versus National Norms and Saline Implants

Five-Year Safety Data for More than 55,000 Subjects following Breast Implantation: Comparison of Rare Adverse Event Rates with Silicone Implants versus National Norms and Saline Implants
Singh, N et al
Plastic and  Reconstructive Surgery: October 2017 - Volume 140 - Issue 4 - p 666–679

Background: The U.S. Food and Drug Administration has required postapproval studies of silicone breast implants to evaluate the incidence of rare adverse events over 10 years after implantation. Methods: The Breast Implant Follow-Up Study is a large 10-year study (>1000 U.S. sites) evaluating long-term safety following primary augmentation, revision-augmentation, primary reconstruction, or revision-reconstruction with Natrelle round silicone breast implants compared with national norms and outcomes with saline implants. Targeted adverse events in subjects followed for 5 to 8 years included connective tissue diseases, neurologic diseases, cancer, and suicide. 
Results: The safety population comprised 55,279 women (primary augmentation, n = 42,873; revision-augmentation, n = 6837; primary reconstruction, n = 4828; and revision-reconstruction, n = 741). No targeted adverse events occurred at significantly greater rates in silicone implant groups versus national norms across all indications. The standardized incidence rate (observed/national norm) for all indications combined was 1.4 for cervical/vulvar cancer, 0.8 for brain cancer, 0.3 for multiple sclerosis, and 0.1 for lupus/lupus-like syndrome. Silicone implants did not significantly increase the risk for any targeted adverse events compared with saline implants. The risk of death was similar with silicone versus saline implants across all indications. The suicide rate (10.6 events per 100,000 person-years) was not significantly higher than the national norm. No implant-related deaths occurred. 
Conclusions: Results from 5 to 8 years of follow-up for a large number of subjects confirmed the safety of Natrelle round silicone implants, with no increased risk of systemic disease or suicide versus national norms or saline implants.