Silicone breast implants not associated with a higher incidence of autoimmunity. #ClinicSpeak #ResearchSpeak
Summary: A large study in over 55,000 women undergoing breast augmentation with saline and silicone implants demonstrates that breast implants are not associated with a higher risk of developing MS.
Theoretical ClinicSpeak scenario: A patient with MS asked me to write a letter to her plastic surgeon about her planned breast augmentation surgery. Her surgeon was reluctant to do the surgery on the off chance that it would make her MS worse. I dutifully wrote the letter stating that to the best of my knowledge I was not aware of any reason why she shouldn't undergo the surgery because of her MS.
Interestingly, a few years ago there was a crisis about the possibility of silicone breast implants triggering, or causing, autoimmunity. This was thought to relate to ruptured silicone implants. Therefore the large study below is reassuring that both silicone and saline breast implants are not associated with a higher incidence of multiple sclerosis if anything the risk was lower.
Singh et al. 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. Plast Reconstr Surg. 2017 Oct;140(4):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.
Labels: #ClinicSpeak, #ResearchSpeak, breast implants, breasts, plastic surgery, silicone breast implants