The long-term outcomes of breast implants include increased rates of certain conditions for silicone implants, according to a study published online Sept. 14 in the Annals of Surgery.
Research is ongoing regarding the safety of silicone breast implants. Despite the number of patients with breast implants followed by United States Food and Drug Administration large postapproval studies (LPAS), this database has not been thoroughly analyzed or reported.
This is a multicentered, cohort study. LPAS prospectively monitor long-term implant-related outcomes and systemic harms for silicone/saline implants from 2 manufacturers (Allergan and Mentor) placed for primary/revision augmentation/reconstruction.
Systemic injuries, self-harm, and reproductive outcomes are compared with normative data. Implant-related complications are analyzed by implant composition and operative indication in the short and long terms.
This is the largest study of breast implant outcomes. Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants.
Christopher J. Coroneos, M.D., from the MD Anderson Cancer Center in Houston, and colleagues monitored long-term implant-related outcomes and systemic harms for silicone/saline implants from two manufacturers placed for primary/revision augmentation/reconstruction in U.S. Food and Drug Administration large post-approval studies (LPAS).
LPAS data were included for 99,993 patients. The researchers found that 56% of implants were silicone for primary augmentation. The rate of long-term magnetic resonance imaging surveillance was less than 5%.
Silicone implants correlated with higher rates of Sjogren syndrome, scleroderma, rheumatoid arthritis, stillbirth, and melanoma (standardized incidence ratios, 8.14, 7.00, 5.96, 4.50, and 3.71, respectively), compared with normative data.
There was one reported case of breast implant-associated anaplastic large cell lymphoma. No correlation with suicide was reported. The rupture was higher for saline (2.5 versus 0.5%), and capsular contracture was higher for silicone (5.0 versus 2.8%) in the short-term.
The reoperation rate at seven years was 11.7 and 25% for primary augmentation and primary/revision reconstruction, respectively. In 7.2 and 12.7% of primary augmentations and primary reconstructions, respectively, capsular contracture occurred.
"Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence," the authors write.