Study Analyzing Postmarketing Data on Breast Implant Safety Sparks FDA Response
Existing studies that summarize the risks of breast implants are not adequately powered to detect all harms, alleged authors of a study including nearly 100,000 patient outcomes.
In what study authors called the first report of the data collected from large postapproval studies (LPAS) monitoring the safety of breast implants from 2 manufacturers, it was revealed that individuals who receive silicone-based implants may be at an increased risk of developing rare conditions as a result of the implant — with diagnosis rates of Sjögren syndrome, scleroderma, rheumatoid arthritis, and melanoma across this population that were approximately double that of the rates seen in the general population.1
These incidence rates for systemic harms of silicone implants were based on data provided by 1 of the implant manufacturers, Mentor. The other manufacturer named in the study, Allergan, allegedly did not report numerical values for the incidence of rare adverse effects, although it described qualitatively that more rheumatologic events were associated with their silicone implants.
And, based on Mentor data, the researchers concluded that silicone implants were associated with increases in overall cancer diagnoses, neurological disorders, multiple sclerosis, and myositis. The rate of stillbirth in breast implant recipients was found to be more than twice the rate seen across the general population (SIR: 4.50, 95% confidence interval [CI]:3.59-5.56; P < .001).
The study, published in Annals of Surgery, analyzed the postmarketing data from the 2 breast implant manufacturers to assess the potential harms — calculated per 10,000 person-years — of the implants based on information from patient reports submitted to the US Food and Drug Administration (FDA) through the agency's LPAS database.
Based on reports of the long-term outcomes of 99,993 patients, the researchers concluded that silicone implants were associated with more reports of rare harm; that rupture was more common with saline implants than silicone (2.5% vs 0.5%, respectively; P < .001); and that at 7 years, 11.7% of patients who received primary augmentation and 25% of patients who received primary or revision reconstruction went on the get additional breast-related operations (reoperation was a secondary end point of the study, along with the secondary end points of determination of local complications and postoperation imaging surveillance).
According to their analysis, the authors wrote that nearly 36% of patients receiving primary augmentations, and more than half (50.8% to 58.5%) of patients who undergo revision surgeries, or primary/revision reconstruction surgeries “will experience some degree of morbidity in the form of a complication and/or reoperation.”