Long-term Outcomes in 98,000 Breast Implant Patients from the US FDA Post-Approval Studies
Christopher James Coroneos, MD MSc, Jesse C. Selber, MD MPH, Mark W. Clemens, MD.
MD Anderson Cancer Center, Houston, TX, USA.
Despite copious data collection on breast implants for the US Food and Drug Administration Post-Approval Study (FDA-PAS), this database has not been thoroughly analyzed. The objective of this study is to analyze FDA-PAS long-term safety and efficacy data for silicone and saline breast implants.
Prospectively collected FDA-PAS data includes silicone/saline breast implants for augmentation/reconstruction. Data abstraction included implant characteristics, intraoperative technique, and imaging surveillance. Adverse events included complications, patient-reported outcomes, and rare harms. Cancer, autoimmune/neurological disease, fertility, and suicide are compared to normative data.
FDA-PAS enrolled 98,207 patients for two manufacturers from 2007-2016. Overall, 68% of implants were silicone for primary augmentation. Allergan(A) report outcomes for 39,069 silicone and 14,487 saline implants, Mentor(M) for 41,452 silicone implants. Infection incidence varies by indication, A:0.3-1.9% at five years; M:3.3-6.3% at seven. Rupture incidence varies by indication, A:1.4-2.6% at five years; M:0.7-2.6% at seven. Device removal, A:2.4-3.4% at two years, is most often for style/size-change(50.7%), capsular contracture(9.8%), and implant malposition(9.1%); M:5.0-13.5% at three years, for size-change(12.4-40.2%), infection(6.7-8.8%), and asymmetry(5.0-25.5%). Further, Mentor's seven-year reoperation following primary augmentation is 11.7%, for capsular contracture(26.8%) and size-change(21.0%). Allergan report four-year BREAST-Q outcomes improve from baseline, median satisfaction:88.9, psychosocial wellbeing:91.7. Mentor report one BIA-ALCL case, and five-year MRI surveillance under 5%.
FDA-PAS data demonstrate favorable safety profiles for breast implants. Receiving an implant is not predictive or protective for breast/lung/brain/melanoma cancer occurrence, fertility, autoimmune disease, or suicide. Long-term outcomes are critical in determining safety profiles for breast implants, and should inform surgeon/patient decision-making.
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