Magnetic Resonance Imaging Screening after Silicone Implant Breast Surgery: Patient Survey of Adherence to U.S. Food and Drug Administration Recommendations

Abstract

Background: The U.S. Food and Drug Administration recommends women with silicone breast implants undergo magnetic resonance imaging surveillance to detect asymptomatic rupture. Screening is costly and often not covered by insurance. The authors assessed awareness of and adherence to these recommendations among patients with silicone breast implants.

Methods: The authors searched electronic medical records for patients aged 18 years or older with silicone breast implants placed between 2011 and 2016. Consenting patients were surveyed by telephone using a standardized script to assess awareness of U.S. Food and Drug Administration recommendations, whether they had undergone magnetic resonance imaging screening, and barriers to testing. Patients who declined to participate or could not be contacted were excluded. Demographics and operative data were collected. Odds ratios were calculated with one-sample 95 percent confidence intervals, and Fisher exact tests of independence were conducted under assumptions of normality. Multivariable logistic regression analysis was performed to test for confounding.

Results: Of 370 patients meeting inclusion criteria, 109 consented to participate. Adherence to U.S. Food and Drug Administration recommendations was 5.9 percent (95 percent CI, 0.15 to 28.7 percent). There was no difference in adherence between patients undergoing cosmetic versus reconstructive surgery ( p = 1.00; OR, 0.80; 95 percent CI, 1.17 to 2.93), having health insurance ( p = 0.58), or residing in a county with median annual household income greater than that of the state of residence ( p = 0.33).

Conclusions: A small proportion of respondents had undergone magnetic resonance imaging in accordance with U.S. Food and Drug Administration recommendations. Low adherence highlights a potential limitation of current federal surveillance recommendations. Additional research is needed to better characterize adherence to magnetic resonance imaging surveillance recommendations, identify barriers to implementation, and determine whether this recommendation remains valid.