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Balloon breast brachytherapy is a catheter-based technique to deliver high local concentration of radiation following breast-sparing surgery. Although this technique is logically appealing--providing more directed radiation to sites at high risk of local failure--there remains little empirical support that this intervention is non-inferior to external beam radiotherapy, a well-established standard. Additionally, observational studies suggest that balloon brachytherapy is associated with high rates of local complications, and higher rates of subsequent mastectomy, a marker of local failure. Here, I explore regulatory and clinical considerations that lead to the widespread adoption of breast brachytherapy. I argue that the therapy spread before its efficacy was confirmed. Breast brachytherapy illustrates ongoing complexities in the approval of novel devices.

Balloon brachytherapy for breast cancer prove that it works? Or, prove that it doesn’t?