RESUMEN
BACKGROUND: SmoothSilk implants (SSI) are the first generation of implants to incorporate a radio-frequency identification device (RFID-M), a non-invasive traceability system. Although the RFID-M is considered compatible with magnetic resonance imaging (MRI), the size of the artifact and its influence on breast tissue vary. This prospective study assessed safety and MRI issues in a cohort of breast reconstruction patients. METHODS: Forty-four SSI were used for breast reconstruction in patients undergoing treatment for breast cancer. All patients were evaluated for magnetic field interactions, MRI-related heating and artifacts in a 1.5-T MRI unit using standard T1/T2-weighted sequences utilized in clinical assessment of breast tissue/implants. RESULTS: Mean patient age was 41.5 years (27-53ys) and body mass index was 28+-6.44 kg/m2. In 18/22 patients (81.8%), mastectomies were unilateral. No patients reported local heat/discomfort. All implants showed RFID-M-related artifacts with an estimated mean volume in T1 of 42.9cm3 (26.2-63.6cm3; SD±8.6 and 95% CI, 40.37-45.45) and in T2 of 60.5cm3 (35.4-97.2cm3; SD±14.7 and 95% CI, 56.29-65.01). Artifact volume was smaller in T1 than in T2, to a statistically significant degree (p <0.001). There were no statistically significant differences in artifact volume according to surgical indication, breast side or implant volume. There were 4/44 (9%) cases of minor rotation (<45°). In all cases, adequate analysis of the breast tissue was performed. CONCLUSIONS: The results demonstrate that SSI with RFID-M technology presented an artifact volume of 42.9cm3 and 60.5cm3 in T1 and T2 images, respectively. Our findings provide detailed information on the quality and location of MRI artifacts in a reconstructed cohort which can help guide clinical decision-making for patients. To our knowledge, this is the first time RFID-M breast implants have been prospectively evaluated for clinical and MRI issues in a cohort of reconstructive patients. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .