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Clinical and MRI Evaluation of Silicone Gel Implants with RFID-M Traceability System: A Prospective Controlled Cohort Study Related to Safety and Image Quality in MRI Follow-Up

  • Original Article
  • Breast Surgery
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Abstract

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

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Author information

Authors and Affiliations

  1. Breast Surgery Group, Plastic Surgery Division, Rua Mato Grosso, 306 cj.1706 Higienópolis ZIP, São Paulo, SP, 01239-040, Brazil

    Alexandre Mendonça Munhoz

  2. Plastic Surgery Department - Hospital Moriah, Hospital Sírio-Libanês, Rua Mato Grosso, 306 cj.1706 Higienópolis ZIP, São Paulo, SP, 01239-040, Brazil

    Alexandre Mendonça Munhoz

  3. Post-Graduation Course Hospital Sírio-Libanês, São Paulo, Brazil

    Alexandre Mendonça Munhoz

  4. Department of Breast Radiology, Fleury Imaging Center, São Paulo, Brazil

    Luciano Chala, Giselle de Melo & Tatiana Tucunduva

  5. Hospital Moriah, São Paulo, Brazil

    Ary de Azevedo Marques Neto

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  2. Luciano Chala
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Contributions

AMM: Data collection, data analysis or interpretation, writing the paper. AAMF, TT: Data collection. LC, GM: Data analysis or interpretation, writing the paper.

Corresponding author

Correspondence to Alexandre Mendonça Munhoz.

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Conflicts of interest

Dr. AMM serves as a member of medical board for Establishment Labs. Drs. LC, GM, AAMN and TC have nothing to disclose.

Ethical approval

The study followed the principles of the Helsinki Declaration and was approved by the institutional review board ethics committee (Instituto Fleury, registration number 3834768) and registered on the Ensaios Clínicos platform (Brazilian Clinical Trials Registry (ReBec), Registration number RBR-4672xj, available online at http://www.ensaiosclinicos.gov.br/rg/RBR-4672XJ/).

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Written consent was obtained from all patients

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Munhoz, A.M., Chala, L., Melo, G.d. et al. Clinical and MRI Evaluation of Silicone Gel Implants with RFID-M Traceability System: A Prospective Controlled Cohort Study Related to Safety and Image Quality in MRI Follow-Up. Aesth Plast Surg 45, 2645–2655 (2021). https://doi.org/10.1007/s00266-021-02355-8

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