A 3D-printed screw mechanism as an alternative method to prevent wire migration in nonpalpable breast lesion localization.

Abstract

Background: Wire localization for nonpalpable breast lesions and pre-neoadjuvant chemotherapy (NAC) clips can lead to complications including wire migration, pneumothorax, and organ injury. This study evaluates the clinical efficacy and safety of a novel 3D-printed screw mechanism designed to prevent wire migration.

Methods: This retrospective descriptive study included 104 patients with nonpalpable breast lesions and pre-NAC clips who underwent wire localization between March 2023 and August 2024. A screw mechanism was designed and manufactured using 3D printing technology with polylactic acid (PLA) material (4 g per device). The device features a 21.7 mm base diameter and elliptical wire hole (2.5 × 4 mm). Wire stability and complications were assessed through imaging and clinical follow-up.

Results: The median age was 47 years (range: 33-82) and median BMI was 24.7 (17.9-40.8). Lesions were primarily located in the upper outer quadrant (49.9%). Among 68 patients receiving NAC, 44.1% achieved pathological complete response (ypT0N0). The screw mechanism successfully prevented wire migration during patient transport from radiology to operating room in all 104 cases (0% migration rate, 95% CI: 0-3.6%). No complications including pneumothorax, organ injury, or skin reactions were observed. The device was easily removed by simple unscrewing on the operating table before surgical skin preparation. Median device application time was 2-4 h.

Conclusion: The 3D-printed screw mechanism effectively prevents wire migration and demonstrates excellent safety profile. Its simple design and ease of application make it a practical solution for improving patient safety during breast lesion localization procedures.

Trial registration: Not applicable. This retrospective study did not require trial registration.