Nipple Reconstruction Using FixNip NRI: A Novel Nipple Reconstruction Implant (First-in-human Trial)

Loss of a nipple after mastectomy can adversely impact a patient's body image. This trial evaluated the performance and safety of the FixNip Nipple Reconstruction Implant (NRI), a hypodermic nipple structure designed to provide a reliable option for nipple reconstruction.

Female patients 22-70 years of age with a history of breast cancer and at least 3 months postmastectomy were eligible. Nipple reconstruction with the FixNip NRI was performed. Patients were followed up for 12 months, with visits at 1 week, and 3, 6, and 12 months post surgery. Follow-up included safety evaluations, nipple projection measurements, and completion of BREAST-Q patient satisfaction questionnaires.

Twelve FixNip NRIs were implanted in 10 patients. Nipple projection remained stable during 12 months, with mean ± SD projections of 3.4 ± 1.6 mm at 1 week and 3.7 ± 1.6 mm at 12 months. BREAST-Q questionnaires showed medium to high patient satisfaction. No intraoperative adverse events occurred, but 1 implant was removed due to postoperative infection and dehiscence.

FixNip NRI appears safe and feasible. Removal of the single implant may reflect the learning curve for patient selection and surgical technique. Use of this permanent implant maintained nipple projection for 12 months with medium to high patient satisfaction, suggesting promising outcomes for future reconstructions.