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. 2025 Sep 23;13(9):e7103.
doi: 10.1097/GOX.0000000000007103. eCollection 2025 Sep.

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

Tal Konfino  1 , Late Michael Scheflan  2 , Jonathan Caspi  3 , Barak Stuchiner  2 , Ariel Tessone  1
Affiliations

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

Tal Konfino et al. Plast Reconstr Surg Glob Open. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

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Conflict of interest statement

The authors have no financial interest to declare in relation to the content of this article. This study was supported by FixNip Ltd.

Figures

Fig. 1.
Fig. 1.
The FixNip NRI is composed of a “floral-shaped” nitinol frame with a silicone overmolding.
Fig. 2.
Fig. 2.
Steps for insertion of the FixNip NRI device. A, A 15- to 25-mm incision a few millimeters from the intended margin of the reconstructed nipple–areola complex. B, The FixNip NRI is placed 3–6 mm from the incision. C, A 5-mm deep flap in the subcutaneous plane is developed. The FixNip NRI implant is folded (D) and placed in the pocket (E). F, The incision line is sutured with layers in the usual manner.
Fig. 3.
Fig. 3.
Representative photographs at (A) 6 months after the procedure and (B) at the final follow-up visit 12 months after FixNip reconstruction.
Fig. 4.
Fig. 4.
Representative photographs at (A) 1 week after the procedure, (B) 6 months after the procedure, and (C) the final follow-up visit 12 months after FixNip reconstruction. D, FixNip reconstruction after makeup, demonstrating the future tattoo.
Fig. 5.
Fig. 5.
Illustration of nipple projection over time. A, Mean nipple projection over time. B, Nipple projection over time for individual patients, showing the overall trend of increased projection (please note that patient number 0110 underwent a bilateral procedure.)
Fig. 6.
Fig. 6.
BREAST-Q questionnaire at 12 months, showing medium to high rates of patient satisfaction.
See this image and copyright information in PMC

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