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

Area of Science:

• Plastic Surgery
• Oncology
• Medical Devices

Background:

• Mastectomy can lead to nipple loss, negatively impacting patient body image.
• Nipple reconstruction is a crucial aspect of breast cancer recovery.
• The FixNip Nipple Reconstruction Implant (NRI) was developed to address this need.

Purpose of the Study:

• To evaluate the performance and safety of the FixNip NRI for nipple reconstruction.
• To assess long-term nipple projection and patient satisfaction after implantation.

Main Methods:

• A trial involving female patients (22-70 years) who underwent nipple reconstruction with FixNip NRI.
• 12-month follow-up including safety assessments, nipple projection measurements, and BREAST-Q questionnaires.
• Eligibility required at least 3 months post-mastectomy.

Main Results:

• Nipple projection remained stable over 12 months (mean 3.4 mm at 1 week, 3.7 mm at 12 months).
• Patients reported medium to high satisfaction with the FixNip NRI.
• One implant was removed due to postoperative infection and dehiscence.

Conclusions:

• The FixNip NRI demonstrates safety and feasibility for nipple reconstruction.
• The implant maintained nipple projection and achieved good patient satisfaction.
• Further use may benefit from refined patient selection and surgical technique.