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

IF 1.8 Q3 SURGERY
Plastic and Reconstructive Surgery Global Open Pub Date : 2025-09-23 eCollection Date: 2025-09-01 DOI:10.1097/GOX.0000000000007103
Tal Konfino, Late Michael Scheflan, Jonathan Caspi, Barak Stuchiner, Ariel Tessone
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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.

Abstract Image

Abstract Image

Abstract Image

使用FixNip NRI进行乳头重建:一种新型乳头重建植入物(首次人体试验)。
背景:乳房切除术后失去乳头会对患者的身体形象产生不利影响。本试验评估了FixNip乳头重建植入物(NRI)的性能和安全性,这是一种皮下乳头结构,旨在为乳头重建提供可靠的选择。方法:年龄22-70岁,有乳腺癌病史且术后3个月以上的女性患者。应用FixNip NRI进行乳头重建。患者随访12个月,分别于术后1周、3、6、12个月随访。随访包括安全性评估、乳头投影测量和完成BREAST-Q患者满意度问卷。结果:10例患者共植入12枚FixNip NRIs。12个月期间乳头突出保持稳定,1周时平均±SD突出3.4±1.6 mm, 12个月时平均±SD突出3.7±1.6 mm。BREAST-Q问卷显示患者满意度中至高。术中无不良事件发生,但有1例种植体因术后感染裂开而被拔除。结论:FixNip NRI安全可行。单个种植体的移除可能反映了患者选择和手术技术的学习曲线。使用该永久植入物可维持乳头突出12个月,患者满意度中至高,为未来重建提供了良好的结果。
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来源期刊
CiteScore
2.20
自引率
13.30%
发文量
1584
审稿时长
10 weeks
期刊介绍: Plastic and Reconstructive Surgery—Global Open is an open access, peer reviewed, international journal focusing on global plastic and reconstructive surgery.Plastic and Reconstructive Surgery—Global Open publishes on all areas of plastic and reconstructive surgery, including basic science/experimental studies pertinent to the field and also clinical articles on such topics as: breast reconstruction, head and neck surgery, pediatric and craniofacial surgery, hand and microsurgery, wound healing, and cosmetic and aesthetic surgery. Clinical studies, experimental articles, ideas and innovations, and techniques and case reports are all welcome article types. Manuscript submission is open to all surgeons, researchers, and other health care providers world-wide who wish to communicate their research results on topics related to plastic and reconstructive surgery. Furthermore, Plastic and Reconstructive Surgery—Global Open, a complimentary journal to Plastic and Reconstructive Surgery, provides an open access venue for the publication of those research studies sponsored by private and public funding agencies that require open access publication of study results. Its mission is to disseminate high quality, peer reviewed research in plastic and reconstructive surgery to the widest possible global audience, through an open access platform. As an open access journal, Plastic and Reconstructive Surgery—Global Open offers its content for free to any viewer. Authors of articles retain their copyright to the materials published. Additionally, Plastic and Reconstructive Surgery—Global Open provides rapid review and publication of accepted papers.
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