Evidence
What we say about FixNip NRI, with the publication or document behind it, the study population, the follow-up and the limitations.
Study results describe what was observed in the study population. They are not a guarantee of individual results. Risks and limitations are described in the Patient Information Leaflet.
Key sources
Clinical studies with patients, published in Plastic and Reconstructive Surgery Global Open.
Peer-reviewed clinical study
Published September 23, 2025
Konfino et al., 2025, Plast Reconstr Surg Glob Open
10
women
12
implants
12 months
follow-up per implant
Prospective, open-label, single-arm trial at two centres in Israel (ClinicalTrials.gov NCT04051892).
Peer-reviewed clinical study
Published January 10, 2025
Riccio et al., 2025, Plast Reconstr Surg Glob Open
40
patients
46
reconstructions
12 months
follow-up
Prospective single-centre series at a university hospital in Ancona, Italy, without a comparison group.
All claims
Newest publication first. Each entry has its own link.
Topic
Type of source
11 entries
Nipple projection was maintained over 12 months: 3.4 mm at one week and 3.7 mm at 12 months.
Projection remained stable over 12 months.
(n=10, 12 months)
3.4 mm
mean nipple projection one week after placement (SD 1.6)
3.7 mm
mean nipple projection at twelve months (SD 1.6)
10
women
12
implants
12 months
follow-up per implant
SourceKonfino et al., 2025, Plast Reconstr Surg Glob Open, doi:10.1097/GOX.0000000000007103
8 of 10 patients were satisfied overall and would recommend FixNip to other women.
(n=10, 12 months)
8
of 10 women, BREAST-Q at twelve months
10
women
12
implants
12 months
follow-up per implant
SourceKonfino et al., 2025, Plast Reconstr Surg Glob Open, doi:10.1097/GOX.0000000000007103
In the first clinical study, the average procedure time was 20 min per breast, under local anaesthesia.
(n=10, 12 months)
20 min
per breast in the first clinical study
10
women
12
implants
12 months
follow-up per implant
The implantation procedure and care setting are determined by the treating surgeon.
SourceKonfino et al., 2025, Plast Reconstr Surg Glob Open, doi:10.1097/GOX.0000000000007103
In a published study, patients reported a significant improvement in psychosocial and sexual well-being after FixNip (BREAST-Q).
(n=36, 12 months)
36
patients with the BREAST-Q before and after
p< 0.001
Wilcoxon signed-rank test
40
patients
46
reconstructions
12 months
follow-up
SourceRiccio et al., 2025, Plast Reconstr Surg Glob Open, doi:10.1097/GOX.0000000000006410
90% of patients were satisfied or very satisfied with the appearance of their reconstructed nipple.
(n=40, 12 months)
90%
of patients were satisfied or very satisfied with the appearance of the reconstructed nipple
40
patients
46
reconstructions
12 months
follow-up
SourceRiccio et al., 2025, Plast Reconstr Surg Glob Open, doi:10.1097/GOX.0000000000006410
100% of patients were satisfied with nipple colour after tattooing.
(n=30, 12 months)
100%
of patients were satisfied with the nipple colour after tattooing
30
of 40 patients had the areola tattooed
40
patients
46
reconstructions
12 months
follow-up
In Canada, tattooing may be considered no earlier than 6 months after implantation, once healing is confirmed by the treating surgeon.
SourceRiccio et al., 2025, Plast Reconstr Surg Glob Open, doi:10.1097/GOX.0000000000006410
Safety and performance have been evaluated in clinical studies.
SourceClinical evaluation report
The manufacturer's evaluation of the available clinical data, including adverse events, implant-related complications and explantations. Not all of these data are published; the published studies are listed on this page.
FixNip Ltd. FixNip NRI Clinical Evaluation Report, CLN001_1001 Rev. 05. Manufacturer document, not published.
A flower-shaped nitinol frame is fully encapsulated in medical-grade silicone.
Device description in the Canadian instructions for use.
SourceInstructions for use, Canada
The controlled Canadian instructions for use of FixNip NRI, written for healthcare professionals.
FixNip Ltd. FixNip NRI Instructions for Use, Canada, MRK003_0013 Rev. 01.
FixNip NRI is MR Conditional. Refer to the current IFU for the specified scanning conditions.
SourceInstructions for use, Canada
The controlled Canadian instructions for use of FixNip NRI, written for healthcare professionals.
FixNip Ltd. FixNip NRI Instructions for Use, Canada, MRK003_0013 Rev. 01.
FixNip NRI is licensed by Health Canada as a Class III medical device (MDL No. 116189).
SourceHealth Canada licence
Health Canada's public Medical Devices Active Licence Listing (MDALL) shows the licence. The licence does not mean that Health Canada endorses individual claims.
Health Canada. Medical Device Licence No. 116189, FixNip NRI, Class III.
About 31,900 new breast cancer cases are found in Canada each year. Not all are candidates for nipple reconstruction.
31,900
new breast cancer cases in Canada each year
SourceCanadian Cancer Society, 2025
Estimates of new breast cancer cases in Canada each year. Incidence is not the number of women who are candidates for nipple reconstruction.
Canadian Cancer Society. Canadian Cancer Statistics, breast cancer estimates, 2025.
Documents
The manufacturer's information for patients, with the risks and limitations. Your surgeon gives it to you before you decide.
The Canadian instructions for use, for healthcare professionals.
Possible complications and when to contact your surgeon.
