Please read this before you rely on anything on this site.

FixNip NRI is licensed by Health Canada as a Class III medical device (Medical Device Licence No. 116189, first issued 21 September 2026). It is supplied only to qualified physicians and is intended for use only as stated in its instructions for use.

FixNip NRI is intended for nipple reconstruction in patients who have undergone mastectomy with removal of the nipple or nipple-areolar complex (NAC).

A licence means that Health Canada has authorized the sale of the device in Canada. It does not mean that the device is right for every person. Information for healthcare professionals is provided only in the professional area, to verified physicians.

The content of this site is general information. It is not medical advice, a diagnosis or a treatment recommendation, and it cannot take your personal medical history, your reconstruction or your wishes into account.

This product may not be right for you. Talk to your healthcare professional. Only a qualified surgeon who has examined you can tell you which reconstruction options are suitable for you, including options that do not involve FixNip NRI, such as tattooing, surgical techniques using your own tissue, or no further procedure.

Every surgical procedure and every implant carries risks. Complications may be related to the procedure, the implant or your own health, and they vary from person to person. The instructions for use and the Patient Information Leaflet for FixNip NRI, which your surgeon gives you before you decide, name the following possible complications. The list is not exhaustive.

• Allergic reaction to the implant materials, with itching, swelling or redness
• Inflammation, infection, seroma (fluid collection), hematoma (blood collection) and bleeding
• Changes in sensation: numbness, or tingling and prickling sensations, which may be temporary or lasting
• The implant shifting, flipping, folding, or pushing through the skin and becoming visible
• Reduced blood flow to the tissue, tissue damage or tissue death, fragile skin, skin discoloration, pressure sores or skin breakdown
• Hardening of the tissue, or scar tissue forming around the implant (capsular contracture)
• Palpation (feeling) of the implant's metal framework, including exposed framework, discomfort, an unnatural feeling, or pain
• A nipple projection that is less or more than expected, or a reconstructed nipple whose size or shape is not as expected, which may need further adjustment

Some of these may need further treatment, a correction or the removal of the implant.

FixNip NRI should not be implanted in patients with known sensitivity to nickel or titanium, an active infection, pregnancy or breastfeeding, or tissue at the intended implant site less than 1.0 cm thick. The implant may contain trace amounts of chromium that could cause an allergic reaction.

Tell your surgeon about previous radiation treatment, breast implants or surgical mesh, diabetes, autoimmune disease, chemotherapy, smoking and allergies. If you have received radiation treatment to the same breast or chest region, your surgeon should consider the timing of implantation, including the IFU precaution to wait at least one year after the final treatment. Safety and performance with different breast implant types or supportive materials, such as mesh, have not been thoroughly evaluated due to limited clinical evidence.

Mammography should not be performed within two months after implantation.

MRI safety information: MR Conditional

FixNip NRI is MR Conditional. Patients with the implant may undergo MRI examinations only under specified conditions. Failure to follow these conditions may result in injury. Before undergoing MRI, inform your healthcare provider and MRI personnel about the implant, and present your Implant Card and the MRI safety information.

1.5 Tesla and 3 Tesla MRI. A patient with FixNip NRI may be safely scanned under the following conditions:

The presence of other implants or the patient's health condition may require a reduction in the applicable MRI limits. Under the conditions above, FixNip NRI is expected to produce a maximum temperature rise of 1.5 °C after 15 minutes of continuous scanning. In non-clinical testing, the image artifact extended approximately 5 mm from the implant using a gradient echo pulse sequence and a 3-Tesla MRI system.

7 Tesla MRI: important limitations

MRI testing at 7 Tesla was limited to assessment of magnetic field interactions and image artifacts. The evaluated system had transmit/receive RF head and knee coils, but no transmit/receive RF body coil. FixNip NRI is not implanted in the anatomical regions of the head or knee. MRI-related heating has not been evaluated for the relevant body-coil application. The MRI team must consider these limitations before performing a 7-Tesla MRI examination. The listed magnetic field conditions alone do not establish the safety of scanning the implanted breast at 7 Tesla.

Important information for patients. Always inform healthcare professionals that you have FixNip NRI before MRI or other breast imaging. Keep your Implant Card and ensure the MRI team has access to the current MRI safety information. FixNip NRI may interfere with breast imaging, including ultrasound and MRI, and could obscure detection of breast cancer recurrence or breast implant rupture. Consult the current Canadian Instructions for Use (MRK003_0013 Rev. 01) for further information.

Breastfeeding may not be feasible after implantation.

If you choose to have the reconstructed nipple tattooed, wait at least six months after implantation and until your surgeon confirms that the site has healed.

There are ways to reconstruct the nipple that do not use an implant. Your surgeon will explain the risks and benefits of each option, the aftercare and your situation, based on the instructions for use of the device. Only your surgeon can weigh these risks for you.

The current Canadian Instructions for Use (MRK003_0013 Rev. 01) are available as a PDF in English and French: FixNip NRI Instructions for Use.

Results differ from person to person and depend among other things on your tissue, your previous treatments, your healing and the procedure. Images on this site are illustrations or show individual cases; they do not predict your result. Figures from studies describe the groups that were studied and are not a promise for an individual. Where before-and-after images are shown, they are of real patients who have consented in writing to their use, with no retouching beyond cropping and colour balance. They do not guarantee any result.

FixNip NRI is a device for nipple reconstruction. It is not a treatment, a preventive measure or a cure for breast cancer or any other disease, and nothing on this site should be read that way. Questions about your cancer treatment and follow-up belong with your oncology team.

Where personal stories are shown, they reflect the individual experience of the person concerned and are published only with that person's prior written consent to the published version. They are not representative of the results others can expect. If a person received any compensation, this is stated next to the story. Personal stories are not endorsements by any physician.

FixNip NRI is licensed in Canada for the indications specified in its Canadian Instructions for Use. This website describes those licensed indications and does not promote uses outside them. Professional information supports but does not replace the current Instructions for Use or independent clinical judgment.

• In a medical emergency, call 911 or go to the nearest emergency department.
• If you have a concern after a procedure, contact your surgeon.
• To report a problem with the device, see report a product problem.
• Patients in Canada may also report suspected medical device-related problems directly to Health Canada through its medical device problem-reporting system.