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Dear Patient,
You receive this Patient Information Leaflet from your surgeon, as you have expressed an
interest in nipple reconstruction.
As with any surgical procedure, potential complications may occur in association with nipple
reconstruction procedures with implants, as a result of individual health conditions,
medication, surgical technique, and postoperative care. General risks, such as those related
to anesthesia, medication and infection, are general, and are present with any surgical
procedure.
There are alternatives for nipple reconstruction that do not include the use of implants. Your
surgeon should inform you fully and comprehensively about the available procedures prior to
your decision.

You should receive educational material, take time to think about this information, discuss it
with your surgeon and ask questions, to make sure you have fully understood all the risks
and benefits of each procedure. If you are not convinced, do not feel pressured to undergo
any procedure.

At FixNip Ltd. we believe in providing comprehensive safety-related information to patients,
your decision should be personal and informed. Please read this form carefully.
When making your final decision, consider both risks and benefits of breast surgery involving
implants and the specific risk-benefit profile of implants. Your express and unconditioned
decision in favor of nipple reconstruction with FixNip NRI implants must be recorded in the
appropriate Informed Consent forms, provided to you by the surgery team in advance.
If you opt for nipple reconstruction with FixNip NRI implants, after the procedure you will
receive from your surgeon an Implant Card, with the identification of your implants and our
contact information, in case of enquiries or to report an issue. Please always keep this
document safely with you.
After nipple reconstruction surgery, it is important that you follow your surgeon’s
recommendations, and that you undergo regular check-ups. If you experience swelling,
aesthetic changes, pain, or other concerns, contact your surgeon immediately.
We wish you all the best in this journey, whatever direction you choose.

 

The FixNip Ltd. Team

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Device Overview

Device Name: FixNip NRI
Intended Use: FixNip NRI is intended for nipple reconstruction in patients who have undergone
mastectomy with removal of the nipple or nipple-areolar complex (NAC).
The implant should only be placed by a trained physician familiar with nipple reconstruction
procedures.

Who is the Intended Patient Population?
FixNip NRI is intended for patients who have undergone mastectomy with removal of the nipple or
nipple-areolar complex (NAC) and are seeking nipple reconstruction.
Your surgeon will assess your medical history, the condition of the tissue at the intended implantation
site, and other relevant factors to determine whether the FixNip NRI implant is appropriate for you.
About the Device

The FixNip NRI, the Nipple Reconstruction Implant, is an implantable subcutaneous, silicone implant
designed for nipple reconstruction. The implant contains a “floral-shaped” nitinol frame (a metal made
of nickel and titanium) that is embedded within medical-grade silicone (Figure 1).
FixNip NRI is intended to be implanted in the subcutaneous tissue (the layer of tissue just beneath the
skin).

FixNip NRI is provided sterile and is intended for single use only.

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Figure 1: FixNip NRI – Nipple Reconstruction Implant

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What is our implant made of?
The FixNip NRI Implant is made of:

- Nitinol - a metal made from nickel and titanium that is commonly used in medical devices,
- Medical-grade silicone – a type of silicone that is widely used in medical implants designed
to remain in the body.

Important information about implant materials
FixNip NRI contains nitinol, an alloy of nickel and titanium, and medical-grade silicone.
The implant may also contain trace amounts of residual chromium materials, which may cause an
allergic reaction in sensitive individuals.
Inform your surgeon if you have any known allergies or sensitivities to implant materials.

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Regulatory Information
The device is CE-marked for the European market and is licensed by Health Canada for its approved
intended use.
The applicable regulatory status and approved indications may vary by country.
Contraindications
You should not receive the FixNip NRI implant if any of the following apply to you:
- You have known sensitivity or allergy to nickel or titanium.
- You are currently pregnant or breastfeeding.
- The tissue thickness of the treated breast in the nipple area is less than 1.0 cm (10 mm).
- You have an active infection anywhere in your body

Inform your surgeon about your medical history, known allergies, current medications, and any
medical conditions that may affect wound healing.
Your surgeon will determine whether the FixNip NRI implant is appropriate for you.
Note: FixNip NRI is contraindicated in patients who are pregnant or breastfeeding. No studies have
been conducted to evaluate the performance of the implant in patients who are pregnant, may
become pregnant, or are breastfeeding. Breastfeeding may not be feasible following FixNip NRI
implantation.

Warnings and Precautions
- Allergies and sensitivities: Inform your surgeon about any known allergies or sensitivities,
particularly to nickel, titanium, chromium, silicone, or other implant materials.
- Tissue condition and thickness: Adequate tissue thickness of at least 1.0 cm (10 mm) must
be present at the intended implantation site. The tissue should be healthy, well-vascularized,
soft, and pliable.

Your surgeon will assess the tissue thickness and condition before implantation.
- Previous radiation therapy: If you have received radiation therapy to the same breast or
chest region, your surgeon should consider waiting at least one year after completion of your
final radiation treatment before implanting the device.
Radiation therapy may affect tissue healing.

- Medical conditions affecting wound healing: Patients with a compromised immune
system, including those with autoimmune diseases, diabetes, or those undergoing
chemotherapy or radiation therapy, may experience impaired wound healing.
Inform your surgeon about any relevant medical conditions or ongoing treatments.

- Smoking: Smoking may interfere with tissue healing and increase the risk of postoperative
complications. Discuss smoking cessation with your surgeon before undergoing the
procedure.

- Existing breast implants or supportive materials: The safety and performance of FixNip
NRI when used in combination with different breast implant types or supportive materials,
such as surgical mesh, have not been thoroughly evaluated due to limited clinical evidence.
Inform your surgeon if you have existing breast implants or other implanted materials.

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- Tattooing: You should wait at least six months after FixNip NRI implantation before
undergoing tattooing of the reconstructed nipple. The timing of tattoo placement, the quality of
tattooing instruments, and the tattooing technique may affect nipple projection.

-Mammography: Mammography should not be performed within two months following FixNip
NRI implantation.
Inform your healthcare provider that you have a FixNip NRI implant before undergoing breast
imaging.

- Pregnancy and breastfeeding: FixNip NRI is contraindicated during pregnancy and
breastfeeding. If you become pregnant after implantation or plan to breastfeed, consult your
healthcare provider.

 

Possible Risks and Complications

Complications
As with any surgical procedure, nipple reconstruction with FixNip NRI may be associated with
complications.
Potential complications may be related to the surgical procedure, the implant, or individual patient
factors.

The following complications may occur during or after nipple reconstruction. This list is not exhaustive,
and the occurrence and severity of complications may vary between patients.
Discuss the potential risks and benefits of the procedure with your surgeon before making your
decision.

Potential Complications
Possible complications associated with the procedure or device may include:

- Allergic Reaction to implant materials: You may have an allergic response to materials used in
the implant, which may cause itching, swelling, or redness. Please inform your healthcare provider
of any known allergies.
- Inflammation: Redness, warmth, and swelling around the implant area may occur as part of the
healing process. This may be temporary but should be monitored by your provider.
- Implant Migration or displacement: The implant may shift from its original position, which could
affect its appearance and may require correction.
- Implant Extrusion or Exposure: The implant may push through the skin or become visible. This
may require implant removal or other corrective procedures.
- Seroma (fluid accumulation): Fluid may collect around the implant, causing swelling. This may
resolve on its own or may need to be drained by a healthcare provider.
- Hematoma (blood collection): A collection of blood near the implant, leading to swelling or pain. It
may require medical attention.
- Numbness: You may experience a temporary or permanent loss of sensation around the implant
area.
- Paresthesia (tingling or prickling sensations): Tingling or prickling sensations may occur due to
minor nerve irritation. This may improve with time but can be persistent in some cases.
- Infection: Infection at the implant site can cause swelling, redness, and fever, which may require
antibiotics or possibly implant removal.
- Tissue Ischemia: Reduced blood flow to the tissues around the implant can lead to pain or slow
healing. Your healthcare provider will monitor your recovery to address this.

- Localized Necrosis (tissue damage or tissue death): Tissue around the implant may lose blood
supply and die. This may require removal of affected tissue and extended healing time.
- Epidermolysis (skin fragility or breakdown): Fragile skin around the implant can sometimes
become damaged. Special care may be needed for proper healing.
- Skin Discoloration: Changes in skin color around the implant may be temporary but could be
permanent in some cases.
- Induration (hardening of tissue): Hardening or thickening of the skin or tissue around the implant
may occur, which can feel uncomfortable
- Palpation (feeling) of exposed metal framework of the implant
- Bleeding: Bleeding can occur near the implant post-surgery, leading to swelling and discomfort.
- Pressure-related skin injury or sores: Prolonged pressure on the skin around the implant may
cause sores, especially if the tissue is thin or fragile.
- Skin Rupture or breakdown: The skin over the implant may tear or break, requiring immediate
medical care.
- Capsular Contracture: Scar tissue may form around the implant, causing it to feel firm, appear
misshapen, or cause discomfort.
- Implant Inversion (Flip Over): The implant may turn or flip within the tissue, affecting its shape or
appearance and potentially requiring adjustment.
- Implant Folding: The implant may crease or fold, which can impact its appearance and feel.
- Discomfort/Unnatural Feeling: Some patients may feel the implant more than others, which can
feel unnatural. This sensation may decrease over time.
- Pain: Some pain around the implant area may occur after surgery or due to complications such as
inflammation or infection.
- Insufficient or Excessive nipple projection: The size or shape of the reconstructed nipple may
not be as expected. Further adjustments may be required.
If you experience any of these symptoms or have concerns about your recovery, please contact your
surgeon.

 

MRI Safety Information - MR Conditional
The FixNip NRI implant is MR Conditional. This means that you may undergo an MRI examination,
but only under specific conditions.

Before undergoing an MRI examination:
Inform your doctor and MRI staff that you have a FixNip NRI implant.
Present your Implant Card and the MRI safety information below to the MRI staff before your
examination.

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The MRI staff must review the specified conditions to determine whether the examination can be
performed safely. Failure to follow these conditions may result in injury.

MRI Safety Conditions
Information to be presented to MRI personnel
1.5 Tesla and 3 Tesla MRI
Parameter MRI Safety Condition
Static magnetic field 1.5 or 3 Tesla only
Maximum spatial gradient magnetic field

4,000 Gauss/cm (40 T/m) or less

Maximum whole-body averaged SAR Less than 2 W/kg
Operating mode Normal Operating Mode
Scanning duration 15 minutes per pulse sequence

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The presence of other implants or the patients health condition may require a reduction in the
applicable MRI limits.
Under the conditions specified above, the 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 caused by the implant extended approximately 5 mm from
the device when imaged using a gradient echo pulse sequence and a 3-Tesla MRI system.

7 Tesla MRI – Important Limitations
The following conditions are specified for 7-Tesla MRI:

Parameter MRI Safety Condition
Static magnetic field 7 Tesla only
Maximum spatial gradient magnetic field

5,000 Gauss/cm (50 T/m)

MRI testing at 7 Tesla was limited to the assessment of magnetic field interactions and image artifacts.

The evaluated MRI system had transmit/receive RF head and knee coils, but no transmit/receive RF
body coil. The 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.
Therefore, 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 reminder for patients
Always inform healthcare professionals that you have a FixNip NRI implant before undergoing an MRI
examination.
Keep your Implant Card and ensure that the MRI team has access to this Patient Information Leaflet
before your examination.
What to Expect
- Pre-Procedure Consultation: Your surgeon will discuss your medical history and explain the
procedure.
- Placement Procedure: The implant is inserted to achieve nipple shape and projection.
- Post-Procedure Care: Follow all care instructions, including any temporary restrictions on activity.
Note: The FixNip NRI is designed to support reconstructed nipple structure; however, individual
results may vary.
Post-Implant Care and Follow-Up

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Follow your surgeons instructions regarding wound care and activity restrictions.
During the initial healing period, avoid direct pressure, excessive friction, or trauma to the
reconstructed nipple, as directed by your surgeon.
Your surgeon may recommend temporarily avoiding sleeping on your stomach, wearing tight or
compressive garments over the surgical site, strenuous upper-body activity, heavy lifting, or contact
sports.

The duration of these restrictions will depend on your healing progress and your surgeons
recommendations.
Attend scheduled follow-up appointments to allow your surgeon to assess wound healing and the
condition of the reconstructed nipple.
If you experience persistent pain, redness, swelling, drainage, fever, changes in the implant's
appearance, or any other concerning symptoms, contact your surgeon promptly.

Your Implant Card
Following implantation, you will receive an Implant Card containing information that identifies your
FixNip NRI implant.
The card provides important information about your implant, including its identification details and
manufacturer information.

Keep your Implant Card in a safe and accessible location and present it to healthcare professionals
whenever you receive medical treatment or undergo medical imaging.
The information on your Implant Card may be needed to identify your implant if you experience a
device-related problem or require further medical treatment.
If your Implant Card is lost or damaged, contact your surgeon or healthcare provider to obtain the
relevant implant identification information.

 

Frequently Asked Questions

Q: Will the implant interfere with future medical imaging?
A: The FixNip NRI is MR Conditional and may interfere with breast imaging modalities (such as
ultrasound and MRI) and could obscure detection of breast cancer recurrence or breast implant
rupture. Always inform healthcare providers that you have a FixNip NRI implant before undergoing
imaging.

Q: How long is the expected lifespan of the implant?
A: The FixNip NRI is designed for long-term implantation. However, individual outcomes may vary.
 

Q: Can I engage in normal activities after recovery?
A: Once fully healed, you should be able to resume normal activities. Follow your healthcare
provider’s guidance.

Manufacturer Information
Manufacturer:
FixNip Ltd. Address: 13 Bareket Industrial Park St.
Caesarea, Israel 3079544

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Tel: +972-4-8675090
Email: info@fixnip.com
Website: www.fixnip.com

 

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Reporting Adverse Events
If you experience pain, swelling, redness, changes in the appearance of the reconstructed nipple, or
any other symptoms that may be related to your FixNip NRI implant, contact your surgeon or
healthcare provider promptly.
If you experience a serious medical problem or require urgent medical attention, seek immediate
medical care.

You may also report suspected device-related problems to the manufacturer using the contact
information provided in this leaflet or on your Implant Card.

For patients in the European Union:
Any serious incident that occurs in relation to the device should be reported to the manufacturer and
to the competent authority of the EU Member State in which you reside.

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For patients in Canada:
Suspected medical device-related problems may also be reported to Health Canada through its
medical device problem-reporting system.