BioReFeel®
Device description and the method to be followed for safe use of the product. BioReFeel® is a pre-filled syringe containing a viscoelastic, injectable biodegradable gel with a bulking action, based on Hyaluronic Acid of bio-fermentative origin and Amino Acids.
Reserved for healthcare professionals. BioReFeel® should only be administered by healthcare professionals who are properly trained, qualified or accredited in accordance with national legislation. This page reproduces technical and safety information intended for professional use and is not patient-facing advertising.
Purpose and users
Purpose
The purpose of this document is to describe the BioReFeel device and the method to be followed for safe use of the product.
Users
BioReFeel® should only be administered by healthcare professionals who are properly trained, qualified or accredited in accordance with national legislation.
Description
BioReFeel® is a syringe pre-filled with a viscoelastic, injectable biodegradable gel, with a bulking action based on Hyaluronic Acid of bio-fermentative origin, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide, Succinic Acid and Amino Acids. The device is clear, colourless, homogeneous, viscoelastic, sterile, pyrogen-free, latex-free, having physiological pH.
Composition
- Hyaluronic Acid of bio-fermentative origin
- Phenoxyethanol
- Ethylhexylglycerin
- Sodium Hydroxide
- Succinic Acid
- Amino Acids
Each package contains
- A pre-filled sterile disposable syringe with 2.4 ml of solution
- Two sterile disposable needles (29G, 13 mm)
- The instructions for use of the product
- The patient annex
- An implant card
- Two adhesive labels reporting information about the product and the manufacturer
To guarantee traceability, one label must be provided to the patient and the other must be annexed to the patient documentation.
Intended use
This product is an injectable implant indicated for increasing facial tissue volume. Its use is recommended for the correction of severe wrinkles or to redefine the shape of cheekbones, or tear troughs.
Aesthetic indications
- Modification of skin aging
- Correction of severe wrinkles
- Redefinition of cheekbones
- Redefinition of tear troughs
Depending on the area to be treated and the tissue support, the product should be injected between the middle and deep dermis. Depending on the corrections to be made, one or more treatment sessions may be necessary. Thanks to its viscoelastic properties, the product is evenly distributed in the injected tissue and, being a biodegradable implant, is reabsorbed within four weeks.
BioReFeel® is intended to be injected only by authorized medical specialists or, where applicable, by healthcare professionals in accordance with local legislation, professionals who are skilled in injection techniques and have a thorough knowledge of the anatomy and physiology of the injection site and surrounding areas.
The summary of safety and clinical performance can be found in the technical documentation of BioReFeel®. Please provide the patient, before treatment with the device, a copy of the patient annex.
Methods of action
Thanks to the action of Hyaluronic Acid, the main component of the dermal extracellular matrix, the product moisturises the skin and adds volume to the tissues. The characteristic structure of Hyaluronic Acid allows it to trap up to a thousand times its weight in water, guaranteeing it the ability to add volumes and lift tissues.
The combination of amino acids included in the formulation supports the action of hyaluronic acid, resulting in a synergic effect and thus improved results by favoring skin hydration, filling skin depressions, and restoring soft tissue volume, while improving the overall appearance of the skin.
Hyaluronic Acid can trap up to a thousand times its weight in water — the basis of both the volumising and the lifting effect of the implant.
Precautions for use
Before treatment, patient suitability must be assessed by collecting an adequate medical history. Before treatment, the specialist physician must ensure that hyaluronidase be readily available. Injection of filler into soft tissues is a medical procedure that involves a risk of infection and must be carried out in a suitable environment and taking all the usual precautions for such interventions. The specialist physician performing the treatment must have a good knowledge of facial anatomy.
Check before use
- Check the expiration date on the product label and the integrity of the inner package before use.
- Do not use after the expiration date or if the packaging is damaged.
- If the contents of a syringe show signs of separation, bubbles and/or appear cloudy, do not use the syringe.
- Do not use syringes or needles if you notice any damage, or if they have been unintentionally opened before use.
- Do not use or try to straighten a curved needle; discard and replace.
Following the use of the product, vascular occlusions may occur, potentially leading to the following adverse events. The healthcare professional performing the procedure is required to take the customary precautions associated with this intervention.
- Visual disturbances and/or vision loss
- Ischemia
- Tissue necrosis
- Embolism
- Thrombosis
- Infarction
Dosage and administration
Clinical studies have shown the absence of side effects using up to a volume of 2.4 mL. Do not overdo the corrective action: injecting an excessive volume can lead to certain side effects such as necrosis and oedema of the tissues.
BioReFeel® is intended to be injected only by licensed medical specialists or, where applicable, healthcare professionals in accordance with local legislation, who are skilled in injection techniques and have a thorough understanding of the anatomy and physiology of the injection site and surrounding areas.
Patient assessment and preparation
Prior to treatment, patient suitability must be assessed by collecting an adequate medical history, and the patient must be informed of indications, expected outcomes, contraindications, precautions and potential side effects. Before treatment, the specialist physician must ensure that hyaluronidase be readily available.
- Pay particular attention to cleaning and disinfecting the patient’s skin before treatment to avoid bacterial infections.
- Make-up must be completely removed and the area to be treated must be washed thoroughly with soap and water.
- The areas to be treated must be disinfected with an appropriate antiseptic solution before injection.
- Follow the rules for asepsis and all normal usage precautions associated with injection procedures.
Injection
The injection must be performed using the sterile needles provided in the package. BioReFeel® is designed to be injected into the medium or deep dermis, depending on the treatment indication. The choice of the most appropriate technique is left to the doctor’s discretion, depending on the specific needs of the patient and the treatment protocol adopted.
- Avoid injecting too near the surface as the result may be uneven.
- The product must not be injected near a blood vessel or nerve.
- If the patient becomes pale during the injection, the injection must be discontinued immediately and all necessary action taken until the normal complexion returns.
- Stop the injection well before withdrawing the needle from the skin to prevent the product from flowing out of the treatment site.
After the injection and follow-up
The treated sites must be carefully massaged to ensure even distribution of the product in the correct areas. Type and severity of the defect to be treated, depth and injection technique determine the degree and duration of correction.
- Wait for at least 15 minutes to detect any pallor caused by arterial occlusions.
- For optimal results, subsequent treatments may be necessary.
- Wait at least 15 days between treatments to allow effective evaluation of the outcome and, in any case, wait until the side effects have been resolved.
- At the end of treatment, dispose of any unused product and needles.
Preparing the syringe for use
Unscrew the front cap
Remove the cap on the front of the pre-filled syringe.
Fit the sterile needle
Screw in a sterile needle from the package until it is fully inserted, then remove the needle cap.
Prime the needle
Before injecting, press the plunger until the product begins to flow out of the needle.
Aspirate and verify
After inserting the needle and before injecting, it is recommended to pull back the plunger slightly to aspirate and check that the needle is not in a blood vessel.
Inject slowly
Inject slowly and apply the minimum amount of pressure necessary.
Massage and dispose
It is important to massage the treated area after the injection to ensure that the product has been distributed evenly. At the end of treatment, dispose of any unused product and needles.
Use of implant card and traceability label
Label one — to the patient
At the end of the treatment, the doctor must paste one of the traceability adhesive labels on the back of the implant card; he must then fill in the implant card as indicated and deliver it to the patient.
Label two — to the medical record
The second traceability adhesive label must be placed inside the patient’s medical record.
The second implant card is a backup.
| Name of the patient or patient ID | |
| Date of the treatment | |
| Name and address of the healthcare facility / healthcare professional |
Contraindications
Side effects
The specialist performing the treatment must inform the patient about potential side effects that may occur immediately after the injection or after a certain period of time, including the following.
Inflammatory reactions
Transient erythema, oedema, bruising, pain, numbness, tingling, swelling, puncture marks, redness, itching, heat at the implant site, papules at the injection sites and increased surface sensitivity. Compartmental pressure problems and compartment syndrome, transient vascular occlusion, compression, contour irregularities and/or slight asymmetries, as well as surface wounds, haematoma, ecchymosis, changes in surface sensitivity, poor efficacy of the treatment, manifested by a diminished filling effect or reduced duration of the effect in the treated area, seroma, discolouration of the skin or implant site, persistent inflammatory reaction, local swelling may also occur, beside lymphadenopathy, infection, pus, purulent discharge, granuloma, reactivation of herpes, abscess, fever, hives, rash, angioedema, cellulitis, difficulty in wound healing, formation of lumps, bleeding, swelling, protuberances, nodules, hypersensitivity, mass formation at the implant site, implant visibility, hardening, implant vasculitis, capsule formation and contracture, generalized scleromyxedema, telangiectasia, vasculitis, vasospasm and vasovagal reaction during injection.
Allergic and hypersensitivity reactions
Rare allergic/hypersensitivity reactions and related symptoms, such as erythema, hives, itching, oedema (even persistent or prolonged), skin rash, angioedema, anaphylaxis, bronchospasm, hyperventilation, nausea, vomiting, changes in heart rate or blood pressure, loss of consciousness.
Serious rare side effects
Transient or permanent deformity, scar sarcoidosis, scarring and scar hyperpigmentation, discolouration of the skin (hypo-hyperpigmentation), prolonged oedema, embolization and thrombosis, infarction and tissue necrosis, loss of vision, severe visual disorders, vascular occlusion, compression, nerve damage, stroke, ischaemia and death.
If a patient shows any of the symptoms described herein, stop the injection immediately and seek immediate medical evaluation by a medical professional.
The specialist shall ask the patient to keep him/her informed of any “abnormal” developments. The patient shall inform the doctor of any of the above side effects or the appearance of other adverse events. Any undesirable effects, even if not present on this document, must be promptly reported to the Distributor and the Manufacturer.
Incompatibility and attention
Incompatibility
There is a known incompatibility between hyaluronic acid and quaternary ammonium salts; do not put BioReFeel® in contact with these substances and/or with surgical medical material treated with these substances.
Attention
- Check the expiration date on the product label.
- Adopt the storage conditions given in the leaflet. Do not freeze or refrigerate the product.
- If the contents of a syringe show signs of separation, bubbles and/or appear cloudy, do not use the syringe. The gel may deteriorate, reducing its efficiency and dry out, preventing extrusion from the needle.
- Do not reuse. The sterility of this device cannot be guaranteed if the device is reused.
- Do not resterilise.
- At the end of the treatment, throw away the unused product.
- The needles must be disposed of in special containers. Proceed in the same way for syringes. For their correct disposal, refer to the applicable current directives.
Provisions
To avoid biohazards, handle and dispose of syringes and needles in accordance with health facility procedures and relevant regulations. The Manufacturer disclaims all liability for direct, indirect or consequential damages caused by misuse or abnormal use of BioReFeel® or its use in a manner other than that described in this leaflet. The user is responsible for verifying the suitability of the product for the intended use and assumes all risks and responsibilities in this regard.
In case of malfunction or deterioration of the characteristics or performance of the medical device, or inadequacies in these instructions for use, or incidents related to the use of the device from which serious damage to the health of the patient or operator is derived or may arise, must immediately notify in writing the Manufacturer and the competent authority of the Member State.
Following the report received, the Manufacturer will immediately implement the procedure for examining and resolving the reported non-conformity.