The composition may be subject to variations, so we advise you to always check the list on the purchased product.
The list of ingredients may vary, so we recommend you always check the list on the product you buy.
Ingredients:
- Cross-linked Hyaluronic Acid (BDDE) 20 mg
- Lidocaine hydrochloride Buffer 3mg
- Phosphate and mannitol buffer - pH 7.2 qsp 1 g
- 1 ml pre-filled syringe
ACTION MODE
The products must be injected into the area to be treated, where they will generate volume by filling the injected area. The products are then slowly reabsorbed over time. The duration of the products depends on the patient's Skin type and the depth of injection. Depending on the characteristics of the area treated, the patient and the depth of the injection, one or two injection sessions are required for optimal treatment of the aesthetic defect. Regular touch-up sessions will ensure that the desired correction lasts.
CONTRAINDICATIONS
The products must not be used
- In association with a peel, laser treatment or dermabrasion. The practitioner must decide how long to wait after these treatments before injecting.
- In patients with a tendency to develop hypertrophic scars.
- In patients with a known hypersensitivity to one of the components.
- In pregnant or milk feeding women or Children.
- In or near areas with inflammatory or infectious skin problems (acne, herpes, etc.).
In addition, Stylage® L and Stylage® L Lidocaine must not be used:
- For injections to treat superficial wrinkles.
- In areas where the Skin is thin (e.g. forehead, periorbital region with eyelids, dark circles, crow's feet), in areas where the vascular network is exposed (e.g. glabellar region) or in the Lips.
Products containing lidocaine (Stylage® S Lidocaine, Stylage® M Lidocaine and Stylage® L Lidocaine) must not be used:
- In patients with known hypersensitivity to amide-type local anaesthetics.
- In patients with porphyria.
PRECAUTIONS FOR USE
- It is strongly recommended that informed consent be obtained from the patient prior to treatment.
- If your patient has a history of herpes, there is a risk that needle punctures may cause a new outbreak of herpes.
- For patients with a history of autoimmune disease, the practitioner must decide on the indication on a case-by-case basis, depending on the nature of the disease and associated treatments. In addition, the practitioner will have to monitor these patients closely, in particular by offering them a double test beforehand and by not injecting them if the disease is progressive.
- Patients with a history of streptococcal disease, such as recurrent sore throat or rheumatic fever, should undergo a double test before any injection. In the case of rheumatic fever with cardiac localisation, injection is not recommended.
- The association of Stylage® S Lidocaine, Stylage® M Lidocaine or Stylage® L Lidocaine with certain drugs which reduce or inhibit hepatic Metabolism is not recommended.
- In the case of haemostasis disorders or anticoagulant treatment, the risk of haematomas is increased.
- Aspirin, NSAIDs, platelet aggregation inhibitors, anticoagulants or Vitamin C should not be taken in the week preceding the injection.
- The products must not be injected into blood vessels. Any accidental intravascular injection could cause vascular occlusion, which could lead to rare but serious complications such as visual impairment, blindness, necrosis of the skin and/or underlying tissues, depending on the area injected.
- The products must not be injected into the nerves. Any accidental nerve damage could cause transient paresthesia.
- It is recommended that Stylage® implants are not injected into an area that has already been corrected with implants other than those in the Stylage® range, as no clinical data is available for such cases.
- It is advisable not to mix with any other product.
- Only the needles supplied with the products should be used for injection, as the combination of these two devices has been validated.
- Foam-tipped cannulas (sterile, CE-marked, with a tapered connector) may be used. In this case, the practitioner should :
- Select the appropriate cannula size (gauge and length) for the correction to be performed.
- Scrupulously respect aseptic conditions (pre-hole in particular).
- Inject slowly to avoid overcorrection.
- In the event of increased pain during injection, stop the procedure and remove the needle/cannula.
- Do not use if packaging is damaged (syringe, blister, seal).
- Inject immediately after opening.
- Dispose of the syringe and the residual product at the end of the injection, as well as the needles/cannula in an appropriate collection point, in accordance with the national regulations in force.
- Stylage® implants are for single use only. Do not reuse.
An implant must only be used for one patient in order to prevent any risk of cross-contamination.
- After opening, the product cannot be resterilised under any circumstances, even if the implant has not been injected.
- Stylage® S Lidocaine, Stylage® M Lidocaine and Stylage® L Lidocaine contain the active ingredient lidocaine hydrochloride, which may produce a positive reaction in doping control tests.
ADVICE TO PATIENTS
- Recommend the use of a high protection factor Suncare cream for a fortnight following treatment.
- Recommend that patients do not wear make-up for 12 hours after the injection and that they avoid exposing the treated area to sources of intense heat (UV, sauna, hammam) or extreme cold, at least until any post-injection swelling or redness has disappeared.
- The practitioner must inform the patient that he/she must keep him/her informed of any "abnormal" development of the treated area (see adverse reactions).
UNDESIRABLE EFFECTS
The practitioner must inform the patient of possible immediate or delayed adverse reactions that may occur after the injection of the products, in particular (non-exhaustive list):
- Inflammatory reactions such as redness, oedema or erythema potentially associated with itching and/or Pains at the injection site, which usually resolve within a week.
- Haematomas.
- Induration or nodules, Colouring or discolouration at the injection site.
- Poor efficiency or poor filling effect.
- Local mobility of the implant.
- Rare cases of necrosis, abscess, granuloma and hypersensitivity have been described in the literature following Hyaluronic Acid injections. Patients should be informed of these cases.
- The incidence of adverse reactions may be increased in patients with a severe allergic background, dermatological pathology, haemostasis disorders or inflammatory pathology, or if the precautions for use are not observed.
- The patient should inform the practitioner of any of the above adverse reactions that persist for more than a week, or of the appearance of any other adverse reaction. The practitioner should report this to the retailer or manufacturer as soon as possible and provide appropriate management.
STORAGE - EXPIRY DATE
- The products must be used before the expiry date indicated on the packaging and on the syringe.
- Products must be stored in their original packaging at between 2°C and 25°C, protected from frost and light.
- Failure to comply with storage conditions may affect product performance.
