PERFECTHA® DEEP Lidocaine

Perfectha results can last up to 18 months in areas such as cheekbones or the chin. For dynamic areas such as the lips, results tend to last approximately 6 months. The period of time between Perfectha treatments will vary depending on product used, treatment area(s) and individual differences. Your physician will also have their own preferred timeline, post procedure, where they can assess your treatment results over time to determine the optimal time to ‘top-up’ different treatment areas, for the best results.

PERFECTHA DEEP LIDOCAINE is an injectable implant for subcutaneous injection. It is indicated for the filling of deep lines and depressions such as nasolabial folds and marionette lines. It is also indicated for moderate contouring and volumisation in areas such as cheekbones, chin, jawline, temples, nose, sub-orbicularis oculi fat (SOOF); and for lip augmentation.

Perfectha Deep Lidocaine is a cross-linked hyaluronic acid gel filler, formulated to treat deep facial lines and skin depressions. Perfectha Deep can also be used to increase lip volume, redefine the nose and treat nasolabial folds and marionette lines. With a cross-linking rate of 90%, the gel is injected into the deep DEEPis (deepest layer of skin). Suitable for filling of deep wrinkles through injection in the medium to deep DEEPis.

1. Take extra care when injecting PERFECTHA DEEP LIDOCAINE into the nose or lips as these are high risk, sensitive areas more prone to developing adverse events.
2. Before starting treatment, the healthcare professional must obtain information about the patient's history and state of health. The healthcare professional must examine the compatibility of the patient, the chosen treatment and the anatomical area to be treated; in particular, it is recommended that double testing or preventive treatment are offered before any injection. The healthcare professional must adhere strictly to the conditions of use for which the device is intended. The healthcare professional must inform the patient about the indications, precautions for use, contraindications and possible side effects of the device.
3. Assemble the syringe ready for injection:
   1. Holding the syringe upright, pull tip cap off the syringe (Fig 1).
   2. Unscrew cap from the needle casing. Holding the Luer Lock firmly in a fixed position, screw the needle into the Luer lock of the syringe by rotating the needle (Fig 2).
   3. Remove needle casing.
4. Before starting the injection, expel all the air from the needle/ cannula by pushing on the plunger until a drop of gel appears at the tip of the needle/ cannula.
5. The patient should be seated at an angle of at least 45° in order to prevent the face from becoming distorted, which increases the risk of "imprecise treatment".
6. Marking the area to be treated should help guarantee the precision of the injection. The area to be treated should first be cleaned and disinfected with an appropriate antiseptic solution. The use of PERFECTHA LIDOCAINE does not require additional anaesthesia.
7. The quantity to be injected depends on the area to be corrected. Do not inject more than 3.0 ml per treatment site during each session.
8. Inject the product slowly; injection of one 1.0 ml syringe takes between 4 to 5 minutes. A low injection speed may help to prevent the detachment of accessories during injection and to reduce the occurrence of local adverse events after injection.
9. If the needle/ cannula becomes blocked, do not increase the pressure on the plunger rod; stop the injection and replace the needle/ cannula. A bubble in the syringe barrel does not constitute a known risk during administration.
10. Administration must be halted just before withdrawing the needle/ cannula in order to prevent spillage of the product at the administration site.
11. As the results are immediate, the quantity administered must correct the defect without producing over-correction.
12. The treated area should be massaged gently to ensure the implant is well distributed.
13. Application of ice packs to the treated area for several minutes is recommended in order to minimise swelling.
14. Dispose of syringe and needle/ cannula as contaminated clinical waste.

Contraindications

• Do not mix with other products before injection. This can alter the functionality of the product and affect the sterility of the gel leading to an increased risk of infection.
• Do not inject via the intramuscular or intravascular route, as there is risk of vascular compression events, which can manifest as discoloration, necrosis or ulceration at the implant site or in the area supplied by the affected blood vessels; risk of ischemic events in other organs as a result of embolism.
• In the event of superficial discoloration or blanching of the skin during treatment, the injection must be stopped immediately and the area massaged until its normal color is restored.
• Do not over-correct.
• Avoid injections in patients with known hypersensitivities to avian proteins, feathers and egg products, as patients with known hypersensitivities to these items may also be sensitive to sodium hyaluronate.
• Do not use in patients:
  • with epilepsy which is not controlled by treatment
  • with tendency to develop hypertrophic scars
  • with known hypersensitivity to hyaluronic acid
  • with known hypersensitivity to lidocaine or to amide-type local anesthetics
  • with porphyria
  • with active (or a history of) autoimmune disease
  • with a history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement)
  • with areas affected by inflammatory and/or infectious skin problems (acne, herpes etc.) or tumors at or near the treatment site
  • undergoing laser or UV treatment, deep chemical peel, dermabrasion or prolonged sun exposure. Following a superficial peel, injection is not recommended if the inflammatory reaction induced by the peel is significant and/or still visible
  • receiving medical treatment that reduces or inhibits liver metabolism (cimetidine, beta blockers)
  • that are pregnant or breastfeeding women, children
• Do not use on areas previously treated with fillers of animal origin, permanent implants or implants containing a substance other than hyaluronic acid. Risk of incompatibility between products could lead to risk of activation or reactivation of the immune system and/or latent infections.
• Do not inject PERFECTHA DEEP LIDOCAINE into the periorbital region (eyelids, under-eye dark circles, crow's feet, tear trough) or glabella region as there is risk of ocular ischemic events leading to loss of vision.

After-care

• The maximum recommended dose of PERFECTHA DEEP gel is no more than 30ml per 60kg bodyweight per full course of treatment without prior anesthesia, and should not exceed 60ml per 60kg bodyweight per year.
• The patient should be advised not to apply make-up for 24 hours following the injection and to avoid prolonged exposure to UV rays, temperatures below 0°C, saunas and Turkish baths for 2 to 3 weeks following the injection.
• Take extra care when injecting into the nose or lips as these are high risk, sensitive areas more prone to developing adverse events.