PERFECTHA® SUBSKIN

Perfectha® can yield outcomes enduring up to 18 months in regions like the cheekbones or chin, while dynamic areas such as the lips typically exhibit results for about 6 months. The interval between Perfectha® treatments will fluctuate based on the product utilized, treated area(s), and individual variances. Additionally, your physician will establish their own preferred post-procedure timeline to evaluate your treatment results over time and ascertain the ideal timing for "topping up" various treatment areas, to achieve optimal results.

PERFECTHA® is a line of resorbable hyaluronic acid (HA) gel implants intended for reconstructive purposes in the treatment, for instance, of facial lipoatrophy, or morphological asymmetry associated with the aging process or other underlying conditions. PERFECTHA® is for intradermal and sub-cutaneous application and is implanted in the areas of the face and hands to fill skin depressions and also for the augmentation of tissue volume.

This PERFECTHA® product is an injectable implant for deep sub-cutaneous to supraperiosteal injection. It is indicated for significant loss of volume in areas such as cheekbones, chin, jawline, temples, forehead, bridge of the nose and hands.

Perfectha® Subskin is an useful injectable dermal filler indicated to redefine facial contours and to volumize malar areas, chin, cheeks, hands and nose. In addition, hyaluronic acid filler can be used to treat skin depressions and scars. Perfectha® Subskin is ideal to augment and lift upper cheeks and re-contour chins. The crosslinked hyaluronic acid gel has a cross-linking rate of 90% and is intended to be injected into the Sub-cutaneous dermis. For remodelling, treating age-related conditions, lipoatrophies or facial asymmetries.

The device is intended to be used by registered healthcare professionals and intended to be used in adult patients (over 18) whom are not pregnant or breast-feeding and are deemed appropriate for treatment by the healthcare professional.

PERFECTHA® SUBSKIN is a sterile cross-linked hyaluronic acid gel of non-animal origin. The gel is supplied in a pre-filled, ready-to-use, single-use syringe.

With PERFECTHA® implants, it is possible to fill lines and restore volume to the face via the action of hyaluronic acid, which has the ability to bind to water. These are "passive" products, the main effect of which is achieved without any biological or pharmacological action. Their filling effect is a function of the quantity of implant injected; the maximum recommended dose must however not be exceeded.

Effects are immediately apparent; how long they last depends on the volume and depth of injection, the healthcare professional's injection technique and the patient's lifestyle. This PERFECTHA® formulation is biodegradable and is broken down by the metabolic pathways of hyaluronic acid already present in the body. PERFECTHA® is an implantable dermal filler. Treatment effects have variable duration** dependant on the product variant used, medical practitioner injection technique, patient lifestyle and metabolic rate.

**studies have shown effects from 6-18 months dependant on product variant.

1. 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, contraindications, incompatibilities, side effects, and undesirable effects of the device.

2. Assemble the Syringe ready for injection:

3. Holding the syringe upright on the ribbed part of the Luer lock, tilt the white cap to break seals (Fig 1).
4. Remove the syringe cap in a straight upward direction (Fig 2).
5. Unscrew cap from the needle/ cannula casing. Holding the Luer Lock firmly in a fixed position, screw the desired needle/ cannula into the Luer lock of the syringe by rotating the needle/ cannula (Fig 3).
6. Remove needle/ cannula casing.

7. 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.

8. 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".

9. 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. Local or regional anaesthetic block may be used depending on patient/ healthcare professional preference.

10. The quantity to be injected depends on the area to be corrected. Do not inject more than 3.0ml per treatment site during each session.

11. Inject the product slowly; injection of one 1ml 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.

12. 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.

13. Administration must be halted just before withdrawing the needle/cannula in order to prevent spillage of the product at the administration site.

14. As the results are immediate, the quantity administered must correct the defect without producing over-correction.

15. The treated area should be massaged gently to ensure the implant is well distributed.

16. Application of ice packs to the treated area for several minutes is recommended in order to minimize swelling.

17. 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 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.
• Do not inject via the intramuscular or intravascular route. 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, 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 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; risk of activation or reactivation of the immune system and/or latent infections.

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 makeup 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.