Collagen Dermal Implant

-- Description
Sunmax Collagen Implant I-Plus is a sterile injectable device composed of  highly purified SPF (Specific Pathogen Free) porcine dermal collagen that is purified through several advanced purification process. The final collagen implant product has been sterile filtered and filled in a single use syringe, which is then packaged with a sterile needle under a sterile condition.
-- Composition
Each syringe contains 35 mg/ml purified collagen.
-- Functions
For correction of facial defects and soft tissue augmentation.
-- Mode of action
Sunmax Collagen Implant I-Plus is mainly composed of Type I atelocollagen. After injection, the suspended collagen bears appropriate protease resistance and therefore can slow down the degradation. The implant forms a soft cohesive network of fiber, which is responsible for restoring contour for a long time. Over a period of months, the implant is colonized by host connective tissue cells; once established, the implant takes on the texture and appearance of normal host tissue and is subjected to the same stress and ageing processes. As a result of being biodegradable, the suspended collagen injected will remain approximately more than 6 months depending on the injected location.
-- Direction for use
1. Prior to the treatment of Sunmax collagen Implant I-Plus, the patient should be fully informed of the indications, contraindications, warnings, precaution, possible adverse events and method of administration.
2. At least perform implantation test once prior to treatment with Sunmax Collagen Implant I-Plus so as to evaluate the suitability of treatment.
3. In order to prevent inflammation and infection, hygienic and aseptic conditions must be observed. The area to be treated should be washed and swabbed with alcohol or other antiseptics.
4. Sunmax Collagen Implant I-Plus is implanted intradermally through a 30 gauge of sterile needle. The needle should be placed into the plane(s) of apparent deformity at 10~25 degree angle.
5. If blanching is not achieved, withdraw the needle immediately as it has probably been placed too deeply in the dermis.
6. Avoid injecting Sunmax Collagen Implant I-Plus into blood vessels as collagen can initiate platelet aggregation and may cause vascular occlusion and localized infarction or embolic phenomena. Inject a suitable amount of the collagen implant sequentially in the defected area followed by gently massaging the injection area.
7. The injection amount is determined based on experience according to the different regions for correction. Some regions need several repeating treatments. The correction amount is decided by the supervision of a medical doctor.
8. Sunmax Collagen Implant I-Plus is for single use only. Sterility is maintained only if the package is intact and undamaged.
-- Contraindications
1. Patients with a positive response to the required implantation test.
2. Patients with a history of anaphylactic reactions or severe allergies.
3. Patients with known hypersensitivity to collagen products or allergy arose from local injection with other implants.
4. This product is not for use in breast augmentation or implantation into bone, tendon, ligament or muscle.
5. The safety of Sunmax Collagen Implant I-Plus in pregnancy or breast-feeding woman has not been established.
-- Warnings
1. In order to the perfective results, the over correctional amount of injection should be according to the need for regional defect correction.
2. Sunmax Collagen Implant I-Plus should be used with a great caution in patients on immunosuppressive therapy.
3. Patients using substances which may reduce coagulation, such as aspirin and non-steroidal anti-inflammatory drugs, as with any injection, may experience increased bruising or bleeding at injection sites.
4. The syringe needle and any unused material must be discarded after a single treatment visit.
5. This medical device can only be used by a medical doctor.
-- Adverse events
1. Sensitisation (allergic) reactions characterized by erythema, swelling, induration and/or pruritus at treatment sites.
2. Systemic complaints (any response which involves symptoms at non-injected sites) have included flu-like symptoms (fever, headache, myalgia, nausea, malaise, or dizziness); pruritus; urticaria; rash; transient visual disturbances including blurred vision tingling and numbness; transient polyarthralgia; and various systemic diseases including immune-mediated diseases.
-- Storage conditions
‧Sunmax Collagen Implant I-Plus should be stored between 2 ℃ ~8 ℃.
‧Do not freeze.
-- Package specification
1ml / 0.5ml / 0.1ml / each syringe
EXP. DATE: 2 years