|
| |
About The Product
Indications (where ArteSense can be used)
Contraindications (when ArteSense can’t be used)
Side Effects
Skin Testing
Techniques and Tips
Granulomas
|
| |
Q. What is ArteSense?
A. ArteSense is the next generation of Artecoll® with a new & improved delivery system. It is the only permanent injectable implant used for the long-lasting correction of wrinkles and other skin depressions. ArteSense is composed of microscopic beads which are folded into a collagen solution containing anesthetic for the relief of mild post-treatment tenderness.
ArteSense received approval in July 2006 and Artecoll has been approved in Canada since September 1998.
Q. How does ArteSense work?
A. ArteSense utilizes the body’s natural ability to encapsulate foreign bodies by the formation of connective tissue surrounding the PMMA microspheres. The process of encapsulation of the microspheres by the body’s own connective tissue (collagen) is complete in about 3 months. Absorption (phagocytosis) and/or dislocation of the microspheres is prevented by the encapsulation of each individual microsphere with connective tissue.
It is possible that after the swelling has gone down, your wrinkles may temporarily return after a few weeks. This is a normal occurrence, and they will start to disappear again over the next few months as the body forms its own connective tissue.
Q. Does the ArteSense injection have to be repeated as done with collagen?
A. Depending on the patient and the correction to be made, a second or third injection may be needed if the degree of correction from the first injection is not optimal. ArteSense is a permanent implant that remains for the life of the patient. Unlike collagen which lasts 3-6 months, ArteSense’s effects have been shown to last 10 years and longer. However, final results will vary depending on each patient as the skin continues to age, as well as facial mimicry (frowning, squinting, smiling, etc.).
Q. Is ArteSense safe?
A. Yes. ArteSense is extremely safe. There have been no reports of rejection of the microscopic beads (PMMA). PMMA has been used since the early 1930's in dental prostheses, and since 1947, when the first hip prosthesis was introduced. Many scientific articles on bone repair have mentioned the chemical inertness and biocompatibility of PMMA.
Q. What is the source of the collagen used in ArteSense?
A. The atelocollagen used in ArteSense is sourced from a closed herd of cattle located in the Australia, which has been declared as a BSE free country by the Canadian Food Inspection Agency (CFIA).
Q. Can a face-lift be performed after an ArteSense implantation?
A. Yes. The skin on the face is thick enough to prevent the implants from becoming visible after a face-lift. ArteSense should not be used in thin, loose skin. It is possible that an implant in thin skin will be visible after a face-lift.
Q. Is an ArteSense injection painful?
|
|
A. Injections are often painless, however, anesthesia can allay any worry and is recommended before treatment. Normally, a topical anesthetic such as Betacaine® Gel (5% lidocaine) is put on the area to be treated 20-30 minutes prior to the procedure. Also, ArteSense contains lidocaine to minimize post-treatment tenderness. The needle used for ArteSense is very fine and the injection is virtually painless.
Q. How long does the ArteSense implant last?
A. The improved results have been shown to last 10 years or longer depending on the patient. The implant will remain for the rest of the patient’s life. The cosmetic effect of the implant will diminish over time as new wrinkles are formed.
Indications (where ArteSense can be used)
ArteSense is an injectable implant for skin augmentation, the lasting correction of wrinkles and other skin depressions.
Common uses:
|
| · |
Folds and wrinkles of the face |
| · |
Acne scars |
| · |
Laugh lines (nasolabial folds) |
| · |
Horizontal forehead frowns |
| · |
Frown lines (glabellar) |
| · |
Depressed corners of the mouth
| |
|
|
|
 |
|
Other uses:
| · |
Subcutaneous skin defects |
| · |
Filling of orbita of the eyes |
| · |
Augmentation of cheekbones, chin or bridge of the nose |
| · |
Irregularities of the nose |
| · |
Small facial bone or hand bone defects |
| · |
Augmentation of the nipple | |
|
| |
|
Contraindications (when ArteSense can’t be used)
|
| · |
Positive reaction to skin test |
| · |
Known allergy to lidocaine |
| · |
Known allergy to collagen or bovine products |
| · |
Known immune diseases |
| · |
Susceptibility to enlarged scars (keloids) |
| · |
Thin, loose skin
| |
|
Q. Can ArteSense be used during pregnancy?
A. Consult your physician to evaluate the potential benefits versus the possible side effects.
Side Effects
Q. What are the possible side effects?
A. As with all injectable implants, swelling, redness, lumps/bumps, bruising and itchiness may occur following treatment. These symptoms normally subside within a few days.
Q. What is the purpose of the skin test?
A. The skin test is used to determine if the patient is senstive or allergic to the collagen or lidocaine in the product.
Q. What is contained in the ArteSense test syringe?
A. The test syringe contains a collagen solution and lidocaine (no microscopic beads).
Q. Is it necessary to do skin testing?
A. Due to the low incidence of sensitivity reaction (< 0.1%), skin testing is not mandatory. Skin testing is now optional, at the discretion of the physician.
Q. I have been previously injected with collagen. Do I need to receive an ArteSense skin test?
A. The absence of an allergic reaction to previous collagen injections is highly indicative that ArteSense will be well tolerated and that an additional skin test is not required.
Techniques and Tips
Q. Can ArteSense be used in thin skinned areas?
A. Thin, loose skin is inadvisable (contraindication) for ArteSense. The risk of the skin becoming lighter (blanching) increases, as does the potential for the implant to be detectable resembling rubber-like nodules.
Q. Has ArteSense been injected into elderly skin?
A. Yes. ArteSense has been injected in women over 70 years old. Care must be taken in patients with thin or loose skin.
Q. Is there data in patients who have been injected more than 10 years ago?
A. The use of ArteSense was first investigated in 1989 and there are patients who have had implants for more than 10 years (personal communication from Dr. Lemperle). However, ArteSense does not stop time and new wrinkles can be expected to appear close to the site of implant. There are no reports of problems with these first treatments.
Granulomas
Q. What is the incidence of granuloma (inflammation under the skin) formation with ArteSense?
A. The development of granulomas after the administration of ArteSense has been reported very rarely. There are 24 reported cases from more than 100,000 syringes used (0.018%). In the event of a granuloma, it can be effectively treated with corticosteroids.
|
|