|
|
- AGING
Permanent Injectables for Wrinkle Reduction
- May Have Drawbacks
- This is the text of a press release from the ASPS (The American Society of Plastic Surgeons) about Drawbacks of Permanent Injectables for Wrinkle Reduction.
- FOR RELEASE ON RECEIPT:
- CONTACT: Theresa Hill
February 28, 2003
- (847) 228-9900 ext. 349, 350
- media@plasticsurgery.org
Media Statement
Permanent Injectable for Wrinkle Reduction May Have Drawbacks
FDA General and Plastic Surgery Device Panel Recommends Approval of Artecoll®
In the race to produce the ultimate non-surgical wrinkle reduction therapy, many products await decisions from the FDA for use in the United States.
One in particular, Artecoll®, has completed its clinical trials and today the FDA's General and Plastic Surgery Device Panel recommended its approval with conditions. The conditions include patient education materials, physician training and product labeling of approved applications. The panel also recommended a 5-year follow-up study.
Artecoll is an injectable soft tissue filler composed of 75 percent collagen and 25 percent polymethylmethacrylate microspheres (non-silicone, carbon–based polymers). Artecoll’s manufacturer claims the injectable is permanent, as the microspheres do not absorb into the body.
Because of its permanence, Artecoll requires greater skill to inject. There have also been reports that some patients experience lumping of the product after injection. A potentially serious adverse effect of Artecoll is granulomas – localized skin reactions to foreign bodies in the tissue, which can appear as hardness or inflammation with itchiness (a rash). Another concern with Artecoll is the possibility that the microspheres can move to areas of the body other than was originally intended.
Conclusion
As the largest plastic surgery organization in the world and the foremost authority on cosmetic and reconstructive plastic surgery, the American Society of Plastic Surgeons welcomes the introduction of new and exciting therapies and products. Artecoll seems to have benefit as an injectable soft tissue filler, however, without meaningful scientific evaluation, physicians may be unwilling to use it until there is convincing evidence that the benefits outweigh the risks to patient safety.
-
|
- people who read this
- enjoyed these articles:
-
|
