Inamed, Medicis Hyaluronic Acid Dermal Fillers Share Nov. 21 Panel Review

[Joyce]

Inamed, Medicis Hyaluronic Acid Dermal Fillers Share Nov. 21 Panel
Review

Hyaluronic acid-based dermal filler products will be reviewed by FDA's
General & Plastic Surgery Devices Panel Nov. 21.

The panel is scheduled to cover premarket approval applications for
Inamed's Hylaform and Medicis/Q-Med's Restylane. Both injectable
devices are intended to restore soft tissue facial contours, such as
nasolabial folds.

Inamed's facial wrinkle treatment, Hylaform, was developed by Genzyme.
The primary active component is hylan B, a modified form of
hyaluronan; the product is derived from an avian source. Inamed filed
the final module of a PMA in July 2003.

Medicis holds U.S. and Canadian rights to Q-Med's Restylane gel. The
company claims that because Restylane is non-animal based (unlike
Hylaform), patients can receive the filler without allergy tests. The
PMA was submitted in June 2002.

Other Medicis HA-based products include Perlane (a condensed version
of the same treatment) and Restylane Fine Lines, both available
internationally.

Inamed offers a broader line of fillers than Medicis. In March, Inamed
earned PMA supplemental approval of CosmoDerm and CosmoPlast human
collagen fillers. The approvals were based on a PMA for Inamed's
Zyderm and Zyplast bovine collagen implants. Internationally, Inamed
markets Hylaform Plus and Fineline.

The same panel reviewed Inamed's silicone breast implant PMA Oct.
14-15, voting 9-6 in favor of approval.

To arrange for webcasts, videotapes or live videoconferencing of this
meeting, email ***@elsevier.com or call 800-332-1370 ext.
7210.
Posted: Thursday, October 30, 2003

[Joyce]

Post by Joyce
Inamed, Medicis Hyaluronic Acid Dermal Fillers Share Nov. 21 Panel
Review
Hyaluronic acid-based dermal filler products will be reviewed by FDA's
General & Plastic Surgery Devices Panel Nov. 21.
The panel is scheduled to cover premarket approval applications for
Inamed's Hylaform and Medicis/Q-Med's Restylane. Both injectable
devices are intended to restore soft tissue facial contours, such as
nasolabial folds.
Inamed's facial wrinkle treatment, Hylaform, was developed by Genzyme.
The primary active component is hylan B, a modified form of
hyaluronan; the product is derived from an avian source. Inamed filed
the final module of a PMA in July 2003.
Medicis holds U.S. and Canadian rights to Q-Med's Restylane gel. The
company claims that because Restylane is non-animal based (unlike
Hylaform), patients can receive the filler without allergy tests. The
PMA was submitted in June 2002.
Other Medicis HA-based products include Perlane (a condensed version
of the same treatment) and Restylane Fine Lines, both available
internationally.
Inamed offers a broader line of fillers than Medicis. In March, Inamed
earned PMA supplemental approval of CosmoDerm and CosmoPlast human
collagen fillers. The approvals were based on a PMA for Inamed's
Zyderm and Zyplast bovine collagen implants. Internationally, Inamed
markets Hylaform Plus and Fineline.
The same panel reviewed Inamed's silicone breast implant PMA Oct.
14-15, voting 9-6 in favor of approval.
To arrange for webcasts, videotapes or live videoconferencing of this
7210.
Posted: Thursday, October 30, 2003

Dear Kathi,
I sincerely apologize for over posting on you. I didn't know
you were posting the same article. I will try to be more cautious from
here on in. I know sometimes we post since the article is not showing
and then another is posting at the same time, but I didn't mean to do
this.
Looks like we just wanted to get the message to the board and
let them know that our good buddies at Inamed are still trying to
destroy others, not just the sisters,
Hugs & Smiles, Joyce

[h***@gmail.com]

Hyaluronic acid fillers
Hyaluronic acid is a natural substance found naturally in the body. By filler treatment is hyaluronic acid injected into wrinkles to fill them up. Hyaluronic acid produced as a gel of non-animal active substance. This gel is injected into the skin with very thin needles. Examples of typical areas treated are wrinkles between and on the side of the eyes, wrinkles around the mouth, deeper lines from the nose (nasolabial furrow) and mouth. The treatment gives immediate results. There are several different hyaluronsyrefillere: Restylane , Perlane, Juvederm , Stylage, Revanesse, Esthelis and Elevess.
http://www.oslohudlegesenter.no/