FDA Staff Questions Value of Implant Data

[Guest guest]

Note from Ilena:

I see this as very hopeful news!

www.BreastImplantAwareness.org

http://abcnews.go.com/Health/wireStory?id=646329

FDA Staff Questions Value of Implant Data

Reuters

Apr 6, 2005 — WASHINGTON (Reuters) - New data from Inamed Corp. and

rival Mentor Corp. on their silicone breast implants are of " limited

value " in assessing the risk of ruptures, U.S. regulatory staff said

in reports made public on Wednesday.

The Food and Drug Administration released the staff evaluations

ahead of a three-day advisory panel meeting next week on whether

silicone breast implants should return to the market after they were

banned for most women in 1992 over health concerns.

Many women and plastic surgeons say the silicone devices have a more

natural look and feel than saline-filled breast implants.

Although studies have failed to find a link between silicone

implants and chronic diseases such as cancer, lupus and rheumatoid

arthritis, some are convinced that leaking silicone can cause

sickness.

" These data are of limited value to address the rupture rate over

the lifetime of the device due to the short duration of follow-up, "

the FDA staff wrote about Mentor's information, adding it was

also " of limited value to address the local health consequences of

rupture due to the small number of ruptures observed. "

The reviewers made similar comments about studies by Inamed, that is

being acquired by Medicis Pharmaceutical Corp.

Officials for both companies could not immediately be reached for

comment.

Inamed shares were off $1.12 at $66.98 in early afternoon trading on

Nasdaq. Medicis shares were off 81 cents at $28.82 and Mentor shares

were up 2 cents at $32.78, both on the New York Stock Exchange.