Fw: Inamed Gets FDA OK For Breast Implant Full-Scale Silicone GelStudy

[Guest guest]

This is a bad omen....

Patty

From: ilena rose <ilena@...>

Sent: Monday, March 05, 2001 7:47 PM

Subject: Inamed Gets FDA OK For Breast Implant Full-Scale Silicone GelStudy

> THE WALL STREET JOURNAL

> March 5, 2001

>

> Inamed Gets FDA OK For Breast Implant Full-Scale Study

>

> Dow Newswires

>

> SANTA BARBARA, Calif. -- Inamed Corp. (IMDC) received Food and

> Drug Administration approval for the expansion of McGhan Medical's IDE

> clinical study of the Style 410 silicone-filled breast implant to a

> full-scale

> study.

>

> McGhan Medical is a unit of Inamed Corp.

>

> In a press release Monday, the company said the expanded study will

> involve 940 patients at 100 institutions and addresses all of the

clinical

> requirement of the FDA's breast implant guidances.

>

> The original feasibility study, approved Sept. 8, 2000, was limited to

25

> patients. The new study will include separate patient cohorts for

> augmentation, reconstruction and revision of existing implants.

>

> Upon completion, the study will serve as the basis for a premarket

> application to market the Style 410 in the U.S. The Style 410 has been

> marketed outside the U.S. since 1994 by McGhan Ltd, also an Inamed unit.

>

> Inamed sells breast implants and facial implants.

>

> - Park; Dow Newswires; 201-938-5388

>

>

>