Fw: Inamed Completes Filing of Its Regulatory Submission with

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From: " Kathi " <pureheart@...>

Sent: Tuesday, December 31, 2002 6:10 PM

Subject: Inamed Completes Filing of Its Regulatory Submission with

> Click here: 12/31: Inamed Completes Filing of Its Regulatory Submission

> with the FDA for Silicone

>

> Inamed Completes Filing of Its Regulatory Submission with the FDA for

> Silicone Breast

> Implants

>

>

> SANTA BARBARA, Calif.--(BUSINESS WIRE)--Dec. 31, 2002--

>

> Premarket Approval Application for Silicone Gel-Filled

>

> Breast Implants Contains Clinical Data from Augmentation,

>

> Reconstruction and Revision Patients

>

> Inamed Corporation (Nasdaq:IMDC), a global medical device company, today

> announced the filing

> of the fifth and final module of its Premarket Approval Application

> (PMA) covering its line of

> McGhan® Silicone Gel-Filled Breast Implants with the U.S. Food and

> Drug Administration (FDA).

> The Company said that the final module included data from its U.S. Core

> and Adjunct Clinical

> Studies, plus additional information required by the FDA.

>

> " Many women who are participating in our U.S. clinical studies as breast

> augmentation,

> reconstruction or revision patients have benefited from the availability

> of our silicone-filled breast

> implant products, " said Nick Teti, Chairman, President and Chief

> Executive Officer of Inamed. " We

> stated last summer that we were on track to file our PMA for silicone

> gel-filled breast implants by

> the end of 2002 and we have achieved that objective. "

>

> Mr. Teti added, " This achievement is the culmination of a true team

> effort by many departments

> within the Company, working together - Clinical Research, Regulatory

> Affairs, Technologies,

> Manufacturing, Quality, Product Support and Marketing. I am very proud

> of the standard of

> excellence and dedication that our team has demonstrated. "

>

> According to the American Society of Aesthetic Plastic Surgery and the

> American Society of Plastic

> Surgeons, more than 80,000 breast reconstruction procedures and 210,000

> breast augmentation

> procedures were performed in 2001, versus the American Society of

> Plastic Surgeons' figures of

> 78,832 breast reconstruction procedures and 187,755 breast augmentation

> procedures in the prior

> year.

>

> Additional Information

>

> For further information about Inamed's Adjunct Clinical Study for

> reconstruction and revision

> patients, please see:

> http://www.inamed.com/products/recon/us/patient/silicone/studies.html.

>

> About Inamed Corporation

>

> Inamed (Nasdaq:IMDC) is a global healthcare company with over 25 years

> of experience

> developing, manufacturing and marketing innovative, high-quality,

> science-based products. These

> products include breast implants for aesthetic augmentation and for

> reconstructive surgery

> following mastectomy; a range of dermal products to treat facial

> wrinkles; and minimally invasive

> devices for obesity intervention, including the LAP-BAND® System for

> morbid obesity. The

> Company's web site is www.inamed.com.

>

> Forward-Looking Statements

>

> This press release contains, in addition to historical information,

> forward-looking statements. Such

> statements are based on management's current estimates and expectations

> and are subject to a

> number of uncertainties and risks that could cause actual results to

> differ or differ materially from

> those described in the forward-looking statements. Inamed is providing

> this information as of

> December 31, 2002 and expressly disclaims any duty to update information

> contained in this press

> release.

>

> This press release contains forward-looking statements, including,

> without limitation, Inamed's

> anticipated product development program. These forward-looking

> statements involve risks and

> uncertainties, which could cause actual results to differ materially

> from those expressed or implied

> here. Readers are referred to the documents filed by Inamed Corporation

> with the Securities and

> Exchange Commission, specifically the most recent reports which identify

> important risk factors

> that could cause actual results to differ from those contained in the

> forward-looking statements,

> including but not limited to: exposure to product liability claims;

> exposure to liabilities that may not

> be adequately covered by insurance; potential negative publicity

> concerning product safety;

> potential fluctuations in quarterly results; the effect of changing

> accounting and public reporting

> rules and regulations; volatility of Inamed's stock price; changes in

> the economy and consumer

> spending; uncertainty in receiving timely regulatory approval or market

> acceptance for new

> products; introduction of new products by competitors; dependence on a

> single supplier for each

> of Inamed's silicone raw materials and bovine and human collagen-based

> products; and adverse

> changes in the regulatory or legislative environment (both in the U.S.

> and internationally) affecting

> our business. The information contained in this press release is a

> statement of Inamed's present

> intention, belief or expectation and is based upon, among other things,

> the existing regulatory

> environment, industry conditions, market conditions and prices, the

> economy in general and

> Inamed's assumptions. Inamed may change its intention, belief or

> expectation, at any time and

> without notice, based upon any changes in such factors, in Inamed's

> assumptions or otherwise.

> Inamed undertakes no obligation to review or confirm analysts'

> expectations or estimates or to

> release publicly any revisions to any forward-looking statements to

> reflect events or circumstances

> after the date hereof or to reflect the occurrence of unanticipated

> events.

>

> By including any information in this press release, Inamed does not

> necessarily acknowledge that

> disclosure of such information is required by applicable law or that the

> information is material.

>

> CONTACT:

>

> Inamed Corporation

>

> Vaters, 805/692-5420

>

> SOURCE: Inamed Corporation

>