Fw: McGhan Received Registration Approval for Silicone Gel Breast Implants in Australia

[Guest guest]

From: " ilena rose " <ilena@...>

Sent: Thursday, July 19, 2001 8:47 AM

Subject: McGhan Received Registration Approval for Silicone Gel Breast

Implants in Australia

> ~~~ thanks Kathy Nye for the news ... bad news for the Australian women

~~~

>>

> Inamed Demonstrates Execution of Growth Plan; BioEnterics Corp. Initiates

> Shipments of the Lap-Band System in the United States

> SANTA BARBARA, Calif.--(BUSINESS WIRE)--July 19, 2001--

>

> McGhan and DTA have Received Registration Approval for Silicone Gel

> Breast Implants in Australia; FDA Has Granted Approval for Production At

> Inamed's Los Carneros Plant Inamed Corp. (Nasdaq:<aol://4785:IMDC> IMDC)

> today announced three significant business developments that further

> position the company for continued growth: BioEnterics Corp. initiated

> shipments of the Lap-Band® System in the United States; McGhan has

> received registration approval for silicone gel breast implants in

> Australia; and the FDA has granted approval for production at the Los

> Carneros plant.

>

> " This is an extremely exciting time for Inamed, " said G. Babbitt,

> Inamed's chairman and chief executive officer. " We are well-positioned to

> sustain our global franchise position in breast

augmentation/reconstruction

> devices and dermal fillers, and expect our new obesity product -- the

> Lap-Band® System -- to have a significant impact to 2002 earnings. We

> will continue to focus on the growth of our strong and promising product

> portfolio while controlling costs, in order to increase shareholder

> value. " Inamed's subsidiary, BioEnterics Corp., has begun shipping the

> Lap-Band® System Adjustable Gastric Banding System to United States

> hospitals.

>

> Babbitt said, " BioEnterics has supplied the FDA with the final product

> labeling as required by the premarket approval (PMA) letter of June 5,

> 2001. The company has quickly and efficiently prepared for introduction

of

> this innovative product, developing both patient and surgeon information

> as well as training materials. " The Lap-Band® System is a minimally

> invasive approach to obesity surgery. The band is inflatable and can be

> adjusted after surgery to customize patient treatment. The procedure is

> reversible and, unlike gastric bypass procedures, does not require

cutting

> or stapling of the stomach, or gastrointestinal re-routing to bypass

> normal digestion.

>

> Patient benefits include reduced surgical trauma, complications, pain,

> scarring, and shorter hospitalization and recovery time compared with more

> invasive obesity surgeries. After surgery, patients can achieve

significant

> and sustained weight loss, which has been demonstrated to improve health

> and quality of life.

>

> Ellen Duke, president and CEO of BioEnterics, noted: " This concept has

been

> under development and studied in the United States for 15 years.

> Internationally, where the Lap-Band® System has been used extensively

> since 1994, its positive impact on health and quality of life has been

> impressive and well documented. This experience has demonstrated the

> importance of the qualification and training of surgical centers, which

is

> now required in the U.S. by the condition of FDA approval and the

approved

> labeling. " Obesity is the second-leading cause of preventable death in

> the United States, and an estimated 11 million American adults are

> severely obese. U.S. health care costs for treating obese adults have

> reached $238 billion, according to a 1999 study by the Lewin Group.(a)

> McGhan Medical International, a subsidiary of Inamed, and Device

> Technologies Australia, distributor of McGhan's breast implants, have

> received Australian Therapeutic Goods Administration (TGA) registration

> approval of McGhan's silicone gel breast implants. The company is the

only

> approved source in Australia for silicone breast implants.

>

> The registration application, which was submitted to the Australian

> regulators in 1997, included in-depth data evaluating design, materials

and

> testing, manufacture and quality control, biocompatibility and human

> clinical experience.

>

> McGhan's saline breast implants have previously received registration in

> Australia.

>

> In addition, the FDA has reviewed McGhan Medical's submission for the Los

> Carneros plant in California and granted approval to commence production

of

> breast implants at the new facility. The company expects production to

>