FDA Approves Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

  FDA Approves Natrelle® 410 Highly Cohesive Anatomically Shaped
  Silicone-Filled Breast Implants

NATRELLE^® Line Now Includes Saline, Round Silicone Gel and Newly Approved 410
                         Shaped Silicone Gel Options

Business Wire

IRVINE, Calif. -- February 20, 2013

Allergan, Inc. (NYSE: AGN) today announced that the company has received
approval from the U.S. Food and Drug Administration (FDA) to market the
Natrelle^® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast
Implants for use in breast reconstruction, augmentation and revision surgery.

“The FDA approval of Natrelle^® 410 shaped gel implants provides an important
new alternative to traditional round implants for women considering breast
augmentation, reconstruction or revision surgery,” said David E.I. Pyott,
Allergan’s Chairman of the Board, President and Chief Executive Officer. “The
Natrelle^® 410 is the most selected shaped gel implant in markets where the
product is already available, such as Europe and Canada. We are pleased that
the FDA has recognized the benefits and safety of the Natrelle^® 410, and has
now made the product available as an additional option for women in the United

The Natrelle^® 410 shaped gel implant is designed to mimic the slope of the
breast and is filled with a highly cohesive silicone gel, which is intended to
enable the implant to hold its shape over time while remaining soft to the

The FDA approval of the Natrelle^® 410 shaped gel implants was based on an
extensive review of various studies and data, including pre-clinical device
testing and clinical data from Allergan’s 10-year prospective, multi-center
pivotal study, involving nearly 1,000 women who have undergone breast
reconstruction, augmentation or revision surgery.

“For many patients, round silicone and saline breast implants are good
options. For others, they may not provide the aesthetic outcome they desire,”
said Scott L. Spear, M.D., FACS, Chairman, Department of Plastic Surgery,
Georgetown University School of Medicine. “As well, patients may have minimal
breast tissue remaining after the removal of a tumor or have lost breast
volume over the years, so the option of a shaped breast implant designed with
an anatomical shape that lasts over time is an important one as it may help
these patients obtain the aesthetic look they are seeking.”

Allergan requires surgeons to complete a certification program, which includes
instruction on surgical techniques and patient selection, before they are able
to offer the Natrelle^® 410 shaped gel implant option to their patients.
Please visit www.allerganacademy.com for more information and to complete the
certification program. Women interested in seeking a consultation about the
Natrelle^® 410 breast implant can locate qualified surgeons by visiting the
Natrelle^® website at www.natrelle.com.

Conditions of approval -

1.Submission of the final report for the 10-year clinical study.
2.Continued follow-up through 5 years of patients in the Continued Access
    Revision/Reconstruction Expansion (CARE) and Continued Access studies.
3.A large study of newly enrolled patients followed for 10 years.
4.Participation in developing the National Breast Implant Registry and
    contributing data from the large new enrollment study upon implementation
    of the registry.
5.Completion of case-control studies on five rare disease outcomes.
6.Completion of a focus group study to evaluate the patient labeling.
7.Annual reporting of analyses conducted on all 410 devices explanted and
    returned to Allergan.

Important Natrelle^® 410 Highly Cohesive Anatomically Shaped Silicone-Filled
Breast Implant Safety Information


  *Breast augmentation for women at least 22 years old. Breast augmentation
    includes primary breast augmentation to increase  the breast size, as well
    as revision surgery to correct or improve the  result of a primary breast
    augmentation surgery.
  *Breast reconstruction. Breast reconstruction includes primary
    reconstruction to replace breast tissue that has been removed due to
    cancer or trauma or that has failed to develop properly due to a severe
    breast abnormality. Breast reconstruction also includes revision surgery
    to correct or improve the result of a primary breast reconstruction


Breast implant surgery should NOT be performed in:

  *Women with active infection anywhere in their body.
  *Women with existing cancer or pre-cancer of their breast who have not
    received adequate treatment for those conditions.
  *Women who are currently pregnant or nursing.


  *There are many factors that can affect the outcome and appropriate timing
    of a breast reconstruction
  *Many of the changes to breasts following implantation cannot be undone,
    and if the implants are removed without replacement, dimpling, wrinkling,
    or puckering may be experienced
  *Breast implants are not lifetime devices, and additional unplanned
    surgeries will likely be necessary
  *In order to screen for silent rupture, regular MRI screenings are


Safety and effectiveness have not been established in patients with the

  *Autoimmune diseases (for example, lupus and scleroderma)
  *A weakened immune system (for example, currently taking drugs that weaken
    the body’s natural resistance to disease)
  *Planned chemotherapy following breast implant placement
  *Planned radiation therapy to the breast following breast implant placement
  *Conditions that interfere with wound healing and blood clotting
  *Reduced blood supply to breast tissue
  *Clinical diagnosis of depression or other mental health disorders,
    including body dysmorphic disorder and eating disorders. Please discuss
    any history of mental health disorders with your surgeon prior to surgery.
    Patients with a diagnosis of depression, or other mental health disorders,
    should wait for resolution or stabilization of these conditions prior to
    undergoing breast implantation surgery.

Adverse events

The most commonly reported adverse events for Natrelle^® 410 Breast Implants
are: reoperation, implant removal (with and without replacement), implant
rupture, and Baker grade III/IV capsular contracture.

Other potential complications include: swelling, implant malposition, pain,
ptosis, infection, changes in breast sensation, nipple complications, seroma,
delayed wound healing, hematoma, redness, scarring, asymmetry,
wrinkling/rippling, extrusion, bruising, implant palpability/visibility, upper
pole fullness, and necrosis.

Important: For full safety information please visit www.natrelle.com or call
Allergan Product Support at 1-800-433-8871.

Caution: Natrelle^® 410 Breast Implants are available by prescription only.

About Allergan, Inc.

Allergan is a multi-specialty health care company established more than 60
years ago with a commitment to uncover the best of science and develop and
deliver innovative and meaningful treatments to help people reach their life’s
potential. Today, we have approximately 10,800 highly dedicated and talented
employees, global marketing and sales capabilities with a presence in more
than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals,
biologics, medical devices and over-the-counter consumer products, and
state-of-the-art resources in R&D, manufacturing and safety surveillance that
help millions of patients see more clearly, move more freely and express
themselves more fully. From our beginnings as an eye care company to our focus
today on several medical specialties, including eye care, neurosciences,
medical aesthetics, medical dermatology, breast aesthetics, obesity
intervention and urologics, Allergan is proud to celebrate more than 60 years
of medical advances and proud to support the patients and physicians who rely
on our products and the employees and communities in which we live and work.
For more information regarding Allergan, go to: www.allergan.com.

Forward-Looking Statements

This press release contains "forward-looking statements," including the
statements by Mr. Pyott, Dr. Spear and other statements regarding the safety,
effectiveness, approval and market potential of Natrelle^® 410 highly cohesive
anatomically shaped silicone-filled breast implant. These statements are based
on current expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results could
vary materially from Allergan's expectations and projections. Risks and
uncertainties include, among other things, general industry and medical device
market conditions; technological advances and patents attained by competitors;
challenges inherent in the research and development and regulatory processes;
inconsistency of treatment results among patients; potential difficulties in
manufacturing; and governmental laws and regulations affecting domestic and
foreign operations. Allergan expressly disclaims any intent or obligation to
update these forward-looking statements except as required by law. Additional
information concerning these and other risks can be found in press releases
issued by Allergan, as well as Allergan's public filings with the U.S.
Securities and Exchange Commission, including the discussion under the heading
"Risk Factors" in Allergan's most recent Annual Report on Form 10-K and any
subsequent Quarterly Reports on Form 10-Q. Copies of Allergan's press releases
and additional information about Allergan are available on the World Wide Web
at www.allergan.com or you can contact the Allergan Investor Relations
Department by calling 1-714-246-4636.

   © 2013 Allergan, Inc. Irvine, CA 92612. ^® marks owned by Allergan, Inc.


Bonnie Jacobs, 856-912-9965; 714-246-5134; Jacobs_bonnie@allergan.com (media)
Cathy Taylor, 949-293-4453; 714-246-5551; Taylor_cathy@allergan.com (media)
Jim Hindman, 714-246-4636 (investors)
Joann Bradley, 714-246-4766 (investors)
David Nakasone, 714-246-6376 (investors)
Press spacebar to pause and continue. Press esc to stop.