|[February 20, 2013]
FDA Approves Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
IRVINE, Calif. --(Business Wire)--
Allergan, Inc. (NYSE: AGN (News - Alert)) 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 States."
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 touch.
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 -
Submission of the final report for the 10-year clinical study.
Continued follow-up through 5 years of patients in the Continued
Access Revision/Reconstruction Expansion (CARE) and Continued Access
A large study of newly enrolled patients followed for 10 years.
Participation in developing the National Breast Implant Registry and
contributing data from the large new enrollment study upon
implementation of the registry.
Cmpletion of case-control studies on five rare disease outcomes.
Completion of a focus group study to evaluate the patient labeling.
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
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
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
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.
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
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.
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
© 2013 Allergan, Inc. Irvine, CA (News - Alert) 92612. ® marks owned by
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