DUBLIN, Jan. 3, 2017 /PRNewswire/ -- Allergan plc
(NYSE: AGN) today announced that it has received approval from the
U.S. Food and Drug Administration (FDA) to market NATRELLE
INSPIRA® SoftTouch breast implants, offering women
undergoing breast reconstruction, augmentation or revision surgery
a new medium firmness gel, or cohesive, implant option. With this
addition the NATRELLE® line of breast implants is
the only implant line with three levels of cohesive
gel.1
Logo - http://photos.prnewswire.com/prnh/20150612/222796LOGO
"Adding NATRELLE INSPIRA® SoftTouch
breast implants to our already robust line of offerings gives
Allergan the most extensive variety of implants in the industry and
provides doctors with a wide range of options," said David Nicholson, Chief R&D Officer of
Allergan plc. "Now, the INSPIRA® line of breast
implants helps physicians to better meet diverse, patient-specific
needs based on available breast tissue and desired outcomes. We're
delighted to have this offering available in the U.S. since they
are so popular with doctors and patients
internationally."2,3
The FDA approval of NATRELLE INSPIRA®
SoftTouch breast implants marks the most recent addition to
the broad portfolio of currently available
NATRELLE® products in the U.S.
NATRELLE® offers implants with differing
gel firmness for differing levels of form
stability.4-6
"I am excited to have yet another option available within the
NATRELLE® portfolio. This is one of the
most exciting times in the history of breast surgery and what a
great time for women, who are looking to have augmentation or have
to have reconstruction," said Dr. Allen
Gabriel of PeaceHealth Plastic Surgery. "My patients now
have so many options available to them thanks to companies like
Allergan who are supporting ongoing research and innovation in this
area."
Natrelle® Breast Implants Important
Information
Who may get breast implants?
Natrelle® Breast Implants are approved for
women for the following:
- Breast augmentation for women at least 22 years old for
silicone-filled implants.
Breast augmentation for women at least 18 years old for
saline-filled implants.
Breast augmentation includes primary breast augmentation to
increase breast size and 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. It also includes revision surgery to
correct or improve the result of a primary breast reconstruction
surgery.
IMPORTANT SAFETY INFORMATION
Who should NOT get breast implants?
Women with active infection anywhere in their body, with
existing cancer or precancer of their breast who have not received
adequate treatment for those conditions, and women who are
currently pregnant or nursing.
What should I know before getting breast implants?
Breast implants are not lifetime devices or necessarily a
one-time surgery. If you have your implants removed and not
replaced, you may experience unacceptable dimpling, puckering,
wrinkling, or other cosmetic changes of the breast, which may be
permanent. Breast implants may affect your ability to produce milk
for breast-feeding. Silicone-filled implants may rupture without
symptoms. You should have MRI examinations 3 years after surgery
and then every 2 years thereafter in order to detect ruptures.
What should I tell my doctor?
Tell your doctor if you have any of the following conditions:
autoimmune diseases, a weakened immune system, planned radiation
therapy to the breast or planned chemotherapy following breast
implant placement, conditions/medications that interfere with wound
healing and blood clotting, reduced blood supply to breast tissue,
or a clinical diagnosis of depression, other mental health
disorders, body dysmorphic disorder, or eating disorders.
What are some complications with breast implants?
Key complications are reoperation, implant removal with or
without replacement, implant rupture with silicone-filled implants,
implant deflation with saline-filled implants, and severe capsular
contracture (severe scar tissue around the implant). Talk to your
doctor about other complications.
Talk to your doctor. For more information see the patient
brochures at www.allergan.com/labeling/usa.htm. To report a problem
with Natrelle® Breast Implants, please call
Allergan at 1-800-433-8871.
Natrelle® Breast Implants are available by
prescription only.
Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the difficulty of predicting the timing or
outcome of FDA approvals or actions, if any; the impact of
competitive products and pricing; market acceptance of and
continued demand for Allergan's products; difficulties or delays in
manufacturing; and other risks and uncertainties detailed in
Allergan's periodic public filings with the Securities and Exchange
Commission, including but not limited to Allergan's Annual Report
on Form 10-K for the year ended December 31,
2015 and Quarterly Report on Form 10-Q for the quarter ended
June 30, 2016 (such periodic public
filings having been filed under the "Actavis plc" name). Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
1. NATRELLE® Silicone-Filled Breast Implants
and NATRELLE INSPIRA® Breast Implants Directions
For Use, 2016.
2. Important Information for Women about Breast Augmentation
with NATRELLE® Silicone-Filled Breast Implants and NATRELLE
INSPIRA® Breast Implants (PDF)
3. Important for Women about Breast Reconstruction with
NATRELLE® Silicone-Filled Breast Implants and NATRELLE INSPIRA®
Breast Implants (PDF)
4. Data on file, Allergan, September 6,
2016; Study Report MD16062-DV.
5. Data on file, Allergan, August 31,
2016; Study Report MD16064-DV.
6. Data on file, Allergan, March 2,
2016; Study Report MD16002-DV.
© 2016 Allergan. All rights reserved. All trademarks
are the property of their respective owners.
CONTACTS:
Investors:
Lisa
DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
Ember Garrett
(714) 246-3525
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/allergan-announces-fda-approval-of-natrelle-inspira-softtouch-breast-implants-300384060.html
SOURCE Allergan plc