DUBLIN, Sept. 23, 2016 /PRNewswire/ -- Allergan plc
(NYSE: AGN) today announced the company has received approval from
the U.S. Food and Drug Administration (FDA) to market
NATRELLE INSPIRA® Cohesive breast
implants, offering women undergoing reconstruction, augmentation or
revision surgery a new breast shaping option that combines a high
gel fill ratio and Allergan's highly cohesive gel1,2 for
a customized result. The new NATRELLE
INSPIRA® Cohesive line of breast implants is the
newest entry into the category of breast implants commonly referred
to as "gummy" implants, designed for women who are interested
in increased breast fullness.
Logo - http://photos.prnewswire.com/prnh/20150612/222796LOGO
"NATRELLE INSPIRA® Cohesive breast implants
are just the latest example of our commitment to innovation in
breast aesthetics and plastic surgery, and we are proud that we are
able to continue to offer advancements in technology that allow
physicians and their patients more options," said David Nicholson, Chief R&D Officer of
Allergan plc. "NATRELLE INSPIRA® Cohesive allows
patients to get the same high gel fill ratio and fullness offered
by the NATRELLE INSPIRA® line of implants, with
our highly cohesive, form-stable gel.1-3"
The FDA approval of NATRELLE INSPIRA®
Cohesive breast implants, which are available with both smooth and
BIOCELL® textured surfaces, marks the most
recent addition to the broad portfolio of currently available
NATRELLE® products in the US. The smooth version
of the NATRELLE INSPIRA® round
gel-filled breast implants with responsive gel was approved by
FDA in February 2015, and the
textured version of the NATRELLE INSPIRA®
round gel-filled breast implants with responsive gel were
approved by the FDA in June 2015.
"I make it my personal mission to give my patients the best
possible cosmetic results after breast reconstruction," said Dr.
Lisa Cassileth of Cassileth Plastic
Surgery. "I've been waiting for a form stable, cohesive round
implant. I've been waiting for NATRELLE
INSPIRA® Cohesive"
NATRELLE INSPIRA® Silicone
Filled Breast Implants Important Information
Who may get breast implants?
Approved for women for the following:
- Breast augmentation for women at least 22 years old for
silicone-filled implants. Breast augmentation includes primary
breast augmentation to increase 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 surgery.
IMPORTANT SAFETY INFORMATION
Who should NOT get breast implants?
- 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.
What should I know before getting breast implants?
- Breast implants are not lifetime devices, and not necessarily a
one-time surgery.
- Many of the changes to your breasts following implantation
cannot be undone. If you later choose to have your implant(s)
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 breastfeed, either
by reducing or eliminating milk production.
- Rupture of a silicone-filled breast implant is most often
silent and may not be detected by you or your doctor. You should
have an MRI 3 years after your surgery and then every 2 years after
that for as long as you have your breast implants to determine if
rupture is present. If implant rupture is noted on an MRI, you
should have the implant removed, with or without replacement.
- With breast implants, a routine screening mammography and
self-examinations for breast cancer will be more difficult.
- Ask your doctor to help you distinguish the implant from your
breast tissue. Symptoms of a ruptured implant may be hard knots or
lumps surrounding the implant or in the armpit, change or loss of
size or shape of the breast or implant, pain, tingling, swelling,
numbness, burning or hardening. Tell your doctor of these symptoms
and remove ruptured implants.
- Inform any other doctor who treats you of the presence of your
implants to minimize the risk of damage to the implants.
What should I tell my doctor?
Tell your doctor if you have any of the following conditions, as
the risks of breast implant surgery may be higher:
- 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.
What are some complications with breast implants?
Key complications are reoperation, implant removal with or
without replacement, implant rupture, and severe capsular
contracture (severe scar tissue around the implant). Other
complications include asymmetry, nipple/breast/skin sensation
changes, scarring or wrinkling/rippling. 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 INSPIRA® Breast Implants, please call
Allergan at 1-800-433-8871
NATRELLE INSPIRA® 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. Data on file, Allergan, August 31,
2016; Study Report MD16064-DV.
2. NATRELLE® INSPIRA Cohesive Directions For
Use, 2016.
3. Data on file, Allergan, September 6,
2016; Study Report MD16062-DV.
© 2016 Allergan. All rights reserved. All trademarks
are property of their respective owners.
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Garrett
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246-3525
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SOURCE Allergan plc