FDA Approves Allergan’s NATRELLE INSPIRA™ Round Gel-Filled Breast Implants
February 27 2015 - 8:30AM
Business Wire
NATRELLE INSPIRA™ Represents Company’s Latest
Innovation in Breast Implants
Provides New Implant Option for Surgeons and
Patients Seeking Reconstruction, Augmentation or Revision
Surgery
Allergan, Inc. (NYSE: AGN) today announced that the company has
received approval from the U.S. Food and Drug Administration (FDA)
to market NATRELLE INSPIRA™ round gel-filled smooth breast
implants. The NATRELLE INSPIRA™ line is different from other
available breast implant styles as it has a higher fill ratio that
provides an additional breast shaping option for women undergoing
reconstruction, augmentation or revision surgery.
“The FDA approval of NATRELLE INSPIRA™ round gel-filled implants
exemplifies our commitment to scientific innovation and to meeting
the dynamic needs of plastic surgeons and their patients,” said
Scott Whitcup, M.D., Executive Vice President, Research and
Development, Chief Scientific Officer, Allergan. “In the past two
years, Allergan has received FDA approval for three new and
important breast implant options which represent the latest
advancements in Allergan's growing product portfolio.”
The FDA approval of NATRELLE INSPIRA™ round
gel-filled smooth breast implants marks the most recent
addition to the broad portfolio of currently available NATRELLE®
products, which include the NATRELLE® 410 anatomically shaped
implants, classic round gel implants and saline implants.
Allergan’s NATRELLE® breast implants offer the largest number of
round gel breast implants with 243 size options and a variety of
projection styles. The comprehensive NATRELLE® product line enables
plastic surgeons to provide a tailored fit based on a patient’s
desired look and her individual size and dimensions.
“The FDA approval of NATRELLE INSPIRA™ breast implants heralds a
major advancement in the art and science of aesthetic and
reconstructive breast implant surgery in the United States,” said
Mark Jewell M.D., founder of The Jewell District Medical Spa and
Plastic Surgery Center and former president of the American Society
for Aesthetic Plastic Surgery (ASAPS). “The NATRELLE INSPIRA™
breast implants provide women seeking breast augmentation the
option of fullness in breast shaping that can become lost after
pregnancy. Additionally, this implant will provide a great revision
option to the millions of women in America who have aging saline or
silicone breast implants.”
NATRELLE INSPIRA™ Gel-Filled Breast Implants
Important Information
Who may get breast implants (INDICATIONS)?
NATRELLE INSPIRA™ Gel-Filled Breast Implants are indicated 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
(CONTRAINDICATIONS)?
- 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 else should I consider (WARNINGS)?
- 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 types of conditions require more study
(PRECAUTIONS)?
Caution: Notify 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
(COMPLICATIONS)?
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). 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 or
call the Allergan Product Support line at 1-800-433-8871.
To report a problem with NATRELLE INSPIRA™ Gel-Filled Breast
Implants, please call Allergan Product Surveillance at
1-800-624-4261.
NATRELLE INSPIRA™ Gel-Filled Breast Implants are available by
prescription only.
About Allergan
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 10,500 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 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.
Allergan ContactsBonnie
Jacobs, Allergan (714) 246-5134 (media)Cathy Taylor, Allergan (714)
246-5551 (media)Joann Bradley (714) 246-4766 (investors)David
Nakasone (714) 246-6376 (investors)
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