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FDA Approves Allergan’s NATRELLE INSPIRATM Round Gel-Filled Breast Implants

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Allergan, Inc. (NYSE:AGN) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market NATRELLE INSPIRATM round gel-filled smooth breast implants. The NATRELLE INSPIRATM 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 INSPIRATM 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 INSPIRATM round gel-filled smooth breast implants marks the most recent addition to the broad portfolio of currently available NATRELLE(R) products, which include the NATRELLE(R) 410 anatomically shaped implants, classic round gel implants and saline implants. Allergan’s NATRELLE(R) breast implants offer the largest number of round gel breast implants with 243 size options and a variety of projection styles. The comprehensive NATRELLE(R) 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 INSPIRATM 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 INSPIRATM 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 INSPIRATM Gel-Filled Breast Implants Important Information

Who may get breast implants (INDICATIONS)?

NATRELLE INSPIRATM 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 INSPIRATM Gel-Filled Breast Implants, please call Allergan Product Surveillance at 1-800-624-4261.

NATRELLE INSPIRATM 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.

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