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FDA Approves Allergan's NATRELLE INSPIRA™ Round Gel-Filled Breast ImplantsAllergan, Inc. (NYSE: AGN (News - Alert)) 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:
Who should NOT get breast implants (CONTRAINDICATIONS)?
What else should I consider (WARNINGS)?
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:
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.
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