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Allergan Announces FDA Approval of NATRELLE INSPIRA® Cohesive Breast Implants | ||||||||||||||||||||||
By: PR Newswire Association LLC. - 23 Sep 2016 | Back to overview list |
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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:
IMPORTANT SAFETY INFORMATION Who should NOT get breast implants?
What should I know before getting breast 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:
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.
SOURCE Allergan plc |
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Copyright 2016 PR Newswire Association LLC. | Back to overview list |