Allergan Announces FDA Approval of NATRELLE INSPIRA® SoftTouch Breast Implants
-- Adds New Cohesive Implant for Physicians Seeking Wide Range of Options to Meet Diverse Patient Needs --
DUBLIN, Jan. 3, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market NATRELLE INSPIRA® SoftTouch breast implants, offering women undergoing breast reconstruction, augmentation or revision surgery a new medium firmness gel, or cohesive, implant option. With this addition the NATRELLE® line of breast implants is the only implant line with three levels of cohesive gel.1
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"Adding NATRELLE INSPIRA® SoftTouch breast implants to our already robust line of offerings gives Allergan the most extensive variety of implants in the industry and provides doctors with a wide range of options," said David Nicholson, Chief R&D Officer of Allergan plc. "Now, the INSPIRA® line of breast implants helps physicians to better meet diverse, patient-specific needs based on available breast tissue and desired outcomes. We're delighted to have this offering available in the U.S. since they are so popular with doctors and patients internationally."2,3
The FDA approval of NATRELLE INSPIRA® SoftTouch breast implants marks the most recent addition to the broad portfolio of currently available NATRELLE® products in the U.S. NATRELLE® offers implants with differing gel firmness for differing levels of form stability.4-6
"I am excited to have yet another option available within the NATRELLE® portfolio. This is one of the most exciting times in the history of breast surgery and what a great time for women, who are looking to have augmentation or have to have reconstruction," said Dr. Allen Gabriel of PeaceHealth Plastic Surgery. "My patients now have so many options available to them thanks to companies like Allergan who are supporting ongoing research and innovation in this area."
Natrelle® Breast Implants Important Information
Who may get breast implants?
Natrelle® Breast Implants are approved for women for the following:
- Breast augmentation for women at least 22 years old for silicone-filled implants.
Breast augmentation for women at least 18 years old for saline-filled implants.
Breast augmentation includes primary breast augmentation to increase breast size and 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. It 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, with existing cancer or precancer of their breast who have not received adequate treatment for those conditions, and women who are currently pregnant or nursing.
What should I know before getting breast implants?
Breast implants are not lifetime devices or necessarily a one-time surgery. If you have your implants 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 produce milk for breast-feeding. Silicone-filled implants may rupture without symptoms. You should have MRI examinations 3 years after surgery and then every 2 years thereafter in order to detect ruptures.
What should I tell my doctor?
Tell your doctor if you have any of the following conditions: autoimmune diseases, a weakened immune system, planned radiation therapy to the breast or planned chemotherapy following breast implant placement, conditions/medications that interfere with wound healing and blood clotting, reduced blood supply to breast tissue, or a clinical diagnosis of depression, other mental health disorders, body dysmorphic disorder, or eating disorders.
What are some complications with breast implants?
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). 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® Breast Implants, please call Allergan at 1-800-433-8871.
Natrelle® 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. NATRELLE® Silicone-Filled Breast Implants and NATRELLE INSPIRA® Breast Implants Directions For Use, 2016.
2. Important Information for Women about Breast Augmentation with NATRELLE® Silicone-Filled Breast Implants and NATRELLE INSPIRA® Breast Implants (PDF)
3. Important for Women about Breast Reconstruction with NATRELLE® Silicone-Filled Breast Implants and NATRELLE INSPIRA® Breast Implants (PDF)
4. Data on file, Allergan, September 6, 2016; Study Report MD16062-DV.
5. Data on file, Allergan, August 31, 2016; Study Report MD16064-DV.
6. Data on file, Allergan, March 2, 2016; Study Report MD16002-DV.
© 2016 Allergan. All rights reserved. All trademarks are the property of their respective owners.
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SOURCE Allergan plc
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