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09.23.2016 | Investors

Allergan Announces FDA Approval of NATRELLE INSPIRA® Cohesive Breast Implants

Company Continues to Lead the Breast Aesthetics Industry; Adding Its Highest Gel Cohesivity Round Implant with High Gel Fill Ratio

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:

  • 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?

  • 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 should I know before getting breast implants?

  • 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 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:

  • 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?

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.

 

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SOURCE Allergan plc

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