Actavis Announces FDA Approval of NATRELLE INSPIRA™ Round Gel-Filled Textured Breast Implants

DUBLIN, June 4, 2015 /PRNewswire/ -- Actavis plc ACT, which recently completed the acquisition of Allergan, Inc., today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market NATRELLE INSPIRA™ round gel-filled textured breast implants, offering women undergoing reconstruction, augmentation or revision surgery another breast shaping option for a customized result. The NATRELLE INSPIRA™ line of breast implants is designed for women who are interested in increased breast fullness. NATRELLE INSPIRA™ breast implants are fuller than Allergan's round, gel-filled breast implants currently available in the U.S.

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"NATRELLE INSPIRA™ is just the latest example of our commitment to breast aesthetics and plastic surgery which will continue into the future," said Philippe Schaison, President, Allergan Medical.

The FDA approval of NATRELLE INSPIRA™ round gel-filled textured breast implants marks the most recent addition to the broad portfolio of currently available NATRELLE^® products in the U.S. The smooth version of the NATRELLE INSPIRA™ round gel-filled breast implants was approved by FDA in February 2015.

"NATRELLE INSPIRA™ round gel-filled breast implants have been available in Canada since 2011 and are of particular interest to women seeking to gain breast fullness following pregnancy or undergoing revision or reconstruction surgery," said Dr. Paul Whidden of MacLeod Trail Plastic Surgery. "Although there are many breast implant options available today, my patients continue to request the combination of fullness and softness NATRELLE INSPIRA™ breast implants can provide them."

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:

• 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 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 Actavis

Actavis plc ACT, headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Actavis is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Actavis markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Actavis is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Actavis is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

Actavis intends to adopt a new global name – Allergan – pending shareholder approval in 2015.

For more information, visit Actavis' website at www.actavis.com.

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 Actavis' current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' 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 Actavis' products; risks associated with acquisitions, mergers and joint ventures; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Quarterly Report on Form 10-Q for the quarter ended March 31, 2015. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

 

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SOURCE Actavis plc