FDA Approves 28 Additional Styles Of Allergan's Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

Aug 05, 2015, 16:26 ET from Allergan plc

DUBLIN, Aug. 5, 2015 /PRNewswire/ -- Allergan, plc. (NYSE: AGN) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market 28 additional styles of Natrelle® 410 silicone-filled breast implants, giving surgeons and patients more options to achieve desired outcomes. The FDA approved extra-full projection styles (X), along with additional low projection, low height styles (L) from the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant line, for use in breast reconstruction, augmentation and revision surgery.

Logo - http://photos.prnewswire.com/prnh/20150612/222796LOGO

Designed to mirror the shape of a woman's breast, the Natrelle® 410 Shaped Gel Breast Implants are filled with a highly cohesive silicone gel which enables the implants to have long-lasting shape over time. The additional projection styles offer surgeons more options to better meet the individual needs of each patient.

"The FDA approval of additional Natrelle® 410 shaped gel implants is further proof of Allergan's long-standing and continued commitment to medical aesthetics and plastic surgery," said David Nicholson, Executive Vice President.  "Natrelle® 410 breast implants are the most selected shaped gel implants in the United States."

The approval of the X and L projection styles adds to a wide range of breast reconstruction, augmentation and revision surgical options across the Natrelle® 410 Shaped Gel Breast Implants line. The complete 12 style matrix includes three heights and four projection styles, including a 7.1 cm option – the highest projecting implant available in the U.S., giving surgeons and patients more options to achieve desired outcomes.

The FDA approval of  additional Natrelle® 410 shaped gel implant styles is based on 3-year data from a study of over 350 women who underwent breast reconstruction, augmentation or revision surgery with the previously approved range of Natrelle® 410 breast implants.

These additional implant styles will be available to surgeons and patients in October 2015. Allergan requires surgeons to complete a certification program, which includes instruction on surgical techniques and patient selection, before they are able to offer Natrelle® 410 breast implants to their patients. Physicians can learn more about Natrelle® 410 breast implants by visiting www.natrellesurgeon.com.  Patients interested in seeking a consultation for the Natrelle® 410 breast implants can locate qualified surgeons by visiting the Natrelle® website at www.natrelle.com.

Important Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Safety Information

Indications:

  • Breast augmentation for women at least 22 years old. Breast augmentation includes primary breast augmentation to increase the 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.

Contraindications

Breast implant surgery should NOT be performed in:

  • 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

Warnings

  • There are many factors that can affect the outcome and appropriate timing of a breast reconstruction
  • Many of the changes to breasts following implantation cannot be undone, and if the implants are removed without replacement, dimpling, wrinkling, or puckering may be experienced
  • Breast implants are not lifetime devices, and additional unplanned surgeries will likely be necessary
  • In order to screen for silent rupture, regular MRI screenings are recommended

Precautions

Safety and effectiveness have not been established in patients with the following:

  • 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.

Adverse events

The most commonly reported adverse events for Natrelle® 410 Breast Implants are: reoperation, implant removal (with and without replacement), implant rupture, and Baker grade III/IV capsular contracture.  

Other potential complications include: swelling, implant malposition, pain, ptosis, infection, changes in breast sensation, nipple complications, seroma, delayed wound healing, hematoma, redness, scarring, asymmetry, wrinkling/rippling, extrusion, bruising, implant palpability/visibility, upper pole fullness, and necrosis.

Important: For full safety information please visit www.natrelle.com or call Allergan Product Support at 1-800-433-8871. 

Caution: Natrelle® 410 Breast Implants are available by prescription only. 

About Allergan Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Allergan 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.

Allergan 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. Allergan 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, Allergan 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.

For more information, visit Allergan's website at www.Allergan.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 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2015 (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.

CONTACTS:  Investors: Lisa DeFrancesco (862) 261-7152

Media: Mark Marmur (862) 261-7558

Ember Garrett  (714) 246-3525

SOURCE Allergan plc



RELATED LINKS

http://www.actavis.com