IRVINE, Calif.--(BUSINESS WIRE)--Allergan, Inc. (NYSE: AGN) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market two new styles, X and L, of the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast reconstruction, augmentation and revision surgery.
“The FDA approval of additional Natrelle® 410 shaped gel implants underscores Allergan’s long-standing commitment to innovation and R&D investment in medical aesthetics and plastic surgery,” said David E.I. Pyott, Allergan’s Chairman of the Board and Chief Executive Officer. “The approval provides plastic surgeons with additional implant options enabling them to better meet the individual needs of women considering breast augmentation, reconstruction or revision surgery.”
The Natrelle® 410 X and L styles provide surgeons additional options to customize their patients’ fit by matching the implant’s height and width with the patient’s body type while providing optimal projection, based on the desired aesthetic outcome. The new Natrelle® 410 X styles provide extra full projection, while the new L styles feature low height and low projection. The entire line of Natrelle® 410 shaped gel implants are designed to mimic the slope of the breast and are filled with a highly cohesive silicone gel, which is intended to enable the implants to hold their shape over time while remaining soft to the touch.
The FDA approval of the additional Natrelle® 410 shaped gel implant styles is based on 10-year data from a study of nearly 1,000 women who underwent breast reconstruction, augmentation or revision surgery with the previously approved range of Natrelle® 410 breast implants. Natrelle® 410 breast implants are the most selected shaped gel implants in the United States and are one of the most extensively studied shaped gel implants.
“Breast augmentation, revision and reconstruction patients have varying needs when it comes to implants. Having additional implant options, such as the Natrelle® 410 X and L styles, available to me and my patients enables me to provide the aesthetic outcomes they desire,” said Patrick Maxwell, M.D., a board certified plastic surgeon and Founder of Maxwell Aesthetics in Nashville, TN. “Based on my experience with the implants and a decade of safety data available, I feel confident recommending Natrelle® 410 breast implants to my patients.”
Physicians can learn more about Natrelle® 410 breast implants by visiting www.natrelle.com. Women 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 is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have approximately 11,500 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work. For more information regarding Allergan, go to: www.allergan.com.
Forward-Looking Statements
This press release contains "forward-looking statements," including but not limited to the statements by Mr. Pyott and Dr. Maxwell, as well as other statements regarding the safety, efficacy and market potential of Natrelle® 410 breast implants. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development process; challenges related to new product marketing; inconsistency of treatment results among patients; potential difficulties in manufacturing; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risks can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. Copies of Allergan's press releases and additional information about Allergan are available at www.allergan.com.
© 2014 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc.