FDA announces Approval for the Natrelle 410 Highly-Cohesive Anatomically-Shaped Silicone Gel Breast Implant for Breast Augmentation, Revision, and Reconstruction
On February 20, 2013 the FDA announced approval for the Natrelle® 410. A modified copy of the press release appears below. This implant will provide some women with another option for breast augmentation, and will be a good option for breast reconstruction. This is the breast implant that has often been referred to as the ‘Gummi bear’ implant. It is filled with highly-cohesive silicone gel and is form stable. It has a contoured anatomic shape and therefore is available only witha textured surface. Dr. Sterkin and Dr. Dembny will offer this implant to qualified patients when it is available for use. We will provide more information as we learn more.
FDA Approves Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
NATRELLE® Line Now Includes Saline, Round Silicone Gel and Newly Approved 410 Shaped Silicone Gel Options
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 the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast reconstruction, augmentation and revision surgery.
“The FDA approval of Natrelle® 410 shaped gel implants provides an important new alternative to traditional round implants for women considering breast augmentation, reconstruction or revision surgery,” said David E.I. Pyott, Allergan’s Chairman of the Board, President and Chief Executive Officer. “The Natrelle® 410 is the most selected shaped gel implant in markets where the product is already available, such as Europe and Canada. We are pleased that the FDA has recognized the benefits and safety of the Natrelle® 410, and has now made the product available as an additional option for women in the United States.”
The Natrelle® 410 shaped gel implant is designed to mimic the slope of the breast and is filled with a highly cohesive silicone gel, which is intended to enable the implant to hold its shape over time while remaining soft to the touch.
The FDA approval of the Natrelle® 410 shaped gel implants was based on an extensive review of various studies and data, including pre-clinical device testing and clinical data from Allergan’s 10-year prospective, multi-center pivotal study, involving nearly 1,000 women who have undergone breast reconstruction, augmentation or revision surgery.
“For many patients, round silicone and saline breast implants are good options. For others, they may not provide the aesthetic outcome they desire,” said Scott L. Spear, M.D., FACS, Chairman, Department of Plastic Surgery, Georgetown University School of Medicine. “As well, patients may have minimal breast tissue remaining after the removal of a tumor or have lost breast volume over the years, so the option of a shaped breast implant designed with an anatomical shape that lasts over time is an important one as it may help these patients obtain the aesthetic look they are seeking.”
Allergan requires surgeons to complete a certification program, which includes instruction on surgical techniques and patient selection, before they are able to offer the Natrelle® 410 shaped gel implant option to their patients. Women interested in seeking a consultation about the Natrelle® 410 breast implant can locate qualified surgeons by visiting the Natrelle® website at www.natrelle.com.
Conditions of approval for the Natrelle® 410:|
1. Submission of the final report for the 10-year clinical study.
2. Continued follow-up through 5 years of patients in the Continued Access Revision/Reconstruction Expansion (CARE) and Continued Access studies.
3. A large study of newly enrolled patients followed for 10 years.
4. Participation in developing the National Breast Implant Registry and contributing data from the large new enrollment study upon implementation of the registry.
5. Completion of case-control studies on five rare disease outcomes.
6. Completion of a focus group study to evaluate the patient labeling.
7. Annual reporting of analyses conducted on all 410 devices explanted and returned to Allergan.
Important Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Safety Information
— 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.
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.
· 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
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.
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, Inc.
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 10,800 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, obesity intervention 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.
This press release contains “forward-looking statements,” including the statements by Mr. Pyott, Dr. Spear and other statements regarding the safety, effectiveness, approval and market potential of Natrelle® 410 highly cohesive anatomically shaped silicone-filled breast implant. 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 and regulatory processes; 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 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 on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
© 2013 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc.
Bonnie Jacobs, 856-912-9965; 714-246-5134; [email protected] (media)
Cathy Taylor, 949-293-4453; 714-246-5551; [email protected] (media)
Jim Hindman, 714-246-4636 (investors)
Joann Bradley, 714-246-4766 (investors)
David Nakasone, 714-246-6376 (investors)
Source: Allergan, Inc.