Healthcare Industry News: Magnetic Resonance Imaging
News Release - November 17, 2006
Allergan Announces FDA Approval of INAMED(R) Silicone-Filled Breast Implants for Breast Augmentation, Reconstruction and Revision Surgery
Women in the United States Now Have New Options in Breast AestheticsIRVINE, Calif.--(HSMN NewsFeed)--Allergan, Inc. (NYSE:AGN ) today announced that the United States Food and Drug Administration (FDA) has approved Allergan's INAMED® Silicone-Filled Breast Implants for use in breast augmentation, reconstruction and revision surgery. Until today, INAMED® Silicone-Filled Breast Implants were only available in the United States to women seeking breast reconstruction and revision surgery through clinical studies. The approval is a significant development for women in the United States who now have the same options that women in more than 60 countries have had for the last 25 years.
"Allergan is pleased that the FDA has further recognized the vast body of scientific evidence supporting the performance of these devices and has approved INAMED® Silicone-Filled Breast Implants for re-entry to the U.S. market," said David E.I. Pyott, Allergan's Chairman of the Board and Chief Executive Officer. "Our ability to offer surgeons in the United States a comprehensive portfolio of saline-filled and silicone gel-filled breast implants results in greater options for women considering breast augmentation, reconstruction or revision surgery."
Silicone gel-filled breast implants are among the most studied medical devices in existence, with thousands of peer-reviewed and published reports on studies, including robust epidemiological studies supporting their safe use. The safety of INAMED® Silicone-Filled Breast Implants is supported by the company's extensive pre-clinical device testing, their use in approximately 1,000,000 women worldwide and nearly a decade of U.S. clinical experience involving more than 80,000 women. Furthermore, silicone is used safely in the body in many medical devices and products, including pacemakers, heart valves, artificial joints and baby pacifiers.
"The FDA's decision confirms what we in the plastic surgery community have known for some time - silicone gel-filled breast implants are a safe and effective option for women seeking breast implant surgery," said Scott L. Spear, M.D., F.A.C.S., Chairman, Department of Plastic Surgery, Georgetown University School of Medicine, Washington, D.C. "For decades, I have had the ability to offer silicone gel-filled breast implants to my breast reconstruction patients. Now, with the FDA approval of INAMED® Silicone-Filled Breast Implants, I am able to offer a broader range of options to all of my patients, many of whom are seeking breast augmentation surgery following significant life events such as child bearing."
Like many other medical devices on the market today, INAMED® Silicone-Filled Breast Implants have evolved over the last two decades. Today's implants have an advanced technology and enhanced safety profile due to several refinements in product design and manufacturing, including a more cohesive silicone gel. Today's implants also have a thicker shell, which contains an additional barrier layer that is distinct from earlier breast implant devices and is designed to withstand more than 25 times the force of a normal mammogram without failure.
INAMED® Silicone-Filled Breast Implant Clinical Studies
The FDA's approval of INAMED® Silicone-Filled Breast Implants follows its review of, among other data, four-year data from 715 women involved in the company's Core Clinical Study, which is an ongoing, 10-year prospective, multi-center safety study of women who have undergone breast augmentation, reconstruction or revision surgery. In the Core Clinical Study, less than 1 percent of implants had a reported rupture at 4 years. All study participants received regular exams to detect rupture and approximately 33 percent additionally received a Magnetic Resonance Imaging (MRI). Patient follow-up occurred at 0-4 weeks and six months after surgery, and will continue annually for up to 10 years.
Conditions of FDA Approval
The FDA requires post-market surveillance for all medical devices and drugs as a standard condition of approval. As part of the FDA approval, Allergan will meet the following conditions:
- Continuation of the Core Clinical Study until all patients have completed their 10-year evaluation;
- Continuation of pre-clinical studies to characterize the long-term modes and causes of failure of explanted retrieved devices;
- Through an independent group, the completion of a focus group study of the augmentation and reconstruction patient labeling to obtain feedback on the format and content;
- Distribution of the Allergan Breast Surgery Patient Planner to physicians and patients to assure that a patient has obtained the labeling within sufficient time prior to surgery and fully understands the risks associated with breast implant surgery. The Allergan Breast Surgery Patient Planner is available through Allergan Silicone Certified Physicians to women who are considering breast implant surgery; and
- Cessation of new enrollment into the company's Adjunct Study and continuation of follow-up for all currently-enrolled patients through their five-year evaluations.
In addition, upon FDA approval, Allergan will initiate a robust 10-year prospective study referred to as the Breast Implant Follow-up Studies (BIFS) program to further validate the long-term safety and effectiveness of INAMED® Silicone-Filled Breast Implants.
"Allergan welcomes the opportunity to address any outstanding patient concerns related to silicone gel-filled breast implants, and is fully engaged with the FDA to fulfill our commitment to further validate the existing long-term data and science that support the robust safety profile of our breast implant devices," said Patricia Walker, M.D., Executive Vice President, Regulatory Affairs, Research and Development, Allergan Medical, a division of Allergan.
Upon FDA approval, the BIFS program will be conducted through Allergan Silicone Certified Physicians to ensure enrollment of tens of thousands of patients. A large patient base will allow Allergan to monitor potential statistical trends and further validate earlier conclusions based on worldwide clinical experience and scientific evidence which show no association between silicone gel-filled breast implants and diseases or adverse events (e.g., connective tissue diseases, neurological disorders, etc.) that are rare among the general and studied patient populations.
Allergan is highly committed to the rapid and successful enrollment of patients in the BIFS program, which will be voluntary for Allergan Silicone Certified Physicians and their patients to facilitate long-term compliance in the study.
"We are confident in having developed a robust, surgeon-friendly study design and protocol that meets our high standards of scientific excellence and will encourage patients to enroll in the study for its full duration," said Dr. Walker.
Furthermore, Allergan has initiated a Device Tracking program for its INAMED® Silicone-Filled Breast Implants according to federal regulation. Device Tracking is a program intended to facilitate prompt notification to patients of new safety information regarding their breast implants.
Allergan's Corporate Commitment
As a world leader in specialty pharmaceuticals and medical devices, Allergan is committed to the Science of Medical Aesthetics(TM), which includes providing the highest-quality education to patients and surgeons, as well as offering patients and plastic surgeons the most technologically advanced breast implant options on the market. For more than 25 years, INAMED® products have led the innovation in breast aesthetics and have consistently demonstrated a commitment to furthering the science of breast implant surgery. Unique to Allergan is the INAMED® Matrix of breast implants, which provides surgeons an unprecedented array of implant options and enables them to select the implant size, shape, texture and implant filler - saline or silicone gel - that will provide a result that is in line with a woman's expectation of surgery.
Through the ALLERGAN ACADEMY(TM) (www.allerganacademy.com) education programs, the company offers surgeons a forum for peer-to-peer discussion and a comprehensive curriculum in-person and via the Web. With the FDA approval, the ALLERGAN ACADEMY(TM) education programs will facilitate the Allergan Physician Certification Program. Upon completion of the Allergan Physician Certification Program, surgeons will gain access to an unprecedented array of implant options designed to enable them to precisely match the appropriate implant to each individual patient's body type and surgical goals.
To access the latest information about INAMED® Silicone-Filled Breast Implants and breast implant surgery, or to locate a surgeon who has completed the Allergan Physician Certification Program and has access to the unique INAMED® Matrix of breast implant options, please visit Allergan's consumer-dedicated Web site at www.breastimplantstoday.com. To learn more about Allergan, Inc., please visit www.allergan.com.
Important INAMED® Silicone-Filled Breast Implants Safety Information
INAMED® Silicone-Filled Breast Implants are indicated for breast augmentation in women 22 years and older, or for women undergoing breast reconstruction or revision surgery.
In clinical studies, the most commonly reported adverse events in augmentation patients at four years post-implantation were: capsular contracture, breast pain, swelling, nipple complications, implant malposition and implant rupture. The most commonly reported adverse events in reconstruction patients at four years post-implantation were: asymmetry, capsular contracture, swelling, wrinkling and infection.
Breast implant surgery should not be performed in women with active infections anywhere in their bodies, existing cancer or pre-cancer of their breasts who have not received adequate treatment for those conditions or who are currently pregnant or nursing.
For complete patient safety information, please visit www.breastimplantstoday.com.
Forward-Looking Statements
This press release contains "forward-looking statements", including the statements by David E.I. Pyott, Dr. Patricia Walker and Dr. Scott Spear and other statements regarding the safety, effectiveness and adverse events associated with INAMED® Silicone-Filled 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 and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new medical device products and/or the acceptance of product line extensions for such products; the potential for product failures; potential difficulties in manufacturing new products; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2005 Form 10-K for fiscal year 2005 and Allergan's Form 10-Q for the quarter ended September 29, 2006. 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.
About Allergan Medical
Allergan Medical, a division of Allergan, Inc., offers the most comprehensive, science-based, aesthetic product offerings under its Total Rejuvenation portfolio, including BOTOX® Cosmetic; hyaluronic acid and collagen-based dermal fillers; and physician-dispensed skin care products. Allergan Medical also offers the industry's widest range of breast implant options for reconstructive and aesthetic breast surgery, and leading minimally invasive devices for obesity intervention treatment.
About Allergan, Inc.
With more than 55 years of experience providing high-quality, science-based products, Allergan, Inc., with headquarters in Irvine, California, discovers, develops and commercializes products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics, obesity intervention and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.
®(TM) Marks owned by Allergan, Inc.
Source: Allergan
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