Healthcare Industry News: Allergan
News Release - December 23, 2011
Allergan Reassures Patients and Surgeons of the Quality and Safety of Its Breast Implant Devices Sold and Distributed WorldwideMARLOW, England--(Healthcare Sales & Marketing Network)-- Allergan, Inc. seeks to reassure patients and surgeons around the world utilizing Allergan’s breast implant devices (NATRELLE™, McGhan™ and CUI™) that its products are not part of the recent investigation into breast implant devices manufactured by French manufacturer, Poly Implant Prosthese (PIP) by regulatory authorities in Europe. It’s important to recognise that there are a number of different breast implant manufacturers around the world. The health authorities are specifically concerned about breast implants made by the company called Poly Implant Prosthese (PIP). Allergan maintains rigorous clinical development processes, extensive manufacturing and quality assurance testing, as well as an industry-leading post-marketing surveillance program, to ensure the highest quality and safety of its breast implants that patients and surgeons can rely on.
All Allergan implants are manufactured at our state-of-the-art facility using silicone and saline that is approved for use in medical devices and are designed to meet all relevant national and international Quality Control Standards and Current Good Manufacturing Practice (CGMP). Allergan is audited many times a year by various regulatory authorities including the European Notified Bodies and the U.S. Food and Drug Administration (FDA), to ensure its ongoing compliance with all applicable regulations and legislation such as the European Medical Devices Directive, US FDA regulations and guidance and relevant International Organization for Standardization (ISO) Standards, as well as the Company’s own exacting requirements. Such procedures ensure that all of Allergan’s medical devices are manufactured under a strictly controlled environment and that there is an established and validated process to ensure the consistency and quality of each device. From start to finish, it can take up to 12 days to manufacture an Allergan breast implant which undergoes almost 100 quality control tests, including materials inspection, product inspection and testing. These standards mean that every implant and tissue expander we manufacture is thoroughly evaluated for quality and durability.
In addition to the exacting standards to which we manufacture our implants, we also strive to exceed quality standards for labelling, packaging, shipping and traceability of all our products. These security measures include the use of tamper-evident seals, putting precautions and safeguards in place to prevent damage or interference with the implants and maintaining delivery tracking systems, which allows Allergan to facilitate notification to patients of new safety information regarding their breast implant products.
Allergan’s breast implants have been used with success for nearly 50 years, in more than 60 countries, with gel-filled implants being the most commonly selected implants worldwide. Allergan’s gel-filled breast implants have also undergone extensive assessment and evaluation by the relevant health authorities worldwide and have been CE marked and available in Europe since 1997. The U.S. FDA approval of gel-filled breast implants in 2006 followed the submission of extensive data gathered from the Company’s extensive pre-clinical device testing, use of Allergan’s gel-filled breast implants in more than 1 million women worldwide, and nearly a decade of clinical studies involving more than 150,000 women with either gel- or saline-filled breast implants who had been followed for a total of over 214,000 person-years.
While breast implants have been safely used since the early 1960s, silicone technology has improved to where today’s implants are made with more consistent manufacturing parameters. Allergan’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, the addition of a barrier layer that is distinct from earlier breast implant devices, and a thicker shell that is designed to withstand more than 25 times the force of a normal mammogram without failure. In addition to the advanced cohesive silicone gel, Allergan’s breast implants offer further reassurance by using the unique INTRASHIEL™ Barrier Technology. The INTRASHIEL™ shell design is composed of several high-performance layers of silicone that act as a safety barrier designed to prevent any movement of the silicone gel.
Silicone gel-filled breast implants are among the most studied medical devices in existence, with more than 3,000 peer-reviewed and published reports on studies, including robust epidemiological studies, supporting their safe use. In June 2011, the U.S. FDA issued a report updating the clinical and scientific community on the safety of silicone gel-filled breast implants. This report confirmed that gel-filled breast implants are safe and effective when used as intended.
Health Authorities around the world, the medical profession and Allergan recognize that breast implants, saline or silicone, are not lifetime devices and it is possible, at some point in a patient’s lifetime, that the implant(s) may need to be removed or replaced. Allergan supports the recommendations issued by worldwide Health Authorities that physicians remain diligent in their monitoring of breast implant patients. We encourage patients with breast implants to keep up with their routine medical care and speak with their physician if they suspect any abnormality. We also encourage women who are concerned about their breast implants to contact their plastic surgeon.
As a world leader in specialty pharmaceuticals and medical devices, Allergan is committed to the Science of Medical Aesthetics, which includes providing the highest-quality products and education to patients and surgeons. For nearly 30 years, Allergan’s medical devices have led the innovation in breast aesthetics and have consistently demonstrated a commitment to furthering the science, safety and quality of breast implant devices and surgery.
Notes to Editors
* FDA Update on the Safety of Silicone Gel-Filled Breast Implants report issued by the Center for Devices and Radiological Health Division of the U.S. Food and Drug Administration in June 2011.
* Safety of Silicone Breast Implants report issued by the U.S. National Institute of Health’s Institute of Medicine (IOM) in 1999.
About Allergan, Inc.
Allergan, Inc. 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 10,000 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 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.
This press release contains "forward-looking statements", including but not limited to statements regarding product quality and safety, product manufacturing, adverse reactions, market and product potential, product availability and other statements associated with Allergan’s breast implant devices. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things; technological advances in the breast implant device industry; challenges inherent in the regulatory processes; challenges related to market acceptance for our medical device products; inconsistency of treatment results among patients; potential difficulties in manufacturing a our medical device products; general industry and medical device market conditions; general economic conditions; 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 U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2010 Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.
© 2011 Allergan, Inc. Irvine, CA 92612. ® and ™ marks owned by Allergan, Inc. All rights reserved.
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