Allergan Reassures Patients and Surgeons of the Quality and Safety of Its Breast Implant Devices Sold and Distributed Worldwide
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
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
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
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.
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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
U.S. Food and Drug Administrationin June 2011.
Safety of Silicone Breast Implants report issued by the
U.S. National Instituteof 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
© 2011 Allergan, Inc.
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