Allergan Welcomes 'Keogh Review' Recommendations to Classify All Cosmetic Implants as Medical Devices

MARLOW, England, April 24, 2013 /PRNewswire/ --

Allergan confirms their non-permanent CE marked dermal filler ranges, JUVÉDERM® and SURGIDERM®, already adhere to European regulations and are backed by significant medical evidence and clinical experience

Allergan, Inc. welcomes many of the recommendations outlined in the Review of the Regulation of Cosmetic Interventions, chaired by Sir Bruce Keogh. In particular, Allergan is in favour of regulatory changes to classify all cosmetic implants including dermal fillers as medical devices and supports many of the other proposals such as calls to strengthen the existing European Medical Device Directive, plans to establish accredited training standards for health care professionals administering cosmetic implants, as well as steps to improve consultation and record keeping of patient treatments.

Importantly, contrary to some of the points raised within the report regarding dermal filler regulation and manufacturing, Allergan estimates that over 96% of the dermal fillers sold in the UK are already classified as Medical Devices^[1] and are therefore controlled by European and UK legislation. Allergan's JUVÉDERM® and SURGIDERM® brands of hyaluronic acid (HA) dermal fillers are categorised as Medical Devices, carrying the necessary CE Marks. These dermal fillers are backed by over 10 years of research and clinical experience including 19 Allergan-sponsored clinical trials (involving over 5,500 patients) and 15 investigator-initiated studies.^[2] Today, these products are available in more than 80 countries around the world^[3] and Allergan estimates that 16 million treatments have been given to date.^[4]

"Allergan is supportive of the review into cosmetic interventions by the Department of Health in order to put additional safeguards in place for patients interested in these procedures", said Anthony Sauerman, General Legal Counsel for Allergan EAME. "At Allergan, we only sell our medical aesthetics products to licensed and qualified health care professionals. We have extensive training programs in place to ensure effective use of our treatments in the hands of the right professionals. So many of the proposed changes are in line with our philosophy and should be adopted by all manufacturers entering the aesthetic market segment, particularly those making medical devices intended for cosmetic use".

The report calls for a proposal to re-classify dermal fillers as prescription-only medical devices. This will require further thought to ensure the necessary legislation would bring about positive change in ensuring optimal patient outcomes. Specifically, any legislation change of this type will require significant time and could also mean that medical aesthetic nurses, who are generally already highly skilled and experienced, will need to re-train in order to obtain a prescribing licence.

Finally, with regard to the proposal included in the report calling for better patient consultation and record retention methods, Allergan reinforces in all of its selling and promotional practices to doctors and patients that treatments with dermal fillers are medical procedures. Allergan provides healthcare professionals with detailed information in the product information, called the Directions For Use (DFU), which are supplied within every pack. A thorough understanding of the available products should form a foundation requirement of any accredited training program.

Best practice in patient care includes a discussion of this information between the practitioner and his or her patient as part of the process of gaining informed consent. We welcome the recommendations to strengthen patient understanding of cosmetic interventions and to improve consultation. We are encouraged by the recommendations to strengthen record keeping, as well as the process of reporting of adverse events. We have always encouraged patients to keep a record of their treatments and to speak with their physician if they have any issues or concerns. For breast implants, we already provide an information card that is designed to inform the patient of the type and batch number of the breast implants they have received. That said, we are actively exploring innovative Unique Device Identification systems to allow best practice 'track and trace' for our medical devices.

Notes to Editors

Manufacturing Allergan's dermal fillers

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 medical devices that patients and surgeons can rely on. At our state of the art manufacturing centre in Pringy, Allergan's dermal fillers are produced in a strictly controlled environment specifically designed to comply with all applicable regulations using a 7-stage production process, including:

• Crosslinking (i.e. HA gel creation)
• Purification
• Fill syringes and sterilization
• Labelling and visual inspection (100% of syringes controlled)
• Packaging
• Quality control analysis of each batch
• Release by Quality Assurance

All our fillers (including the JUVÉDERM® range, as well as the SURGIDERM® range) meet the following standards of approval:

• MDD 93/42/EEC: Medical Device Directive & latest amendment 2007/47/EC
• FDA 21 CFR Part 820: Quality System Regulation
• ISO 13485:2003: Quality managements systems - requirements for regulatory purposes
• Compliance of Materials to EP/USP monographs (for parenteral use)
• ISO 10993-1: 2009 - Biological evaluation of MDs -  for implant devices intended for long term contact duration in tissue/bone"
• ICH Guidance for Stability and Validation of Analytical Methods
• ISO 17665-1: 2006, EN 556-1: 2001 & ISO 11737-1: 2006 - for the sterilization of MDs
• ISO 14644 : Manufacturing and Filling in Class ISO 6 (under Class 5 laminar flow), Sterilization in Class ISO 6 and Packaging in Class ISO 7

About Allergan in Medical Aesthetics

Allergan are supportive of the review by the Department of Health into cosmetic interventions in order to put additional safeguards in place for patients interested in these procedures.  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 over 35 years, we have demonstrated a commitment to furthering the science, safety and quality of surgical as well as non-surgical medical aesthetics by investing in robust data collection and clinical studies. We continue to make considerable investments into educational programs, in our quest to make our products and treatments of the highest quality possible to be used in the hands of trained medical aesthetics practitioners.

Forward-Looking Statement

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 dermal fillers and other medical 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; 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 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 2012 Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.  

^© 2013 Allergan, Inc. Irvine, CA 92612. ® and ™ marks owned by Allergan, Inc. All rights reserved.

References

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