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New research initiative for breast implant safety launches

Manufacturers, surgeons unite in “£1 per implant” venture

London – 2 October, 2013 – In his 2013 Report on the Review of Cosmetic Interventions, Sir Bruce Keogh lamented the “insufficient research on the effectiveness and risks of many cosmetic procedures” and welcomed a joint initiative by the British Association of Aesthetic Plastic Surgeons (www.baaps.org.uk ) and the Healing Foundation (www.thehealingfoundation.org.uk ) providing a model to boost research. Directly addressing the sector’s ‘data vacuum’, both organisations last week announces the official launch of the National Institute of Aesthetic Research (www.niar.org.uk), the first of its kind in the world; today marks the announcement of their first official corporate sponsorships.

 

Despite the recent scandal involving Poly Implant Prosthèse (PIP) implants, breast augmentation continues to be the most popular cosmetic surgery procedure. Thus, one of the NIAR’s first priorities is the establishment of the Breast Implant Safety Campaign.  Breast implant manufacturers worldwide are being invited to contribute the equivalent of £1 per device sold towards funding a research programme aimed at improving all aspects of breast implant safety, treatment and aftercare. NIAR’s first official founding partners in this groundbreaking initiative are Nagor, the UK’s only manufacturer of implants (www.nagor.com), and Eurosurgical, distributors for Silimed (www.pureimplants.com), South America’s largest manufacturer of these medical devices.

 

Nic Steventon is General Director for Europe at Nagor, which was also the world’s only implant manufacturer to help PIP victims by offering free replacements for ruptured devices. He says;

“We are thrilled to take part in this pioneering initiative, which reinforces our commitment to patient safety, our own synergy with the plastic surgery community and shared scientific ideals. Our company, which enjoys over 35 years of history is currently under the leadership of the industry’s first-ever female CEO; our mission remains to continue providing high quality products whilst keeping the best interests of female patients at heart.”

 

Peter Cranstone is Managing Director at Eurosurgical, UK distributors of Silimed implants. They were the first non-American company to gain FDA (Food and Drug Administration) approval for gel filled implants in the US. He says;

“At Eurosurgical we are proud to support the National Institute of Aesthetic Research.  Silimed are the largest producer of breast implants in South America and third largest in the world. The importance of independent research and the reporting of clinical outcomes and follow-up are fundamental to our company. The work of the NIAR will help future patients and surgeons to select the best implants, with long safety data, that avoids unnecessary and preventable complications with breast implant surgery.

 

NIAR’s areas of enquiry may include,

         an improved understanding of the psychosocial factors behind women seeking breast enhancement surgery,

         providing an independent analysis and comment on data which will come from the Breast Implant Register which Government has recommended,

         promoting clinical research into the safety and efficacy of surgical techniques in breast implant surgery,

         analysing existing data on breast surgery to provide evidence based advice for surgeons which may help to define “best practice”,

         scientific research into the causes of capsular contracture following breast implants, and

         longer term scientific research into implant design and technology for the prospects of developing implants with more favorable interface characteristics with the breast.

 

According to consultant plastic surgeon and BAAPS President Rajiv Grover;

"We are pleased the National Institute of Aesthetic Research enjoys Government endorsement. In a sector often derided for its unbridled expansion, unrestricted marketing and unrealistic claims, NIAR will play an important role in examining clinical evidence and analysing outcomes, to truly separate fact from fiction. Sir Bruce Keogh's findings confirm that the cosmetic sector urgently requires detailed scrutiny, and the Institute will be the first to explore the evidence base for cosmetic treatments, with a view to providing information on efficacy and best practice."

 

According to Brendan Eley, Chief Executive of the Healing Foundation;

“The public may be surprised to know that whilst there are ongoing, systematic investigations into healthcare treatments and policy (such as the Cochrane Reviews), this has never before taken place in the area of cosmetic surgery. At the Healing Foundation we are delighted to launch the National Institute of Aesthetic Research in conjunction with the BAAPS, with the backing of our corporate partners to help the profession, as well as the public, make sense of a sector where the objectives of business and medicine are known to regularly collide.”

 

According to Sir Bruce Keogh, medical director of the NHS;

“I welcome the announcement from the Healing Foundation and BAAPS on the launch of the National Institute of Aesthetic Research (NIAR). This joint initiative is the first recommendation of my review to be implemented and I know it will provide a major contribution to patient safety.”

 

All research undertaken by the Healing Foundation under the auspices of the NIAR is subject to the charity’s existing, stringent processes of research management.  The Healing Foundation is a registered charity and a member of the Association of Medical Research Charities (AMRC).

 

ENDS

About the BAAPS

The BAAPS (www.baaps.org.uk), based at the Royal College of Surgeons, is a not-for-profit organisation, established for the advancement of education and practice of Aesthetic Plastic Surgery for public benefit. Members undergo thorough background screening before they can join. Information about specific procedures and surgeons’ contact details can be found on the website, or by contacting their office at 020 7430 1840. Further materials can be posted to members of the public seeking specialised information. BAAPS is also on Twitter: www.twitter.com/BAAPSMedia and Facebook: www.facebook.com/BritishAssociationofAestheticPlasticSurgeons 

For all media enquiries, please contact pr@baaps.org.uk

 

 

About the Healing Foundation

The Healing Foundation (www.thehealingfoundation.org.uk ) is a national fundraising charity championing the cause of people living with disfigurement and visible loss of function, by funding research into pioneering surgical and psychological healing techniques. Through research, we also raise awareness about the cause and provide information about the sources of support. To contact the organisation call 020 7869 6920 or emailinfo@thehealingfoundation.org.uk

About Nagor

Nagor (www.nagor.com ) is the only British manufacturer of silicone breast implants with facilities situated in Cumbernauld in Scotland and Ashby De La Zouch in central England, employing 125 highly skilled and dedicated people. They have been selling implants since 1979 and offer a lifetime patient guarantee on all breast implants.

All Nagor products are designed, developed and manufactured in facilities compliant with the ISO 13485 standards and requirements demanded for class III sterile breast implant medical devices. They are manufactured under a quality management system in accordance with ISO and EN requirements and have CE mark certification.  For all press and media enquiries please contact Kate Chaundy of Cacique Public Relations on +44(0)207 2504750 /kchaundy@caciquepr.com  

About Silimed

Since 1978 Silimed (www.pureimplants.com ) have been one of the world's leading manufacturers of quality silicone breast implants and other medical implantable devices. In March 2012, Silimed became the first non-American silicone implant company to receive FDA approval for their silicone round and anatomical smooth and textured breast implants. The first and only company to receive FDA approval for anatomical shaped implants. Eurosurgical have set up this web-site to offer more information for all women, those with implants and women who are considering implants. Eurosurgical is the UK distributor for Silimed – for more information visit www.eurosurgical.co.uk or contact +44 (0)1483 456007

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