Breast implant registry must be permanent and compulsory

21st December 2013

 

The British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) responded today to comments made by Department of Health Minister Dr Dan Poulter about the pending government response to the Review of Regulation on Cosmetic Interventions that was led by Sir Bruce Keogh.

Tim Goodacre, BAPRAS Chair of Professional Standards and a member of the Keogh Review’s Working Group on Training and Education in Cosmetic Surgery, said:
“It has been two years since the PIP breast implant crisis and over eight months since Sir Bruce Keogh made clear recommendations around how to protect people seeking cosmetic interventions. 

“We are pleased to hear that the Government is planning to take robust action and look forward to seeing the details of their plans in January. Our members are getting frustrated about the lack of momentum and need to understand both the timetable the Government is working to, and the financial commitment it is making to ensure the proposed changes are implemented.

“We have been pushing for the creation of a compulsory register for breast implants and as well as being part of ICOBRA, the International Collaboration of Breast Registry Activities, are already working on a UK specific database pilot with Clinical Practice Research Datalink (CPRD), a research service jointly funded by the NHS National Institute for Health Research (NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA).  

“It is good the Government has announced its commitment to the breast implant registry pilot but in order to protect all women and avoid any future health scares it must quickly become a permanent infrastructure that all cosmetic providers have to use.  

“Dr Poulter says that this is the first time that there will be proper training for cosmetic surgeons and here we must correct him.  As the professional association for plastic surgery, including cosmetic surgery, we have run advanced training courses for many years, working to an examined syllabus which includes cosmetic surgical procedures.  If passed, this leads to specialist registration with our regulator the General Medical Council – which is why the GMC Specialist Register is the only objective measure of a practitioner’s experience and field of expertise. 

“Unfortunately not everyone using the title ‘cosmetic surgeon’ is qualified in this way and we are working as part of the Cosmetic Surgery Inter-Specialty Committee which is chaired by the Royal College of Surgeons England to create a standardised training model for all. We also urge public use of the GMC Specialist Register as a means of checking a surgeon’s qualifications.

“Finally, it is very good news for the public that the Government plans to clamp down on irresponsible advertising and marketing of cosmetic interventions.  We hope that any form of financial incentive will be banned and that particular attention will be paid to protecting people under 18 years old.  

“It is critical that all the women involved in the PIP implant crisis continue to feel supported and our advice remains the same; they should return to their implanting clinic for a consultation and that clinic should take full responsibility for their care. However, if women are not getting the help they need, then they should talk to their GP and be referred to an appropriately qualified surgeon operating within the NHS.”

The Association has encouraged its members to contribute to the European Commission-led public consultation regarding PIP implants to improve patient safety. The consultation will close on 3rd January 2014.

Ends

For further information, please contact Amanda Powell-Smith or Adam Stones on 07711 444549 or 07971 250741.

2013 BAPRAS member research


•  94% of plastic surgeons deplore lack of progress since government-led review of cosmetic interventions
•  97% of plastic surgeons want a national implant register set up within the next 12 months 
•  103 BAPRAS registered consultant plastic surgeons were surveyed in November 2013 

About the PIP breast implant crisis 


•  23 Dec 2011: French government recommends all women with PIP implants have them removed as a precaution
•  6 Jan 2012: Expert committee says NHS will remove and replace PIP implants if women want and private firms should do same
•  18 June 2012: Final report by expert review panel finds PIP implants not toxic or carcinogenic but twice as likely to rupture as other implants
•  April 2013: Department of Health’s Review of Regulation on Cosmetic Interventions published 

BAPRAS Priorities


Summary of BAPRAS priorities for future regulation of cosmetic interventions, as put forward as part of the Department of Health’s Review of Regulation on Cosmetic Interventions:
•  Information, consent & advertising
•  One clear set of rules relating to cosmetic surgery advertising with decisive action taken against practitioners who break the rules
•  Statutory protection across all forms of media to prohibit any form of financial incentive and any promotion to under 18s
•  Accurate use of language with number of years practitioners have been on a specific GMC Specialist Register as the only objective measure of experience and a ban on terms ‘leading’ or ‘expert’
•  Regulation of practitioners
•  Practitioners who use the term surgeon in their title must be on the GMC Specialist Register and work within the defined scope of practice for their designated specialty
•  Cosmetic surgeons should be trained via the NHS and have appropriate mentoring programmes when they establish independent practices
•  ‘Fly in/Fly out’ visiting surgeons must be subject to exactly the same standards and regulations as UK surgeons, and healthcare providers must be able to prove that such surgeons have validated assessment of surgical competence / ability
•  Regulation of providers
•  Private providers of cosmetic surgery must adhere to the same code of conduct and standards as those expected of the NHS, including mandatory reporting of procedures undertaken
•  Provider institutions need to be subject to robust regulation through active inspection and enquiry. There should be an annual reporting mechanism to the agreed regulator, who should at all times have the expertise and authority to act in the public interest
•  Private cosmetic surgery providers must be made responsible for the aftercare of their patients, regardless of the timeframes in which the interventions took place.  This is likely to require a system to support patients affected by provider bankruptcy
•  Medical implants, devices and other products; data and registries
•  A national, compulsory register for medical devices including breast implants must be developed
•  Improved surveillance of breast implants and other cosmetic devices must be conducted in order to ensure poor quality products are recognised and dealt with early
•  All injectable materials need to be registered as medical devices and CE marked, including both absorbable and permanent fillers, to ensure they are subject to the appropriate regulatory procedures
•  All practitioners using fillers and toxins by injection must maintain full records of treatments and record outcome data to a standard that can be audited independently


About BAPRAS


BAPRAS, the British Association of Plastic, Reconstructive and Aesthetic Surgery, is the voice of plastic surgery in the UK.  It aims to increase the understanding of the professional specialty and scope of plastic surgery, promoting innovation in teaching, learning and research.

Founded in 1946 (originally as the British Association of Plastic Surgeons), today BAPRAS has over 800 members and is the professional representative body for reconstructive and aesthetic Plastic Surgeons providing services to patients on the NHS and privately in the UK.

Members of the public can find a member Plastic Surgeon in their area by logging on towww.bapras.org.uk. Anyone can check the GMC to find out if a surgeon is on the plastic surgery specialist register

 

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