Exhibit DD: Plastic Surgeons submit evidence to Government review
Summary of Points Raised by the British Association of Aesthetic Plastic Surgeons
London – 15 October, 2012 – For the last two months (since 15 August) a cosmetic surgery review by the Government has been calling for evidence from both the profession and patients. Today this process ends and the British Association of Aesthetic Plastic Surgeons (www.baaps.org.uk) reveals the main points they have put forward to assist in the inquiry.
Measures proposed by the BAAPS to help protect the public include the re-classification of dermal fillers as medicines; defining who should be allowed to perform cosmetic (surgical and non-surgical) procedures; establishing a compulsory register for practitioners; requiring surgeons from abroad to have UK-based indemnity insurance; severely restricting advertising; and making legal claims histories part of revalidation, among others.
According to consultant plastic surgeon and BAAPS President Rajiv Grover;
“The call for evidence by the Keogh review has given our sector an ideal platform to air issues that have long been concerning many of us. The PIP implants crisis demonstrated beyond a shadow of a doubt that there are clear failures in the system, as well as vulnerable people being taken advantage of. It may not be possible to prevent criminal activity in the future, but certainly safeguards can be put in place to protect the public as much as possible.
It is of paramount importance that the growing area of largely unregulated dermal fillers be controlled and we have put forward for consideration the simple measure of reclassifying these injectables as medicines. This will ‘kill three birds with one stone’: regulating which ones come on the market, automatically banning their advertising and defining who is qualified to dispense them. We are also calling for the term ‘surgeon’ to be legally protected, for practitioners to be audited and listed on a compulsory register run independently and for an insurance scheme to help protect patients from another medical device scandal. We propose as well that overseas surgeons who operate in Britain have UK-based indemnity insurance, and – if it cannot be outright banned – for cosmetic surgery advertising to be severely restricted to protect the young and vulnerable.”
Summary of the points put forward by the BAAPS:
NON SURGICAL PROCEDURES & PRODUCTS
- Fillers reclassified as Medicines not medical devices – “Killing three birds with one stone”
- Will regulate which come on the market and after proper testing
- Will automatically ban advertising as they are a “Medicine”
- Will automatically regulate who can give them as they are a “Medicine”
- Who should perform non-surgical procedures? This is likely to be addressed by the new EU standards. The potential reclassification of fillers as medicines would also have an effect on dictating which practitioners can perform which procedures.
- Regulation of the non-surgical sector similar to the “Treatments You Can Trust” scheme but this should be mandatory, and run by an independent entity such as the Care Quality Commission rather than the IHAS
- The need for compulsory audit of procedures and complications: this will strengthen revalidation and allow it to be a mechanism for promoting clinical governance.
- Full records and note keeping required for patients having nonsurgical treatments just as for surgical procedures.
- BAAPS denounces the deregulation of laser and light treatments.
SURGICAL PROCEDURES & PRODUCTS
- The word “Surgeon” should be protected and used only for someone on the Specialist Register for a surgical speciality. This has been strongly recommended by the RCS also.
- Who can perform which operation? Credentialing of which type of surgeon can perform which procedure in accordance with CEN guidance due out in 2013. Aesthetic surgery forms an integral part of surgical subspecialty training in the UK so surgeons on the specialist Register of the GMC are trained within their anatomical region. Which procedures they can safely perform is likely to be answered by the work of CEN committee
- The need for compulsory audit of procedures and complications. This will strengthen appraisal and revalidation, allowing it to be a mechanism for promoting clinical governance.
- Medical negligence claims should be reported by Doctors when they perform their annual appraisal and revalidation. Perhaps Defence Organisations should also report this to the GMC so that it compulsorily forms part of the appraisal and revalidation process because it is a true and objective measure of poor outcome
- Ensuring that foreign surgeons who operate in the UK, also have medical insurance in the UK. Otherwise patients needing to seek legal redress may not be able to fight a claim for negligence.
- Strengthening of the regulation of implants (Breast and others) so they undergo FDA style pre market testing and post market surveillance.
- The setting up of a national breast implant register so prostheses are correctly monitored and records of devices are not lost even if a clinic closes.
- Improving the consent process by ensuring that any consultation is with the operating surgeon only, is at least 30 minutes long, allows for a second consultation if required before deciding and under no circumstances should surgery be booked without a cooling off period of two weeks minimum. If necessary, psychological assessment and support should be available.
- A ban on cosmetic surgery advertising, or at the very least, the incorporation of the 12 recommendations outlawing the “dirty dozen” advertising practices that can mislead the public.
- A ban on unethical marketing practices such as time limited offers, BOGOF and refer a friend as well as packages that prey on the vulnerable (e.g. divorce feel good” etc)
- Development of an ABTA-type insurance scheme to protect patients who have a breast or other permanent implant, such that if there is product failure, the patient is insured for further treatment regardless of whether the original provider is accessible.