Cosmetic Injections following PIP Breast Implant Scandal
This week we saw the long awaited response by the Department of Health to a review of the cosmetic market by the NHS medical director Prof Sir Bruce Keogh.
Sir Bruce Keogh was asked to review the standards and training within the surgical and non-surgical cosmetic sector following the PIP breast implant scandal. PIP were a French company who were found to be using inferior products in their breast implants. Many women were affected and thousands had to have their breast implants removed and replaced.
Sir Bruce Keogh made a number of recommendations affecting breast implants, plastic surgery and other medical devices and injectables such as dermal fillers and Botox.
Qutis were hopeful like many other professional clinics in the industry that the Government would insist on higher standards for everybody, providing dermal fillers and Botox injections. However this does not seem to have been made clear in the latest report.
The original paper with its recommendations was published by Sir Bruce Keogh several months ago and we have been waiting for the government Department of Health to review these recommendations and to support or enhance them, or even to disagree with them.
Department of Health Response to Sir Bruce Keogh’s Report
So, after several delays the government have finally responded this week. We would like to give you a simple summary of what has been said and perhaps more importantly summarise how Qutis and MBNS are responding and what steps we already have in place to meet the key recommendations in the report, published in April 2013.
1. The government has not insisted upon a national register for all clinics providing Botox and dermal fillers. We believe this is unfortunate and Qutis feel that customers would feel safer with a national body to approve registration of clinics providing Botox and dermal fillers.
2. Botox is already classified as a prescription only medicine (POM). This gives patients an added level of security and safety when they meet with a nurse prescriber or Dr face-to-face for a consultation and prescription before any Botox injection can take place. We were hoping that dermal fillers such as Restylane and Juvederm would be treated in exactly the same way by law. Qutis and MBNS clinics ALREADY treat dermal fillers as prescription only, but this is not enforced by law and this is not the case everywhere.
3. We were hoping that the government would insist that only doctors and nurses are suitably qualified to perform Botox and dermal filler injections. At Qutis clinics and MBNS this is already the case. However, this is not the law and there are many unregulated, non-healthcare professionals in the UK who are injecting Botox and dermal fillers. We believe this is not a safe position for patients and that the government should insist on better control and training in this area.
4. Health Education England (HEE) are working with the Royal College of Surgeons and other medical professionals and stakeholders to conduct a review of the training and skills needed. We hope this leads to clearer guidelines both on the training of medical professionals within the cosmetic industry and to greater clarity around who is responsible for supervising clinics and practices providing cosmetic injections such as Botox and dermal fillers. We believe that customers expect the government to insist on a national standard for training and that this will bring greater safety for patients.
5. It seems that there may now be a national register of all breast implants. Breast implants are classified as medical devices. We hoped and expected that dermal fillers would be treated in a very similar way but this seems to not be the case.
Overall many in the industry are disappointed with the lack of clarity and standards which being proposed by the government in the area of surgical and non-surgical cosmetic treatments. This view is supported by many including the president of the British Association of Aesthetic Plastic Surgeons (BAAPS), Mr Rajiv Grover who said in response to the recent report;
“Frankly, we are no less than appalled at the lack of action taken – this review, not the first one conducted into the sector, represents yet another thoroughly wasted opportunity to ensure patient safety. With all the evidence provided by the clinical community, choosing not to reclassify fillers as medicines with immediate effect or setting up any kind of compulsory register beggars belief. Legislators have clearly been paying only lip service to the sector’s dire warnings that dermal fillers are a crisis waiting to happen. Most shockingly of all, the fact that there is no requirement for the actual surgeon involved to provide consent for the procedure makes a mockery of the entire process. It’s business as usual in the Wild West and the message from the Government is clear: roll up and feel free to have a stab.”
So in light of all this, what steps do Qutis and MBNS take to ensure the highest standards of patient safety and quality of treatment for our customers?
Highest Quality Products
We only use the highest standard of Botox and dermal fillers. Allergan, one of our main suppliers, who manufacture Botox and other dermal fillers meet the high standards in the industry, all Allergan 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
- 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
Qualified Medical Practitioners
At Qutis & MBNS all our cosmetic injections are performed by qualified, registered and trained nurses. All our nurses are registered by and are accountable to the Nursing and Midwifery Council (NMC). Most of our nurses also have an advanced practitioner qualification and are also qualified to PRESCRIBE as well as inject Botox and dermal fillers. This is known as the nurse Independent prescriber (NIP) qualification.
Specialist Training and Supervision
All non-surgical procedures are performed under the responsibility of the clinical professional who has gained the accredited qualification to prescribe administer and supervise aesthetic procedures. At Qutis & MBNS Clinics this professional is Marea Brennan Thorns MSc RN NIP. She is an advanced nurse practitioner in aesthetic medicine (Rotherham School of Nursing 1976, Oxford Brookes University, 2006, 2010).
Laser and IPL treatments are carried out by accredited laser therapists under the supervision of Marea Brennan Thorns MSc RN NIP and Stephanie Green RN, who both have BTec qualifications in Laser Applications to the Skin (Loughborough College 2001).
Qutis Nurses Provide Input
The government’s mandate for Health Education England (HEE) includes the development of appropriate accredited qualifications for providers of non-surgical interventions and it should determine accreditation requirements of the various professional groups. The work already carried out by the British Association of Cosmetic Nurses in 2013 in their published and peer reviewed competency document is being utilised by the HEE. The HEE qualification recommendations should be completed by April 2014. Nurses from Qutis & MBNS Clinics have worked on this document (BACN Competency Framework Document 2013).
Operating from Safe Premises
All Qutis and MBNS practitioners have a clear understanding of the requirement to operate from a safe premises, and the responsibilities involved. Our training curriculum include topics such as infection control, treatment room safety and adverse incident reporting.