WhatClinic.com: Cosmetic interventions 	

Creating an informed
and empowered
public
And a review of the recommendations ma...
Why regulation is key for the long term
safety of cosmetic surgery consumers.

WhatClinic.com

Share this report
A better ...
What’s all the fuss about?
It was discovered that a company in France had been
cutting corners by using industrial silicon...
How could this happen?
Recklessness, greed, oversights, loop holes and a lack of legislation.

WhatClinic.com

Share this ...
Dangerous Loopholes
In 2010, founder of Poly Implant Prothese (PIP), Jean-Claude Mas was implicated in a breast implant sc...
So what happened next?
In the UK, the then Secretary of State for Health, the
Rt Hon Andrew Lansley MP, asked Professor Si...
The report is

67

pages long.
WhatClinic.com

Share this report
A better way to choose a clinic
The report is

67

pages long.
WhatClinic.com

But that’s OK. We read it.
We picked out bits that were interesting.
To pat...
The report covers “cosmetic interventions”.
What exactly does that include?	
Elective treatments are ones that aren’t nece...
‘Cosmetic interventions’ include
surgical treatments like these
•	 Face-lifts
•	 Tummy tucks
•	 Breast implants

WhatClini...
‘Cosmetic interventions’ include
non-surgical treatments like these
•	 Dermal fillers
•	 Botox®
•	 Laser
•	 Intense pulsed...
The report
has a list of all
their risks.
These make
scary reading

WhatClinic.com

Share this report
A better way to choo...
Did you know that cosmetic intervention in
the UK was valued at £2.3 billion in 2010, and
is estimated to rise to £3.6 bil...
What did the review say?
It set out recommendations to protect people who choose cosmetic surgery.
If focused on three imp...
What did the review say?
It set out recommendations to protect people who choose cosmetic surgery.
If focused on three imp...
We liked this report a lot,
because it used clear, plain English.
It is detailed, thorough, well supported,
non-judgementa...
We liked this report a lot,
because it used clear, plain English.
It is a detailed, thorough, well supported,
non-judgemen...
So there was a great report done, 	 hat made lots of sense.
t

Are we done?
Well, no. Because nothing has actually changed...
1.

That the Royal College of Surgeons (RCS) should establish
a Cosmetic Surgery Interspecialty Committee to set
standards...
And for non-surgical treatments...
4.

All non-surgical procedures must be performed
under the responsibility of a clinica...
And you can’t get in unless you are qualified, adhere to code of practice which includes
handling complaints and having th...
This bit was so good we didn’t want to shorten it one bit:
It’s not a recommendation, more like a giant WTF.

“ Non-surgic...
This is a great recommendation:
UK legislation should be introduced to make fillers a prescription only medical device.
Th...
This is a great recommendation:
UK legislation should be introduced to make fillers a prescription only medical device.
Th...
And another thing - Prescriptions.
Making a high risk substance prescription only sounds very sensible.

But when you thin...
The report calls for an:

Informed and Empowered Public

WhatClinic.com

Share this report
A better way to choose a clinic
“people need access to
independent and evidencebased information to help
inform their decisions.”

WhatClinic.com

Share t...
“people need access to
independent and evidencebased information to help
inform their decisions.”
Hey!
Isn’t that what we ...
The report says:
There is little reliable data to assist patients in making
assessments of the efficacy and risks of treat...
Well, maybe, maybe not.
But can’t do any harm,
certainly.

WhatClinic.com

“A patient
cannot give
informed
consent if they...
The report says:
“Patients should be aware of the implications of surgery, the limitations of the
procedure and the potent...
The report looked abroad for learnings.

They looked at
Hong Kong, Australia,
Denmark & Sweden.
Very wise.

WhatClinic.com...
They looked to Australia, who had a good
think about the same stuff back in 2010.
In November 2010, the Australian Health ...
1.

Tighter restrictions on advertising, including
prohibiting cosmetic procedures being offered as
prizes and financial i...
Nice one, Oz!

WhatClinic.com

Share this report
A better way to choose a clinic
Back to the report...
What does it say about advertising?

WhatClinic.com

Share this report
A better way to choose a clin...
So we’re quite interested in this bit. Why?
Well, we’re a marketing service for clinics.
Clinics that offer the treatments...
The report says, quite accurately that:
“Previous attempts at self-regulation in the industry have failed, largely because...
The report recommended the prohibition of
the following calling them “socially irresponsible”
1.

Time limited deals

2.

...
but
WhatClinic.com

Share this report
A better way to choose a clinic
It’s very easy to have a good idea.

A sensible idea. 								
A logical idea.
But when it gets put into
practice, it has ...
When Good
Ideas go Bad
a Case Study

Baby seats
on airplanes.

Is that a trick
question?

Macro effects from micro

Good i...
The American Academy of Pediatrics recommends that
kids ride in child safety seats on airplanes. They looked at
studies wh...
The FAA also recommends that children sit
in child safety seats during air travel.

WhatClinic.com

Share this report
A be...
The NTSB recommends that children sit in
child safety seats or other restraints during
air travel.

WhatClinic.com

Share ...
But statistically...
Road travel is far more
dangerous than airline travel.
Compulsory car seats on
planes will force fami...
Making baby seats compulsory on planes would increase
the number of infant deaths over time, as more families
would be dri...
You see? Macro effects from micro changes.
The growth in popularity of cosmetic intervention has driven governments around...
In Singapore, restrictions on publicity
for clinics had a far reaching effect.
Reviews, testimonials, star ratings and con...
The final area of examination was REDRESS.
They made LOTS of recommendations. Numbers 32-38
cover things like complaints, ...
What does the report say about medical tourism?
“The Review Committee was very concerned about the
practice of cosmetic to...
Medical tourism

And…

“The Review Committee
recognises that people

On page 45 of the report they

may consider cosmetic
...
Medical tourism
On page 45 of the report they list 8 serious issues which were felt to increase the risk,
difficulties and...
There are two sides to medical tourism
Risks and benefits.

That’s why they go!

If a consumer is fully

By travelling abr...
“The Review Committee
recognises that people may
consider cosmetic tourism
in future..”
Over 5o countries have
identified ...
In fact…

Decisions made today about regulation of the industry
could very well drive more people to go abroad. DOH.

Macr...
Here is a full list of all the recommendations.
We’ve made some of them a bit shorter.

WhatClinic.com

Share this report
...
Recommendation 1
•	 The Royal College of Surgeons (RCS) should establish a Cosmetic Surgery Interspecialty Committee.
Reco...
Recommendation 5
•	 Non-healthcare practitioners who have achieved the required accredited qualification may perform these...
Recommendation 9
•	 The CQC should work with professional organisations to produce inspection guidelines for cosmetic surg...
Recommendation 13
•	 ‘Independent healthcare providers should only allow practising privileges to those cosmetic surgeons ...
Recommendation 17
•	 All European Notified Bodies should be regularly and rigorously assessed and audited, to ensure they ...
Recommendation 21
•	 Until such a system is developed, a National Breast and Cosmetic Implant Registry should be establish...
Recommendation 25
•	 Evidence-based standardised patient information should be developed by the RCS Interspecialty Committ...
Recommendation 30
•	 CAP should extend its guidance note on cosmetic surgery advertising to cover non-surgical cosmetic pr...
Recommendation 34
•	 The remit of the Parliamentary and Health Service Ombudsman (PHSO) should be extended to cover the wh...
Recommendation 38
•	 Patients’ rights should be protected even when a provider goes out of business. Providers of cosmetic...
So in summary…
Regulation? 							Good thing.
Prohibition? 							Bad thing.
Informed choice? 					Good thing.
Restriction...
Click to share this report

Add comment

WhatClinic.com

A better way to choose a clinic
Upcoming SlideShare
Loading in …5
×

Report: Regulation of the cosmetic surgery business - Creating an informed and empowered public

4,209 views

Published on

Patient Champion @Whatclinic Reviews Best (and Worst!) of UK Government Recommendations for Cosmetic Surgery Clinics.

And a review of the recommendations made in April 2013 on the
regulation of the cosmetic surgery business.

Published in: Health & Medicine
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
4,209
On SlideShare
0
From Embeds
0
Number of Embeds
908
Actions
Shares
0
Downloads
23
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

Report: Regulation of the cosmetic surgery business - Creating an informed and empowered public

  1. 1. WhatClinic.com: Cosmetic interventions Creating an informed and empowered public And a review of the recommendations made in April 2013 on the regulation of the cosmetic surgery business. WhatClinic.com Share this report A better way to choose a clinic
  2. 2. Why regulation is key for the long term safety of cosmetic surgery consumers. WhatClinic.com Share this report A better way to choose a clinic
  3. 3. What’s all the fuss about? It was discovered that a company in France had been cutting corners by using industrial silicone oils as fillers for their breast implants. Implants from that company had been shipped to countries all over the world. The sub-standard implants ruptured or leaked high amounts of oil, and the health of hundreds of thousands of women all around the world was compromised. WhatClinic.com Share this report A better way to choose a clinic
  4. 4. How could this happen? Recklessness, greed, oversights, loop holes and a lack of legislation. WhatClinic.com Share this report A better way to choose a clinic
  5. 5. Dangerous Loopholes In 2010, founder of Poly Implant Prothese (PIP), Jean-Claude Mas was implicated in a breast implant scandal and arrested by French gendarmes for reported bodily harm. However, it has been claimed by certain individuals in the know (such as regulatory bodies, medical professionals and those who work in medical devices companies) that the impotence of the European regulatory system is also to blame. The then French regulator, AFSSAPS (succeeded in late 2012 by ANSM, the French National Agency of Medicine and Health Products Safety) did not review new devices. Instead, this responsibility was shouldered by one of about 80 European Notified Bodies. The Notified Body involved in the appraisal of PIP was the German TUV Rheinland. TUV Rheinland approved PIP breast implants for the EU market. The US Food and Drug Administration (FDA) rejected this type of implant, but nevertheless marketing of said product was sustained for years afterwards. TUV Rheinland PIP AFSSAPS began to receive accusations from French specialists regarding PIP implants’ worryingly high rupture rates. TUV Rheinland PIP Following an investigation of the factory where PIP implants were produced, these devices were banned from the French market. Other jurisdictions were also forewarned. ASSAPS ASSAPS PIP Labs WhatClinic.com Share this report A better way to choose a clinic
  6. 6. So what happened next? In the UK, the then Secretary of State for Health, the Rt Hon Andrew Lansley MP, asked Professor Sir Bruce Keogh, the NHS Medical Director, to review how the safety of people considering or undergoing cosmetic interventions might be better ensured. That report was issued in April 2013. Read the full report WhatClinic.com Share this report A better way to choose a clinic
  7. 7. The report is 67 pages long. WhatClinic.com Share this report A better way to choose a clinic
  8. 8. The report is 67 pages long. WhatClinic.com But that’s OK. We read it. We picked out bits that were interesting. To patients, to clinics and to us. Share this report A better way to choose a clinic
  9. 9. The report covers “cosmetic interventions”. What exactly does that include? Elective treatments are ones that aren’t necessary but that really should be carried out by someone with medical training. These obviously include surgical treatments, but also include special non-surgical ones too. WhatClinic.com Share this report A better way to choose a clinic
  10. 10. ‘Cosmetic interventions’ include surgical treatments like these • Face-lifts • Tummy tucks • Breast implants WhatClinic.com Share this report A better way to choose a clinic
  11. 11. ‘Cosmetic interventions’ include non-surgical treatments like these • Dermal fillers • Botox® • Laser • Intense pulsed light (IPL). WhatClinic.com Share this report A better way to choose a clinic
  12. 12. The report has a list of all their risks. These make scary reading WhatClinic.com Share this report A better way to choose a clinic
  13. 13. Did you know that cosmetic intervention in the UK was valued at £2.3 billion in 2010, and is estimated to rise to £3.6 billion by 2015? Non-surgical treatments account for nine out of ten of these procedures and are worth 75% of the market value. WhatClinic.com Share this report A better way to choose a clinic
  14. 14. What did the review say? It set out recommendations to protect people who choose cosmetic surgery. If focused on three important areas: 1. High quality care with safe products, skilled practitioners and responsible providers. 2. An informed public to ensure people get accurate advice and that the vulnerable are protected. 3. Accessible redress and resolution in case things go wrong. WhatClinic.com Share this report A better way to choose a clinic
  15. 15. What did the review say? It set out recommendations to protect people who choose cosmetic surgery. If focused on three important areas: 1. High quality care with safe products, skilled practitioners and responsible providers. 2. An informed public to ensure people get accurate advice and that the vulnerable are protected. 3. Accessible redress and resolution in case things go wrong. WhatClinic.com An informed public. We liked this bit. Share this report A better way to choose a clinic
  16. 16. We liked this report a lot, because it used clear, plain English. It is detailed, thorough, well supported, non-judgemental and written by experts. WhatClinic.com Share this report A better way to choose a clinic
  17. 17. We liked this report a lot, because it used clear, plain English. It is a detailed, thorough, well supported, non-judgemental and written by experts. If you are thinking about having cosmetic surgery, or if you work in the business, we highly recommend you read it. WhatClinic.com Share this report A better way to choose a clinic
  18. 18. So there was a great report done, hat made lots of sense. t Are we done? Well, no. Because nothing has actually changed. What!? Why not? Well, not YET. The review made some recommendations. Over 30 actually. The first three relate to cosmetic surgery. WhatClinic.com Share this report A better way to choose a clinic
  19. 19. 1. That the Royal College of Surgeons (RCS) should establish a Cosmetic Surgery Interspecialty Committee to set standards and training across all areas, using experts. 2. That only doctors on a GMC Specialist Register should 3. The development of clear, credible outcome measures for perform cosmetic surgery. cosmetic surgery that people could easily get their hands on. So people would know honestly what to expect. WhatClinic.com Share this report A better way to choose a clinic
  20. 20. And for non-surgical treatments... 4. All non-surgical procedures must be performed under the responsibility of a clinical professional who has gained the accredited qualification. 6. Health Education England (HEE) should determine accreditation requirements for practitioners administering non-surgical cosmetic treatments (fillers, Botox, laser, IPL) 7&8. A non-commercial independent central register of practitioners, funded by registration fees. So you might not have to be qualified, but you need to be supervised. You’d think this was the case right now – but no – anyone with a white coat and a credit card can inject your face full of stuff. Very sensible WhatClinic.com Share this report A better way to choose a clinic
  21. 21. And you can’t get in unless you are qualified, adhere to code of practice which includes handling complaints and having the right insurance. BRILLIANT! WhatClinic.com Share this report A better way to choose a clinic
  22. 22. This bit was so good we didn’t want to shorten it one bit: It’s not a recommendation, more like a giant WTF. “ Non-surgical procedures 3.33. The Review Committee finds that the current regulation of non-surgical providers is insufficient to adequately protect public health and safety. Given the known risks, it is not appropriate that the public has no more consumer rights when receiving a dermal filler injection than when buying a toothbrush. The Review Committee is alarmed by the casual use of some cosmetic interventions by unqualified individuals, and by reports of people buying injectable products over the internet and self-administering.” WhatClinic.com Share this report A better way to choose a clinic
  23. 23. This is a great recommendation: UK legislation should be introduced to make fillers a prescription only medical device. There are lots of solid recommendations that are in direct response to the errors made by PIP – things like not having to announce factory inspections days in advance. But it’s this next bit that we think is the most interesting. WhatClinic.com Share this report A better way to choose a clinic
  24. 24. This is a great recommendation: UK legislation should be introduced to make fillers a prescription only medical device. There are lots of solid recommendations that are in direct response to the errors made by PIP – things like not having to announce factory inspections days in advance. But it’s this next bit that we think is the most interesting. We bet you thought they already were! They’re not. And as a prescription only medical device, they would be subject to better quality controls. WhatClinic.com Share this report A better way to choose a clinic
  25. 25. And another thing - Prescriptions. Making a high risk substance prescription only sounds very sensible. But when you think about it… Really think about it… How does this really help people? What’s really important (to us anyway) is that: it comes from an approved pharmaceutical manufacturer who is held to the highest standard, and if it is used by a qualified professional. Really – prescriptions add cost, and don’t fix the main problem. WhatClinic.com Share this report A better way to choose a clinic
  26. 26. The report calls for an: Informed and Empowered Public WhatClinic.com Share this report A better way to choose a clinic
  27. 27. “people need access to independent and evidencebased information to help inform their decisions.” WhatClinic.com Share this report A better way to choose a clinic
  28. 28. “people need access to independent and evidencebased information to help inform their decisions.” Hey! Isn’t that what we do at WhatClinic.com? OMG, yes it is! WhatClinic.com Share this report A better way to choose a clinic
  29. 29. The report says: There is little reliable data to assist patients in making assessments of the efficacy and risks of treatments, or of the expertise and experience of the practitioner. Totally true. That’s why we started WhatClinic.com in the first place WhatClinic.com Share this report A better way to choose a clinic
  30. 30. Well, maybe, maybe not. But can’t do any harm, certainly. WhatClinic.com “A patient cannot give informed consent if they are not provided with time to reflect.” Share this report A better way to choose a clinic
  31. 31. The report says: “Patients should be aware of the implications of surgery, the limitations of the procedure and the potential complications. When the risks of surgery are discussed patients should be alerted to the risks of medical complications and also the possibility of an unsatisfactory aesthetic outcome.” Totally true. That’s why we started WhatClinic.com in the first place. WhatClinic.com Share this report A better way to choose a clinic
  32. 32. The report looked abroad for learnings. They looked at Hong Kong, Australia, Denmark & Sweden. Very wise. WhatClinic.com Share this report A better way to choose a clinic
  33. 33. They looked to Australia, who had a good think about the same stuff back in 2010. In November 2010, the Australian Health Ministers’ Advisory Council published its report Cosmetic Medical and Surgical Procedures – a National Framework. It made recommendations to Ministers for improved regulation across five areas of the cosmetic medical and surgical industry: the procedures, the promotion of the procedures, the practitioner, the patient and the place. WhatClinic.com Share this report A better way to choose a clinic
  34. 34. 1. Tighter restrictions on advertising, including prohibiting cosmetic procedures being offered as prizes and financial incentive schemes 2. Here’s what they did: The introduction of minimum training and accredited standards for practitioners 3. A public consultation on regulating unregistered practitioners 4. Developing guidelines on consent and follow-up care 5. Improved, accessible information for people considering procedures 6. Clear avenues for redress, regardless of status of practitioner WhatClinic.com Share this report A better way to choose a clinic
  35. 35. Nice one, Oz! WhatClinic.com Share this report A better way to choose a clinic
  36. 36. Back to the report... What does it say about advertising? WhatClinic.com Share this report A better way to choose a clinic
  37. 37. So we’re quite interested in this bit. Why? Well, we’re a marketing service for clinics. Clinics that offer the treatments, both surgical and non-surgical – that is the main focus of this report. So we’re not unbiased, right? But we want what’s best for the patient. Don’t believe us? Well it’s simple. Happy, safe patients = more patients over time. This is good for business. Good for clinics = good for us. Simple. WhatClinic.com Share this report A better way to choose a clinic
  38. 38. The report says, quite accurately that: “Previous attempts at self-regulation in the industry have failed, largely because voluntary codes have meant that only the best in this disparate sector commit themselves to better practice, whilst the unscrupulous and unsafe carry on as before.” It advises that existing advertising recommendations and restrictions should be updated and better enforced. “The use of financial inducements and time-limited deals to promote cosmetic interventions should be prohibited to avoid inappropriate influencing of vulnerable consumers.” WhatClinic.com Share this report A better way to choose a clinic
  39. 39. The report recommended the prohibition of the following calling them “socially irresponsible” 1. Time limited deals 2. Financial inducements 3. Packages 4. Cosmetic procedures as competition prizes We mostly agree WhatClinic.com Share this report A better way to choose a clinic
  40. 40. but WhatClinic.com Share this report A better way to choose a clinic
  41. 41. It’s very easy to have a good idea. A sensible idea. A logical idea. But when it gets put into practice, it has effects you never really thought about. WhatClinic.com Share this report A better way to choose a clinic
  42. 42. When Good Ideas go Bad a Case Study Baby seats on airplanes. Is that a trick question? Macro effects from micro Good idea or bad idea? Lets look at the US for this. changes. WhatClinic.com Share this report A better way to choose a clinic
  43. 43. The American Academy of Pediatrics recommends that kids ride in child safety seats on airplanes. They looked at studies which show preventable deaths and injuries have occurred in children who are just held on laps. WhatClinic.com Share this report A better way to choose a clinic
  44. 44. The FAA also recommends that children sit in child safety seats during air travel. WhatClinic.com Share this report A better way to choose a clinic
  45. 45. The NTSB recommends that children sit in child safety seats or other restraints during air travel. WhatClinic.com Share this report A better way to choose a clinic
  46. 46. But statistically... Road travel is far more dangerous than airline travel. Compulsory car seats on planes will force families to buy an extra ticket, instead of restraining the child in their lap. More families will travel long distances by car. WhatClinic.com Therefore, wait for it… Share this report A better way to choose a clinic
  47. 47. Making baby seats compulsory on planes would increase the number of infant deaths over time, as more families would be driving long distances, instead of flying. Nuts, isn’t it? WhatClinic.com Share this report A better way to choose a clinic
  48. 48. You see? Macro effects from micro changes. The growth in popularity of cosmetic intervention has driven governments around the world to examine safety. In Singapore regulations have been put in place to improve safety, and to protect people. They covered hospitals, medical clinics, labs and healthcare establishments. WhatClinic.com Share this report A better way to choose a clinic
  49. 49. In Singapore, restrictions on publicity for clinics had a far reaching effect. Reviews, testimonials, star ratings and consumer feedback were all banned. Anything which might make someone choose one healthcare institution over another. Read the full report Outcome: • WORSE FOR PATIENTS. • No informed choice. • No access to independent information. • And no voice. WhatClinic.com Share this report A better way to choose a clinic
  50. 50. The final area of examination was REDRESS. They made LOTS of recommendations. Numbers 32-38 cover things like complaints, insurance cover, and aftercare. They were all excellent. We hope they all get implemented. but they probably won’t WhatClinic.com Share this report A better way to choose a clinic
  51. 51. What does the report say about medical tourism? “The Review Committee was very concerned about the practice of cosmetic tourism with people travelling abroad for a procedure.” Lots of people use WhatClinic.com to find treatment abroad. WhatClinic.com Share this report A better way to choose a clinic
  52. 52. Medical tourism And… “The Review Committee recognises that people On page 45 of the report they may consider cosmetic list 8 serious issues which tourism in future but were felt to increase the risk, recommends that the difficulties and costs  individual considers surrounding treatment abroad. all aspects of the offer very carefully, including limitations of remote care, and that they speak to their GP before committing to such an arrangement.” WhatClinic.com Share this report A better way to choose a clinic
  53. 53. Medical tourism On page 45 of the report they list 8 serious issues which were felt to increase the risk, difficulties and costs surrounding treatment abroad. And… “The Review Committee recognises that people may consider cosmetic tourism in future but recommends that the individual considers all aspects of the offer very carefully, including limitations of remote care, and that they speak to their GP before committing to such an arrangement.” Hmm…One sided much? WhatClinic.com Share this report A better way to choose a clinic
  54. 54. There are two sides to medical tourism Risks and benefits. That’s why they go! If a consumer is fully By travelling abroad, • wider range of informed and empowered patients take on certain treatments risks. But they also can • more choices of facilities avail of greater benefits. why can’t they decide where to go? • more experienced practitioners • greater privacy • cheaper prices WhatClinic.com Share this report A better way to choose a clinic
  55. 55. “The Review Committee recognises that people may consider cosmetic tourism in future..” Over 5o countries have identified medical tourism as one of their national industries. It’s not going anywhere. WhatClinic.com Share this report A better way to choose a clinic
  56. 56. In fact… Decisions made today about regulation of the industry could very well drive more people to go abroad. DOH. Macro effects from micro changes, people. WhatClinic.com Share this report A better way to choose a clinic
  57. 57. Here is a full list of all the recommendations. We’ve made some of them a bit shorter. WhatClinic.com Share this report A better way to choose a clinic
  58. 58. Recommendation 1 • The Royal College of Surgeons (RCS) should establish a Cosmetic Surgery Interspecialty Committee. Recommendation 2 • The RCS Interspecialty Committee should work with the CQC and the new Chief Inspector of Hospitals to ensure that providers follow the standards developed. In the meantime, the Review Committee recommends that only doctors on a GMC Specialist Register should perform cosmetic surgery, and that those doctors should work within the scope of their Specialty specific training. Recommendation 3 • The RCS Interspecialty Committee should be responsible for developing clear, credible outcome measures for cosmetic surgery that are published at individual surgeon and provider level on the NHS Choices website. Recommendations 4 • All non-surgical procedures must be performed under the responsibility of a clinical professional who has gained the accredited qualification to prescribe, administer and supervise aesthetic procedures. WhatClinic.com Share this report A better way to choose a clinic
  59. 59. Recommendation 5 • Non-healthcare practitioners who have achieved the required accredited qualification may perform these procedures under the supervision of an appropriate qualified clinical professional. Recommendation 6 • The Government’s mandate for Health Education England (HEE) should include the development of appropriate accredited qualifications for providers of non-surgical interventions by the end of 2013. Recommendation 7 • All practitioners must be registered centrally. The register should be independent of particular professional groups or commercial bodies, and should be funded through registration fees. Recommendation 8 Entry to the register should be subject to: • achievement of accredited qualification • premises meeting certain requirements • adherence to a code of practice that covers handling complaints and redress, • insurance requirements, responsible advertising practice and consent practices • continued demonstration of competence through an annual appraisal. WhatClinic.com Share this report A better way to choose a clinic
  60. 60. Recommendation 9 • The CQC should work with professional organisations to produce inspection guidelines for cosmetic surgery providers. • Full participation in all clinical audit and data collection programmes that have been recommended by the RCS Interspecialty Committee should be part of CQC registration requirements and full participation by surgeons should be an essential component of their annual appraisal and revalidation. The CQC should use this data and clinical audit findings to analyse outcomes and assess risk, and this data should be used to guide inspection teams. Risk-based and unannounced CQC inspections should be performed. The inspection teams should have appropriate expertise and experience in this sector. Recommendation 10 • Data on performance should be made publicly available at surgeon and provider level. Recommendation 11 • Providers should be required to notify the public on their websites of any CQC inspection concerns or notices. Recommendation 12 • All providers must keep full patient records, including clear operative records and precise details of any implant or device used. Providers should also be able to access data of implant cohorts readily and this should be available to regulatory authorities. Details of the surgery and implant used must be sent to the patient and to the patient’s GP. Furthermore, the Review Committee accepts the recommendation made by the NCEPOD in its report On the face of it. WhatClinic.com Share this report A better way to choose a clinic
  61. 61. Recommendation 13 • ‘Independent healthcare providers should only allow practising privileges to those cosmetic surgeons who can demonstrate that they have achieved and are able to maintain competence in the procedures which they offer’. Recommendation 14 • Those training to be non surgical practitioners should have a clear understanding of the requirement to operate from a safe premises, and the responsibilities involved. The training curriculum should include topics such as infection control, treatment room safety and adverse incident reporting. The code of conduct for those on the register should include an obligation to abide by certain clearly defined minimum standards for premises. Recommendation 15 • The scope of the EU Medical Devices Directive should be extended to cover all cosmetic implants, including all dermal fillers. UK legislation should be introduced to make fillers a prescription only medical device. Recommendation 16 • The EU General Product Safety Directive (GPSD) should be revised so that products used as part of a professional service are no longer exempt from product safety legislation. WhatClinic.com Share this report A better way to choose a clinic
  62. 62. Recommendation 17 • All European Notified Bodies should be regularly and rigorously assessed and audited, to ensure they all work to the same high international standards; and reports of these assessments should be made public. Recommendation 18 • There needs to be unannounced inspections of manufacturers of class III and IIb medical devices to ensure production is compliant with the regulations. Reports of such inspections should be made public where possible. Recommendation 19 • Manufacturers should inform the MHRA when bringing a new product to the UK market and the MHRA should publish a list of the cosmetic devices available in the UK. Recommendation 20 • A system should be developed by the MHRA to link the Unique Device Identifier for all implants to the patient’s electronic record, enabling routine collection through Hospital Episode Statistic (HES) data. This information would enable assessment of implant performance, and the tracking and tracing of patients in case of a safety alert. The use of HES in the private sector hospitals which implant devices into people should be a CQC registration requirement. WhatClinic.com Share this report A better way to choose a clinic
  63. 63. Recommendation 21 • Until such a system is developed, a National Breast and Cosmetic Implant Registry should be established and operational within 12 months. All cosmetic surgery providers need to keep a minimum data set that should be defined by the RCS Interspecialty Group. This should include details of the implant, the surgeon, the hospital and appropriate outcomes, and these data need to be held in electronic format until the registry is operational. These data should be easily accessible in the case of a product recall. Recommendation 22 • The Director of Patient Safety for NHS England should develop a framework to encourage and support the reporting of suspected device failures to the MHRA. Recommendation 23 • Formal relationships need to be developed between the MHRA, and professional organisations such as the Academy of Medical Royal Colleges and the Specialist Associations whose members implant medical and cosmetic devices and deal with the consequences of failure. Recommendation 24 • Assessment of systems for reporting adverse events should be part of CQC’s registration and assessment of providers. Adverse incident reporting should be a standard component of professional appraisals and revalidation. WhatClinic.com Share this report A better way to choose a clinic
  64. 64. Recommendation 25 • Evidence-based standardised patient information should be developed by the RCS Interspecialty Committee on Cosmetic Surgery. This should be done with input from patient organisations. This information should be available on NHS Choices and the Parliamentary Health Service Ombudsman (PHSO) website. Recommendation 26 • Patient Decision Aids (PDAs) should be developed for cosmetic procedures and these should be piloted by the RCS Interspecialty Committee on Cosmetic Surgery. Recommendation 27 • The RCS Interspecialty Committee on Cosmetic Surgery should develop and describe a multi-stage consent process for operations. This consent process should be undertaken by the operating surgeon and its use should be mandated as part of the Code of Practice. Recommendation 28 • For non-surgical procedures, a record of consent must be held by the provider. Recommendation 29 • The RCS Interspecialty Committee should develop a code of ethical practice developed for all practitioners of cosmetic interventions, and this should include standards to ensure that any advertising is conducted in a socially responsible manner. WhatClinic.com Share this report A better way to choose a clinic
  65. 65. Recommendation 30 • CAP should extend its guidance note on cosmetic surgery advertising to cover non-surgical cosmetic procedures, and the sponsoring of TV and other programmes. Recommendation 31 The Review Committee considers that the following advertising practices are socially irresponsible and should be prohibited by the professional registers’ codes of practice: • Time-limited deals • Financial inducements • Package deals, such as ‘buy one get one free’ or reduced prices for two people such mother and daughter deals, or refer a friend. • Offering cosmetic procedures as competition prizes. Recommendation 32 • Providers and practitioners should provide continuity of care. Patients should be offered appropriate follow-up and after-care, rather than stand-alone procedures. Recommendation 33 • All organisations providing cosmetic surgery should have a doctor on the Board as Medical Director who is professionally accountable for all work carried out by the provider organisation and for its procedures, practices and wider activity. WhatClinic.com Share this report A better way to choose a clinic
  66. 66. Recommendation 34 • The remit of the Parliamentary and Health Service Ombudsman (PHSO) should be extended to cover the whole private healthcare sector, including cosmetic procedures and ophthalmology. Providers should offer advice on their complaints procedures to their patients, and where appropriate this advice should be available on their websites. Recommendation 35 • Complaints against providers that are investigated and upheld by the Ombudsman should be publicly available. Recommendation 36 • All individuals performing cosmetic procedures must possess adequate professional indemnity cover that is commensurate with the type of the operations being performed. Recommendation 37 • Device manufacturer risk pools should be established. The Department of Health should work with the EU and industry to help support this. This risk pool would meet the costs of complications or corrective surgery in the event of wholesale problems with a device. WhatClinic.com Share this report A better way to choose a clinic
  67. 67. Recommendation 38 • Patients’ rights should be protected even when a provider goes out of business. Providers of cosmetic surgery must either enter a risk pool or have appropriate insurance/financial arrangements to provide treatment following certain complications. The NHS should be able to recoup costs for management of certain complications following cosmetic procedures if the provider has been found to have failed the patient following surgery. A similar arrangement already exists following motor vehicle accidents. Recommendation 39 • The insurance status of all practitioners should be displayed on the practitioner register. Recommendation 40 • In order to ensure that all patients are adequately protected, overseas surgeons operating in this country should have the same level of professional indemnity as UK-based surgeons. WhatClinic.com Share this report A better way to choose a clinic
  68. 68. So in summary… Regulation? Good thing. Prohibition? Bad thing. Informed choice? Good thing. Restriction on information? Bad thing. You’ve seen the recommendations. Now let’s see what actually happens… WhatClinic.com Share this report A better way to choose a clinic
  69. 69. Click to share this report Add comment WhatClinic.com A better way to choose a clinic

×