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s we detailed in our blog entitled Sir Bruce Keogh`s Review of the UK Cosmetic Surgery Industry Gets Underway, since 15th August 2012 the review has been officially launched with a ‘call for evidence’ to include experiences and views from both the industry and patients in order to assist the inquiry.
The call for evidence is asking for people’s views on:
Along with Sir Keogh, an expert panel has been convened to assist in the evidence gathering and the making of recommendations to government, based on the criteria being looked at and the results of the public consultation.
It’s hoped that tighter restrictions on those operating within the cosmetic surgery and non-surgical (cosmetic injectable) markets will result from the findings.
The consultation will be open for two months, ending on 15th October 2012. The expert panel and Sir Bruce Keogh will make their recommendations to the government by March 2013.
As part of this ‘call for evidence,’ the Department of Health has issued a 71-page document to explain the background behind the review and the areas that it hopes to investigate.
Here is the list of the questions and key areas under review. We have highlighted those areas which affect the medical aesthetic and injectables arena, and thus most of our members.
1. What are the risks and benefits presented by dermal fillers?
2. What clinical evidence might be required to regulate dermal fillers (with no claimed medical purpose or benefit) under the existing medical devices regulations?
3. Are any further changes needed to the categories of devices and implants subject to regulation in addition to the likely changes set out above?
4. Are there any other areas where additional strengthening of the regulatory system is required that will not be addressed in the forthcoming revision of the medical devices legislation?
5. Earl Howe’s review of the actions of the MHRA and Department of Health in relation to PIP silicone breast implants recommended that this review should ‘examine ways of promoting a stronger culture of clinical governance, clinical audit and reporting in cosmetic surgery. Routine incident reporting and review of outcome data by individual surgeons and providers should be the norm.’ How can health providers, professional bodies, regulators and patient groups promote the best possible understanding of the role of the incident reporting system and ensure that professionals in particular understand what they have a duty to report?
6. Is there evidence that the current requirements for doctors practising cosmetic surgery are insufficient? Should all cosmetic surgeons be required to have specialist training, i.e. be on the Specialist Register?
7. Currently ‘cosmetic surgery’ is not recognised as a specialty for which doctors can train and achieve a Certificate of Completion of Training (CCT) leading to inclusion on the Specialist Register. Is there evidence to suggest a need to introduce a new Specialty for ‘Cosmetic Surgery’ or are there alternatives, such as a different form of training, e.g., credentialing, that would demonstrate competence?
8. Do people who deliver cosmetic interventions like fillers, Botox®, laser treatments or chemical peels, have the appropriate skills to deliver them? How could their performance be monitored?
9. Earl Howe’s review of the actions of the MHRA and Department of Health in relation to PIP silicone breast implants recommended that this review should ‘examine ways of promoting a stronger culture of clinical governance, clinical audit and reporting in cosmetic surgery. Routine incident reporting and review of outcome data by individual surgeons and providers should be the norm.’ How can medical revalidation be used to promote this?
10. Should practitioners be required to ensure that records of all cosmetic interventions are kept? This is generally done for implants but is it reasonable to do for other devices such as dermal fillers?
11. Is it right that private providers of cosmetic surgery meet the standards expected of the NHS?
12. The CQC registration requirements place a duty on providers to protect their patients from unsafe treatment, but it is not clear how far this extends in the private sector to providing appropriate after-care where a patient has suffered harm as an unexpected consequence of treatment. Do we need to impose a clearer legal requirement on registered organisations to provide after-care to their patients? If so, for how long after the original treatment?
13. Do you think the existing regulation of lasers and lights is proportionate to the risks they present with regard to cosmetic interventions?
14. Should providers of surgical cosmetic interventions be required to audit their processes and ensure that all their practitioners take part in clinical audit?
15. Should providers of non-surgical cosmetic interventions delivered in non-healthcare settings, for example beauticians administering dermal fillers or laser hair removal, be required to audit their processes and ensure that all their practitioners take part in clinical audit?
16. Should providers be required to ensure that records are kept on the implants and devices they implant? If so, for how long?
17. Should providers be required to take out an adequate indemnity arrangement and/or to participate in a bond arrangement such as provided by ABTA in the travel industry? If so, for how long?
18. How could cosmetic surgery organisations make it easier for patients to access their health records?
19. What can be done to protect patients if their provider goes out of business?
20. What more, if anything, is needed to ensure that people have the information and time they need to give informed consent? Is sufficient weight given to the psychological assessment of the individual?
21. Should providers be required to carry out a two-stage consent process (i.e. allowing a ‘cooling-off’ period between consultation and surgery)?
22. Do you think the existing regulation of the advertising of cosmetic interventions is proportionate?
23. Is there evidence that advertising on cosmetic interventions needs to be regulated using a different system used for general products and services?
24. What is your view on the use of incentives to promote the sale of cosmetic interventions (such as time-limited price offers)?
25. How could a national implant registry be set up and funded? Which treatments should it cover? Should participation be a statutory requirement for providers? Should patients have the right to opt out of having their information recorded?
26. Are there any specific forms of treatment or sectors which you think should be subject to more (or less) regulation than at present? Examples include surgical body modification e.g., tongue splitting; body enhancement implants; cornea tattooing and jewel implants into the cornea.
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