Introduction to Dermal Fillers Regulation
Dermal fillers are delicate medical devices that require clinical trials of the same rigour as Phase III drug trials. Because of the risks involved in dermal filler treatments, ensuring safety and efficacy is important before these products can be used in aesthetic treatments. The regulatory bodies have recognized the need for greater oversight.
Historical Context and Key Reports
The regulation of cosmetic interventions gained more attention after the Poly Implant Prothèse (PIP) breast implant scandal which highlighted the safety issues in the aesthetic medicine sector. In response, Sir Bruce Keogh did a full review in 2013 and recommended:
A register of all practitioners performing cosmetic procedures.
Dermal fillers are to be prescription only.
Practitioners to have the right qualifications.
Non-surgical procedures are to be done under the supervision of a qualified clinical professional.
These were the recommendations to improve patient safety and accountability in the industry.
Current Regulatory Framework
In Scotland, independent clinics offering aesthetic treatments are regulated by Healthcare Improvement Scotland (HIS), which requires registration and compliance with certain standards. However, beauty therapists performing treatments are not currently required to register, so there is a gap in the regulation that could put patients at risk.
The Joint Council of Cosmetic Practitioners (JCCP) was set up to implement the guidelines from Health Education England (HEE) which set out the qualification requirements for practitioners in aesthetic medicine. These guidelines state:
Practitioners doing injectable treatments must have postgraduate qualifications.
Clinical oversight during treatment is mandatory.
Training providers must meet certain educational standards.
Challenges and Criticisms
Despite these developments, there are still big challenges in enforcing the regulations in the aesthetic sector. There is no legal framework so non-medical practitioners can do dangerous procedures without oversight or accountability. Critics say the existing voluntary bodies don’t have the power to enforce compliance.
And there is still debate about the role of non-medical practitioners in doing injectable treatments. Some say they should be allowed to do them based on experience and training, others say medical qualifications are necessary for patient safety.
What’s Next?
As non-surgical cosmetic procedures continue to grow in popularity the regulatory frameworks must catch up. Public awareness of practitioner qualifications and product safety is key to protecting the consumer. JCCP will continue to improve standards and drive accountability in this booming area.
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