Clinical position statement on the use of injectable hyaluronic hydrogel dermal fillers in the foot
The Royal College of Podiatry recognises the emerging interest in the use of injectable hyaluronic acid-based dermal fillers and emphasises that patient safety, regulatory prescribing compliance, and clinical governance must remain paramount.
Key messages
- Hyaluronic hydrogel dermal fillers for medical use are a Class III medical device and therefore governed by strict MHRA regulation with audit and outcome requirements.
- To safely administer and manage patient risk you need to be annotated as an independent prescriber with immediate access to prescription-only medicine hyaluronidase as an antidote.
Remember your insurance covers you for your scope of practice.
Additionally:
- there is no safety data for risk assessment to evaluate the use of dermal fillers in the foot
- non-compliance of prescribing annotation could lead to HCPC fitness to practice investigations or legal proceedings
Position
The Royal College of Podiatry recognises the emerging interest in the use of injectable hyaluronic acid-based dermal fillers, such as Curacorn® for the management of atrophy over bony prominences.
While early evidence suggests potential clinical benefit in carefully selected patients, the College emphasises that patient safety, regulatory prescribing compliance, and clinical governance, including reporting audit of outcomes, must remain paramount.
At present, there are significant areas of uncertainty and concern regarding current practices associated with these interventions which members should consider:
- The regulatory status of products used in clinical practice must be clearly established. Clinicians must abide fully with UK Medical Device Regulations and Medicines legislation. The use of unverified or non-compliant products presents unacceptable risks to patient safety. Products that are not licensed or are being used off-license should not be used. Injectable hydrogels with hyaluronic acid are a Class III medical device and as such are governed by strict regulation and compliance on reporting and evidencing outcomes.
- Prescribing governance must be strictly adhered to. Non-medical prescribers must operate within their legal and professional scope of practice. Providing a prescription-only medicine remotely requires a valid clinical management plan with patient consent. Prescribing for patients outside an established care relationship is not permitted. Informal or ad hoc prescribing arrangements, including reliance on external networks for emergency prescribing, do not meet required standards of clinical governance. If you do not have your independent prescribing annotation you should not be dealing with prescription-only medicines that are not included in your POM-A and POM-S annotation. Failure to comply within the scope of annotation could result in legal proceedings or fitness to practice investigations from the HCPC.
Please make sure you are following correct medicine legislation.
- Clinicians undertaking these procedures must possess advanced clinical knowledge and skills, including the recognition and urgent management of complications. This should be with post-registration education and training at an academic credit level. Within this is the practice of explicit, documented informed consent which must be obtained, including clear discussion of the limited and evolving evidence base, potential risks (including rare but serious complications), alternative treatment options, and the non-routine nature of this intervention.
It is unknown what the clinical risk of injecting dermal hydrogels into the periphery is.
Vascular occlusion is a known adverse reaction to dermal hydrogels: it is a time-critical emergency, requiring intervention within a narrow therapeutic window to prevent irreversible tissue damage.
Access to, and competence in the use of, appropriate reversal agents such as hyaluronidase is required before treatment.
In this context hyaluronidase may be regarded as an emergency medicine and understanding of dosing, administration, and supply pathways are essential.
POM-A and POM-S annotation do not allow you to acquire this medication lawfully. To do so you need to have completed post-registration training and annotated in non-medical prescribing.
Alternatively, if working in an NHS Trust, the medicine may be made available via an approved Patient Group Direction (PGD) signed off within the Trust’s clinical governance structure.
Summary
The Royal College of Podiatry does not consider these procedures to fall within routine podiatric practice.
Any adoption should be restricted to clinicians with independent prescribing annotation working at an advanced clinical level within organisational robust clinical governance frameworks with full transparency regarding risks, benefits, and uncertainties.
The College supports continued research into this area and acknowledges the potential for innovation to improve patient outcomes.
However, such developments must be underpinned by rigorous evidence, clear regulatory compliance and a commitment to the highest standards of patient safety.