Member Article

Dr Tracey Bell welcomes long-awaited new regulations to safeguard patient safety

After treating a growing number of young women who’d been left with scarring and potentially fatal complications as a result of facial fillers, Dr Tracey Bell, who has clinics in Douglas, Ramsey and Castletown, has welcomed the change to the law which means that, for the first time, dermal fillers will be regulated as medical devices.

Under the new EU regulations for medical devices (MDR), dermal fillers will be subject to the same safety checks as medical devices by May 2020 (and this change will still apply post-Brexit).

Dr Bell has been a high-profile proponent of the need for stricter regulations for the use of Botox and dermal fillers, speaking out on the issue after she’d treated several young women from the Isle of Man who’d experienced facial disfigurement as a result of botched fillers at cut-price beauty salons.

She said: “We’ve been treating what is a medical product in the US as a beauty treatment, and if something goes wrong, there’s no comeback because there’s no regulation. That’s what a lot of people don’t realise.”

Adding: “It’s about time consumers in the Isle of Man were given the same level of protection they’d have automatically in the States. Dermal fillers are a medical treatment and should only be offered in a medical environment, where any complications that occur can be swiftly dealt with and ongoing care can be given.”

Demand for dermal fillers, which are used to add volume to lips and fill wrinkles, has been growing year on year in the UK, but until the new regulations were announced this month, they were only subject to the same level of regulation as ballpoint pens and toothbrushes.

However, the EU’s MDR (2017/745) now expressly classifies dermal fillers, even those without a medical purpose, as medical devices, although this will not mean that dermal fillers become prescription only.

Dermal fillers currently placed on the UK market with a medical purpose are classified as medical devices and require a CE mark. There are, however, dermal fillers that are marketed for aesthetic use only that are not classified as medical devices as the manufacturer is not making a medical claim.

The new legislation is addressing this regulatory anomaly by making all dermal fillers medical devices irrespective of the claims attached to the product by the manufacturer. This is not the same as making dermal fillers prescription only.

Although Dr Bell has welcomed this change to the legislation, she remains concerned about people without the requisite skills and experience administering fillers.

Her advice to people considering Botox or dermal fillers is to do your research and find out as much as you can about the products being used and the qualifications held by the person who’ll be administering them before booking in for your treatment. While we’re waiting for the new regulations to come into full force in the UK, Dr Bell will continue to offer only fillers that are FDA approved in her clinics. She will also continue to offer her support to those who have been affected by cowboys offering cut-price back-street treatments.

This was posted in Bdaily's Members' News section by Emma Hill .