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The MDU, Medical Defence Union, the UK's leading medical defence organisation has announced some important changes to the provision of medical indemnity for those involved in facial aesthetics and the service provision of dermal fillers.
From 1st April 2013, the MDU membership benefits for members performing treatments with dermal fillers will change and they won’t be covered for dermal filler brands which don’t have an American FDA approval, despite dermal fillers in the UK being regulated by European CE Mark regulation. The MDU underwriters stated in a letter to members;
“While we carefully consider requests for help, it is unlikely that the MDU will provide support or representation for any claim arising in respect of a treatment or procedure carried out on or after 1st April 2013 which involves any dermal filler, unless the product is one which has been approved, prior to your use of it, by the Food and Drug Administration (FDA) in the United States of America.”
They went on to say;
“Insured cover for claim notifications arising from non-FDA approved filler use after April 2013 will extend only up until the end of the current policy year. There will be an exclusion in respect of claims arising from the use of non FDA approved dermal fillers in subsequent membership periods.”
A list of US FDA approved dermal fillers can be found on the FDA website:
However, as many who view the list will note, it includes some now discontinued brands such as Evolence, Hylaform, Cosmoderm/Cosmoplast and Zyderm/Zyplast which simply confuse the issue.
The main brands used in the UK marketplace who have FDA approval include Restylane (with and without lidocaine), Radiesse, Sculptra and Belotero (Balance in America known as Basic in Europe). The list detailed on the above FDA link is however also incomplete, as it doesn’t mention the approvals for Juvéderm Ultra and Juvéderm Ultra Plus, as well as the lidocaine versions which include the notation XC after the product name, which are also FDA approved and branded slightly differently in the UK.
There are those who wish the MDU had published a comprehensive list of their own, even if it is said to rely on the FDA list, as many confusions are possible due to differing branding.
The MDU is advising members who administer dermal filler products as part of their practice, and use products/brands which have not been approved by the FDA to urgently review their indemnity arrangements for this work.
Many we have spoken to within the aesthetic industry find this to be an unusual stance for the indemnity provider to take, yet welcome a nod towards those products with a wealth of clinical data to back up their safety, compared to the now saturated levels of CE marked products available with little to substantiate their safety and efficacy.
With both the European Parliament and the Keogh Review both looking at the current regulation of medical devices, including dermal fillers, this MDU announcement perhaps is a pre-emptive move towards the likelihood of tighter European and UK regulation of these products in the future. It will be interesting to see if other insurers choose to follow suit or simply pick up extra business as a result of this decision from the MDU.
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