UK dental technicians are calling for full disclosure regarding the origin of crowns and dentures.
It follows reports in the US of lead poisoning of patients whose dental restorations originated in China.
Dental authorities there reacted swiftly to reports of lead found in dental work imported from both China and India – Florida lawmakers are pushing for full disclosure and the American Dental Association (ADA) has issued guidelines to both its members and patients over the issue of cheap, imported dental devices.
Here in the UK, dental experts argue that without disclosure, both the patient and the dentist are without protection and fear that if the situation isn’t addressed, then it is only a matter of time before there is a similar case as in the US.
There has been a huge surge in the number of cost-cutting dental restorations imported from China.
These imports apparently now make up 5% cent of the market, compared with less than 1% three years ago.
They are made in unregulated laboratories and it is possible to use materials that contain banned substances such as lead.
David Smith, of Phoenix Dental Laboratories, and a board member of the Dental Technologists Association (DTA) said: ‘They do not understand the issue with toxicity because there are no limits in China.
‘We don’t really know if we are in any better position in the UK than they are in the US and, if a dentist is not told where each device is made how can they be culpable?’
Looking at the situation from three perspectives, he pointed out that: ‘The patient has no right to know what his/her device is made from or who made it or how much it cost.
‘If a dentist sends his work directly outside the EU, the dentist must register with MHRA and place the devices on the market.
‘If the dentist uses an EU manufacturer or agent he has no right to know where the laboratory work was actually manufactured.’
A UK laboratory must use registered dental technicians.
But ‘it can also send the work to be sub-contracted to anywhere in world but it should issue a certificate for the dentist with each device saying it meets the essential requirements of MDD but does not need to disclose where it was manufactured’.
Last year the dental laboratories associations of Europe convinced the EU Commission it was important that:
• A certificate issued with every device was passed on to the dentist AND the patient.
• The certificate would carry details of the device including its place(s) of manufacturer including the address.
• A declaration that the device met all the essential requirements of the directive and the lab was registered with the competent authority. This would have given disclosure to dentist and patient and ensured traceability and safe use of CE materials and qualified technicians.
Mr Smith pointed out: ‘This would have given disclosure to dentist and patient and ensured traceability and safe use of CE materials and qualified technicians.
But although the EU Commission agreed disclosure was necessary for patient protection and was included in the draft directive, at the Council of Ministers these requirements were eroded so they now do not apply in the new directive.
He said: ‘We were told by the EU representatives and the DoH, it was the MHRA, our regulator, that had these requirements diluted down to being irrelevant, despite Rosie Winterton, the then minister assuring the DLA that the British Government would support these amendments.’
He added: ‘So the tools to prevent this from happening in Europe were destroyed by our regulator.
‘The patient and the dentist are left having no protection and no disclosure unless they put their own measures into place.’
The DLA recently met with the DoH to discuss the possibility of transposing the EU directive into UK regulations.
The requirement of disclosure will be inserted, too, if the DoH agrees it is beneficial.
David concluded: ‘If we can convince the DoH and MHRA that mandatory disclosure to the dentist and the patient is beneficial, it is still possible to include this provision when the directive is transposed into UK law.’
Meanwhile, Chris Mangnall, business development co-ordinator with dental lab Aesthetic World, is all for the demand to verify the origins of all dental restorations.
‘As a UK-based dental laboratory, Aesthetic World prides itself on the fact that it use only CE-marked materials and GDC-registered dental technicians to manufacture dental restorations,’ he says.
‘All work undertaken is carried out in the laboratory allowing us to provide UK-based surgeons with high standards of work and peace of mind regarding full traceability of materials.
‘The dental industry is seeing surgeons and dental groups looking towards procurement and the potential financial savings of using Chinese dental laboratories.
‘Aesthetic World feels that many may fail to understand the potential legal ramifications of using these labs.’