Dentist reprimanded for using products not cleared for use in Australia

A Canberra dentist has been formally reprimanded after using products on patients that hadn’t been approved for use in Australia.

Dr Pradeepa Niranjara Pathmaperuma was found to have engaged in professional misconduct and was reprimanded by the ACT Civil and Administrative Tribunal (ACAT), outlined in a decision published earlier this month.

Presidential Member Geoffrey McCarthy said the dentist, who had been a registered dental practitioner since 2004, engaged in conduct that was substantially below the standard reasonably expected of a registered health practitioner of an equivalent level of experience.

Last year, the Dental Board of Australia launched disciplinary action against him over four allegations and Dr Pathmaperuma ultimately agreed with the facts in the matter.

Legally, therapeutic goods must be entered into the Australian Register of Therapeutic Goods before they can be imported, exported, manufactured and supplied in Australia.

But between mid-2018 and August 2021, Dr Pathmaperuma imported and supplied therapeutic goods to patients which were not included in the register nor had an exemption.

The dental board alleged he had imported and supplied biologicals and medical devices – being Renovix Plus, LifeNetHealth Oragraft products, Hahn tapered implants and Hahn implant abutments – to patients when they were not included in the register nor subject to an exemption.

The board also alleged he failed to get informed consent for the use of these products from these patients and failed to keep accurate records of the services provided to the patients.

The Therapeutic Goods Administration raided Dr Pathmaperuma’s practice in May 2021, seized certain items and issued 20 infringement notices to him that totalled $266,400, which he has since paid off.

“The public have an expectation that health professionals will undertake procedures, treatments, and generally manage patients using approved therapeutic products,” Presidential Member McCarthy said.

“The failure by the practitioner to obtain informed consent is a serious matter.”

He said Dr Pathmaperuma had admitted his wrongdoing and expressed remorse and insight into the seriousness of his actions.

The dentist did say he was unaware the products were not approved for use in Australia until April 2021.

While an expert, Professor John Abbott, said the dentist broke the law by using these products, he also said there was a “good evidence base and substantial research to give confidence in their efficacy”.

“Additionally, they have been CE and or FDA approved and I would suggest that the actual risk to [his] patients would be negligible,” the professor said.

Professor Abbott believed Dr Pathmaperuma was carrying out what he thought was best practice for his patients and had studied in the USA “to develop his implant skills to a very high level”.

The professor did note the patients may not have consented to the implant or graft procedures if they had been aware the dentist was using illegally imported products.

“There is no evidence any patient was harmed by the practitioner’s conduct,” Presidential Member McCarthy said.

He said conditions had been placed on Dr Pathmaperuma’s registration as a dental practitioner, being that he complete a program on the maintenance of adequate patient health records and submit to an audit of his practice.

He must also pay the dental board’s legal costs of the proceedings.