elringtons health law update – faulty aortic valve replacement devices

Update by Tom Maling

Australians who have had aortic valve replacement surgery since 2010 may have been fitted with a faulty replacement valve.

On 3 May 2017, the UK Government issued a medical device alert for Mitroflow LX (sizes 19mm and 21mm) devices, which are biological aortic valve replacement devices.  It was issued after research revealed they were prone to early structural deterioration, leading to potentially serious health consequences.

On 10 July 2017, the Australian Therapeutic Goods Administration (TGA) forwarded the UK alert as part of its medical device update for July 2017.  The TGA had considered risks posed by the Mitroflow devices in March 2016, but no action was taken.  The devices were approved for use in Australia in June 2010, and the TGA acknowledges that the device was implanted into Australians prior to its cancellation of sale in 2016.

The UK is requiring doctors to follow up with patients, particularly younger patients, who have had this device implanted.  While there is no current requirement in place in Australia, we recommend you follow up with your doctor urgently if you may have had this valve implanted.

If you have experienced problems following aortic valve replacement surgery please do not hesitate to contact us for assistance.

p: +61 2 6206 1300 | e: Info@elringtons.com.au