The PIP breast implant scandal, in which a French company was found to have used substandard silicone, led to the setting up of a national breast devices database in Australia. It was created after a successful bid by Monash University, which had piloted a register in South Australia and Victoria.
The custodian of the database, Prof John McNeil, said that in Australia there was a contrast between the way new drugs and new medical devices were tested before going to market.
“New drugs have been tested extensively and go through toxicological testing, but devices typically aren’t put through anything like that intensity of evaluation before they’re clinically used,” he said.
He said some devices should be seen as obviously high risk, even in the absence of clinical evidence showing complications, and that those devices needed to be monitored as part of a national registry. Breast implants should have been considered high risk and monitored from the start, he said.
“This is because they are most often inserted into young women, often who are going to have a lifetime of experience with them and that is a lot of years to be worried about things going wrong. Our choice as to what will need to be monitored will depend on what sort of people they’re inserted into and for what conditions.”
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Work on building the database began about four years ago. Neil said it was still being refined and it would take a while for patterns to emerge. He is focused on identifying cases of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin lymphoma that affects the immune system and has been linked to breast implants.
“The issue with breast implants is ALCL is very, very rare and it has only been recently identified,” he said. “So with medical devices we must have in our mind the fact that there are possibly things that will develop we never thought were possible. And if they do, we need a quick way of identifying patients at risk and contacting them.”
He said maintaining the database was labour-intensive and hospitals needed to opt in. “There has to be some sort of encouragement to make it compulsory. In the majority of cases hospitals don’t sign up, mostly because they think it’s a nuisance. That’s why we are trying to keep our database as simple as possible and the forms easy, to reduce the data burden.”
Many medical device registries in other countries had failed because they were over-complicated or run on an opt-in basis, he said.
“We have been very much at the forefront of trying to work with overseas colleagues so we all collect the same information in the same way,” he said. “In Australia we implant 20,000 breast implants a year but we still can’t quickly get the information we need to answer questions quickly like which implants are highest risk. The more data we have the easier identifying patterns and risks will be.”
