Breast implants recalled in Europe over cancer link still available to Australian women
Breast implants deemed unsafe in Europe will continued to be used in Australia, according to local health authorities.
- European health authorities recall a type of breast implant linked to cancer
- In response, the Australian regulator says no new stock of the implants would be used here, but women could receive those still on the shelf
- A doctor close to the case says now Europe has acted, “Australian regulators can’t ignore that”
French health authorities announced European regulators had pulled a controversial type of breast implant off the market, which had been linked to a rare kind of blood cancer.
“From now on, these medical devices can no longer be marketed in France and in Europe and [we have asked] Allergan to recall products in stock at all health facilities,” a statement from the National Security Agency of Medicines and Health Products said.
In response, the Australian regulator, the Therapeutic Goods Administration (TGA), said no new textured implants made by Allergan would be allowed to be used here, but that would not stop existing implants on shelves from being used.
The French announcement came in the wake of a probe by the International Consortium of Investigative Journalists (ICIJ), including the ABC, which highlighted significant flaws with the way medical devices were approved for use in patients and monitored once on the market.
Textured implants are used in about 90 per cent of Australian breast augmentations and the Allergan brand is the most popular among surgeons.
An estimated 40,000 breast surgeries take place in Australia each year.
A spokesman for the TGA said it was working with Allergan and French regulators to determine the “most appropriate course of action in Australia”.
“The TGA will continue to collaborate with our expert panel as required.”
‘We should not get cancer from having an implant’
Sydney woman Carol Camilleri was diagnosed with the rare blood cancer after receiving textured breast implants.
Carol Camilleri said she hoped the Australian regulator would follow France’s lead. (ABC News: Tom Hancock)
She said she was relieved to hear overseas health authorities had acted to remove the implants from sale to protect patients.
“It shows the severity of this issue that the Australian regulators haven’t really grasped,” she said.
“I hope the TGA does the same thing to remove these implants.
“We should not get cancer from having an implant.”
When Ms Camilleri was getting her implants, the TGA knew of just eight cases of the rare blood cancer linked to breast implants, but the actual number was four times higher than that, according to plastic surgeon Anand Deva’s research.
Doctors said in some patients with the textured implants, bacteria could enter the body and slowly cause scar tissue to harden around the implants.
Over several years, the infection could put stress on the patient’s lymphatic system and, in some cases, trigger the rare blood cancer.
As of April 2018, there were 81 cases in Australia and New Zealand linked to 110 implants, including four deaths.
The data has also revealed between 2012 and 2015, the cases of the new type of lymphoma continued to rise sharply around the country while the TGA remained unaware of the scale of the problem because of flaws in its database.
Professor Deva said there was increasing recognition all breast implants needed greater scrutiny.
“Is the risk with textured implants high enough to take them off the market? Now that France has acted, Australian regulators can’t ignore that,” he said.
French authorities said there was no immediate health risk for women with the implants, but all women with them should be seen by a doctor each year.
You can explore the International Medical Devices Database, a searchable portal that gathers global recall notices, safety alerts and field safety notices.