The TGA is asking manufacturers to provide in-depth data on implants. (ABC News: Jack Fisher)
Textured breast implants linked to a rare cancer will continue to be available to Australian women having surgery, despite a crackdown on similar products by regulators in France and Canada.
- France have banned textured implants after they were linked to a rare type of lymphoma
- Therapeutic Goods Administration (TGA) has decided not to ban them, instead requiring more data from manufacturers
- Women say they are not properly informed about risks and specialist surgeons want breast device registry to be mandatory
The Therapeutic Goods Administration asked an expert panel for advice on whether to follow the lead of these countries and on Tuesday released its decision.
Textured implants are used in about 90 per cent of Australian breast augmentations and there are more than 13,300 procedures in Australia each year.
Instead of banning the products, the TGA will write to all implant manufacturers, asking them to provide in-depth data on how many implants have been supplied as well as physical samples of the products within 10 days.
“After receiving information from suppliers, the TGA will consider whether to suspend or cancel particular products from the Australian Register of Therapeutic Goods,” a spokesman said.
Many patients have contacted the ABC saying they were not told about the risk of breast implant-associated anaplastic large cell lymphoma (ALCL) when their doctors discussed giving them textured implants.
The cancer is believed to be caused by a bacteria which builds up in the grooves of highly textured implants, causing infections. (Supplied)
A female doctor, who did not want to be identified, had both breasts removed because of cancer and was given textured implants.
She said her plastic surgeon never mentioned the potential risk.
“Despite seeing a top plastic surgeon, my surgeon provided me with absolutely no information on [the possible link]. It was not mentioned once,” she said.
Australian health regulators have urged doctors to use the Australian Breast Device Registry to record details of removal of implants and lymphoma.
Currently about 10 per cent of surgeons do not use the register.
Countries that have banned textured implants
- The Netherlands
- Australian implants with European approval mark after December 17, 2018 can’t be sold
Specialist plastic surgeons said that to be effective, the registry should be made mandatory.
Australian Society of Plastic Surgeons president Professor Mark Ashton said a full register would allow clinicians to contact every woman with an affected implant, let them know whether they were at risk, and what action to take.
“At the moment there are lots of patients out there who are saying: ‘Am I at risk? I don’t know what my implants are’ or ‘They gave me some information but I’ve lost it’, or ‘I don’t even know if I can find my surgeon’ or he might have died or moved on, or so forth,” he said.
“So it would be enormously helpful if we could have, in one central location, a record of every breast implant that’s inserted into Australian women.”
Infection control the key to cancer
Plastic surgeons said the rising rates of lymphoma could be traced back to some “cosmetic” surgeons who weren’t as qualified as fully trained specialist plastic surgeons.
The lymphoma is believed to be caused by a bacteria which builds up in the grooves of highly textured implants and reacts in those who have a genetic predisposition.
Professor Ashton said it was possible the bacteria was being introduced by surgeons with improper infection-control procedures.
He pointed to high numbers of cases being traced back to commercial cosmetic surgery companies and practitioners.
“One of the key components is that the implant must become infected, so if it has been put in in a proper hospital by a proper surgeon, then the chances of that occurring are very low,” he said.
But he emphasised patients with Allergan or other highly textured implants didn’t need to be concerned if they had no symptoms.
“It’s not that if you have an Allergan product you need to have your implant removed,” he said.
What is BIA-ALCL?
- Breast implant-associated anaplastic large cell lymphoma is a type of blood cancer
- It often presents as a build-up of fluid in a sac on the breast, and grows in the scar tissue around the breast
- It is thought to be linked to a bacteria that grows in a groove of textured implants and enters during the initial surgery
- Symptoms typically appear after about seven years
- Any women with concerns should consult their surgeon
“It means that you need to be aware of your implant, and like everything else you need to monitor it and keep in close contact with your surgeon.”
If people do develop the rare cancer, it can be treated.
“If we get onto it within 12 to 18 months, it is eminently treatable and curable,” Professor Ashton said.
“It’s a very rare disease affecting a very select group of people and can be cured but it is something, like everything, we need to be aware of.”
The society has also published a list of specialists who are offering free consultations to women with concerns who have a referral from their GP.
Source: ABC NEWS