Eight implant types suspended for six months but TGA says no need for women to remove implants if no symptoms

This article is more than 1 year old

This article is more than 1 year old

The Therapeutic Goods Administration (TGA) has launched a crackdown on textured breast implants following about 100 cases of a rare cancer, including four deaths, in Australia linked to the devices.

In a statement, the agency said it would suspend eight types of breast implants – covering 13% of the Australian market – from sale for six months while safety and performance concerns are addressed. Un-implanted models will be pulled from the shelves.

It comes as medical regulators grapple with concerns about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which has resulted in 23 deaths and more than 700 confirmed cases around the world.

Under the new rules, manufacturers will be required to report all cases of the cancer linked to their products within 10 working days.

Australian ban on textured breast implants recommended over apparent cancer link Read more

The TGA did not suspend breast tissue expanders, which are mainly used for breast reconstruction surgery, while some micro-textured implants were also not suspended.

The agency’s decision to impose new regulations is the result of a review into the breast implants and breast tissues expanders in which it conducted laboratory testing and a full statistical review of all BIA-ALCL cases.

The decision to suspend some implant types mirrors the actions of regulators in France and Canada and follows a global investigation by the Guardian and other media organisations that revealed the widespread use of faulty medical implants.

In Australia, breast implant sponsors will now be required to provide six monthly reports that include all adverse events and complaints related to its products.

After the TGA commenced its review, two industry sponsors also cancelled the supply of their highly textured implants and tissue expanders.

It will be illegal to supply, import, or export the suspended implants from 25 October. The regulator said it could revoked the suspensions if “the devices are addressed to the TGA’s satisfaction”.

“If concerns persist, the suspension may be extended or the entries of the devices may be cancelled,” it said.

Sign up to receive the top stories from Guardian Australia every morning

In detailed comments on its website, the TGA said the removal of the implants was not required among those who have no symptoms or concerns.

“For women who already have implants, the current consensus of expert opinion is that screening or prophylactic removal in asymptomatic patients is not recommended,” the TGA said.

It advised women who detect a change in their breast or armpit, such as swelling, a lump or pain, to consult a doctor.

Surgeons should disclose the risk of breast implant-associated ALCL when obtaining informed consent from a patient, the TGA said.

The currently available data suggest that the risk might be reduced by using smooth implants.

The new regulations were welcomed by the Australian Society of Plastic Surgeons, which described the TGA’s decision as a “reasonable outcome” and in line with its own recommendations.

“These actions balance minimising risk for women seeking breast implants, while also ensuring women who require reconstructive surgery following breast cancer aren’t restricted in their options,” the society’s president, Gazi Hussain, said in a statement.

“We have not opposed the suspension of the macro-textured breast implants as emerging data shows these represent the most common association with ALCL.

“However, we are pleased that micro-textured, grade 2 breast implants remain available to women. The associated risk of ALCL with micro-textured implants remains low and if detected early is typically curable.”

The Australian Medical Association was contacted for comment.

SUSPENDED PRODUCTS