Australia suspends sales of certain textured breast implants

October 3, 2019 By Nancy Crotti Leave a Comment

Australian health officials have suspended sales of some textured breast implants for six months and recalled models of those implants already distributed due to concerns about an uncommon form of lymphoma.

The Australian Therapeutic Goods Administration (TGA) temporarily halted import, export and supply of eight models of breast implants following reports of about 100 cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in the country, including four deaths. During the suspension, which begins October 25, health officials will address “a number of safety and performance concerns” with implant makers, the TGA said in a news release.

Any stock of unused devices in the market will also be recalled during the suspension period. No models of breast tissue expanders have been suspended. The suspensions and cancellations affect 13% of the supply of breast implant devices on the Australian market by volume, based on 2018 data.

The eight models of breast implants suspended by the TGA are:

Allied Scientific Products Pty Ltd (Nagor) Model 142863, Nagor mammary implant gel-filled — textured.
Allied Scientific Products Pty Ltd (Nagor) Model 277757, 9-cell CoGel gel-filled Nagor mammary implant range — textured.
Allied Scientific Products Pty Ltd (Nagor) Model 277785, Impleo gel-filled Nagor mammary implant range — textured.
Emagin Pty Ltd (Groupe Sebbin SAS) Model 309613, anatomical breast implants — textured —high cohesive gel.
Euro Implants Pty Ltd (Eurosilicone SAS) Model 132040, Cristaline I Aptex/Vertex Paragel natural cohesive gel implant.
Euro Implants Pty Ltd (Eurosilicone SAS) Model 132037, Cristaline Paragel cohesive gel implant.
JT Medical Pty Ltd (Polytech Health & Aesthetics GmbH) Model 171782, Sublime line, Microthane, silicone gel-filled mammary implants.
JT Medical Pty Ltd (Polytech Health & Aesthetics GmbH) Model 185060, 4Two Line, single-lumen, micro polyurethane, silicone gel-filled mammary implants.

Allergan (NYSE:AGN) voluntarily recalled its Biocell textured breast implants and tissue expanders globally in July, following bans in Canada and France and its withdrawal of the devices in Europe. The FDA asked the company to recall the implants in July, after concluding that they are six times as likely as other textured breast implants to cause BIA-ALCL. AirXpanders, which filed for Chapter 7 bankruptcy in the U.S. in July, had already recalled its Aeroform tissue expanders from Australia.

The TGA announced in July that it was reviewing safety concerns about textured breast implants and tissue expanders. The agency will now require all breast implant manufacturers that do business within Australia to:

Report to TGA all cases of BIA-ALCL within 10 working days of becoming aware of them.
Provide the agency with six monthly reports of Australian and worldwide supply data, complaints and adverse events.
Provide clear, written information about the risk of BIA-ALCL with all devices, to both clinicians and patients.

The agency warned that it may ban sales of the suspended implants if these conditions are not met and if safety and performance concerns around them are not resolved.

The TGA is not recommending that women with no symptoms of BIA-ALCL have their implants removed. More information about the agency’s decision is available here.

The FDA said in May that it would not ban sales of highly textured breast implants after one of its advisory panels said there’s not enough evidence to support the move. In February, the agency reported having received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths.

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