Eight breast implant models suspended by TGA
Eight breast implant models have been suspended from supply in Australia for six months and conditions have been placed on supply of all other breast implants. SEE THE FULL LIST
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Eight breast implant models have been suspended from supply in Australia for six months and conditions have been placed on supply of all other breast implants and tissue expanders.
The Therapeutic Goods Administration has imposed the regulations following reports of about 100 cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in Australia, including four deaths.
The TGA on Thursday released the findings of its review into breast implants and tissue expanders.
“Eight models of breast implants are to be suspended from supply in Australia for six months, while a number of safety and performance concerns are addressed,” the TGA said in a statement.
“This means that these devices will not be able to be imported, exported, or supplied within Australia while the TGA works with industry sponsors to ensure the devices meet all the necessary requirements for patient safety.
“Any stock of these un-implanted devices in the market will also be recalled during the suspension period.”
News Corp has been campaigning for the companies to pay for the removal of the devices in cancer cases, for all breast devices to be recorded on a device registry and for it to be made mandatory for surgeons to check women with the implants every 12 months.
The eight models that have been suspended come from manfucturers including Allied Scientific Products, Emagin, Euro Implants and JT Medical (Polytech Health).
The TGA stated their devices will no longer be able to be supplied, imported, or exported from Australia for the duration of the suspension which takes effect on October 25.
“A suspension can be revoked if concerns about the devices are addressed to the TGA’s satisfaction,” the statement read.
“If concerns persist, the suspension may be extended or the entries of the devices may be cancelled.”
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The TGA is also calling for reports to be provided every six months from manufacturers.
“The reports must include supply data and detail all adverse events and complaints received regarding breast implant and tissue expander devices, both in Australia and worldwide, including BIA-ALCL, capsular contracture, or rupture of the implant,” it stated.
“To support informed patient choices, all breast implant and tissue expander devices must have access to a patient information leaflet that includes information about warnings and risks associated with the product. Information relating to the Australian Breast Device Registry must also be included, to support ongoing reporting and monitoring.”
As well as the suspensions, the TGA said two industry sponsors have cancelled supply of their highly textured implants and tissue expanders since the review was initiated.
Unused stock of the implants suspended from supply is being recalled, but the TGA said removal of implants is not required in a person who has no symptoms or concerns of the “very rare” BIA-ALCL.
The suspensions and cancellations affect 13 per cent of the supply of breast implant devices on the Australian market by volume.