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Medical Devices / Regulatory Affairs

TGA Begins Review of Breast Implant-Associated ALCL

May 6, 2019

Australia’s Therapeutic Goods Administration (TGA) launched a review of the link between breast implants and anaplastic large cell lymphoma (ALCL).

The agency is reviewing the surface topography of more than 150 breast implants. It also plans a statistical analysis of the breast implant supply and the known cases of implant-associated ALCL to estimate the risks for each type of implant.

“Based on the outcomes of the testing and statistical analysis, we anticipate that a decision on whether regulatory action will be undertaken relating to specific implants will be made in mid-June,” the agency said.

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