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Medical Devices / Postmarket Safety

TGA Warns Consumers of Breast Implant and Expander Recall

Sept. 4, 2019
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Australia’s Therapeutic Goods Administration (TGA) said in an advisory that Allergan has recalled all of its un-implanted macro-textured breast implants and tissue expanders over rare instances of cancer.

Rare cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) have been observed, the agency said, but noted that Allergan’s micro textured and smooth breast implants are not included in the recall, and advised asymptomatic patients not to seek removal or replacement.

While fatalities have been documented, most cancer cases have been cured by removing the implant and its surrounding capsule, the agency said.

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