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QUOTED. 30 July 2019. Ned Sharpless.

Executive Summary

Device manufacturer Allergan PLC announced a worldwide recall of its Biocell textured breast implants and tissue expanders last week, shortly after the US FDA released a safety communication citing additional data linking the implants with a rare form of cancer. See what acting agency head Ned Sharpless said about it here.

“While the risk of BIA-ALCL to patients is low, once the evidence indicated that Allergan’s textured breast implants appeared to be directly linked to significant patient harm, including death, we took action to protect women’s health.” – Ned Sharpless, acting commissioner, US FDA

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