Thread by @sashachavkin

We've updated our story on today's major #ImplantFiles news of Allergan's global recall of Biocell implants. Here are few important points we added after hearing from the FDA & other experts (thread)...
icij.org/investigations…

A key factor in FDA's decision was a recent surge of BIA-ALCL death reports, from 9 deaths in February to 33 today. Almost 2/3 of the 33 deaths were outside the US. In other words, an influx of new reports from outside US (not clear where) was crucial
fda.gov/medical-device…

Plastic surgeon and BIA-ALCL expert @saferimplants says the FDA decision reflects improved BIA-ALCL data and an evidence-based decision process. “What we’re seeing is the first sign that data and evidence is driving regulatory decision-making,” he said
icij.org/investigations…

@saferimplants But the recall only covers one brand, not all models linked to BIA-ALCL. “This recall will reduce that risk but it won’t eliminate it," said patient advocate Diana Zuckerman of @NC4HR. Here's her full statement
center4research.org/nchr-statement…

@saferimplants @NC4HR The FDA also said in a press conference today that it wasn't done reviewing breast implant safety. Among the other steps it is considering? A black box label warning and patient checklist
icij.org/investigations…