Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group
Note: Today, the U.S. Food and Drug Administration (FDA) ordered a recall of Allergan BIOCELL textured breast implants. The FDA said that there are now 573 unique cases globally of large-cell lymphoma (BIA- ALCL), a rare form of cancer, 481 of which are attributed to the implants. But the agency asserts that “once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.”
Why has the FDA recklessly and dangerously been treating women as second-class citizens? The kind of evidence now, belatedly, being cited as enough for a recall previously led to a ban of these implants in France in April, followed by bans in the rest of Europe and the U.K. Canada also banned these implants the first week in April.
This is not the first time that the FDA has lagged behind other countries in its responsibility to protect the public’s health. This delay has unnecessarily put American women at risk.