Medical treatment company Allergan has announced a global recall of textured implants on the heels of the United States Food and Drug Administration discovering a concerning rise in rare cancers—and associated deaths—linked to the product. Of course, the FDA asked the company to pull these products from the US market.
Specifically, the Dublin-based pharmaceutical company said it is recalling Biocell textured breast plants and tissue expanders from every market where they are sold. These devices had already been recalled—even banned—in many other countries.
According to the FDA, the new data points to 573 cases around the world linking the implants with this rare form of cancer since the agency started tracking the issue eight years ago. While these incidents have been somewhat broad in scope, most of the cases involve products from Allergen. And of these 573 cases, 33 women have died as the result of a condition known as breast implant-associated anaplastic large cell lymphoma (an immune system cancer). Of those 33 fatalities, authorities have identified which manufacturer sold the implant in 13 cases: Allergan sold 12 of them.
The FDA last updated their implant-associated illness numbers in February. At that point, the FDA reported 457 cases and 9 deaths. Thus, the agency now says the latest data suggests the risk of disease is actually six times greater with the Allergan Biocell textured implants than with other textured implant products that are currently sold in the United States.
All that in mind, FDA Center for Devices and Radiological Health Jeffrey Shuren reports the FDA’s new stance on the Biocell product, specifically, is a reversal from just a few months ago. At that time, the FDA said there was insufficient evidence to remove the devices from the market. Shuren notes the agency changed its position, in part, after identifying such a sharp increase in reported deaths.