February 7, 2019 — There are now 457 cases of women with breast implants who developed Anaplastic Large Cell Lymphoma (ALCL), including 9 deaths, according to update provided by the FDA.
The majority of ALCL cases have been linked to breast implants with a textured surface rather than a smooth surface. Even so, the FDA has not issued a specific warning about textured breast implants.
Because not every report provides information about surface texture, the FDA says it is “more difficult to know if any particular breast implant characteristic is associated with BIA-ALCL or if higher reports of BIA-ALCL are simply due to higher implantation rate of a particular manufacturer.”
Even so, the pharmaceutical company Allergan recently withdrew textured breast implants from the market in Europe, possibly due to concerns about ALCL, but they remain on the market in the U.S.
In December 2018, health regulators in France ordered that Allergan can no longer manufacture or sell its Microcell and Biocell implants, which have significant surface texturing.
Textured breast implants are intended to reduce complications, such as capsular contracture, which happens when the scar tissue around the implant tightens and the implant become hard. The problem is that some studies suggest that the textured surface may harbor bacteria that can promote low-level inflammation that leads to lymphoma.
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