Allergan has announced a global recall of textured breast implants that are linked to a rare
type of cancer, at the request of the Food and Drug Administration.
type of cancer, at the request of the Food and Drug Administration.
"Biocell saline-filled and silicone-filled textured breast implants and tissue expanders will
no longer be sold.
no longer be sold.
The FDA said in a statement that while the overall incidence of the cancer appears to
be low, it asked Allergan to initiate the Biocell implant recall "once the evidence indicated
that a specific manufacturer's product appeared to be directly linked to significant patient
harm, including death."
be low, it asked Allergan to initiate the Biocell implant recall "once the evidence indicated
that a specific manufacturer's product appeared to be directly linked to significant patient
harm, including death."
The agency does not recommend that people who already have the textured implants get
them removed unless there are symptoms or problems, but it is providing information for patients and providers to consider.
them removed unless there are symptoms or problems, but it is providing information for patients and providers to consider.
The FDA said it requested the recall after a "significant increase" in cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin lymphoma.
Since its previous report in February, there have been 116 new cases and 24 deaths.
Since its previous report in February, there have been 116 new cases and 24 deaths.
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