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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. Since its previous report in February, there have been new cases and 24 deaths. The agency said of the cases are attributed to the Allergan implants, and that among the deaths "12 of the 13 patients for which the manufacturer of the implant is known, are confirmed to have an Allergan breast implant at the time of their BIA-ALCL diagnosis. The group's report does not distinguish between textured implants and other kinds. It's not clear whether the texturing is actually responsible for the cancer or is just associated with a higher incidence of the disease. But Maman and others say the surface can interact with the surrounding scar tissue that the body forms as an immune response to the implant.
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Breast Implant Recall: What You Need to Know
Textured Breast Implants Linked To Rare Type Of Cancer Are Recalled : Shots - Health News : NPR
Members must warn prospective patients of the potential risk when counselling them and provide both verbal and written information. It is estimated that between 5 and 10 million women have breast implants. Due to the rarity of a diagnosis of ALCL believed to be in the order of ,, a worldwide collaboration is required to provide robust data to investigate the link. When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Over time, a fibrous scar called a capsule develops around the implant, separating it from the rest of the breast. In women with breast implants, the ALCL was generally found adjacent to the implant itself and contained within the fibrous capsule. BIA-ALCL appears to be related to textured breast implants and it appears to have occurred with textured implants made by every manufacturer.
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ALCL risk from breast implants
At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk. In a report summarizing the Agency's findings, we emphasized the need to gather additional information to better characterize ALCL in individuals with breast implants. In , the World Health Organization designated breast implant-associated anaplastic large cell lymphoma BIA-ALCL as a T-cell lymphoma that can develop following breast implants and noted that the exact number of cases remained difficult to determine due to significant limitations in world-wide reporting and lack of global breast implant sales data.
In March , the Food and Drug Administration FDA issued a press release about a rare cancer called breast implant-associated anaplastic large cell lymphoma BIA-ALCL , which is associated with breast implants women receive after surgery cosmetic or reconstructive surgery. The majority of women had received a textured-surface breast implant during their breast procedure. One in 30, women with textured-surface breast implants may develop it. Breast implants are safe. BIA-ALCL appears to be associated with textured-surface breast implants only, which account for a small number of implants.
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