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Food and Drug Administration asks for breast implant recall

On Behalf of | Sep 2, 2019 | Pharmaceutical Litigation

Allergan Plc manufactures Biocell tissue expanders and breast implants. After reviewing the evidence, the Food and Drug Administration determined these products could cause significant harm to those who use them here in Ohio or elsewhere. Recently, the agency requested that the company recall these products here in the United States.

The FDA received evidence indicating that the textured form of these products could lead to anaplastic large cell lymphoma, which is rare form of cancer associated with breast implants. It should be noted that the recall only applies to the textured implants, not the smooth ones. The textured implants are designed to prevent the implants from moving around or change position inside a woman’s breast.

The sandpaper-like implants made by Allergan Plc present a six times higher risk of contracting this breast-implant associated cancer than the ones made by other companies such as Johnson & Johnson’s Mentor unit and Sientra Inc. There is a risk that women could contract this cancer from any manufacturer, it is just due to this substantial increase in the danger that led to the recall. Other countries already recalled the products, and when the FDA received the appropriate evidence, only then did it follow suit.

There is no indication as of yet regarding whether the delay in the Food and Drug Administration calling for the recall put more women at risk. Ohio women with these implants may need to keep a closer eye on their health than they intended, and some may want to have the implants removed. Only those individuals and their doctors can make those determinations. For women who receive a diagnosis of the associated form of cancer, it may be possible to pursue compensation to help with their current and future medical and other needs.

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