USA- The washingtonpost.com reports that the Food and Drug Administration has altered its position on breast implants and is now urging manufacturers to include a box warning on the products. The FDA’s box warning is its most serious warning label.
This development comes after findings last July that certain breast implants might be liked to a rare and potentially deadly form of cancer. The Biocell textured breast implants, which are made by Allergan, appear to be linked to hundreds of cases of a type of cancer that impacts a person’s immune system. After connecting the rare disease to women who had Biocell implants, Allergan issued a worldwide recall of the product.
Last March, women claiming to have sustained injuries as a result of breast implants took part in a hearing in which they demanded that the FDA step in and make sure patients are given the proper information about the risks associated with breast implants. Many of the women stated that they were not presented with all the information they needed to make an informed decision when they chose to undergo breast implant surgery.
The FDA will not be banning any types of breast implants, including the Allergan model. The agency stated that the information it currently has is not enough to meet the legal standard necessary for it to ban a product.
The new warnings would include information about the possible link to rare forms of cancer, and the FDA is also issuing new guidelines for screening patients for possible ruptures and the inclusion of a product ingredient list on the breast implant labels.
While the FDA has stopped short of banning any products, the box warning represents the agency’s willingness to involve itself in the regulation of this product, and its acknowledgment of the possible risks presented by breast implants.
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