FDA Supports Highest Level of Warning Labels on Breast Implants

The United States Food and Drug Administration (FDA) announced that it may begin requiring the addition of “black box” warning labels on breast implant packaging. A black box warning label is the highest level of warning label that can be issued by the FDA; it is reserved for products that are identified by the FDA as especially dangerous.

Breast implants have been associated with the development of cancer and “breast implant illness,” a condition that is characterized by assorted physical and mental symptoms. Breast implant illness is not a medically recognized term but has been reported by many women who link their symptoms to their silicone implants. A person who believes they have breast implant illness may experience swelling, fatigue, pain, and fever, as well as emotional and cognitive issues.

Allergan, a breast implant manufacturer, recently recalled their textured implants because of the heightened risk of cancer. Their brand of textured breast implants was specifically associated with the condition of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of cancer that is different from breast implant illness. The symptoms of BIA-ALCL include swelling, pain, redness, and changes in the appearance of the breasts.

Breast implant patients are not often warned of the risks of having implants. The majority of people who get a breast augmentation have no say or knowledge of the types of implants that are used during their surgery, says a CBS News source. This raises questions about the efficacy of black box labels, which would be affixed to products patients may never see.

The MR Civil Justice legal team is dedicated to protecting consumers from the effects of dangerous products, careless manufacturers, and negligent regulatory agencies. The risks associated with breast implants have long been hidden from consumers. Contact us if you experienced an illness or injury that is linked to silicone breast implants.

To schedule a free consultation with the attorneys of MR Civil Justice, complete our contact form or call (214) 307-8387.

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