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FDA Statement Warns Of Link Between Breast Implants And Cancer

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The U.S. Food and Drug Administration has issued a warning against breast implants, linking it to a higher risk of rare cancer.

In a statement, the public health agency provided an update on the number of cases of anaplastic large cell lymphoma, a type of non-Hodgkin's lymphoma associated with breast implants. As of September 2018, the number of unique cases in the United States has increased to 457 women, with 9 patients dying.

"I know there are many choices of breast implants available to patients, including the size, implant fill and surface texture," said Binita Ashar of the FDA's Center for Devices and Radiological Health in the statement released on Wednesday, Feb. 6. " We want to provide patients with the most up-to-date information about the variety of breast implants available so that patients and providers can have thorough and thoughtful discussions weighing the benefits and risks of different products."

Breast Implants Linked To Cancer

The FDA has already warned about the risk of anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) for years. In 2011, the public health agency first identified a possible link between breast implants and this rare cancer but admitted that they need to gather more evidence. In 2016, the World Health Organization recognized anaplastic large cell lymphoma as a T-cell that can develop with breast implants.

ALCL is not breast cancer. Rather, it is a type of blood cancer that develops when T-cells, the subtype of white blood cells that plays a key role in the immune system, become abnormal.

The increased risk of developing the disease was linked with both smooth and textured breast implants. However, on its website, the FDA noted that more cases were associated with textured breast implants. The disease is also linked to both silicone-filled and saline-filled breast implants.

BIA-ALCL often develops in the fibrous capsule that develops around the implant, separating it from the breast. Treatment of the disease involves the removal of the implants and sometimes, radiation and chemotherapy.

Current estimates claim that 1 in between 3,817 and 30,000 patients with breast implants will develop ALCL.

Symptoms And Diagnosis

In its letter to Health Care Providers, the FDA shared that patients who were diagnosed with BIA-ALCL experienced pain, lumps, swelling, and asymmetry that developed after the surgical sites fully healed. To check for BIA-ALCL, health care providers are instructed to examine the collection of fluid (seroma) and the capsule surrounding the breast implant.

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