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Breast Implant Cancer

A MedWatch Alert : Breast Implants: Letter to Health Care Providers – Due to Associated-Anaplastic Large Cell Lymphoma was just added to the FDA Letter to Health Care Provider webpage. Read the complete letter at: https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm630863.htm

Over 400 breast implant patients have been diagnosed with ALCL, Anaplastic Large Cell Lymphoma, according to the U.S. Food and Drug Administration (FDA). BIA-ALCL (Breast Implant- Associated ALCL) is a type of non-Hodgkin’s lymphoma which is cancer of the immune system. BIA-ALCL is typically in scar tissue and fluid near the implant, but may spread throughout the body. Nine of the 414 women have died as of September 2017.

10 to 11 million women worldwide have breast implants with data indicating the ALCL-BIA occurrence more frequently in implants with a textured surface than in smooth surface implants. However, ALCL can occur in both saline and silicone implants. The FDA cautions that patients with smooth surface implants are still at risk of developing ALCL. The reality is most patients are not likely to be aware of what surface their implants consist of, and multiple factors may contribute to the develop of ALCL, including patient characteristics, operative procedure history, implant characteristics and duration of placement.

Currently in the United States, there are FDA-approved implants manufactured by Ideal Implant, Inc.; Allergan; Mentor (Johnson & Johnson); and Sientra, Inc. Lawsuits have been filed against Allergan and Johnson & Johnson on behalf of breast implant patients diagnosed with BIA-ALCL.

The World Health Organization, Plastic Surgery Foundation and regulatory bodies have all recognized BIA-ALCL as a unique form of ALCL and have provided information and resources regarding the disease. BIA-ALCL has generally only been identified in patients exhibiting late-onset symptoms such as pain, lumps, swelling and breast asymmetry. Most patients will have spontaneous fluid collection; 40 percent will feel a mass or lump. Diagnosis of BIA-ALCL is possible with a screening test called CD30 and can be missed without adequate screening.

Breast implants have been recalled in Europe due to the risk of BIA-ALCL. The implants manufactured by Allergan are textured breast implants. The manufacturer said it “has suspended sales of textured breast implants and tissue expanders and is withdrawing any remaining supply” in Europe. It will still be offered in the U.S.

If you or a loved one has been diagnosed with BIA-ALCL, contact us at 1-800-814-4540 for a free consult. Deadlines apply, so contact us now.

 

 

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