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You are here: Home / Medical Devices / Breast Implants / FDA Wants Cancer Warning on Breast Implants

FDA Wants Cancer Warning on Breast Implants

November 26, 2019 By Sandra Dalton 1 Comment

FDA Wants Cancer Warning on Breast Implants

The U.S. Food and Drug Administration (FDA) is proposing labeling changes on breast implants. The agency says that women are not fully informed of the risks before choosing implants, including the risk of cancer, and that the changes would help women make a more informed decision. According to the agency there have been 573 reported cases of breast-implant-associated anaplastic large-cell lymphoma (BIA-ALCL) worldwide and 33 deaths from the rare cancer, as of July 2019.

Allergan Recall

The majority of BIA-ALCL cases, 481, have been attributed to Allergan BIOCELL implants. In 12 of the 13 deaths in which the type of implant was known, the women had Allergan BIOCELL Implants. Allergan initiated a voluntary recall of its BIOCELL textured breast implants and tissue expanders after the FDA requested that it remove certain models from the market.

Proposed Label Changes

On October 23, 2019, the FDA issued draft guidance proposing that a black box warning be included on breast implants, warning women of the many risks they may not be aware of including the risk of developing BIA-ALCL and the fact that breast implants are not lifetime devices and the risk of complications increases over time.

The agency is also recommending that manufacturers include an informational booklet or brochure with a patient decision checklist at the end to help patients have conversations with their doctors about the risks and their concerns.

If you or someone you love has developed BIA-ALCL, please contact an experienced product liability attorney and schedule your free consultation.

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Filed Under: Breast Implants

About Sandra Dalton

With a background as a paralegal, focusing on criminal defense and civil rights, Sandra Dalton launched her freelance writing career in 2000 with a weekly column on Freedom for Suite 101 and pro bono projects for individuals and organizations supporting causes close to her heart. One of her first projects was for the Police Compliant Center writing about police misconduct. Sandra’s legal writing quickly expanded to include personal injury, animal welfare, criminal defense, disability discrimination, family law and much more.

Comments

  1. Kathryn Moore says

    November 27, 2019 at 3:05 pm

    Allergen implants for 6 years. Explant planned but no date yet. I am so very sick.

    Reply

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