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.
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On October 23, 2019, the FDA issued draft guidance proposing that a black box warning be included on breast implants, warning women of the many risks they may not be aware of including the risk of developing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.
Kathryn Moore says
Allergen implants for 6 years. Explant planned but no date yet. I am so very sick.