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WASHINGTON, D.C. — The U.S. Food and Drug Administration decided not to ban certain silicone breast implants suspected of causing cancer. Instead, the FDA determined that a Black Box warning prominently displayed on the labeling and marketing of the products should sufficiently warn physicians and patients of the dangers of silicone breast implants. According to […]
Breast implant black box warning
WASHINGTON, D.C. — The U.S. Food and Drug Administration decided not to ban certain silicone breast implants suspected of causing cancer. Instead, the FDA determined that a Black Box warning prominently displayed on the labeling and marketing of the products should sufficiently warn physicians and patients of the dangers of silicone breast implants. According to Lymphoma NewsToday, the FDA believes that the link between silicone breast implants and anaplastic large-cell lymphoma is well known in the United States. The agency said it is considering of mandating a list of precautions so that prospective textured breast implant recipients can make an informed decision regarding the implants.
The FDA discussed mandating physicians follow a series of precautions to obtain the patient’s informed consent before undergoing textured silicone breast implant surgery. The FDA is considering requiring the physician to obtain written consent for receiving textured breast implants along with requiring a prominent Black Box warning that is easy to read and understand. The Black Box warning must contain a statement about the possibility that the patient could develop cancer from the implants. Additionally, the FDA would require textured silicone breast implant manufacturers to enhance the flow of information to give doctors and their patients the most up-to-date information possible.
The FDA declined to ban textured breast implants from sale in the U.S. due to the lack of quality data to support making that decision. Lymphoma News Today cited a New York Times story that reported the FDA was aware of 600 cases worldwide and 265 in the United States of women developing anaplastic large-cell lymphoma after receiving textured silicone breast implants. Twenty of the anaplastic large-cell lymphoma cases occurring in the U.S. were fatal. The latest figures suggest that over 10 million women globally have silicone breast implants from either breast augmentation surgery or breast reconstruction surgery. Only 10% of those women in the U.S. have textured implants, whereas the number could be as high as 80% in other parts of the world.