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CDRH Statement: CDRH’s Continued Commitment to Breast Implant Safety

February 28, 2024

The following is attributed to Binita Ashar, MD, MBA, FACS, Director of the Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality (OPEQ), CDRH

CDRH is committed to protecting the public health and providing information to patients and providers to better understand the safety risks of breast implants, and to help strengthen the evidence generated to inform regulatory actions in this space.

CDRH would like to acknowledge the article published recently in the Plastic and Reconstructive Surgery journal. The article describes evidence regarding the risk, diagnosis and management of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and the link to textured breast implants. It also discusses prophylactic explantation (removal) and the potential for risk reduction in certain cases, and emphasizes that explantation should be a shared decision between the patient and surgeon.

CDRH welcomes thoughtful, scientific and transparent public dialogue concerning breast implant safety and effectiveness, and we continue to evaluate all available information about BIA-ALCL and other breast implant related illnesses. Given that the occurrence of BIA-ALCL is uncommon, prophylactic removal of textured implants is not recommended in asymptomatic patients. However, individual patients should discuss possible benefits and risks of removal with their health care providers to make an informed decision about their health. 

Textured breast implants overall are less common in the U.S. compared to other countries. Prophylactic surgery presents a range of risks depending on individual patient risk factors including history and anatomy. Additionally, there are different types of breast implants currently marketed in the U.S. and risks vary by type of implant and patient characteristics.   

In most cases, BIA-ALCL is found in the scar tissue and fluid around the implant. However, in some cases, it can spread throughout the body. While uncommon, a BIA-ALCL diagnosis is serious and can lead to death if not diagnosed early and promptly treated. We encourage patients and providers to report any issues related to breast implants to the FDA’s Adverse Event Reporting Program.

In recent years, CDRH has taken a number of steps to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. In 2019, we convened the General and Plastic Surgery Devices Advisory Panel to publicly discuss the long-term benefits and risks associated with breast implants indicated for breast augmentation and reconstruction.

In 2021, we issued new orders restricting sales and distribution of breast implants and approved new labeling to ensure consumers are equipped with the information they need to make informed decisions. The orders restrict sale and distribution of breast implants to only health care providers and facilities that provide information to patients utilizing the Patient Decision Checklist to ensure they understand the risks, benefits and other information about the device. In 2022 and 2023, we provided new information on breast implant safety, including information on Squamous Cell Carcinoma, various lymphomas other than BIA-ALCL, and various malignancies of the breast in patients with breast implants.

We continue to meet with patient and provider stakeholders and regularly update our breast implant-related communications. Additionally, we continue to closely monitor and analyze all information regarding risks associated with breast implants, and remain committed to communicating publicly when we receive any new or significant information so that patients, together with their providers, can make thoughtful and informed decisions. Our continuous work serves to strengthen the evidence that is generated regarding breast implant safety and inform our regulatory actions in this space.

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