Breast implant label guidance finalized by FDA

Regulatory NewsRegulatory News | 28 September 2020 |  By 

Updated 29 September to add comment from CDRH official

The US Food and Drug Administration (FDA) issued final guidance on improving patient information regarding breast implants on 28 September. The final guidance largely echoes draft labeling guidance issued in October 2019, with some clarifications surrounding the relationship between implants and systemic disease, language to improve the readability of the patient device card, and information on specific registries to track real-world data on breast implants.
FDA recommends that breast implant manufacturers include a boxed warning and a patient decision checklist; examples of these tools in the guidance appendices remain the largely same as presented in the draft guidance. The final guidance recommends that overall incidence rates of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) be included in the patient decision checklist, as well as device-specific incidence rates. The patient device checklist also should include specific information regarding ongoing patient registries.
To clarify the patient device card, FDA recommends including language stating that “This card belongs to the patient. Please give it to the patient” so that the physician can do so immediately after implantation. Specifics including serial number, lot number, device style, device size and unique device identifier (UDI) also should be included. The addition of web links to provide the most up-to-date access to the patient device checklist, boxed warning and labeling of the specific implant also should be included.
The guidance was issued in response to increasing evidence regarding the relationship between breast implants and BIA-ALCL and breast implant illness, a term used to describe a set of symptoms such as fatigue, memory loss and joint pain that breast implant patients ascribe to their implants. FDA convened an advisory committee meeting in March 2019 to look into the situation and give recommendations (RELATED: FDA panel recommends new postmarket requirements for breast implants, Regulatory Focus 26 March 2019).
The 2019 draft guidance was developed in part from the advisory committee’s recommendations (RELATED: FDA calls for new warning on breast implants, Regulatory Focus 23 October 2019).

"As new information has become available about the risks and complications of breast implants, it is critical that women have access to information they need to make informed decisions," Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in a statement. "We are recommending format and content changes to breast implant labeling so the information is presented in an easy to understand way. It is important that patients discuss the risks and benefits of breast implants with their health care provider and we hope that these labeling recommendations will help in facilitating these discussions."

The updated recommendations also have been incorporated in an updated version of FDA’s main guidance document on breast implants, Saline, Silicone Gel, and Alternative Breast Implants.


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