Posted 28 September 2020 | By
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decision checklist; examples of these tools in the guidance appendices remain the largely same as presented in the draft guidance.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The 2019 draft guidance was developed in part from the advisory committee’s recommendations (RELATED: FDA calls for new warning on breast implants, Regulatory Focus 23 October 2019).
“The agency will continue to monitor information about potential safety risks and take steps to ensure they are being adequately conveyed to and understood by physicians and patients,” according to the guidance.
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.
Guidance
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).
“The agency will continue to monitor information about potential safety risks and take steps to ensure they are being adequately conveyed to and understood by physicians and patients,” according to the guidance.
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.
Guidance
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Breast implant label guidance finalized by FDA - Regulatory Focus
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