Breast implant checklist requirement: What you need to know
What you – and your staff – need to know about the new breast implant checklist
The FDA recently issued new requirements for breast implant manufacturers to ensure patients are made aware of potential risks associated with the device. These requirements, however, include a stipulation that surgeons must provide, discuss and sign a patient-decision checklist (which must be provided by the manufacturer of the implant being used) during the informed-consent process.
The following information is important for ASPS members and their office staff to understand about these new requirements:
- Breast implant manufacturers must provide device-specific checklists to physicians. Please note that the model checklist included as part of the ASPS ICR (informed-consent resource) is NOT currently manufacturer-specific and is provided purely as an example. At this time, it should NOT be used as the official checklist.
- Checklists are specific to each manufacturer's device and considered (along with the new "black box warning" and other required information) part of the package labeling.
- Manufacturers are prohibited from selling breast implants to physicians AND facilities – unless the implanting surgeon attests, in writing and prior to the sale, that he or she will use the patient checklist as part of the informed-consent process.
- This checklist review with the patient is to be completed in addition to – not as a replacement for – the informed-consent process.
- The implanting surgeon MUST sign the checklist after reviewing it with the patient. This responsibility may NOT be delegated to a non-physician provider, staff member, resident or a non-implanting physician.
- The Patient must be provided the opportunity to sign the checklist after reviewing it with the physician.
ASPS encourages all members to share this information with their office and O.R. staff. No information is currently available regarding how these requirements will be audited, but ASPS will continue to update its members as additional details emerge.
If you have questions, please contact the Society at firstname.lastname@example.org.