A draft guidance has been drawn up on the risks associated with saline or silicone gel filled breast implants, including recommendations of measures to ensure patients and physicians are mindful of them.
Breast implants are medical devices implanted under the breast tissue to increase size or replace tissue that has been removed due to cancer, trauma or abnormal development. Two types of implants, saline-filled and silicone gel-filled, are approved in the United States (US). Recently, the US Food and Drug Administration (FDA) has received information associated with the risks of breast implants including anaplastic large cell lymphoma and systemic symptoms such as fatigue, memory loss, rash and joint pain. A causal relationship has not been established, but the FDA have issued the draft guidance recommending the addition of a new boxed warning and patient decision checklist.
The boxed warning should advise the patients of the following:
- Breast implants are not considered lifetime devices;
- The chance of developing complications increases over time;
- Some complications will require more surgery;
- Breast implants have been associated with the risk of developing lymphoma and may be associated with systemic symptoms
The patient decision checklist, highlighting key safety information, is suggested to be included at the end of the patient information booklet. A template is included in the appendix of the draft guidance.
Manufacturers are also encouraged to update the checklist as and when additional data is collected through post-marketing surveillance. The guidance further outlines additional labelling recommendations such as rupture screening protocol, material and device descriptions, and patient device cards. The device card should be issued to patients who have decided to have surgery, and should accommodate information such as the device’s serial number, style, size and Unique Device Identifier (UDI).
The FDA believes it is essential that this information is provided by manufacturers to enable patients to have a balanced discussion with their physicians, leading to an informed decision. The FDA intends to collaborate with manufacturers through the pre-market approval application (PMA) process, to incorporate these significant labelling warnings.
To view the draft guidance, click here.