The US Food and Drug Administration recently issued final guidance on labeling recommendations for breast implants to make them easier for patients to understand.1
“After working with stakeholders, including patients, today we are recommending format and content changes to breast implant labeling so the information is presented in an easy to understand way,” said Binita Ashar, MD, Director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, in a press release.2
The risks of certain breast implants have emerged in recent years, with some patients developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Although it is considered rare, BIA-ALCL can be fatal if not treated quickly. Some patients with breast implants have also reported systemic symptoms like fatigue, memory loss, rash, brain fog, and joint pain — collectively known as breast implant illness by some.
The final guidance specifically recommends that manufacturers add a boxed warning and patient decision checklist to their labeling. Labeling should also include updated rupture screening recommendations for silicone gel-filled breast implants, which is to start screening for ruptures between 5 and 6 years after surgery and then every 2 to 3 years after that.
Manufacturers should also provide a patient information booklet or brochure, which should include a “detailed” description of the materials that make up the breast implant shell and filling. This information may include a list of breast implant materials, chemicals that breast implants might release, and heavy metals that breast implants contain.
If a patient pursues surgery for breast implants, a patient device card should be given to the patient afterwards. This card should contain information about the breast implant, such as the device’s serial or lot number, manufacturer’s phone number, and weblink to patient decision checklist, boxed warning, and labeling.
- US Food and Drug Administration. Breast implants – certain labeling recommendations to improve patient communication. Published September 29, 2020. Accessed October 4, 2020.
- US Food and Drug Administration. FDA issues final guidance for certain labeling recommendations for breast implants [news release]. Published September 28, 2020. Accessed October 4, 2020.