Assessment, Complications, and Surveillance of Breast Implants: Making Sense of 2022 FDA Breast Implant Guidance

Abstract

As more information about the potential risks and complications related to breast implants has become available, the United States Food and Drug Administration (FDA) has responded by implementing changes to improve patient education, recalling certain devices and updating the recommendations for screening for silicone implant rupture. In addition to staying up-to-date with FDA actions and guidance, radiologists need to maintain awareness about the types of implants they may see, breast reconstruction techniques including the use of acellular dermal matrix, and the multimodality imaging of implants and their complications. Radiologists should also be familiar with some key differences between the updated FDA guidelines for implant screening and the imaging recommendations from the American College of Radiology Appropriateness Criteria. The addition of US as an acceptable screening exam for silicone implant rupture by the FDA is one of the most notable changes that has potentially significant implications.

Keywords: breast MRI; breast implants; guidelines; implant rupture; silicone implants; ultrasound.