FDA Recommends Breast Implant Warning
Over the past week, I appeared on two separate news stations (KTLA & CBSN) discussing the US Food and Drug Administration (FDA) recommendation that breast-implant manufacturers help make sure patients are wise to the risks and benefits associated with the devices.
The agency has drafted guidance to the manufacturers to lay out risks relating to symptoms like joint pain and fatigue, the link between breast implants and a rare cancer, and to clarify that implants are not lifetime devices.
The FDA is recommending a “boxed warning” on labeling materials for breast implants.
The FDA has heightened the awareness regarding breast implants since their recall on the following Allergan™ Natrelle Biocell textured products on July 24, 2019:
– Allergan™ Natrelle Saline-Filled Textured Breast Implants
–Allergan™ Natrelle Silicone-Filled Textured Breast Impants
–Allergan™ Natrelle 410 Highly Cohesive Anatomicallly Shaped Silicone-Filled Textured Breast Implants
KTLA 5 Morning News with Beverly Hills plastic surgeon Dr. Stuart Linder is ask about textured implants and how they have been linked to a cancer BIA-ALCL.
CBSN Los Angles. This warning is the FDA’s highest warning on the implant box. Dr. Linder Beverly Hills plastic surgeon explains this warning allows the patient to understand the risks, complications, side effects and points out that these devices are not life long and that they will be needed to be replaced at some point.