Warning about magnetic interference between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators (ICDs) or pacemakers

This message is to inform you that this morning the FDA posted a letter warning health care providers about magnetic interference between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators (ICDs) or pacemakers.  This communication stems from an issue analyzed by the Electro-cardio Signal Team. The FDA is aware of reports of magnetic interference between breast tissue expanders with magnetic injection ports and either ICDs or pacemakers in patients, interfering with the functioning of these cardiac devices. The FDA analyzed peer-reviewed literature, device labeling, adverse event medical device reports, and information from ICD manufacturers, health care organizations, and professional societies. At this time, the FDA believes that there is a very small population at risk, as it is generally uncommon for patients with an ICD or pacemaker to have breast reconstruction. However, we are alerting health care providers to this risk, so it can be prevented.

I encourage you to distribute this information widely to relevant providers.

Steve L. Morin
Office of Health and Constituent Affairs
Food and Drug Administration

Helene Clayton-Jeter
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the Cardiovascular & Endocrine Liaison Program visit the FDA Patient Network