March 9, 2016

FDA warns about magnetic interference between breast tissue expanders and ICDs, pacemakers

By: Judy Mathias
Share

Editor's Note

The Food and Drug Administration (FDA) on March 8 issued a warning about magnetic interference between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators (ICDs) or pacemakers in patients.

The breast expanders can interfere with the functioning of these cardiac devices, causing them to go into "magnet mode." ICDs in magnet mode will not deliver life-saving shocks or anti-tachycardia pacing therapy. Pacemakers in magnet mode continuously pace without sensing the patient’s heart rhythm, which can result in abnormal heart rhythms or more serious harm.

 

FDA3

March 8, 2016 Dear Breast Surgeons, Cardiac Electrophysiologists, Cardiologists, and Plastic Surgeons: The FDA is aware of reports of magnetic interference between breast tissue expanders with magnetic injection ports and either implantable cardioverter-defibrillators (ICDs) or pacemakers in patients, interfering with the functioning of these cardiac devices.

Read More >>
Live chat by BoldChat