FDA Warning about the Magnetic Port in Tissue Expanders Potentially Interfering with ICD/Pacemaker Devices

 

RMahabir

A Message From…
Raman Mahabir, MD
PSEN Co-Editor

On March 8, 2016, the FDA wrote a letter to health care providers warning them about potential interference between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators (ICD’s) or pacemakers.  While they recognized there is a very small population at risk, they were aware of adverse events.  They made the following recommendations:

  • Avoid, whenever possible, implanting a magnetic-port breast tissue expander in a patient with a pacemaker or an ICD.
  • If a patient has an ICD or pacemaker, a non-magnetic reconstructive option should be used.
  • When a patient with an implanted magnetic breast tissue expander requires the placement of an ICD or pacemaker, careful consideration should be given to choice of cardiac device, location and timing of implantation, the possible need for more frequent cardiac device checks and whether a different breast tissue expander might be used.
  • Warn patients who have a magnetic-port breast tissue expander and an ICD or pacemaker of the possibility of magnetic interference. Tell patients who have an ICD that emits an electronic tone when the device experiences interference to seek care if they hear the tone.
  • Report any adverse events that come to your attention. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.  Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Please see this FDA letter for further details and additional resources.  http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/ucm489327.htm