The FDA today released a letter warning on magnetic interference issues between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators or pacemakers.
The federal watchdog warned that it has received reports of the 2 devices interacting in a way that interferes with the function of the cardiac implants, but that the issue presents a very small population at risk as it’s uncommon for patients with an ICD or pacemaker to have breast reconstruction.
The agency reported that the magnetic port on certain breast tissue expanders can come close enough to the cardiac devices to cause magnetic interference, and force the ICDs or pacemakers into “magnet mode”, in which they will not deliver life-saving shocks or anti-tachycardia pacing therapy.
When the cardiac devices enter magnet mode, they will being to continuously pace without sensing the patient’s natural heart rhythm, which can result in symptoms such as irregular heartbeats, abnormal heart rhythms or more serious patient harm.
The FDA said that labelling warns against issues with magnetic interference, and that magnetic-port breast tissue expanders labeling includes a contraindication for patients with implanted devices that could be affected by the magnetic field.
Alternative breast tissue expanders are available for patients with ICDs or pacemakers, the FDA said, which use non-magnetic metal discs or remote ports.
The federal watchdog recommended avoiding the implantation of magnetic-port breast tissue expanders in patients with pacers or ICDs, and advised for the review of device labeling before use of any such devices.