FDA issues warning regarding breast tissue expanders with magnetic ports and pacemakers

The FDA has issued a warning to health care providers concerning reports of magnetic interference between breast tissue expanders with magnetic injection ports and other implantable cardioverter-defibrillators (ICDs) or pacemakers in patients, which could interfere with the functioning of the cardiac device.

"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," the agency stated in the warning to breast surgeons, cardiac electrophysiologists, cardiologists and plastic surgeons. "However, we are alerting health care providers to this risk, so you can help prevent it."

Literature, device labeling, adverse event medical device reports and information from the ICD manufacturers, health care organizations and professional societies were analyzed by the FDA, according to the warning.

Breast tissue expanders are temporarily used for no longer than 6 months to prepare patients for reconstructive breast surgery after mastectomy, as well as to treat under-developed breasts or soft-tissue deformities. A magnetic injection port is part of some breast tissue expanders to help guide the surgeon when injecting saline fluid to expand the device, the warning reported.

If the magnetic port comes close enough to an ICD or pacemaker, it can cause magnetic interference, which causes the ICD or pacemaker to go into "magnet mode," according to the warning.

"ICDs in magnet mode will not deliver life-saving shocks or anti-tachycardia pacing therapy, which can be life-threatening to the patient if a dangerous amount of abnormal heart rhythm were to occur,” the agency stated.

The FDA reports that alternatives to magnet-port tissue expanders include breast tissue expanders with a nonmagnetic port, nonmagnetic metal disc or a remote port

The agency is recommending that physicians avoid implanting magnetic port tissue expanders in patients with a pacemaker or ICD and to discuss all available treatment options with the patient.

Patients who have a magnetic port tissue expander and an ICD or pacemaker should be warned of the possibility of magnetic interference, the warning states.

The FDA is requesting that adverse events be reported to MedWatch, the agency's safety information and adverse event reporting program.

Reference: www.fda.gov