A Curious Case of Breast Tissue Expander

Subhashish Agarwal, MD, MS¹, Nishant Verma, MD, MPH¹, John Y.S. Kim, MD², Bradley P. Knight, MD¹, and Alexandru Chicos, MD¹

¹ Division of Cardiology, Electrophysiology Section, Northwestern University, Chicago, Illinois, USA
² Division of Plastic Surgery, Department of Surgery, Northwestern University, Chicago, Illinois, USA

Abstract

We present a case of an individual who was found to be emanating a sound from her implantable cardioverter defibrillator (ICD). She had developed breast carcinoma requiring mastectomy and breast tissue expander implantation. The magnetic port on the breast tissue expander led to electromagnetic interference and magnet mode conversion. The ICD’s conversion to magnet mode can be dangerous, because it blocks tachyarrhythmia detection and therapy.

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Marc Rozner — Oct 13, 2015 4:02 PM
University of Texas MD Anderson Cancer Center — Anesthesiology and Perioperative Medicine — Houston, Texas United States

Our authors have reported a serious interaction between a life saving implanted device (implanted cardioverter defibrillator - ICD) and a device implanted for cosmesis (Breast Tissue Expander - BTE). As non-cardiac medical devices proliferate, the potential for adverse interactions with pacemakers or ICDs also increases. Given the widely divergent nature of the implanting physician services, clear understanding of interactions prior to the discovery of an adverse event might be difficult. For additional educational value, I believe that a number of questions should be addressed: First, please identify the manufacturer of the BTE. Both Mentor or Allergan directions for use contain specific contraindications to the placement of their devices in the presence of an already implanted pacemaker (and we should assume, by inference, an ICD). The Mentor manual states: "CONTRAINDICATIONS It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the contraindications associated with the use of this product. Patient Groups in which the product is contraindicated: The use of this expander is contraindicated in patients who have any of the following conditions: • Implanted devices such as pacemakers, drug infusion devices, artificial sensing devices, etc., that would be affected by a magnetic field." Second, which device was implanted second? Was the ICD implanted after the BTE was already in place or vice-versa? Regardless, the implanting physicians of the second device should have been aware of the potential for an adverse interaction. Third, what was the brand of the implanted ICD? If it were a Boston Scientific device, it should have beeped continuously in the presence of a magnet. Most Medtronic ICDs will emit sound for 10-30 seconds when the magnet sensor is activated. Even if the magnet switch remains activated, the sound stops at the end of the sound reporting cycle and will not recur until the magnet switch returns to the "no magnet" position, then gets reactivated. However, Medtronic ICDs can have the sound turned off. St. Jude Medical, Sorin-ELA and Biotronik ICDs do not have any audible tones. Did the implanting physician for second implanted device report any sounds when the second device was implanted? Fourth, as the authors point out, magnet proximity to the ICD can suspend high voltage therapy which can be life-threatening. As such, was this event reported to the FDA either directly or via the MedWatch program? Was this event also reported to the ICD manufacturer and the BTE manufacturer, both of whom should have been informed of this adverse interaction? If not, this should be done at this time with as much detail as possible. Finally, I am aware of a couple of other cases but do not have specific details as they were not my patients and those cases were never published, making the reports are anecdotal. But as more patients with cardiovascular implanted electronic devices undergo advanced cancer surgery and reconstruction, keeping all groups educated about potential interactions will likely remain a difficult job.

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In response to: Our authors have reported a serious interaction between a life saving implanted device (implanted cardioverter defibrillator - ICD) and a device implanted for cosmesis (Breast Tissue Expander - BTE). As non-cardiac medical devices proliferate, the potential for adverse interactions with pacemakers or ICDs also increases. Given the widely divergent nature of the implanting physician services, clear understanding of interactions prior to the discovery of an adverse event might be difficult. For additional educational value, I believe that a number of questions should be addressed: First, please identify the manufacturer of the BTE. Both Mentor or Allergan directions for use contain specific contraindications to the placement of their devices in the presence of an already implanted pacemaker (and we should assume, by inference, an ICD). The Mentor manual states: "CONTRAINDICATIONS It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the contraindications associated with the use of this product. Patient Groups in which the product is contraindicated: The use of this expander is contraindicated in patients who have any of the following conditions: • Implanted devices such as pacemakers, drug infusion devices, artificial sensing devices, etc., that would be affected by a magnetic field." Second, which device was implanted second? Was the ICD implanted after the BTE was already in place or vice-versa? Regardless, the implanting physicians of the second device should have been aware of the potential for an adverse interaction. Third, what was the brand of the implanted ICD? If it were a Boston Scientific device, it should have beeped continuously in the presence of a magnet. Most Medtronic ICDs will emit sound for 10-30 seconds when the magnet sensor is activated. Even if the magnet switch remains activated, the sound stops at the end of the sound reporting cycle and will not recur until the magnet switch returns to the "no magnet" position, then gets reactivated. However, Medtronic ICDs can have the sound turned off. St. Jude Medical, Sorin-ELA and Biotronik ICDs do not have any audible tones. Did the implanting physician for second implanted device report any sounds when the second device was implanted? Fourth, as the authors point out, magnet proximity to the ICD can suspend high voltage therapy which can be life-threatening. As such, was this event reported to the FDA either directly or via the MedWatch program? Was this event also reported to the ICD manufacturer and the BTE manufacturer, both of whom should have been informed of this adverse interaction? If not, this should be done at this time with as much detail as possible. Finally, I am aware of a couple of other cases but do not have specific details as they were not my patients and those cases were never published, making the reports are anecdotal. But as more patients with cardiovascular implanted electronic devices undergo advanced cancer surgery and reconstruction, keeping all groups educated about potential interactions will likely remain a difficult job.

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A Curious Case of Breast Tissue Expander

Abstract