Deaths Reported After Radio-Frequency Ablation of Lung Tumors

The FDA issued a notice Dec. 11 informing physicians of deaths associated with the use of radio-frequency (RF) devices during lung tumor ablation. Similar reports have appeared in the literature.

Patient selection, subsequent treatment and technical use of the RF ablation device, including placement and operation, may have contributed to the fatalities, the agency said.

The FDA has cleared many RF devices for general ablation of soft tissue by thermal coagulation necrosis. These devices also have been cleared for certain indications; however, they have not been cleared specifically for lung tumor ablation.

Manufacturers of ablation devices cannot legally market them for use with lung tumors because clinical data establishing their safety and effectiveness for this purpose have not been submitted to the agency. This includes promoting their safety and effectiveness in training programs.