The FDA made a public announcement recently about the association between radiofrequency ablation (RFA) of lung tumors and patient deaths. The FDA has received several reports of patient deaths linked to lung tumor ablation with RFA devices. According to the government agency, patient selection, follow-up care, and technical use of these devices may have contributed to patient deaths.
Radiofrequency ablation is a minimally invasive procedure in which tumors are heated with highly focused energy. RFA is ideal for local control of some cancers. RFA can also be used to heat nerve tissue to reduce arthritis pain and chronic back pain. Needles must be inserted at the locus of the pain or tumor before the radiofrequency ablation takes place.
The FDA has not cleared RFA devices for anything more than general ablation. The devices may not be legally marketed to treat lung tumors, because their clinical efficacy in the treatment of such tumors has not yet been fully established by the agency.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.