FDA RF Ablation Device Warning Sparked by Deaths
A medical device being used to remove lung tumors has been implicated in the deaths of several patients. According to a Food and Drug Administration (FDA) warning, these Radio Frequency (RF) Ablaton Devices have not been approved to remove lung tumors at the current time.
RF Ablation Devices use extreme heat to remove diseased tissue. The FDA has approved RF Ablation Devices as tools for general ablation of soft tissue by thermal coagulation necrosis. These devices have also been cleared for certain specific indications, including partial or complete ablation of non-resectable liver lesions and palliation of pain associated with metastatic lesions involving bone.
In February 2003, the FDA’s General and Plastic Surgery Devices Advisory Committees met and discussed the subject of thermal ablation of lung tumors. Concerns were raised about the safety and adverse event reporting associated with RF Ablation of lung tumors.
Using RF Ablation Devices to remove lung tumors is an off label use of this device. Such use is not illegal, as doctors are free to use FDA approved medical devices as they see fit. However, medical device manufacturers may not promote off-label uses of their products.
The FDA has received several reports of patient deaths associated with the use of RF Ablation Devices in lung tumor removal, and similar reports have appeared in medical literature.
The FDA warning cautioned medical professionals to avoid using RF Ablation Devices for lung tumor removal. The FDA recommended that doctors who wish to have their patients treated with these devices enroll them in a clinical trial designed to investigate the use of RF Ablation Devices in lung tumor removal.
Reference:
"RF Ablation Device Warning Sparked by Deaths during Procedures to Remove Lung Tumors," newsinferno.com, December 2007.
