A medical device being used to remove lung tumors has been implicated in the deaths of several patients.  According to a Food & Drug Administration (FDA) warning, these Radio Frequency (RF) Ablaton Devices have not been approved to remove lung tumors.

RF Ablation Devices use extreme heat to remove damaged or 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.

Ablation devices from companies including  Boston Scientific, Johnson & Johnson and CR Bard have won approval to treat various conditions.   These medical devices consist of some type of energy generator and a catheter that is used on the patient’s damaged or diseased tissue.

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 physicians 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.  This includes promoting the safety and effectiveness of a device for off-label uses in training programs.

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.  According to the FDA, patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the deaths.

The FDA warning cautioned physicians to avoid using RF Ablation Devices for lung tumor removal.   The FDA recommended that physicians 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.   Information on such clinical trials can be obtained at www.clinicaltrials.gov by entering the search terms “ablation lung tumor.”

This entry was posted on Thursday, December 13th, 2007 at 2:20 pm and is filed under Defective Medical Devices, Legal News.