It may seem like using surgical robotic devices may be less risky than traditional surgical methods. After all, advances in technology may mean that large incisions and other surgical risks are minimized. However, Texans may be concerned to learn that the U.S. Food and Drug Administration has issued a warning stating that the use of robotic devices in cancer operations may be unsafe.
The FDA stated that surgical robotic devices may increase safety risks and could even lead to poor surgical outcomes for those who undergo operations using these devices. The FDA reviewed recent studies that claimed that there is limited data on the risks of using robotics during cancer operations. Thus, the FDA determined that it cannot properly verify whether robotic devices are an effective way to perform operations on those with cancer.
When a robotic device is used in surgery, incisions can be more precise, which could result in less pain, scarring and infection in patients. The amount of time it takes a person to recover from such operations may be quicker than traditional operations. However, the FDA determined that mastectomy patients are not being made fully aware that the safety of using robotics in cancer operations has yet to be established. Moreover, other studies show that operations for those with cervical cancer in which robotics are used result in a lower survival rate than operations on those with cervical cancer that undergo traditional surgical procedures. The FDA wants robotic surgical devices to contain warnings that the use of the devices for cancer procedures has not been completely evaluated.
Unfortunately, such warnings may come too little, too late for those who had robotic surgery and suffered a worsened condition or even death. When this happens, the patient or his or her loved one in the event of a fatality may want to pursue defective medical device litigation. Doing so cannot undo all the harms suffered, but it can at least provide patients with compensation for medical expenses, lost wages, pain and suffering and other financial damages they incurred due to the ineffective surgery.