In July, the Food and Drug Administration sent a letter of warning to Intuitive Surgical, Inc. concerning the marketing and advertising of its robotic surgical equipment. In spite of advertisements touting the benefits of this technique, several patients reportedly suffered harm from a surgical error caused by these devices. A medical director for Massachusetts General Hospital stated that the facility has been deluged by literature and offers promoting robotic surgery.
There are several fields of surgery where robotic equipment is utilized on a fairly regular basis. One of these fields is gynecology surgery, with the promotional literature boasting minimally-invasive procedures and rapid recovery. However, one patient who chose this type of surgery apparently suffered a perforated bowel in the process. She spent days in intense pain until the problem was discovered. She then underwent several additional surgeries to correct the condition and spent days in and out of the hospital.
This patient is not alone in her painful experience as there are reports of other being harmed. The FDA issued the warning over the company’s failure to include information concerning alternatives to the robotic procedures. The director for Massachusetts General admitted that the hospital does utilize robotics in a limited scope and that it has refused further overtures from Intuitive Surgical to expand their use and to host conferences touting the devices.
One surgeon who boasted about his prowess with the device reportedly cut a patient’s aorta during a kidney surgery. Moreover, a surgical sponge was apparently left in her body. That surgery is said to have resulted in the patient suffering nerve damage. She exercised her right to file a medical malpractice claim over the multiple surgical error incidents. Every patient is ensured the right to pursue monetary compensation when they have suffered harm and financial loss at the hands of those whom they trusted to provide quality healthcare.
Source: bloomberg.com, “Robot Surgery Damaging Patients Rises With Marketing”, Robert Langreth, Oct. 8, 2014