Safety communication has recently been issued by the Food and Drug Administration (FDA) involving the effectiveness and safety of cancer procedures utilizing robotically-assisted surgical devices. Some preliminary evidence is showing when these surgical devices are used for cancer prevention or treatment of women, the patients have lower long-term rates of survival.

Robotically Assisted Surgical Devices

These devices are designed to help surgeons perform many different types of surgical procedures. It normally involves making small cuts in a person’s body. In many cases, it has helped decrease infection, blood loss, as well as scarring and post-surgical recovery time when compared to traditional surgery. During this type of surgical procedure, a computer and software technology is used to help surgeons control surgical instruments that have been placed on a mechanical arm. It enables a surgeon to view the surgical area three-dimensional high definition.

Benefits And Risks

Benefits to utilizing a robotically-assisted surgical approach to cancer treatment instead of conventional surgery has never been established. The peer-reviewed literature covering its clinical outcomes is known by the FDA. These reports cover treating cancer using robotically-assisted surgical devices, the long term survival rate using minimally invasive surgery for cervical cancer hysterectomies and more.

Marketing Authorization

Robotically-assisted surgical devices have not been granted marketing authorization in the United States by the FDA. They are not permitted to be advertised as a treatment or prevention of cancer. When robotically-assisted surgical devices are labeled and legally marketed in the United States, they must have a warning that states cancer treatment outcomes have not been evaluated by the FDA.

Patient recommendations

Should someone be considering robotically assisted surgery to prevent or treat cancer, there are certain things a patient should know. They need to realize the safety and effectiveness of robotically-assisted surgical devices used in these situations have not been established. The risks and benefits of this option should be discussed with your healthcare provider, and you should not go forward with this option until they can make an informed decision. A patient should ask a surgeon about their experience and training with regard to performing this type of procedure using robotically-assisted surgical devices. They should also ask about any and all possible complications associated with the procedure.

Complications

Should someone have had surgery with a robotically-assisted surgical device and experienced complications, the treating surgeon should file a report. It should be filed with the FDA Safety Information and Adverse Event Reporting program known as MedWatch. The FDA monitors adverse events with events reported to them. It encourages research institutions, academic institutions, as well as experts and robotically-assisted surgical device experts to maintain registries of patients who have had this type of surgery. The purpose of these registries is to produce data to be analyzed in hopes of improving the technology.

The FDA is aware of what is happening with robotically-assisted surgical devices. They are trying to develop a better understanding of all the risks associated with using them. Should anyone have experienced harm from having surgery with the use of a robotically-assisted surgical device, they should consider speaking with an attorney. Legal experts can determine if a victim would qualify to receive compensation for their injuries. If you believe you were injured through the use of a robotically-assisted surgical device, contact KBA Attorneys. With years of experience with the medical industry, we are experts at helping victims of surgical mistakes and know how to help a victim of surgical malpractice get fair compensation.