FDA cautions that robotic surgery is unproven and potentially dangerous for cancer surgeries

The men and women in suits who run hospitals love to advertise when their facilities offer robotic surgery. In many cases, they suggest that robotic surgery offers greater safety and other benefits to patients when compared to conventional surgical procedures.

It’s understandable that they want to recover the significant investment required to purchase robotic surgical equipment. Yet, a growing body of research shows that claims about the superiority of robotic surgery aren’t backed up by any evidence.

Most recently, on February 28, 2019, the U.S. Food and Drug Administration (FDA) issued a safety communication addressing robotically-assisted surgical devices in women’s health and cancer-related surgeries.

This statement by the FDA really sums it up: “It is important for health care providers and patients to understand that the safety and effectiveness of using robotically-assisted surgical devices and mastectomy procedures or in the prevention or treatment of cancer has not been established.”

If that wasn’t enough to get your attention, how about this? The FDA highlighted preliminary evidence that using robotically-assisted surgical devices for the treatment of patients with primarily breast cancer or exclusively cervical cancer may actually reduce their long-term survival rates. Let’s make this clear: based on the limited evidence currently available, patients who have robotic surgery for these types of cancer are more likely to die than patients who choose conventional surgery.

At this stage, it’s hard to say why this is the case. That’s probably a big reason why the FDA has not evaluated and cleared robotic surgery devices for mastectomy and other cancer-related procedures.

In my experience as a Houston, Texas medical malpractice attorney, I have found that surgeons performing robotic procedures often don’t have adequate training or demonstrated skills and proficiency in robotic surgical techniques. Just because a surgeon performs robotic procedures doesn’t necessarily mean that he or she was properly trained and is competent.

Plus, many clients who’ve been injured by botched robotic surgeries have told me that their surgeons did not discuss with them an alternative conventional surgery.

I wholeheartedly agree with the FDA’s recommendation to patients whose surgeons recommend robotic surgery to prevent or treat cancer. In fact, I would go even farther and recommend that patients keep these points in mind for any robotic surgery, not just a procedure related to cancer. Here are the significant patient recommendations:

• Have a detailed discussion with your surgeon about alternative treatment options that are available. Ask your surgeon to compare the benefits and risks of each potential procedure.

• Ask if the robotic surgery that your surgeon is recommending has been FDA approved.

• Inquire about your surgeon’s training, experience, and patient outcomes with robotically-assisted surgeries.

• Ask if your surgeon had any training with the manufacturer of the robotic equipment.

• Ask your surgeon how many robotic surgeries like yours he or she has performed.

• Make sure you understand all the potential complications and how often they happen to patients.

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Robert Painter is a medical malpractice attorney at Painter Law Firm PLLC, in Houston, Texas. He is a former hospital administrator who represents patients and family members in medical negligence and wrongful death lawsuits against hospitals, physicians, surgeons, anesthesiologists, and other healthcare providers. A member of the board of directors of the Houston Bar Association, he was honored, in 2018, by H Texas as one of Houston’s top lawyers. Also, in 2018, the Better Business Bureau recognized Painter Law Firm PLLC with its Award of Distinction.

Robert Painter
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Robert Painter

Robert Painter is an award-winning medical malpractice attorney at Painter Law Firm Medical Malpractice Attorneys in Houston, Texas. He is a former hospital administrator who represents patients and family members in medical negligence and wrongful death lawsuits all over Texas. Contact him for a free consultation and strategy session by calling 281-580-8800 or emailing him right now.