By Tracy Colman  |  April 23, 2019

Category: Legal News

Thoughtful young woman with cervical cancerThe U.S. Food and Drug Administration (FDA) released a safety communication in February 2019 that questioned robotic urgery for cervical cancer and mastectomies in women.

The FDA alert was partially targeted toward patients considering surgery as a preventative action—as in the case of a high-risk individual—or as a curative method. The notice was also directed toward medical professionals that advise on or provide robotically-assisted surgeries in either case.

The stated aim of the safety communication was to let women and health care providers know that the long-term survival statistics of using robotic surgery for cervical cancer and mastectomies has not been established.

This also should be said of its use with other cancers as well. According to the FDA, in fact, there is a small amount of baseline evidence that suggests lower rates of survival over the long-term when this methodology is used.

According to MedPage Today, the FDA is concerned that the public might get confused about the basis from which current surgical robotic devices have their market approval.

Often, open incision conventional surgery has been compared to robotic surgery for cervical cancer and mastectomies based on how many complications show up within a 30-day window of the procedure.

As indicated by the FDA, the tiny incisions used in robot-assisted surgical procedures automatically have an advantage over conventional methods in terms of reducing the chance of infection, bleeding, scarring, and recovery when measured over the short-term.

The technology involved also allows for very precise targeting of problem areas due to software displays and computer monitor definition.

According to a more recent article posted on the Cancer Therapy Advisor website, Dr. Michael Sabel, Chief of Oncology Surgery at the Michigan Medicine at the University of Michigan at Ann Arbor, is in agreement with the FDA’s cautionary approach. He uses robotic methods in the context of general open surgery, but says that claims of exclusive robotic surgical techniques having superiority across the board lacks scientific backing.

Dr. Sabel indicates that such methods have become ubiquitous and popular among medical consumers because of quicker recovery times and less inconvenience.

According to Cancer Therapy Advisor, he claims that a certain number of physicians will always push the limits in terms of technology without the data backup. It is up to the cancer patient to do her or his research and get more than one opinion.

The article reveals that there have been 32 adverse medical event reports regarding the use of robotic devices with cancer over the past three years. This data, while not hugely statistically significant given the number of procedures undertaken in this country daily, was likely the motivation for the warning.

Four of the adverse events concerned patients who succumbed from cervical cancer after having had robotic surgery for cervical cancer which involved total hysterectomies.

In these situations, the cancer had undergone metastases. The situations raise the question whether this type of surgery may actually stimulate the process of cancer spreading.

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