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After FDA Morcellator Warning, Surgical Robot Manufacturer Reduces Projected Growth

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Following the FDA warning concerning power morcellators in uterine surgery, Intuitive Surgical, makers of the da Vinci robot, cut back on its projection for growth.

According to a report in the Wall Street Journal, the technology company had initially expected to see an increase of 9 to 12 percent in the number of procedures performed with the robot—which typically include hysterectomies and the surgical removal of uterine fibroids. After the FDA discouraged physicians from using power morcellators in uterine surgeries because of the risk of cancer, however, the company cut those projections to 2 to 8 percent.

Surgery with the da Vinci Robot

The da Vinci robot is a machine with four robotic arms that surgeons use during a number of procedures, including cardiac, thoracic, urologic, and gynecologic surgery. The surgeon operates the arms from a large console with a 3D high-definition vision system and advanced computer software. The da Vinci instruments have mechanical wrists that mimic the motions of a human wrist, but with more precision.

Benefits of surgery with the da Vinci often include smaller incisions, less blood loss, minimal scarring, and faster recovery. Studies have been mixed on whether the technology provides any benefits beyond traditional surgery, however.

The Risk of Cancer

Women who are suffering from uterine fibroids, which are typically benign tumors in the uterine wall, may elect to have them removed via da Vinci robotic surgery. The procedure involves the robot for the initial incisions, after which the surgeon may use an instrument called the power morcellator to cut up pieces of tissue for easier removal through the small incisions.

The way the procedure is currently done, however, creates a risk that some of the minced tissues will be left behind to migrate to other parts of the body. If they are harmless tissues, this usually isn’t an issue, but if they are cancerous, they can seed cancer in other areas, sometimes resulting in an advanced-stage disease that is harder to treat than it would have been had the cancerous tissues remained isolated.

Detecting cancerous tissues in or around the uterus before a robotic or other type of surgery is difficult at best. There are currently no screenings for cancerous fibroids.

FDA Warns Doctors Away from Morcellators

The issue with power morcellators isn’t the only reason Intuitive Surgical has reduced its projected growth rates. Hospitals are struggling to pay for the machines and their upkeep. As more patients enroll in higher-deductible insurance plans, they may not have the funds available to pay for robotic surgery, choosing more traditional operations instead. Some patients have been injured by robotic procedures, and have filed lawsuits against the manufacturer, claiming they failed to provide adequate warnings about the risks.

The FDA advisory has definitely had an effect, though. Intuitive Surgical CEO Gary Guthart stated in an interview that the morcellator problem makes the future use of robots in uterine surgeries more uncertain.

The FDA warned on April 17, 2014, that the use of power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) poses “a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”