After Michelle Zarick complained of excessive vaginal bleeding in 2008, her doctor found growths in her uterus and suggested she undergo a hysterectomy. Her gynecologist described one option, robotic surgery, as “the latest, greatest” minimally invasive technique available. With robotic instruments doing the delicate work usually performed hands-on by doctors, there’d be less pain and bleeding, Zarick was told. “In my mind,” she recalls, “there was no alternative but to use this fabulous technology.”
Five weeks following her 2009 surgery, in which a robot made by Intuitive Surgical (ISRG) was used to remove her uterus, Zarick felt something pop while she was in the bathroom. She looked down and saw her intestine protruding from her vagina. Four years later, the now 41-year-old sports-medicine student from Lincoln, Calif., says she has a hip-to-hip scar from corrective surgery, constipation from damaged rectal muscles, and a diminished sex life. The robot “forever changed my life for the worse,” says Zarick, who in December filed a product liability suit against Intuitive. Damages were not specified.
Angela Wonson, an Intuitive spokeswoman, says it’s company policy not to comment on litigation. In a filing in the Zarick case, Intuitive “denies each and every allegation,” arguing the injuries were caused by events that “were extraordinary,” not foreseeable, and outside the company’s control.
Zarick’s suit is one of at least 10 filed in the past 14 months that stem from serious complications involving Intuitive’s robots. According to a federal lawsuit filed in California, the liver and spleen of a Michigan man were allegedly punctured during a heart valve repair, leading to 15 hours of internal bleeding. Another federal suit in Alabama describes a man who suffered damage to his rectum and bowel after prostate surgery.
The U.S. Food and Drug Administration in January sent out surveys to surgeons about the safety of Intuitive’s robo-surgery gear. The FDA hoped to determine whether a rise in reported mishaps is “a true reflection of problems,” says FDA spokeswoman Synim Rivers.
That’s cast a shadow over one of the fastest-growing medical technologies in the U.S.—and Intuitive, which dominates the field. The Sunnyvale (Calif.)-based company received almost all its $2.2 billion in revenue in 2012 from its da Vinci Surgical System and related products. The original prototype was developed under a U.S. Army contract in the 1980s to build a system for remote-controlled battlefield surgery. Intuitive’s robot was cleared for use in 2000, and the company’s products remain the only robotic systems approved in the U.S. for soft-tissue procedures that include general surgery, gynecological surgery, and prostate operations. The machines, which can cost about $1.5 million apiece, were used in 367,000 U.S. procedures in 2012, up from 228,000 two years earlier. That growth helped boost Intuitive’s stock market value 83 percent in the three years ended Feb. 1, to about $23.2 billion.
Photograph by Todd Tankersley for Bloomberg Businessweek
“Part of what’s driven this market is people seeking out robotic surgery,” says Michael Matson, an analyst with Mizuho Securities USA in New York. “Hospitals market it, and the patients seem to think it’s better.” The real threat to Intuitive is “that the patients would get scared,” he says, and stop seeking robot operations.
In robo-surgery, a doctor peers into a video game-style console several feet from the patient. Foot pedals and hand controls allow the physician, guided by a 3D camera, to maneuver mechanical arms equipped with surgical tools. This differs from other minimally invasive operations in which doctors stand over a patient and manually manipulate instruments and cameras through small incisions. (Many surgeries are still of the traditional variety, with doctors making larger incisions that take longer to recover from.)
The Intuitive machine’s benefits include a high-definition camera system and robot arms and joints designed to precisely mimic natural hand movements, the company says. Critics point to the high price and the lack of large, controlled trials showing clear long-term benefits, compared with standard less invasive operations. A study published in February in the Journal of the American Medical Association found that robotic uterus removal costs 33 percent more than standard minimally invasive hysterectomies, without lowering the complication rate.
A review of adverse event reports—self-reported filings of procedures that don’t go according to plan—sent to the FDA since 2009 shows that reported injuries involving procedures done using Intuitive machines jumped to at least 115 in 2012, from 24 in 2009, and deaths rose to 30 from 11. The robots have been linked to at least 70 deaths since 2009.
The reports—from doctors, patients, and companies—don’t necessarily mean the robots caused any deaths, only that they were involved in procedures in which deaths occurred. Yet adverse event reports have in the past served as an early warning system on medical-device safety. While the number of complications reported may be small given the large volume of operations done, it’s set off warning bells. In January the FDA sent out letters to major hospitals asking surgeons about complications, training, and which procedures Intuitive’s robots may be most and least suited for. Dr. Myriam Curet, Intuitive’s chief medical adviser, says she’s confident the robots are “extremely safe,” noting that the “extraordinarily small” percentage of deaths and injuries hasn’t grown over time.
Martin Makary, a surgeon at Johns Hopkins Hospital, says all complaints may not be reported by hospitals, which often use the machines as a draw to gain patients. “No one knows the [complete] numbers,” says Makary, who’s studied how hospitals market the robots. “But we all have seen or heard of cases of inadvertent injuries.”