March 5 (Bloomberg) -- After Michelle Zarick complained of excessive vaginal bleeding, her doctor found growths in her uterus that needed to be removed. One option: robot surgery, described by her gynecologist as “the latest, greatest” technique available.
With nimble robotic instruments doing the delicate work usually performed by doctors hands-on, there would be less pain and bleeding, she was told.
“In my mind, there was no alternative but to use this fabulous technology,” she recalls thinking.
Five weeks later, she wished she hadn’t. That’s when Zarick felt something pop while she was in the bathroom, looked down and saw her intestine protruding from her vagina. Now, four years later, the 41-year-old Zarick has a hip-to-hip scar from corrective surgery, constipation from damaged rectal muscles and a diminished sex life, she said in an interview.
“It didn’t help me one bit, the robot,” said Zarick, who lives in Lincoln, California and filed suit in December against Intuitive in regard to her hysterectomy. “It forever changed my life for the worse.”
Robot systems made by Intuitive Surgical Inc. are linked to at least 70 deaths in informal incident reports sent to U.S. regulators since 2009, according to a review by Bloomberg News. Now, lawsuits like Zarick’s, one of at least 10 filed in the last 14 months, are adding new details about dangerous complications involving the da Vinci robots made by Intuitive.
Intuitive, based in Sunnyvale, California, dominates the robot-surgery field. It’s the only company whose system is cleared in the U.S. for soft tissue procedures that include general surgery, prostate operations and gynecological surgery, said Angela Wonson, a company spokeswoman.
Intuitive fell 2.9 percent to $525.72 at the close in New York. The shares have gained 2.4 percent in the past 12 months.
The robots, priced at $1.5 million each, have helped make Intuitive one of the hottest stocks in health care, growing 61 percent since the end of February 2010 to a market value of $21.7 billion. The number of U.S. procedures done with the robots has grown to about 367,000 in 2012, compared with 292,000 in 2011 and 228,000 in 2010, according to a company filing.
While more than half of last year’s total involved gynecological treatments, the robots also are used for prostate and gall bladder removals, as well as heart surgery. The benefits include a better camera system, robot arms that can precisely mimic natural hand movements inside the body, and improved surgeon ergonomics to reduce fatigue, according to a regulatory filing by the company.
Still, tough new questions about safety raised in lawsuits and in adverse incident reports to U.S. regulators may threaten the company’s growth. They come as the technology is already facing criticism for raising surgical costs at a time when few large, randomized trials document significant health benefits for the robots, compared with standard less-invasive operations.
In robot surgery, a physician sits at a video-game style console several feet from the patient and peers into a high-definition display. Foot pedals and hand controls maneuver mechanical arms equipped with tools, guided by a 3-D camera that shows the work as it is done inside a patient. This differs from other minimally-invasive operations in which doctors stand over the patient and manually manipulate instruments and a tiny camera through multiple small incisions.
“Part of what’s driven this market is people seeking out robotic surgery; hospitals market it and the patients seem to think it’s better,” said Michael Matson, an analyst with Mizuho Securities USA in New York, in a telephone interview. The threat to the company is “that the patients would get scared.”
Martin Makary, a surgeon at the Johns Hopkins Hospital in Baltimore, said he’s concerned that some complaints may not reach the public because they’re kept quiet by hospitals, which often use the machines as a draw to gain additional costumers.
“No one knows the numbers now,” said Makary, who has studied how hospitals market the robots, in a telephone interview. “But we have all seen or heard of cases of inadvertent injuries.”
Intuitive remains confident the robots are “extremely safe,” according to Myriam Curet, the company’s chief medical adviser. An “extraordinarily small” percentage of deaths and injuries “hasn’t grown” over time, Curet said in a telephone interview.
The safety issue, though, isn’t likely to go away soon, according to Paul Rheingold, a New York-based lawyer who represents the father of a woman who died 13 days after undergoing surgery with an Intuitive robot. Rheingold is in the process of investigating other potential cases, he said in a telephone interview.
A review of adverse incident reports sent to the Food and Drug Administration since 2009 shows an increase. As the popularity of robot surgery has grown, injury reports involving the procedures jumped to at least 115 in 2012 from 24 in 2009, while deaths rose to 30 from 11.
The increases have already spurred the FDA to survey surgeons in January about potential complications, training and the procedures they may be most and least suited for, Bloomberg News reported on Feb. 28.
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 occur. They’re largely unverified by the agency, and can be incomplete or misleading, the FDA has said. Yet they have served in the past as a valuable early-warning system in the past on problems involving medical devices.
The type of complication that Zarick experienced, which can occur when the vaginal wound fails to properly heal after a hysterectomy, is among a variety of injuries cited in the lawsuits, two of which outline deaths allegedly connected to robosurgeries.
In one of the 10 cases against Intuitive Surgical, for instance, the liver and spleen of a Michigan man were allegedly punctured during a heart valve repair, leading to 15 hours of internal bleeding. In another, an Alabama man suffered damage to his rectum and bowel after prostate surgery.
Angela Wonson, an Intuitive spokeswoman, said it was company policy not to comment on individual litigation. Some large population studies have found that robotic prostate surgery has “lower complication and mortality rates than open surgery,” she said in an e-mail.
Vaginal wound complications have been researched in a limited number of studies, none of which are definitive.
In 2009, the Mayo Clinic in Phoenix, Arizona found the complication in 21 of 510 robot hysterectomies done between 2004 and 2008, according to a study. The lead author of that report, Rosanne Kho, a gynecologic surgeon at the clinic, said in a telephone interview that while changes in surgeon techniques have lessened instances of the complication since, she has always used non-robotic methods for most hysterectomy cases.
In 2011, an analysis published in the American Journal of Obstetrics & Gynecology found the complication occurs in almost two percent of robot hysterectomies, or more than twice the rate seen in conventional, less invasive surgery.
Intuitive’s Curet disputes the 2011 finding. The study examined “a much smaller subset of patients and surgeons for robotic surgery, so the data is less robust and may account for the lower rates in laparoscopy,” she said. Minimally invasive surgery in general has higher rates of the vaginal-wound complications, not just with the robots, Curet said.
While the complication has been debated, Zarick said in an interview that no one advised her that her intestines could fall out before she began the robot procedure.
Zarick’s surgery was performed at the Mercy San Juan Medical Center in Carmichael, California. The center’s website says the da Vinci system brings “extraordinary” patient benefits, including “precision, control and dexterity traditional surgeries simply can’t match.”
Scars are “drastically reduced,” the web site says. “And pain and the potential for complications are minimized.”
“Our highest priority is providing the best care for our patients,” said Melissa Jue, a spokeswoman for the hospital, in an e-mailed statement responding to questions. “We respect the privacy of our patients and legally cannot discuss the specifics of their care.”
Zarick said she didn’t realize the robot might be at fault until she visited a new gynecologist last fall. He called her problem a “textbook” example of a side effect increasingly being seen with robot surgery, Zarick said in an interview.
“People are being wheeled into operating rooms every day without the full knowledge that they are putting their lives at risk in the hands of a robot,” she said in an interview in the Los Angeles offices of her attorney, Mark J. Geragos.
Intuitive Surgical “denies each and every allegation” in Zarick’s lawsuit, the company said in a February court filing.
Zarick’s injuries were caused by “events that were extraordinary under the circumstances, not foreseeable in the normal course of events, or independent of or far removed from Intuitive Surgical’s conduct or control,” the filing said.
Gilmore McCalla of the Bronx in New York, whose daughter Kimberley died at age 24 after robot surgery, said he didn’t even know the machine was being used in Kimberley’s case.
His daughter underwent the procedure at Montefiore Medical Center on Aug. 12, 2010 after being diagnosed with early-stage cervical cancer, the hotel maintenance worker said in a telephone interview. It was supposed to be a straightforward operation to remove her uterus and other reproductive organs that would get her out of the hospital a day later. She never left the hospital, he said.
Eleven days after the operation, she was rushed back into surgery, where doctors found a laceration of the iliac artery near the original operation, according to hospital documents provided by Rheingold, McCalla’s attorney.
The doctors sewed the artery up, but it was too late. After two more emergency operations, Kimberley died on August 25 after suffering small bowel damage “incompatible with life,” according to an operative report.
An autopsy found the death was a “therapeutic complication,” resulting in hemorrhage and multi-organ failure.
In a product-liability lawsuit against Intuitive Surgical filed in Federal District Court in New York, McCalla contends the robot deserves blame. The suit contends the robot tools didn’t have adequate insulation, which can result in electrical burns to surrounding tissue.
McCalla has also filed a separate malpractice lawsuit in New York state court contending that Montefiore and Kimberley’s doctors failed to quickly recognize the problem.
Intuitive, in court papers, rejects the charges. “Intuitive denies that the da Vinci Surgical System proximately caused Plaintiff’s Decedent’s alleged injuries, including her death,” the company said in a court filing. “The medical device in question is useful and desirable, and any risk claimed by the Plaintiff with its use and the alleged injury, to the extent it exists, is unavoidable.”
Montefiore “is unable to comment on any pending litigation,” said Mariann Caprino, a spokeswoman for the hospital. The center, which has done thousands of procedures since 2005 with robotic equipment, performs less invasive operations widely as they are “safe, effective, and result in a faster and more comfortable recovery.”
A 2011 study in the American Journal of Obstetrics & Gynecology, done in a laboratory, found that certain types of insulation failed on the robot at as much as four times the rate of conventional minimally-invasive surgery equipment.
Intuitive, though, says the finding doesn’t represent real-world practices. The voltages used “are well outside of anything that would be used clinically,” said David Rosa, an Intuitive senior vice president, in a telephone interview.
Last August, researchers from Memorial-Sloan Kettering Cancer Center reported three cases of blood vessel burns caused by insulation failures with the robot, all of which were caught and fixed before they caused major complications.
Rare cases of burns from electrosurgical equipment are “nothing new that is specific to the robot,” said Sloan-Kettering’s Leitao, who was involved with the research. A key part of the insulation has been improved, he said.
“Everything we use in life doesn’t work 100 percent of the time,” Leitao said.
Many patients have been happy with their robot surgeries. Colleen Marasco, an ultrasound technician in Manalapan, New Jersey, sought out the robot in 2009 to treat uterine fibroids after reading about it on the Internet. She wanted to avoid the long recovery time and big scar she experienced with a previous earlier fibroid surgery.
She had a fertility-sparing robot operation at Hackensack University Medical Center in December 2009 and was home the next day. The pain was far less than the first surgery, and she gave birth to her first child less than two years later.
“It lived up to what they had promised,” said Marasco, who gave birth to her first child less than two year later. “It was a much easier recovery.”
Intuitive officials say the company isn’t competing with doctors already comfortable with minimally invasive surgery. Instead, the robot helps to expand minimally invasive operations to new areas that are especially complex, said Sherry Wren, a Stanford University surgery professor who performed an early trial of the robot in gall bladder surgery.
Robot arms offer greater flexibility, Wren said.
“It really does shorten your learning curve,” she said.
Zarick, meanwhile, said she believes she would have been better off without any robot surgery at all.
“If given the opportunity, I would take back all of the symptoms of the multiple fibroid tumors,” she said. “If I could just have my life back it would be worth it.”
The case is Zarick v. Intuitive Surgical, Inc., 12-cv-237723, Superior Court, Santa Clara County, California.
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