Patients who claim they are victims of botched robotic surgery are suing. Doctors say the state-of-the-art surgery isn't for everyone, or every procedure.
Wrongful death suits and the horrifying case of a woman whose intestines fell out of her vagina following a robotic hysterectomy are bringing more scrutiny to technology touted as the latest and greatest in medical advancements.
When California resident Michelle Zarick opted for robotic surgery for a hysterectomy, she was promised less pain, bleeding and discomfort.
Instead, five weeks post-op, Zarick "felt something pop" while she was in the bathroom and then saw a portion of her small bowel spill out in what she thought were "the last moments of her life," she told Bloomberg News. Zarick, who says she was left with physical and emotional scars after emergency surgery, sued Intuitive Surgical Inc. — the company that makes the da Vinci robotic surgical system — in December.
Intuitive spokeswoman Lauren Burch told MSN News that the company couldn't comment on ongoing litigation but stands behind the safety of the da Vinci, the only robotic system available in the U.S.
"It has an excellent safety record with more than 1.5 million surgeries performed globally, and total adverse event rates have remained low and in line with historical trends," Burch said, adding that Intuitive will continue to innovate to make surgery safer.
'IMPORTANT TO SEPARATE MARKETING HYPE FROM REALITY'
Zarick is not alone. New York attorney Paul Rheingold's firm is handling the cases of other patients who say they underwent botched robotic surgical procedures.
Rheingold said the two most common cases represented by his firm were botched hysterectomies and prostrate surgeries, with the most common injury being burns caused by electricity from the robotic device.
"We have a few cases where, after women have hysterectomies, they take out the cervix and the uterus" and suture the vaginal cuff, he said. But "because of the burn, the cuff doesn't hold," Rheingold said.
He said other patients were left with perforated intestines or colons.
Johns Hopkins Hospital surgeon Martin Makary, who has used da Vinci in the past, said although robotic surgery is extremely popular, its outlandish marketing claims and lax regulations regarding reporting complications to the Food and Drug Administration were symbolic of what's wrong with much of health care today. A vast majority of the complications go underreported, he noted.
"It's an expensive technology with very little good evaluation and data readily available to patients," Makary said, adding that robotic surgery offers a benefit for a small number of surgeries and none for others.
The American College of Obstetricians and Gynecologists recently cautioned women about the surgery, saying, "Robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient.
"It is important to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies," the organization said.
'VAST MAJORITY OF WOMEN DO WELL'
Despite the concerns, there are doctors who say the vast majority of women who undergo robotic surgery do well.
"We compared robotic and laparoscopic surgery in hysterectomy in women without cancer and found that both were very safe and had low complication rates," said Jason Wright, assistant clinical professor with Columbia University's Department of Obstetrics and Gynecology.
According to Makary, the FDA's recent investigation into what's causing complications has increased awareness about robotic surgery's pros and cons.
Rheingold said there were currently at least 25 lawsuits nationwide against Intuitive.
"All of a sudden, doctors who thought robots were safer and caused less bleeding, less infection and needed less recuperation time started pointing out that this isn't true. They realized that robots had worse outcomes, were more expensive and caused more injury," he said.
Rheingold has filed suit against Intuitive for product design and negligence on behalf of Gilmore McCalla, who claims that when his 24-year-old daughter underwent hysterectomy for cancer in Bronx hospital in 2010, the robot burned her artery and intestines, resulting in her death two weeks later.
"We have alerted Intuitive about hundreds, maybe thousands of cases where patients are demanding settlements from robotic injuries," he said. "If they don't want to do it, we will be putting these cases to suit."
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