While the U.S. Food and Drug Administration oversees a database that reports deaths and injuries associated with medical devices, the agency has no authority to force medical providers to contribute to the database. To that end, many hospitals fail to report adverse events associated with robotic surgery procedures, according to a recent Bloomberg investigation.
Patient problems detailed in legal papers and in interviews with patients are missing entirely from the database, according to Bloomberg.
"The adverse event reporting system is a disaster," David Challoner, vice president emeritus for health affairs at the University of Florida, told Bloomberg. "Every link in the chain has a reason not to report."
William Maisel, chief scientist at the FDA's Center Devices and Radiological Health, told Bloomberg that his agency is "well aware of under-reporting of adverse events" and is working to improve the system.
"Even if there is under-reporting, it doesn't mean you can't draw conclusions from the data," Maisel said.
In an email to Bloomberg, meanwhile, Angela Wonson, a spokeswoman for Intuitive, said that she thinks the national surgery database and clinical research provides a "clear picture" of the safety of the company. In many cases, "there was no complaint at the time of the surgery or in the weeks thereafter by the patient, surgeon or hospital," Wonson said, so the company doesn't know about injuries until legal claims are made.
The FDA received 3,697 adverse reports involving deaths, injuries, or malfunctions linked to robotic surgery procedures in 2013 through Nov. 3, compared with 1,595 in all of 2012, an FDA official told Bloomberg.
"Some of the increase may have come as the result of media attention, announcement of recalls of robotic instruments, or more device use," Maisel said.
Some claims are from patients who had surgery years prior and never previously reported any problem with the operation, Wonson told Bloomberg. "The patient calls an attorney, signs a retainer agreement and the attorney contacts Intuitive with a claim that their client was injured," she said. "We are then obligated to file" an adverse event report.
Complications from robotic surgery are widely underreported, according to a study published last fall in the Journal for Healthcare Quality by researchers from Johns Hopkins University School of Medicine. According to researchers, a "slapdash" system of reporting complications paints an unclear picture of the safety of robotic surgery.
In March, the American Congress of Obstetricians and Gynecologists said that robotic surgery for hysterectomies should not be a first or even second choice for women undergoing routine procedures, due, in part, to the learning curve associated with the robotic system. That same month, health officials in Massachusetts sent a letter outlining safety concerns about robotic surgery after two damaging incidents involving robots performing hysterectomies.
The FDA currently is surveying hospitals on complications, outcomes and dangers with Intuitive's da Vinci robot.
To learn more:
- read the article in Bloomberg
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