aGameOfThrones
12-30-2013, 01:26 PM
When Sheena Wilson, 45, underwent robotic surgery for a hysterectomy in May, she didn’t know the Intuitive Surgical Inc. (ISRG) system used by her doctor was previously tied to a variety of injuries for the same procedure.
Her rectum was badly burned in the operation, said Wilson, a mother of two from Parlin, New Jersey. Now she is on long-term disability, fearful of losing her job and facing a third corrective surgery, she said in a telephone interview.
“If I had known there were other people who had injuries, I would never have done this surgery,” said Wilson, who has filed suit against Intuitive and her doctor. “Whatever they have in place is not working.”
The use of complex medical devices is exploding. Last year, Intuitive’s da Vinci robotic surgery system alone helped doctors perform more than 350,000 surgeries in U.S. hospitals. Yet patients like Wilson, whose lives depend on the proper use of increasingly complex high-tech medical equipment, often can’t get a complete picture of potential problems.
While a U.S. database lists reports of deaths and injuries sent to the Food and Drug Administration, the agency has no authority to force doctors to contribute. And while hospitals are supposed to report, they often don’t, critics say.
Photographer: Nicolas Maeterlinck/AFP via Getty Images
In robotic surgery, a physician sits at a console several feet from the patient and... Read More
Indeed, a Bloomberg review of reports for operations with Intuitive’s robotic system found dozens of injuries that went unreported for years. Meanwhile, details of other patient problems involving use of the company’s product, cited in legal papers or in interviews with patients, were missing entirely.
‘A Disaster’
“The adverse event reporting system is a disaster,” said David Challoner, vice president emeritus for health affairs at the University of Florida, who co-authored an Institute of Medicine report urging an overhaul of the FDA’s system for regulating and monitoring devices. “Every link in the chain has a reason not to report.”
The FDA, meanwhile, says it is “well aware of under-reporting of adverse events” and is working to improve the system, said William Maisel, chief scientist at the agency’s unit that oversees devices. “Even if there is under-reporting, it doesn’t mean you can’t draw conclusions from the data,” Maisel said in an interview.
Angela Wonson, an Intuitive spokeswoman, said that information about the safety of the company’s products is available through multiple data sources, including national surgery databases and clinical research. All of these sources, taken together, provide “a clear picture,” she said in an e-mailed response to questions.
3,697 Reports
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 News on Nov. 8. While the number is larger, this doesn’t necessarily mean the rate of adverse events has changed, Maisel, of the FDA, said.
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. The number of robotic operations rose 18 percent worldwide in the first nine months of 2013 compared with the first nine months of 2012, according to a regulatory filing from Intuitive.
A number of claims are from patients who had surgery years ago and never previously reported any problem with the operation, said Wonson, the Intuitive spokeswoman. “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.
http://www.bloomberg.com/news/2013-12-30/unreported-robot-surgery-injuries-open-questions-for-fda.html?cmpid=yhoo
Her rectum was badly burned in the operation, said Wilson, a mother of two from Parlin, New Jersey. Now she is on long-term disability, fearful of losing her job and facing a third corrective surgery, she said in a telephone interview.
“If I had known there were other people who had injuries, I would never have done this surgery,” said Wilson, who has filed suit against Intuitive and her doctor. “Whatever they have in place is not working.”
The use of complex medical devices is exploding. Last year, Intuitive’s da Vinci robotic surgery system alone helped doctors perform more than 350,000 surgeries in U.S. hospitals. Yet patients like Wilson, whose lives depend on the proper use of increasingly complex high-tech medical equipment, often can’t get a complete picture of potential problems.
While a U.S. database lists reports of deaths and injuries sent to the Food and Drug Administration, the agency has no authority to force doctors to contribute. And while hospitals are supposed to report, they often don’t, critics say.
Photographer: Nicolas Maeterlinck/AFP via Getty Images
In robotic surgery, a physician sits at a console several feet from the patient and... Read More
Indeed, a Bloomberg review of reports for operations with Intuitive’s robotic system found dozens of injuries that went unreported for years. Meanwhile, details of other patient problems involving use of the company’s product, cited in legal papers or in interviews with patients, were missing entirely.
‘A Disaster’
“The adverse event reporting system is a disaster,” said David Challoner, vice president emeritus for health affairs at the University of Florida, who co-authored an Institute of Medicine report urging an overhaul of the FDA’s system for regulating and monitoring devices. “Every link in the chain has a reason not to report.”
The FDA, meanwhile, says it is “well aware of under-reporting of adverse events” and is working to improve the system, said William Maisel, chief scientist at the agency’s unit that oversees devices. “Even if there is under-reporting, it doesn’t mean you can’t draw conclusions from the data,” Maisel said in an interview.
Angela Wonson, an Intuitive spokeswoman, said that information about the safety of the company’s products is available through multiple data sources, including national surgery databases and clinical research. All of these sources, taken together, provide “a clear picture,” she said in an e-mailed response to questions.
3,697 Reports
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 News on Nov. 8. While the number is larger, this doesn’t necessarily mean the rate of adverse events has changed, Maisel, of the FDA, said.
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. The number of robotic operations rose 18 percent worldwide in the first nine months of 2013 compared with the first nine months of 2012, according to a regulatory filing from Intuitive.
A number of claims are from patients who had surgery years ago and never previously reported any problem with the operation, said Wonson, the Intuitive spokeswoman. “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.
http://www.bloomberg.com/news/2013-12-30/unreported-robot-surgery-injuries-open-questions-for-fda.html?cmpid=yhoo