(c) 2013, Bloomberg News.
(c) 2013, Bloomberg News.
NEW YORK — When Sheena Wilson, 45, underwent robotic surgery for a hysterectomy in May, she didn't know the Intuitive Surgical Inc. 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, N.J. 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.
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.
"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.
While Wonson acknowledged there was a time gap for many injury reports, she said that's because the company often isn't aware of what happened until legal claims are made. In most cases, "there was no complaint at the time of the surgery or in the weeks thereafter by the patient, surgeon or hospital," Wonson wrote.
Additionally, the adverse event reports don't necessarily mean that robotic devices caused an injury, only that the machines were involved in procedures in which injuries allegedly occurred.
Anupama Raaman, of Phoenix, and Michael Grasso, of Manahawkin, N.J., underwent robotic system surgery in 2010. The injuries they allegedly suffered during those operations, however, don't show up on the FDA database. Raaman has retained a lawyer to explore legal action against Intuitive, while Grasso's injuries are outlined in a legal complaint filed against the company this year.
Raaman spent four months in the hospital in 2010 after a hole in her intestine was found two days after a hysterectomy done with an Intuitive robot, she said in an interview. That same year, Grasso suffered nerve damage to multiple limbs after doctors attempted to use a robot to remove his prostate, according to papers filed in his lawsuit.
"I find it very strange that this has not been reported," Raaman said in a telephone interview.
Asked about Raaman's case, Erica Jefferson, an FDA spokeswoman, said in an email that the agency doesn't confirm patient-level reports. The reports on the database website were last updated on Nov. 30.
Medical device companies have been required to report incidents involving their products since 1984. The database, available online, includes hundreds of thousands of anonymous records that are sometimes vague, incomplete and unverified by the agency. While anyone can submit a report voluntarily, at least 90 percent come from companies, according to an October 2009 report from the Department of Health and Human Services' Office of Inspector General.
While hospitals are supposed to list injuries and deaths, the inspector general's report found the number of incidents reported to the agency by hospitals is low. In 2003, 823 hospitals made at least one report. The number fell to 519 in 2007, a 37 percent decline.
The low rate "raises concerns about potential under- reporting of adverse events," the inspector general wrote.
One estimate cited in an FDA report in 2006 suggests that about 15 percent of 1.1 million patient incidents related to medical devices were reported in 2003. That estimate, based on hospital discharge records, came from an unpublished study that Jefferson, the agency's spokeswoman, declined to verify.
In 2011, the Institute of Medicine report by a panel headed by Challoner concluded that reporting flaws "make it impossible to confidently draw broad conclusions about the safety and effectiveness of products that are on the market."
New surgical technologies are often deployed across the country far faster than scientists can study them to understand how best to use them safely, said John Birkmeyer, a surgeon and surgical outcomes expert at the University of Michigan in Ann Arbor.
"Robotic surgery didn't invent the genre but it certainly is the poster child for what the concerns are," Birkmeyer said in a telephone interview.
In robotic surgery, a physician sits at a 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.
The Intuitive system was cleared by the FDA in 2000, after a trial, done in a Mexico City hospital, of 233 patients in two kinds of surgery, gall bladder removal and heartburn operations. Last year, it was used in the United States for everything from hysterectomies to heart-valve procedures to operations for head- and-neck and prostate cancer.
Still, few robotic operations have been studied in large randomized trials to identify the advantages and disadvantages, compared with standard less-invasive operations.
While Intuitive's robot is an important advance, training requirements for doctors on the machine haven't always been adequate, said Enrico Benedetti, head of the surgery department at the University of Illinois at Chicago, speaking generally. Doctors at some hospitals began using the robots on their own after just a short course, followed by a handful of operations supervised by experts, said Benedetti, who has conducted 400 operations on the machine and calls it very reliable.
After that, they "can undertake any procedure" they want with it, Benedetti said in a telephone interview. "Most of these issues really come back to training."
At the same time, community hospitals that bought the robots were advertising fewer complications, often without proof that the hospitals could reproduce the same good results as top robotic surgeons.
Now reports of patient incidents involving Intuitive's devices are rising.
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.
In the case of Raaman's 2010 operation, a search of the agency's database found no report that matches the details of her injury through October 2013. The listings involving robot system problems during prostate surgery the day of Grasso's operation say that no patient harm was noted.
Raaman's injury kept her in the hospital for months, she said in a telephone interview. Hospital records from her stay list complications that include septic shock, acute kidney failure, respiratory failure, various heart issues, and vocal cord paralysis.
Raaman says she doesn't remember the weeks after surgery because she was on life support. She has recovered kidney function but remains on heart drugs with restrictions on exercise and other activities, she said.
Intuitive was first notified of Raaman's injury on Oct. 17 as part of what the company describes as a "legal claim," and is now reviewing the incident, Wonson said. In Grasso's case, the company wasn't aware of his alleged injuries when it filed an initial report in 2010 with the FDA that cited robot system error codes, but no injuries.
The company only found out about the injuries in March from his lawsuit, Wonson said.
"Medical review of this matter is not complete, and no deadlines for reporting were missed," Wonson said. The company cannot comment on pending litigation, she said.
"Some claims may fall into a group for which the FDA grants additional investigation time," Wonson said. After vetting, injury claims "will be filed" as appropriate.
Too often, detecting adverse events associated with medical devices follows an unfortunate pattern, said Rita Redberg, a cardiologist at the University of California at San Francisco, speaking generally about medical devices.
"The only way we are finding out about lot of these problems is through the lawyers," said Redberg, who is also the editor of JAMA Internal Medicine, a journal of the American Medical Association. "We use far more medical devices than anyone else in the world and yet we can't say what happened to these people. It is a really big problem and it is getting bigger every day."
The FDA began examining adverse events associated with Intuitive's robot in 2011 after identifying issues in some of the reports. The agency issued a warning letter in July 2013 after an inspection found the company hadn't adequately reported adverse events and device corrections in some cases.
This year, the FDA also surveyed 11 doctors who have performed from 70 to 600 robot surgeries each using Intuitive's robotic instrument, the only such product cleared in the U.S. for a wide variety of soft tissue procedures such as gynecologic and prostate operations.
While the unidentified surgeons said the device led to fewer complications and shorter recoveries, they also reported incidents in which robot arms collided or missed a mark and said learning to how to use the system was the biggest challenge, according to results posted on the agency's website on Nov. 8.
While Intuitive and various hospitals have offered training on the robot technology, hospitals determine minimum requirements for certifying surgeons to operate the device. The standards "should remain under control of the academic societies and hospital credentialing committees," Wonson said.
Intuitive's shares dropped 23 percent this year through Dec. 27, the first annual decline since 2008.
Questions about the FDA's ability to more closely track the adverse incidents, or improve how the monitoring system works, have been raised previously on other fronts.
It wasn't data from U.S. regulators, for instance, that first demonstrated high failure rates with metal-on-metal hip implants, but that of officials in Australia and Britain, which track hip implants in the countries using registries, researchers say.
Australia's registry noticed high failure rates in one metal hip model as early as 2007, according to the website of Australia's Therapeutic Goods Administration. Johnson & Johnson cited failure rate data from the British registry as it recalled two of its metal-on-metal devices in August 2010. In 2012, the British data showed metal-on-metal hips from various manufacturers failed at high rates, according to results published in The Lancet.
The FDA made an "initial communication" about potential long-term risks of removable filters to prevent lung blood clots in August 2010, after it received more than 920 reports of serious problems from the filters over five years.
The agency's warning was issued the same day as JAMA Internal Medicine released a study showing some models of the devices could fracture in as much as 16 percent of patients, sometimes leaving shards impaled in internal organs.
When Redberg later asked an official why the FDA hadn't warned doctors about the filter problem earlier, she was told the agency didn't know how many events were tied to the filters until word of the upcoming study spurred them to look more closely at their database.
The study was "an important finding" that prompted the agency to take a broader look beyond the two models examined, Maisel said. As for hips, the FDA "was aware of issues related to metal-on-metal hips for some time" and interacted with J&J on its recall, he said.
"Focusing on two or three products without looking at the entire landscape provides a myopic view of the post-market surveillance system," Maisel said.
Analyzing device incidents is complicated because human factors, such as doctors using devices for inappropriate patients, can cause harm even when a device itself is sound. "Just because you have adverse events piling up doesn't necessarily mean there is a device problem and it shouldn't be used," Maisel said.
Diana Zuckerman, president of the National Research Center for Women & Families in Washington, said the issue isn't how things are found. It's that the FDA database offers only "a very late warning system, sometimes a nonexistent warning system," she said.
"There is generally at least a 10-year wait once a device is on the market to have any kind of sense whether it is safe or effective, and by then the device may have changed five times," Zuckerman said in a telephone interview.
Safety monitoring is even more important for devices than prescription drugs, because devices usually face far less rigorous human testing before they are cleared for widespread marketing, Zuckerman said.
Most devices are cleared under a law that allows them to reach the market without human trials, if they are substantially equivalent to certain devices that are already on the market. Clinical data is submitted for only 8 percent to 10 percent of devices cleared under this procedure, said the FDA's Maisel. Only 1 percent go through a more stringent review process, he said.
The result is that doctors often "are entirely dependent on post-market studies" to reveal concerns, Zuckerman said. The system is particularly challenging for surgical technology that can make it hard to distinguish between device flaws and human error, she said.
One solution may be to create standardized registries that would track outcomes for all patients receiving complex medical devices and surgical procedures, said Martin Makary, a surgeon at Johns Hopkins Hospital in Baltimore, who in August published a study on under-reporting of robotic surgery complications.
Other countries that use registries sometimes do a better job of spotting concerns with widely used devices, said Zuckerman, citing the hip implant registries in Australia and Britain that showed the issues with metal-on-metal hips.
"If it wasn't for those registries we would probably still have most of the metal-on-metal hips being implanted in people," Zuckerman said.
While some registries exist in the U.S., they are "under- developed, under-funded, and lack sound scientific methodology to make conclusions about what is best for patients," Makary said.
The FDA, meanwhile, is working on a four-step plan announced in September 2012 to improve its monitoring of marketed devices, including enhanced use of registries for select devices and automated reporting of safety events. Also, rather than duplicating what exists elsewhere, the agency is sponsoring an international network of orthopedic registries to combine data, Maisel said.
In September, it finalized rules requiring medical devices to have unique identification codes, a step toward more accurate tracking of adverse events. The agency is modernizing its current database with a new version with expanded capacity that is capable of "extracting relevant information in automated fashion," Maisel said.
The ultimate goal would be to create a database that automatically downloads adverse event information from hospital electronic records into a giant database that scans for safety signals, providing a warning system that doesn't rely on voluntary reports, said Challoner of the University of Florida.
Such a vision, though, is years away and still won't address the training and marketing issues that have been spotlighted by the Intuitive system. The FDA doesn't regulate doctor training on devices or most hospital device marketing.
"The system is just not being improved fast enough," Zuckerman said.
For Wilson, the New Jersey mother of two injured during her hysterectomy, there is a bottom line.
"When there is an incident at a hospital, it should be reported right away, not a year later, not two years later," she said.