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Injuries Linked to Da Vinci Surgeries Underreported, Researchers Say

 |  By cclark@healthleadersmedia.com  
   September 04, 2013

Only 245 cases of patient harm in surgeries using the Da Vinci robot system have been reported to the FDA since 2000. The figure seems "very, very low" to researchers, who have identified eight cases of patient harm or death that were not in the FDA's database.

Injuries and death resulting from the minimally invasive Da Vinci surgical robot, which has been used on more than one million patients since 2000, have got to be far more numerous than the 245 cases reported to the U.S. Food and Drug Administration so far, Johns Hopkins University researchers contend.

The team, led by laparoscopic pancreas surgeon Marty Makary, MD, drew that conclusion because he and his research team were able to find eight cases of patient harm or death from robot complications in public court records or media reports.


See Also: FDA Probes Docs Over da Vinci Robot Problems


But no report was made to the FDA's Maude (Manufacturer and User Facility Device Experience) database for five of those cases and for the other three, the report was improperly filed or filed late, after the adverse event was reported by a major newspaper.

"If 60% of those very severe cases were not reported to the FDA, probably many more of less severe or more routine complications were also not reported," Makary says.

Besides, Makary adds, "to have only 245 complications of such a complex technology over a decade, that seems very, very low, especially since in our surgical community, we all know of complications and we discuss them when surgeons get together.

"We commonly hear things like, someone knows someone at their hospital who had a very bad complication from robotic surgery, and I personally know of accounts from other doctors who have told me about dozens of complications."

And that there would only be 245 such adverse events associated with the robot, plus the additional ones his researchers found, is unlikely the true number for another reason, Makary notes.

"We know one attorney in Louisiana who identified about 20 patients who were harmed with robotic surgery, and filed a malpractice claims, and if the 245 is accurate, then he must—just in his region—have 10% of all the complications that have occurred from the robot over the last decade. That's a data point that makes you think this number is just far too low."

Makary's paper, which is published in this week's issue of the Journal for Healthcare Quality, details the rates at which fatal and non-fatal events occur in various specialties and in numerous types of procedures, and the type of patient harm. Of the 245 harmful events reported, 71 patients died and 174 patients sustained other types of harm.

For example, 22 of the 71 patients who died underwent gynecologic robotic surgery, which also resulted in 89 of the 174 non-fatal adverse events. Of the patients who survived 34 had permanent injuries and 49 had damage to soft organ tissue. The next greatest incidence of harm from the robot was found in urological surgeries, with 30 of 36 patients suffering harm during prostatectomy.

The Johns Hopkins researcher and author of the recent book Unaccountable, says the paucity of these reports points to the critical need for a robotic surgical registry, similar to that which collects outcome reports for thoracic procedures.

Makary asks rhetorically, "Why are we having the debate about robotic surgery now, (more than a decade) after it was FDA-approved, when there have been over one million people who have had robotic surgery. The data could have been captured and analyzed in the first few years and we could have had the discussion about which procedures robotic surgery provides benefit for, and for which procedures there is no difference, and for which procedures are there added risks and costs that make it unwise."

"We would do a much better job informing our own community and patients about the risks and options if we had this information."

Made by Intuitive Surgical Inc. of Sunnyvale, CA, the Da Vinci system received FDA market approval in 2000 and by 2011, more than 1,400 units were operating on patients in U.S. hospitals, and another 200 to 400 in hospitals outside the U.S.

Now, however, a growing number of reports question its safety and effectiveness compared with traditional laparoscopy in gynecologic procedures.

Media representatives for Intuitive did not return a request for comment about the study Tuesday. At an investment conference, cited in a media report earlier this year, however,  Intuitive dismissed safety concerns, telling analysts that given the number of procedures it does, it believes its safety record is "exemplary."

Officials for the FDA have said they they are increasingly concerned about the safety of the Da Vinci system since a spike in the number of adverse events associated with the device reported last year.

The FDA earlier this year launched a survey to get physician's opinions about their use of the device, even as Intuitive faces several lawsuits and the FDA issued a recall in July of 30 robot devices.

For surgeons and patients, as well as hospitals, the issue presents an enormous problem because reporting of harmful events to the FDA is not mandatory.

"The main reason there aren't more reports, in my opinion, is that the FDA requirement to report adverse events has no teeth whatsoever in terms of enforcement," Makary says.

"It's like if you gave an exam to a classroom of students and said, 'grade your own exams, and we absolutely will not investigate anybody's authenticity of their scoring. And if you perform really well, there's a bonus, you'll be rewarded.'

"Essentially, that's the system we have now. Many times doctors will just leave it up to the industry, or to the manufacturer, to do the reporting."

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