Injuries Linked to Da Vinci Surgeries Underreported, Researchers Say
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."
Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.
- HCA to Acquire CareNow Urgent Care Centers
- Dental Board Case Before SCOTUS Has Far-Reaching Implications
- BCBS Tries New Drug Contracting Model
- Abington Health, Jefferson Health Plan '100% Equal' Merger
- 76% of Physicians Don't Like CMS Quality Reporting Programs
- The Case for Recycling Surgical Supplies
- Federal Appeals Court Mulls Observation Status
- Ballot Initiative Pits Providers Against Payers in SD
- How the Military's EHR Reboot Will Impact Interoperability
- Aetna Cuts 4 New Accountable Care Deals