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New Concerns Arise Over Robotic Surgery

3 comments

New Concerns About Robotic Surgery

When I underwent robotic surgery several years ago for prostate cancer, I was pleased.  But new reports suggest that the robotic machines used during the surgery are causing issues–serious issues–for some patients.  Take, for example, Erin Izumi who underwent robotic surgery for endometriosis at St. Joseph Medical Center in March 2009.  Her surgery dragged on for 11 hours and resulted in a trip to the ER just 10 days after the surgery where doctors discovered that her rectum and colon had been torn during the operation.  Her injuries resulted in a 5 week hospital stay, a series of surgeries to repair the damage, and a temporary colostomy.

Medical Device Manufacturers Fail to Report Adverse Incident

Medical device manufacturers and hospitals are required to report every device-related incident that occurs within 30 days to a database maintained by the Food and Drug Administration.  Ms. Izumi’s case was apparently never reported to this database and the hospital declined to comment.  The manufacturer stated that it had only found out about the incident following Ms. Izumi’s lawsuit, which settled in 2012.  Unfortunately, a new study recently found that this wasn’t the only incident involving robotic surgeries gone wrong that have not been reported.

New Report Reveals Thousands of Incidents Related to Da Vinci Robotic Surgery Equipment

The new study published in The Journal for Healthcare Quality found that robotic equipment manufactured by da Vinci Surgery has been associated with thousands of mishaps between January 2000 and August 2012.  In the vast majority of cases, the patient was not seriously harmed, but among the reports to the FDA were 174 injuries and 71 deaths.  Furthermore, researchers at Johns Hopkins who conducted the study, were able to glean examples of botched operations not reported to the FDA, and conclude that robotic surgery complications were “vastly underreported”.

Da Vinci Equipment Linked to Aggressive Marketing Tactics, Inadequately Trained Doctors

The new study comes on the heels of reports that are critical of robotic surgery because of alleged aggressive tactics to market the equipment.  The spread of da Vinci robotic surgery equipment has grown substantially since 2007, by 400%.  Surgeons may feel pressure to adopt the equipment without adequate training or in the face of concerns that another procedure would be a better option.  In fact, a 2010 study found that nearly 57% of anonymously surveyed surgeons had experienced irrecoverable operative malfunctions while using robotic equipment.  Additionally, women appear to be at greatest risk of robotic surgery-related complications according to the new study; 43% of injuries were during hysterectomies and nearly one-third of deaths were related to gynecological procedures.

3 Comments

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  1. sweymour kessler says:
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    I fitmally beleive that the only thing wrong with the robatic system for prostate surgery is the greedy lawyers . i had my surgical procedure preformed 5 years ago . the results were not what i had wanted but it was not the fault of the device . not all surgeries turn out well . there is no guarantee on the results . i find it discussing that lawyers that are looking for a big fee will do every tihing to scam and that is what it is it is a scam and the ones s that should be sued should be the theiving lawyers

  2. ProductLiability says:
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    Sweymour and others,
    there is a critical thing everyone should be
    aware of but perhaps missing in all this:

    The current spate of lawsuits are all for product defect/liability. The robotic arms from till mid-2013 at least, have shown degraded or defective insulation that can pass monopolar current arcs on to surrounding vital organ tissue, damaging, burning or tearing them. It does not have to happen in every case, it is random, but when it happens, consequences have been severe, near fatal, fatal, long ICU stays, additional surgeries, disability and heavy $$$ losses to the patients and their insurance companies.

    The current lawsuits are also, additionally discovering “provable” evidence of –

    1) agressive/false marketing to both docs/hospitals as well as directly to patients (put marketing pressure both ways) to have docs suggest – and patients opt – for robotic surgery at consultation
    2) pressure on surgeons by the robot maker’s sales teams to move cases that were originally planned to be non-robotic to be converted to robotic (they make a lot more money in disposables — think Barbie)
    3) lack of sufficient training/certification (weekend classes anyone?)
    4) reports of haphazard reporting of incidents to FDA

  3. ProductLiability says:
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    usually, when serious complication happens after a robotic surgery of routine cases on healthy patients (like a hysterectomy or prostate removal, the 2 main easy operations that Intuitive sales team have pushed for “easy cash cow” revenue), the first legal actions have always been about Medical negligence and/or hospital/doctor liability, not product failure. And, traditionally the law more or less has sided with the doctors or hospitals in most states for medical negligence. Intuitive Surgical had that shield so far.

    This is also the reason why now there is this silent tsunami that is surfacing with force

    Note, these current spate of lawsuits are not going after surgeons, but after the product and the robot maker. Even in the hands of a very good highly experienced surgeon, the patient could have received nicked bowels or other damage unbeknownst to the surgeon, due to random monopolar arc-ing. Lawyers have now found that Intuitive Surgical has known for quite a while by its own research that some technologies it uses like monopolar current have undesirable consequences – but did not do anything about it as the law requires. Finally, Intuitive Surgical acknoweldged defects, including in their insulation etc, through an advisory and a recall/replacement in 2013. They are trying to pass it off as an upgrade or improvement

    People should be aware of these things, not just statistics of an operations success or failure. Additional millions of dollars have been borne by insurance companies and patients due this. Medical negligence, risk of any surgery etc is one thing, a known product defect is entirely something else. This is what the lawsuits are trying to prove.

    It remains to be seen how IS will handle this increasing wave of bad publicity that is not going away, with its stock price’s heavy slide. Every country where they sell these, are watching.

    The guess here is that Intuitive Surgical will do the typical corporate dance initially, refuting accusations and claiming innocence, make the lawyers sweat a bit and drag this up and down to an optimal point, then when costs overcome benefit in this approach, quietly settle most cases out of court, continue to fix their product, fix training and marketing flaws, and act as if nothing happened, and move on.

    Meanwhile ICUs, hopefully not, but unfortunately will, continue to see some patients who no one expected to be there.