Medical technologies have advanced patient care in many ways. But some have done just the opposite and contributed to patient injuries and an uptick in morbidity rates.
At least for some hapless patients, one of those iffy advances may be the da Vinci Surgical System, a robotic-armed device used for almost 400,000 surgeries in the United States in a single year.
Four years ago, due to the deaths and negative patient outcomes from these robotic surgeries, the Food and Drug Administration (FDA) issued a "letter of warning" to Intuitive Surgical Inc., the Sunnyvale, Calif. company that manufactures this sole device.
The robotic system was the only one that had FDA approval to perform soft-tissue surgeries, although additional robotic systems have been approved for other medical purposes in specialties like orthopedics and neurosurgery.
At least five deaths have been linked to the da Vinci, along with additional complications and negative patient outcomes. But that is not its critics' only complaint, as the cost of the system and training has been considered prohibitive by many industry insiders.
The types of surgeries that have used the da Vinci include:
Head and Neck
Surgeons control the robotic arm(s) seated in front of computer screens, which doesn't tire them as much as remaining on their feet over the operating tables. Proponents tout the lack of blood loss and speedy recovery times for patients. That's when all goes well, though.
Some less fortunate patients include a New York patient who suffered a perforated colon during surgery on his prostate, a female who died when the robotic arm nicked her blood vessel during her hysterectomy and a man from Chicago who died following his spleen surgery.
Would negative outcomes have occurred during more conventional procedures? That is a difficult question to answer, as different procedures and surgical approaches all have pros and cons. The FDA is attempting to discern just that.
Almost a quarter of American hospitals use a type of the da Vinci surgical systems at a cost of nearly $1.5 million -- and that doesn't count the annual service agreements that run upwards of $100,000. Some hospitals' marketing efforts have also been called into question, with facilities accused of aggressively selling these surgical options to patients to cover the systems' costs.
If you experienced negative repercussions from a da Vinci surgery, you may have a legitimate class action claim for damages.
Source: New York Daily News, "Surgical robot da Vinci scrutinized by FDA after deaths, other surgical nightmares," The Associated Press, accessed Sep. 29, 2017