Problems with robotic surgery systems emerge constantly, nearly every day it seems, with Intuitive Surgical’s da Vinci robots leading the pack. Several news outlets recently exposed that the actual rates of injury from these robots are far higher than reported. Da Vinci robot attorneys at Pintas & Mullins Law Firm encourage all patients injured by the robotic systems to come forward.
Intuitive’s robots are used for an array of procedures, from hysterectomies to gallbladder removals, despite lax testing in randomized trials. In fact, the only testing the FDA required to approve the system was conducted in Mexico City, on just over 230 gallbladder and heartburn patients. Patients remain overwhelmingly unaware of this and consent to procedures of varying invasiveness, such as hysterectomies and prostate removals, often with dire consequences.
A large part of Intuitive’s problems stem from its insufficient surgical training program. Surgeons are required only to take a short course on the technology, followed by a few supervised operations, before being allowed to use the robots on their own. They can then perform any procedure they wish; and physicians themselves report that learning how to use the system is their most significant challenge.
Knowing this, it is unsurprising that so many injuries, deaths and malfunctions occur during da Vinci robotic surgeries. It is surprising, however, that so few are actually reported. In 2012, there were nearly 1,600 adverse events reported to the FDA. One year later, the likely result of increased media attention, the number jumped to 3,700, and that’s just through November.
A recent article by Bloomberg highlighted three patients’ stories who suffered botched surgeries from da Vinci robots and whose injuries went unreported. One of the patients, Sheena Wilson, who had her rectum severely burned during a routine hysterectomy, is now on long-term disability and facing her third corrective procedure. Wilson told Bloomberg that, had she known about the actual number of injuries from da Vinci, she never would have consented.
The second patient, Anupama Raaman, spent four months in a hospital, a
week of which on life support, after her surgeon accidentally burned a
hole in her intestine during a da Vinci hysterectomy. Her injuries have
not yet been reported to the FDA, though according to her hospital records
she suffered from septic shock, respiratory failure, vocal cord paralysis,
kidney failure, and various heart problems.
Michael Grasso underwent robotic surgery to have his prostate removed in 2010. During the procedure Grasso suffered extensive nerve damage to multiple limbs, and consequently filed a legal complaint against Intuitive. His injuries have not been reported to the FDA.
Intuitive only knows of these three cases because of their legal filings.
This is an enormous problem, particularly because the United States, by
far, uses the most medical devices of any country in the world. Regrettably,
medical devices are subject to much more lenient human testing than prescription
drugs before being approved, and Bloomberg confirms that most are cleared
for marketing before being tested in humans whatsoever – with only
1% subjected to a rigorous review processes. It is becoming increasingly
clear that this is the root of a widespread problem affecting millions
of patients every year.
For its part, the FDA launched an investigation into Intuitive’s adverse reports in 2011, and, two years later, sent the company a warning letter for inadequate reporting. Conversely, the FDA is now under scrutiny for failing to adequately track adverse events and improve guidelines for the robots’ use. One report estimates that about 15% of all adverse patient events associated with medical devices are ever reported to the FDA.
Another study, which specifically focused on the underreporting of da Vinci surgery complications, found that surgeons are not learning from inadequate performance because such insufficiencies are not reported. Unfortunately, at present it seems like the only mode to actually enact change in Intuitive’s practices is through post-injury litigation. Our team of robotic surgery lawyers is currently accepting and investigating these types of cases free of charge, and hope to be part of the solution for robotic surgery systems, which hold so much promise for the future.