Product News and Recalls

New Study Shows That The Da Vinci Surgical System Is Not As Beneficial As Expected

The da Vinci Surgical System has come under quite a bit of fire recently. This system enables a surgeon to sit at a console and perform surgery via remote control.

The device is often used in cancer surgery, prostatectomies, hysterectomies, and gallbladder removals. A study published in the August 2013 edition of Journal of Healthcare Quality indicated that side effects of these procedures — including burns, cuts, and infections (sometimes fatal) — have been “vastly underreported” to the FDA.

Researchers from the University of Texas Southwestern published a study in the October 2013 edition of the journal Obstetrics & Gynecology. They examined data concerning more than 800,000 women who experienced various kinds of hysterectomy, including robot-assisted and laparoscopic. Robot-assisted surgery was supposed to allow for a shorter hospital stay, but the study found no significant difference when compared to standard surgeries. Robotic-assisted surgery was also expected to reduce complications, but the results of the study did not support this expectation.

The study did find an increased risk of pneumonia, possibly because it has been consistently shown that robot-assisted hysterectomies have longer operating times. These patients are also more likely to need intubation after their operations; patients who go through robot-assisted procedures are placed in steep, head-down positions and fluid can build up in the airways. The study also found that hospital costs were higher for patients who underwent robot-assisted hysterectomies ($2,489 per patient).

A number of lawsuits have been filed against the manufacturer of the da Vinci Surgical System—Intuitive Technology, Inc.—and its SEC filings indicate that it is entering into tolling agreements with potential litigants. Tolling agreements postpone filing deadlines in exchange for allowing the company to evaluate claims before lawsuits are on public record. Each state puts a time limit on when an injured party can file a lawsuit, called a statute of limitations, so any person who believes they may have been injured during an operation in which the da Vinci Surgical System was used should consult with an attorney as soon as possible. Failure to do so may result in losing the ability to ever recover for injuries caused by the da Vinci Surgical System.

Lopez McHugh is evaluating da Vinci Surgical System cases. Contact us for a free consult.