New Da Vinci Lawsuit Plaintiff Alleges Burned Rectum, other Complications After Robotic Hysterectomy
Burned rectum, long-term disability, the possibility of having to undergo several corrective surgeries—these are the realities now allegedly faced by one New Jersey woman whose exposure to the da Vinci Surgical System led to serious robotic surgery complications, Bloomberg.com reports.
Similar to those claimed in da Vinci lawsuit filings, the patient’s side effects started after a robotic hysterectomy she underwent last May. According to an article published December 30th, the woman claims she was not warned about the injuries that may stem from the procedure beforehand, and has since filed a lawsuit against Intuitive for allegedly failing to alert the general public about the complications associated with its product.
“If I had known there were other people who had injuries, I would never have done this surgery,” she said.
Around the U.S., the number of procedures using the surgery robot has grown steadily, with more than 350,000 surgeries aided by the device in 2012. Now involved in thyroid and colon cancer surgeries and prostatectomies, to name a few, the da Vinci Surgical System was approved by the U.S. Food and Drug Administration (FDA) in 2000 for use in laparoscopic, urologic and gynecologic procedures. According to Bloomberg, the da Vinci received clearance after a trial conducted at a Mexico City hospital tested 233 patients who underwent gall bladder removal and heart burn operations. Exposure to the surgery robot has allegedly been tied to organ perforations, organ damage, cut ureters, as well as burns and tears to arteries since then.
FDA Announces Class II Recalls for Two da Vinci Components
Given these risks, the FDA’s investigation of the device has also increased over time. During the month of December, two notifications from Intuitive about potential problems with da Vinci components were given Class II recall status by the agency. The first involved its Patient Side Manipulator, which was shown to stall during surgery, and the da Vinci Surgical System’s EndoWrist instrument, which was suggested to detach.
According to a recent report from MassDevice.com, some 110,000 components were affected by the two recalls.
A month earlier, the FDA released findings of a da Vinci survey it conducted to assess the safety and effectiveness of the device. The research looked at the experiences of 11 doctors who performed between 70 and 600 procedures, who said that surgeon training may play a role in whether or not a patient may experience complications, among its other findings.
File a da Vinci Lawsuit Today
Contact an attorney to learn more about da Vinci robot lawsuits at (877) 779-1414.