Unreported Robot Surgery Injuries Open Questions for FDA

[xchrom]

http://www.bloomberg.com/news/2013-12-30/unreported-robot-surgery-injuries-open-questions-for-fda.html


When Sheena Wilson, 45, underwent robotic surgery for a hysterectomy in May, she didn’t know the Intuitive Surgical Inc. (ISRG) system used by her doctor was previously tied to a variety of injuries for the same procedure.

Her rectum was badly burned in the operation, said Wilson, a mother of two from Parlin, New Jersey. Now, she is on long-term disability, fearful of losing her job and facing a third corrective surgery, she said in a telephone interview.

“If I had known there were other people who had injuries, I would never have done this surgery,” said Wilson, who has filed suit against Intuitive and her doctor. “Whatever they have in place is not working.”

The use of complex medical devices is exploding. Last year, Intuitive’s da Vinci robotic surgery system alone helped doctors perform more than 350,000 surgeries in U.S. hospitals. Yet patients like Wilson, whose lives depend on the proper use of increasingly complex high-tech medical equipment, often can’t get a complete picture of potential problems.

[giftedgirl77]

1. The most interesting point in this article is that this

device was only used in a clinical setting in Mexico on 233 patients for gallbladder & another basic surgery before being released in the US. There is no "standard" doctors must meet prior to using it & it's at their discretion what surgeries can be performed.

The reporting is a joke.