The Robotic Surgery Controversy

The Robotic Surgery
Controversy

Robotic Surgery Can Lead to Many Complications When Treating GYN Conditions

Discover Why CIGC Never Uses Robotics or Power Morcellation

What Is Robotic Surgery?

Robotic surgery is performed with the surgeon sitting at a control station, controlling robotic “arms” that have been inserted into the patient’s abdomen at the beginning of the surgery. Under direction from the surgeon, the robotic arms can cut blood vessels, burn tissue, and move organs. Robot-assisted surgery generally requires four to five skin incisions, through which robotic arms can be placed into the patient’s abdomen. These incisions are 8 to 12 mm each and are placed in an arc above and below the belly button.

The robot — called the da Vinci Surgical System — is manufactured by Intuitive Surgical. It costs approximately US $1.5–2 million dollars, with a maintenance cost of $150,000–$180,000 per year; it also requires costly disposable instruments.

The Controversy Surrounding Robotics in GYN Surgery

Despite the increased costs and the lack of benefit to the patient over other laparoscopic techniques, the number of robotic surgeries being performed has increased, mainly due to:

  • Aggressive direct-to-consumer marketing by Intuitive Surgical, the company that manufactures the robot; and
  • Aggressive marketing to doctors and hospitals to convince them to adopt the technology, in order to attract more business

“Aggressive direct-to-consumer marketing of the latest medical technologies may mislead the public into believing that they are the best choice. Our patients deserve and need factual information about all of their treatment options, including costs, so that they can make truly informed health care decisions.” – Dr. James Breeden, former President, American College of Obstetrics and Gynecology

More About Robotic Surgery and the Unnecessary Use of Power Morcellators

Robotics

The Journal of the American Medical Association (JAMA) has published articles concluding that robotic surgery is not a better approach than standard laparoscopy. Many surgeons who use a robot to perform minimally invasive procedures lack sufficient training in laparoscopy.

A March 2015 committee opinion from the American College of Obstetrics and Gynecologists states: “Surgeons should be skilled at laparoscopic approaches for a specific procedure before undertaking robotic approaches. Surgeon training, competency guidelines, and quality metrics should be developed at an institutional level.”

Have There Been Any Legal Actions Against Intuitive Surgical, the Manufacturer of the da Vinci Surgical System Robot, or FDA Warnings?
Yes. Class action lawsuits have been issued and are being developed by multiple law firms throughout the United States, given the complications reported from robotic surgeries. The U.S. Food and Drug Administration issued a recent warning against Intuitive Surgical.

Power Morcellators

The use of a power morcellator in a surgical procedure to remove either fibroids or the uterus has generated a lot of attention for the potential spread of cancer by its spinning blades. The U.S. Food and Drug Administration has issued a black box warning to ensure patients are warned about the risks.

A power morcellator grinds up material within the pelvic cavity, making it easier to remove an enlarged uterus or a large fibroid laparoscopically. With the possible risks, power morcellators should never be used for fibroid removal or hysterectomy.

If your surgeon uses a robot and/or power morcellator to perform hysterectomies, find a GYN surgical specialist who does not. The Center for Innovative GYN Care® (CIGC®) never uses robotics or power morcellators for any of its procedures.

What Is Conventional Laparoscopic Surgery?

“Conventional” laparoscopy does not use a robot to operate the instruments. With these procedures, the surgeon actually holds the instruments and camera. The surgery is typically performed using 5 mm skin incisions in the lower abdomen. Conventional laparoscopy has been done for years, and is the traditional approach to laparoscopic GYN procedures.

How Are CIGC Surgeries Performed?

Advancements in laparoscopy, extensive training, and surgical skill make the CIGC DualPortGYN® and LAAM®  laparoscopic techniques possible. These techniques are performed without using expensive equipment. DualPortGYN and LAAM techniques are used to perform complex procedures like hysterectomy or fibroid removal as outpatient procedures, so patients return home the same day.

Major Journals and Societies Indicate that Robotic Surgery Offers No Benefit Compared to Conventional Laparoscopy

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There is no good data proving that robotic hysterectomy is even as good as — let alone better than — existing, and far less costly, minimally invasive alternatives.
Dr. James Breeden, former President, American College of Obstetrics and Gynecology
Headline Medical Journal/Society Date
Statement on Robotic Surgery by ACOG President James T. Breeden, MD The American College of Obstetricians and Gynecologists (ACOG) MAR 2013
Committee Opinion No. 628: Robotic Surgery in Gynecology Obstetrics & Gynecology MAR 2015
Laparoscopic hysterectomy appears less painful than robotic surgery AAGL DEC 2013
Robotic-assisted laparoscopic surgery in benign gynecology The Journal of Minimally Invasive Gynecology (JMIG) FEB 2013
Comparative effectiveness research on robotic surgery The Journal of the American Medical Association (JAMA) FEB 2013
Robotically Assisted Vs Laparoscopic Hysterectomy Among Women With Benign Gynecologic Disease The Journal of the American Medical Association (JAMA) FEB 2013
The commercialization of robotic surgery: unsubstantiated marketing of gynecologic surgery by hospitals American Journal of Obstetrics & Gynecology (AJOG) SEP 2012
News Headline Publication Date
Robotic surgery linked to 144 deaths in the US BBC JUL 2015
Robot Surgery Isn’t First Choice for Uterus Removals Bloomberg MAR 2013
Intuitive Surgical Loses Bid to Throw Out Robot Lawsuit Bloomberg MAR 2013
Intuitive Marketed Robot to Less-Skilled Surgeons, Witness Says Bloomberg APR 2013
Intuitive Witness Denies Robot Surgery Training Was Watered Down Bloomberg MAY 2013
Intuitive Resembled a Car Dealership, Lawyer Tells Jury Bloomberg MAY 2013
Intuitive Surgical May Not Have Tested Devices Properly Bloomberg JUL 2013
Intuitive Surgical Declines on Warning Letter From FDA Bloomberg JUL 2013
No Safety Benefit Found in Use of Robot for Hysterectomy Bloomberg SEP 2013
Robot Surgery Damaging Patients Rises With Marketing Bloomberg OCT 2013
Intuitive Surgical Robot Incident Reports Double in Year Bloomberg NOV 2013
Unreported Robot Surgery Injuries Open Questions for FDA Bloomberg DEC 2013
Intuitive Surgical’s Robot Surgeons Encounter Human Lawyers Bloomberg MAR 2013
Mass. cautions hospitals about robotic surgery The Boston Globe MAR 2013
A Class Action Lawsuit Has Been Filed Against Intuitive Surgical BusinessWire APR 2013
Robotic Surgery: More Complications, Higher Expense for Some Conditions Columbia University Medical Center OCT 2014
FDA: Intuitive Surgical Failed to Report Warning CNBC JUN 2013
OB-GYNs told robot hysterectomy not best option Fox News MAR 2013
Local news hype of robotic surgery doesn’t match many hysterectomy patients’ experiences HealthNewsReview.org JUL 2018
Study: Robotic Surgery More Costly For Ovarian Problems Kaiser Health News OCT 2014
Robot-surgery firm from Sunnyvale facing lawsuits, reports of death and injury The Mercury News OCT 2017
Medical boon or bust? Suits raise allegations of defects in da Vinci robot Modern Healthcare MAY 2013
Surgical robot use criticized in new report Modern Healthcare OCT 2014
Robot hot among surgeons but FDA taking a new look NBC News APR 2013
Robotic surgery is high-tech ‘tour de force’ – but is it safe? NBC News JUN 2013
The Bleeding Edge Netflix Documentary JUL 2018
Salesmen in the Surgical Suite The New York Times MAR 2013
New Concerns on Robotic Surgeries The New York Times SEP 2013
Robotic Surgery Report Card The New York Times OCT 2014
Are hospital claims about the robotic approach to gynecologic surgery based on reliable data—or mostly hype? OBG Management NOV 2012
Are robotic surgery complications underreported? OBG Management OCT 2013
Robot Maker Sued Over Hysterectomy Patient’s Death Outpatient Surgery Magazine APR 2012
Robot-assisted Hysterectomies booming, but better? USA TODAY FEB 2013
FDA takes fresh look at robotic surgery USA TODAY APR 2013
Robot-Assisted Surgery Costs More But May Not Be Better The Wall Street Journal OCT 2017
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