The Risks Outweigh The Benefits
If your doctor is recommending a robotic procedure to perform a delicate GYN procedure, there is a higher risk of complications. Robotic GYN surgery increases the risk of damage to areas surrounding the reproductive organs, including nicks to the bowel and the ureter, requiring additional surgery to correct.
Robotic GYN Surgery Complications
According to a Fall 2015 article in the Journal of Gynecologic Surgery, (Ten-year Food and Drug Administration Reporting on Robotic Complications in Gynecologic Surgery, Kristin M. Shields, MD, et al) a report from the United States Food and Drug Administration (FDA) Manufacture and User Device Experience (MAUDE) that evaluated 10-year statistics related to robotic GYN surgery demonstrated that there has been a steady increase in reported robotic injuries, deaths or device malfunctions.
Over the 10-year period, 455 injuries and 177 malfunctions from robotic surgery were reported, with the most common gynecologic procedure, hysterectomy leading in both injuries or death.
- Common complications included ureteral injuries (19%), infections (18%), and small-bowel injuries (16%), resulting in 435 surgeries to repair damage done during the initial surgery.
- Thirty deaths were associated with robotic gynecologic surgeries, with sepsis as the most common cause.
“Recently,… there have been safety concerns and high profile lawsuits involving robotic surgery, especially robotic hysterectomy. Intuitive Surgical, Sunnyvale, CA, is currently named in approximately 50 product-liability lawsuits filed by patients who claim death as a result of robotic procedures.” Shields, et al.
A Call For Mandatory Reporting
Under-reporting of robotic complications is a major concern. Reports to the FDA MAUDE database are currently voluntary, so there is no clear indication of risks that can be evaluated and addressed systematically.
However, personal injury claims are required to be investigated, which led to a surge of new reports being filed in 2013. With the increase in reported injuries and lawsuits, the Shields, et al report, and a committee opinion from The American College of Obstetricians and Gynecologists from March 2015 each call for standardization of reporting these incidents for complete risk assessment.
Higher Costs Without Patient Benefit
The use of a robot for GYN surgery has come under scrutiny in the past few years for being more expensive for patients without better results than standard laparoscopic surgery. In 2013, the American Congress of Obstetricians and Gynecologists president James T. Breeden issued a statement:
“…At a time when there is a demand for more fiscal responsibility and transparency in health care, the use of expensive medical technology should be questioned when less-costly alternatives provide equal or better patient outcomes. Hysterectomy is one of the most common major surgeries in the US and costs our health care system more than $5 billion a year.
“At a price of more than $1.7 million per robot, $125,000 in annual maintenance costs, and up to $2,000 per surgery for the cost of single-use instruments, robotic surgery is the most expensive approach. A recent Journal of the American Medical Association study found that the percentage of hysterectomies performed robotically has jumped from less than 0.5% to nearly 10% over the past three years. A study of over 264,000 hysterectomy patients in 441 hospitals also found that robotics added an average of $2,000 per procedure without any demonstrable benefit.
“If most women undergoing hysterectomy for benign conditions each year chose a vaginal or laparoscopic procedure—rather than TAH (total abdominal hysterectomy) or robotic hysterectomy—performed by skilled and experienced surgeons, pain and recovery times would be reduced while providing dramatic savings to our health care system. Conversely, an estimated $960 million to $1.9 billion will be added to the health care system if robotic surgery is used for all hysterectomies each year…”
“Conversely, an estimated $960 million to $1.9 billion will be added to the health care system if robotic surgery is used for all hysterectomies each year…”
The Patient Perspective: Why A Second Opinion Matters
It’s important to know all of the facts about the complications that can arise with robotic surgery and to know that you have options. In addition to the known risks, robotic surgery requires patients to take off more time for recovery, and it creates more pain due to larger and more incisions than standard laparoscopic surgery or DualPortGYN procedures.
“Success in surgery depends on the training and skill of the surgeon,” said Dr. MacKoul. “As more and more OB/GYNs have access to use of a robot for surgery, the number of reported injuries will increase. OB/GYNs are not all trained in advanced laparoscopic procedures, and a tool cannot replace skill. It is essential for women choosing a GYN surgeon to understand exactly how many procedures their surgeon performs annually. On average, OB/GYNs perform 27 hysterectomies per year. At CIGC, our specialists perform over 400 hysterectomies. Volume matters when it comes to surgical skill.”
DualPortGYN allows the surgeon to see the entire anatomy surrounding the uterus and ovaries, providing a more precise procedure, and minimizing complications. The minimally invasive GYN specialists at CIGC never use power morcellation to remove the uterus or fibroids. Power morcellators, often used with robotic surgery, are an unnecessary risk, and have been known to spread cancer in the pelvic cavity.
If your OB/GYN intends to use a robot for your procedure, ask him or her “Why?”
- The American Congress of OB/GYN (ACOG), the premier society in Obstetrics and Gynecology, has issued a statement to OB/GYN’s that they should be using other types of procedures such as standard laparoscopy instead of robotics.
- The American Association of GYN Laparoscopic Surgeons (AAGL), the largest and most well regarded society for minimally invasive GYN surgery worldwide, has also issued statements that robotic surgery should not be used if standard laparoscopy and vaginal hysterectomy are available.
- Many articles have been written in “peer reviewed journals” including the Journal of the American Medical Association (JAMA) and others clearly showing that robotics is not a better approach than standard laparoscopy.
As a patient, be your own best advocate. Ask many questions of your OB/GYN. If your doctor still intends to use the robot for your surgery, seek a second opinion and get more information on standard laparoscopy or DualPortGYN approaches as better options for your procedure. Robotic surgery complications outweigh the benefits.
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GYN surgical specialists can often see women sooner because they are focused entirely on surgery. Each patient gets detailed, in depth attention from Dr. Natalya Danilyants and Dr. Paul MacKoul. This personalized care helps patients understand their condition and the recommended treatment so that they can have confidence from the very start. Our surgeons have performed over 20,000 GYN procedures and are constantly finding better ways to improve outcomes for patients.
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