Advances in medical technology are essential for moving forward in healthcare. At the same time, it is important to evaluate how effective each new device, method or medicine is at treating patients as well as examining risks. Robotic GYN surgery has come under scrutiny in a recent report from the FDA MAUDE database.
If your doctor is recommending a robotic procedure to perform a delicate GYN procedure like a hysterectomy, there is a higher risk of higher risk of complications. Robotic GYN surgery risks include damage to areas surrounding the reproductive organs, including nicks to the bowel and the ureter, requiring additional surgery to correct. When the risks outweigh the benefits, hospitals and surgeons alike should reevaluate their surgical strategy.
Excerpt:
Advances in minimally invasive GYN surgery have improved the lives of many women suffering with GYN conditions. Yet, despite these advances, not enough surgeons are trained in the skills necessary to perform procedures without large open incisions, so that the vast majority of women across the United States face long, painful recoveries. To improve upon these statistics, many hospitals are investing millions of dollars in surgical robots, but at a very high cost to patients.
As shown in the 10-year report card from the Food and Drug Administration (FDA) Manufacture and User Device Experience (MAUDE) database, there has been a steady increase in reported robotic injuries, deaths or device malfunctions. According to the 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) over the 10-year period, 455 injuries and 177 malfunctions from robotic surgery were reported, with the most common gynecologic procedure, hysterectomy leading in numbers of injuries and deaths.
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.
Read the full article: Robotic GYN Surgery Complications: Tools Cannot Replace Skill
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