Intuitive Surgical Inc. (ISRG), the maker of a $1.5 million robot surgery system, told doctors that friction in the arms of some devices may cause the units to stall, the second warning issued about the company’s products in a month.
The company sent an “urgent medical device recall” Nov. 11 alerting customers of the issue, which affects 1,386 of the systems worldwide, the U.S. Food and Drug Administration said in a Dec. 3 notice on its website. The stalling may result in a sudden “catch-up” if the surgeon pushes through the resistance, the agency said.
Intuitive is facing growing questions about its marketing strategies, training procedures and the safety of its devices, Bloomberg News has reported. The FDA said last month that the number of adverse event reports, including deaths, injuries and system malfunctions, has more than doubled this year as of Nov. 3 compared with all of 2012.
“Reports of friction within certain instrument arms can interrupt smooth instrument motion,” the FDA said on its website. Continue reading →
The influential American College of Obstetricians and Gynecologists (ACOG) is warning women that despite an aggressive marketing campaign to promote pricey robotic surgery for hysterectomies, that approach may not be the best choice available for patients.
Citing a recent JAMA study that found robotic hysterectomies cost more but aren’t really better, ACOG president, James T. Breeden, MD, in a statement said it’s “important to separate the hype from reality” when considering this type of robotic surgery.
Here’s the full ACOG statement:
Many women today are hearing about the claimed advantages of robotic surgery for hysterectomy, thanks to widespread marketing and advertising. Robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient. It is important to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies.
The outcome of any surgery is directly associated with the surgeon’s skill. Highly skilled surgeons attain expertise through years of training and experience. Studies show there is a learning curve with new surgical technologies, during which there is an increased complication rate. Expertise with robotic hysterectomy is limited and varies widely among both hospitals and surgeons. While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations that require extensive surgery and removal of lymph nodes, studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes. Consequently, 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. Continue reading →
Robotic-assisted surgery is all the rage — it’s up about 400 percent in the last few years, according to one estimate.
Robotic hysterectomies are also on the rise: in the U.S. thousands of women undergo hysterectomies for various gynecological disorders and many of these are performed using minimally invasive techniques, including laparoscopy and with the help of a surgical robot.
But a new study from the Journal of the American Medical Association that compared robotic and laparoscopic hysterectomies among more than 264,000 women with non-cancerous gynecologic conditions found that there was no difference in complication rates or outcomes. The big difference was cost: the robotic hysterectomy was, on average, about $2,200 more, the study found.
The JAMA report notes that robotic hysterectomies took off in recent years, up from 0.5% in 2007 to 9.5% by 2010.
One driver is likely the intense marketing of surgical robots by its manufacturers. A 2011 study out of Johns Hopkins found that hospitals are misleading patients about the benefits of robotic surgery and that hospital websites routinely use industry-provided content and overstate claims of robotic success. Continue reading →
Covering health care can get depressing. Sickness, medical bills, insurance premiums, death. For that matter, reading about it can get depressing, too. As a modest antidote to all the downers, today CommonHealth is launching an occasional feature called Happy Endings, showcasing medical stories that went very right.
You know you’re in trouble when you get your MRI scans back and your doctor uses words like “huge” and “gigantic.”
“This is not getting off to a good start,” Sophia Watson recalls thinking.
An attorney who lives on Beacon Hill, Sophia had long been aware that she had fibroids, the benign tumors of the uterus that grow in more than half of all women, often causing pain and heavy menstrual bleeding. She had reason to suspect that hers were large; feelings of pressure, even a visible bulge in her lower abdomen when she was lying down. But it wasn’t an issue — until she had trouble getting pregnant at 35.
A previous doctor had played down the fibroids as a potential problem, but Sophia and her husband, David, decided to seek a second opinion at Massachusetts General Hospital. “The radiologist wrote that you have a giant fibroid,” the Mass. General doctor said, openly taken aback by the dramatic language. (Radiologists tend to be hard to impress.) He recommended removing the tumor with traditional surgery, involving a long incision across her abdomen, soon. The fibroid was so big, he said, that it could, in fact, be cancerous.
“I went from infertility to cancer in like four seconds,” Sophia said. “I was like, ‘Get it out, get it out, I don’t care what you do!’”
To the best of their knowledge, her fibroid was the largest that was ever removed using robotic surgery and followed by a spontaneous conception and a live birth. (Actually, two conceptions: Sophia is now pregnant again.)
David, a financial analyst, reacted differently. He follows the biotech industry, and knew from his own research about Intuitive Surgical, Inc., the company that makes the da Vinci robotic surgical system. He knew some hospitals were using it for uterine surgery. When he asked, the doctor said Mass. General did not, but Brigham & Women’s did. Could it be used on such a gigantic fibroid? The doctor did not know.
At the Brigham, Sophia and David met with Dr. Serene Srouji, who was about to go on maternity leave — a good omen, Sophia thought. Yes, Dr. Srouji said, looking at Sophia’s MRI; this is probably why you’re not getting pregnant.
Sophia felt a welcome wash of relief. At least now, her problem seemed fixable, even though she knew that “what was to follow was really intense surgery,” with all the usual risks of a major — though laparoscopic — operation under general anesthesia.
Dr. Antonio Gargiulo, Dr. Srouji’s partner and the director of robotic surgery at the Brigham’s Center for Infertility and Reproductive Surgery, agreed to operate. “It’s a very large fibroid,” he allowed, but “we can do it.”
Just how large was it? For the strong of stomach, the video of Sophia’s March, 2009 operation — with “giant myomectomy” in the title — is here. And below is an instructional video on the surgery, enlivened by music from Boston-area piano rocker Matthew Ebel. In summary: Sophia is a slight woman, and the fibroid was, yes, the size of a cantaloupe.
He may perform robotic surgery, but Dr. Antonio Gargiulo is the opposite of robotic in manner. He exudes Italian warmth: the rolling speech, the high enthusiasm, the easy humor. Even the attitude toward mothers: He told Sophia to warn her family members that when he met with them right after the surgery, he would address himself mainly to her mother. “I always look at the mother,” she recalls him saying, “because it’s the mother who’s struggling the most at the moment.” And indeed, Sophia said, her mother prayed non-stop all five hours of her operation. Continue reading →
Hospitals rely on industry-provided promotional materials to tout the benefits of robotic surgery, a new study finds
Robotic surgery — which is up 400 percent in the last four years — is touted as the latest, greatest high-tech medical breakthrough. Proponents say it’s less painful, less invasive and smarter than conventional operations.
But a new study by Johns Hopkins researchers found that hospital websites routinely overstate the benefits of robot-assisted surgery without any scientific evidence to back those claims, and often rely on industry-provided marketing materials with no mention of potential risks.
“The public regards a hospital’s official website as an authoritative source of medical information in the voice of a physician,” says Marty Makary, M.D., M.P.H., an associate professor of surgery at the Johns Hopkins University School of Medicine and the study’s leader, in a news release. “But in this case, hospitals have outsourced patient education content to the device manufacturer, allowing industry to make claims that are unsubstantiated by the literature. It’s dishonest and it’s misleading.”
In the study, published in the Journal For Health Care Quality, researchers looked at 400 randomly selected hospital websites across the country (none are mentioned by name). Specifically, the researchers (among them Peter Pronovost, the original “checklist” guy) gathered data on the location of robotic surgery information on the hospital website, the use of images or text provided by the manufacturer, direct links to the product maker’s website and any mention of supporting evidence for the benefits of robot-assisted surgery or possible risks.
Here’s what they found:
–Forty-one percent of hospital websites described robotic surgery
–Among these 37% percent presented robotic surgery on their homepage
–73% used manufacturer-provided stock images or text, and 33% linked to a manufacturer website.
–Statements of clinical superiority were made on 86% of websites, with 32% describing improved cancer control, and 2% described a reference group.
–No hospital website mentioned risks.