According to plaintiff, Michelle Zarick, she complained of excessive vaginal bleeding and her doctor recommended hysterectomy. One option: robot surgery, described by her gynecologist as “the latest, greatest” technique available.
Zarick was told that with robotic surgery there would be less pain and bleeding. Five weeks later, Zarick felt something pop and saw her intestine protruding from her vagina. Now, four years later, the 41-year-old Zarick has a hip-to-hip scar from corrective surgery, constipation from damaged rectal muscles and a diminished sex life.
Zarick, filed suit in December against Intuitive in regard to her hysterectomy. “It forever changed my life for the worse.”
Robot systems made by Intuitive Surgical Inc. are linked to at least 70 deaths in informal incident reports sent to U.S. regulators since 2009.
Intuitive Surgical Inc., the Dominant Robotic Company
Intuitive, based in Sunnyvale, California, is the only company whose system is cleared in the U.S. for soft tissue procedures that include general surgery, prostate operations and gynecological surgery.
According to a company filing, the number of U.S. procedures done with the robots has grown to about 367,000 in 2012, compared with 292,000 in 2011 and 228,000 in 2010.
DaVinci Increases Surgical Costs
Tough new questions about safety raised in lawsuits and in adverse incident reports to the FDA may threaten the company’s growth. They come as the technology is already facing criticism for raising surgical costs at a time medical studies show no significant health benefits for the robots, compared with standard less-invasive operations.
FDA Adverse Reports
A review of adverse incident reports sent to the Food and Drug Administration since 2009 jumped to at least 115 in 2012 from 24 in 2009, while deaths rose to 30 from 11.
In 2011, an analysis published in the American Journal of Obstetrics & Gynecology found the complication occurs in almost two percent of robot hysterectomies, or more than twice the rate seen in conventional, less invasive surgery.
DaVinci Insulation Failures
A 2011 study in the American Journal of Obstetrics & Gynecology, done in a laboratory, found that certain types of insulation failed on the robot at as much as four times the rate of conventional minimally-invasive surgery equipment.
Last August, researchers from Memorial-Sloan Kettering Cancer Center reported three cases of blood vessel burns caused by insulation failures with the robot, all of which were caught and fixed before they caused major complications.
The case is Zarick v. Intuitive Surgical, Inc., 12-cv- 237723, Superior Court, Santa Clara County, California.