Da Vinci Robotic Surgery Complications & Recall | Da Vinci Lawsuits
The da Vinci surgical robot, which is manufactured and marketed by Intuitive Surgical Systems, has been under fire by federal regulators who allege that reports of injuries and complications experienced by patients during – as well as after – surgeries performed with the device are on the rise.
On May 8, 2013, Intuitive Surgical issued an "urgent medical device notification" alerting hospitals that it has "identified a potential issue" with the da Vinci surgical robot that can burn patients internally. Specifically, Intuitive revealed that some models of the da Vinci's monopolar curved scissors have "micro-cracks" that can create "a pathway for electrosurgical energy to leak into tissue during use and potentially cause thermal injury."
In early March, federal health officials launched a formal investigation into the safety of surgeries performed with the da Vinci robot; joining that chorus more recently has been the American Congress of Obstetricians and Gynecologists (ACOG), which recently issued a statement about the da Vinci surgical robot, noting that there is little evidence to suggest that it is as effective as other methods for performing a hysterectomy – only one of the many procedures that the unit is touted as having the capacity to perform.
The ability to perform less invasive surgery coupled with a swifter recovery period for the patient are key benefits touted of the da Vinci surgical robot. Additionally, it has been used in a wide and growing variety of procedures, including kidney cancer and other kidney disorders, prostate removal, throat cancer, coronary artery disease, heavy uterine bleeding and obesity surgery, according to the marketing materials accompanying the unit.But as the uses for the device are on the rise, so to are reports of injuries and complications experienced during and after those surgeries.
Injuries Experienced During – and After – Surgery with da Vinci
Serious injuries associated with use of the device are tears, burns and perforations to arteries and organs. In some cases, injuries related to surgery with the da Vinci surgical robot have allegedly caused death. Still, hospitals are increasingly using the da Vinci surgical robot to perform a wide and growing range of surgeries.
The defective medical device lawyers at Parker Waichman LLP are investigating the varying range of da Vinci surgical robot injuries, which include:
Burns and/or tears of the intestines
Punctured blood vessels or ureters
Severe bowel injuries
Vaginal cuff dehiscence
A recent lawsuit was filed by a woman who had been told that the gynecological surgery she was facing would be best performed using the da Vinci surgery robot, which was “the latest, greatest” way to do such procedures, according to a Bloomberg report.
Michelle Zarick said that excessive vaginal bleeding caused her to visit her doctor, who found a growth inside her uterus, Bloomberg reported. The doctor suggested the use of the surgical robot. The surgery seemed to go well. However, Zarick knew something was wrong about five months later; feeling a pop inside her while using the bathroom, she quickly realized that a segment of her intestine was protruding from her vagina.
For the next four years, Zarick went through corrective procedures that have scarred her and damaged her rectal muscles – leaving her constipated. She also has suffered from a diminished libido.
Barbara Levy, vice president for health policy at ACOG, told Bloomberg that some 600,000 hysterectomies are performed each year in the United States. According to a Feb. 4, 2012, regulatory filing, surgical robots were used for 367,000 procedures last year, including 176,000 uterus removals. Levy says that the da Vinci “is absolutely not” the least invasive type of hysterectomy, according to Bloomberg.
Bloomberg has analyzed adverse event reports collected by the federal government and found that at least 70 reports of death seem linked to the use of the da Vinci surgical robot.
Lawsuits Over da Vinci Robot Surgeries are Pending
The da Vinci surgical robot was approved by the U.S. Food & Drug Administration (FDA) in 2000 for use in urologic, laparoscopic, gynecologic and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures.
Among the surgical procedures for which it has been used are:
Kidney cancer and other kidney disorders
Coronary artery disease
Heavy uterine bleeding
The da Vinci surgical robot has four arms, three of which are utilized for holding surgical instruments, while the fourth includes an endoscopic camera. Using the remote control, the surgeon is capable of a larger range of motion than the human hand alone, which is said to enable for less invasive surgery via a smaller incision and reduced recovery time.
Da Vinci lawsuits allege that design flaws in the device, specifically its reliance on monopolar energy, can spark an electrical current that can burn the patient. Still other lawsuits allege that the failure of the da Vinci robot's insulating barriers causes burns.
Because not all injuries resulting from these robotic procedures are apparent during or immediately after surgery, patients may delay seeking treatment for any subsequent related internal problems, which is a dangerous scenario that could lead to death.
Legal Help for Victims of da Vinci Surgical System
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is offering free legal evaluations to anyone who underwent prostate removal, hysterectomies, gall bladder surgery, or any other surgery that involved the da Vinci surgical robot and suffered a serious, life-threatening injury. To discuss your case and protect your legal rights, we urge you to contact our da Vinci surgical robot injury lawyers today.