Underreported Da Vinci Robot Injuries Lead to More Injured Patients
Underreporting of da Vinci robotic surgeries may be contributing to increased incidence of injury to patients who elect the robotic procedures lacking an accurate understanding of inherent risks.
Bloomberg recently published an unsettling news story recently about a 45-year old woman, Sheena Wilson, who underwent da Vinci robotic surgery for a hysterectomy believing it to be safe only to awake from the surgery with serious injuries leaving her disabled.
As reported by Bloomberg, Ms. Wilson said if she had known others had suffered injuries from the da Vinci robotic surgery, she would never have agreed to her doctor using it in performing her hysterectomy. She was left with a badly burned rectum and injuries suffered by others who have had the same da Vinci procedure. Unfortunately, many of the injuries sustained by others involving da Vinci surgeries have either gone unreported or have been grossly underreported by doctors, hospitals and even patients themselves.
The FDA publishes reports of “adverse events” associated with medical devices, but acknowledged to Bloomberg that it is “well-aware” of the problem of underreporting. For instance, in 2010 Anupama Raaman underwent a da Vinci robotic hysterectomy and spent four months in the hospital after a hole was found in her intestine two days later. However, Ms. Raaman’s injury is not included in the FDA “adverse events” database, despite the fact that medical device companies have been required to report such incidents under the FDA Medical Device Reporting (MDR) regulations since 1984.
Manufacturers of medical devices as well as facilities where those devices are utilized are required to report injuries associated with those devices. According to the FDA website:
MDR Mandatory Reporting Requirements:
Manufacturers: Manufacturers are required to report to FDA when they learn one of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to FDA upon becoming aware that one of their devices has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
User Facilities: User Facilities (e.g., hospitals, nursing homes) are required to report a suspected medical device-related death to both the FDA and the manufacturer. User facilities should report a medical device-related serious injury only to the manufacturer. If the medical device manufacturer is unknown, the user facility should report the serious injury to FDA. A user facility is not required by the MDR regulation to report a malfunction, but can use the voluntary MedWatch program to advise FDA of problems with medical devices. …
The Bloomberg investigation into underreporting of medical device injuries revealed that in years past only about 15% of a million patient incidents related to medical devices had been reported. This problem is likely to be further compounded with the fast deployment of new surgical technologies, like the da Vinci robotic system. Bloomberg cited surgeon and surgical outcomes expert John Birkmeyer who opined that new medical devices are being deployed across the country faster than scientists and doctors can understand how to best use them safely.
The FDA approved the Da Vinci robotic devices in 2000. Since then, more than 1.5 million da Vinci robotic surgeries have been performed for common laparoscopic procedures including gynecologic surgeries, cardiac heart valve repairs, prostate removals and others. When the FDA started receiving adverse event reports of patient injuries from the device, the FDA began investigating. The FDA received almost double the reports of adverse incidents in 2013 as it did in 2012. However, the Bloomberg article noted that FDA officials said that the additional reports don’t necessarily mean the actual rate of adverse incidents went up, but rather that incidents may have been underreported in prior years.
The underreporting of injuries from da Vinci robotic devices may serve to jeopardize patient safety. FDA reporting requirements are designed to inform the public potential safety concerns, but the system is compromised when medical device manufacturers and health care professionals do not properly report adverse events.
How Do I Get More Information?
To learn more about da Vinci surgical robotic lawsuits, visit Audet and Partners website at http://davinci-surgical-robot-lawsuit.com.
If you, or a loved one, have experienced problems that may be related to a robotic surgery, contact the experienced attorneys at Audet and Partners, LLP for a free evaluation of your legal options. Call us at (800) 965-1461 or fill out the confidential case inquiry form on the right side of this web page.
*Source: Bloomberg.com; Langreth, Robert; “Unreported Robot Surgery Injuries Open Questions for FDA,” December 29, 2013. (http://www.bloomberg.com/news/2013-12-30/unreported-robot-surgery-injuries-open-questions-for-fda.html.)