According to the FDA, robotically assisted surgical devices allow doctors and surgeons to use computer software to direct surgical instruments via robotic arms. Robotic surgical systems, such as the da Vinci surgical system, usually accomplish the surgery with less invasive incisions. The patient recovers more quickly, but reports suggest the surgery is less effective long-term than traditional methods.
DaVinci Robotically-Assisted Surgical Device
The New York Times reveals that the da Vinci surgical system was approved for sale in 2000 under the FDA’s 510(k) premarket notification process. This process allows the sale and use of medical devices without substantial clinical trials or safety testing as long as the device is “substantially similar” to a device already on the market.
According to the FDA, robotically assisted surgical devices are cleared for cardiac, colorectal, gynecologic, head and neck, thoracic, and urologic surgical procedures. The device can also remove the prostate, perform hysterectomies, and be used for gallbladder removal.
Despite studies showing adverse results, these devices have not been approved to cure or treat cancer, yet surgeons regularly employ them to treat various cancers. One study, published in the New England Journal of Medicine showed that women who underwent hysterectomies to treat cervical cancer via robotic surgery experienced six times as many deaths as women who underwent traditional surgery.
This is because the da Vinci system can malfunction or show an inaccurate image of the operation site. The patient may have to be under anesthesia longer. They may require hand-assisted surgery (which requires a bigger incision). The Davinci system may also cause inadvertent injury to surrounding tissue.
Contact a New York defective medical device lawyer
You may be entitled to financial compensation if you or a loved one suffered an injury after undergoing robotically-assisted surgery. The legal team at Hach & Rose, LLP is prepared to build your case. We will help you understand the complexities of this type of lawsuit. This type of surgery may leave you worse off than you started. We want to do the legal legwork so you can focus on getting better. Call our office at (347) 318-9604 to discuss your options today.