What is a robotically-assisted surgical device, and is it safe?

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 and the patient recovers more quickly, but reports suggest that the surgery is not as effective long-term as traditional methods.

Reporting from the New York Times reveals that the da Vinci surgical system was approved for sale on the market in 2000 by 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 be used for removal of the prostate, hysterectomies, and gall-bladder removal.

These devices have not been approved to cure or treat cancer, and yet surgeons regularly employ them to treat various cancers, despite studies that show adverse results. 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, may require the patient to be under anesthesia longer, may require hand-assisted surgery (which requires bigger incision), and may cause inadvertent injury to surrounding tissue.

Contact a New York defective medical device lawyer

If you or a loved one suffered an injury after undergoing robotically-assisted surgery, you may be entitled to financial compensation. The legal team at Hach & Rose, LLP is prepared to build your case and help you understand the complexities involved with this type of lawsuit. This type of surgery may leave you worse off than you started, and we want to do the legal legwork so you can focus on getting better. Call our office at [phone number] to discuss your options today.

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