Da Vinci Prostatectomy
For patients facing the onset of an enlarged prostate or prostate cancer, the Da Vinci prostatectomy method allows physicians to perform the necessary prostate surgery robotically. These highly-technical devices come both with benefits and possible risks, giving rise to an increasing number of robotic surgery lawsuits.
At the crux of Da Vinci robot litigation is the question of whether the risks of robotic surgery were fully disclosed and whether patients were given enough information about the pros and cons of the surgery to make an informed choice.
Robotic surgeries across multiple areas of medicine have become an increasingly popular alternative due to the reduced recovery time and smaller incision site as compared with traditional and laparoscopic methods.
How Da Vinci is used in robotic prostate surgery
According to the National Cancer Institute, as many as four out of five prostatectomies are performed using the Da Vinci robotic device. Moreover, the use of the Da Vinci robotic system skyrocketed from 9,000 in 2004 to 58,000 in 2008. This increased popularity has resulted in the installation of the Da Vinci robotic surgery system in over 1,000 hospitals across the United States.
The Da Vinci system relies upon a small camera inserted into the affected area. The surgeon, who is actually seated at a computer console, is able to manipulate the camera along with highly-mechanized instruments in order to perform the prostatectomy procedure. The procedure requires very few, small openings as opposed to a traditional or laparoscopic incision.
The prostatectomy procedure is not uncommon, as prostate cancer is the second most common cancer in men. This form of cancer occurs when malignant cells encapsulate the delicate tissues of the prostate gland, which comprises the male reproductive system and is situated below the bladder.
Benefits and risks of Da Vinci robotic prostate surgery
As aforementioned, the benefits of robotic surgery include a smaller incision site and, as a result, a shorter recovery period. Other studies have reported that robotic surgery may be linked with decreased blood loss and a lower chance of potentially dangerous scarring.
As more prostatectomy patients opt for the robotic method of prostate repair, risks of this procedure have begun to emerge, leading many to believe it may not be as safe as once thought. In addition to the increased cost of robotic surgery, the procedure can take significantly longer than open or laparoscopic prostatectomy.
Other reported side effects of the Da Vinci robotic surgery include:
- Damage or burns to surrounding organs, including the bladder and urethra
- Excessive bleeding
- Impotence
- Erectile dysfunction
- Incontinence
- Painful revision surgery
The sheer cost of maintaining a Da Vinci robotic system has proven difficult for some smaller hospitals. The cost for a single Da Vinci system ranges from $1.2 to $1.7 million, including an $150,000 annual maintenance contract. As well, the system requires approximately $2,000 in disposable equipment for each use, adding an estimated $4,800 to the cost of the prostatectomy procedure when compared with traditional or laparoscopic approaches.
The FDA addresses Da Vinci robotic surgery
The FDA began investigating the safety of the Da Vinci robotic surgical system following a spike in reported problems, including the death of a prostatectomy patient after suffering a colon perforation during the procedure. The FDA has, so far, offered physicians and surgeons the opportunity to complete a survey as to the safety and effectiveness of the product and whether its benefits likely outweigh the risks.
Surgeons have also reported bizarre and unexpected incidents involving the Da Vinci robot. In one case, a robotic arm grabbed ahold of a patient’s tissue, refusing to release. In a second, unrelated, incident the robotic arm reportedly hit the side of a patient’s face during surgery.
The Da Vinci robotic surgery device is currently the only robotic arm approved for soft-tissue surgical procedures. The FDA has recently approved robotic devices for other types of surgeries, including neurological and orthopedic procedures.
Robotic surgery litigation
To date, Da Vinci is facing several dozen lawsuits filed by patients having endured problems following the robotic prostatectomy procedure. Complaints filed against the company allege painful da Vinci robot side effects including infection, damaged blood vessels and bowel injuries.
While only one Da Vinci robotic arm lawsuit has reached a verdict (in favor of the defendant), plaintiffs continue to pursue their claims of medical malpractice and product liability against Da Vinci and its manufacturer Intuitive Surgical.
In another lawsuit, surviving family members received a $7.5 million jury verdict after their loved one died immediately following robotic surgery to the spleen. This case, however, hinged on the determination that the doctor performing the robotic procedure had never actually participated in robotic surgery before and was found to be negligent while performing the operation.
- National Cancer Institute: Tracking the Rise of Robotic Surgery for Prostate Cancer, http://www.cancer.gov/ncicancerbulletin/080911/page4
- NBC News: Robotic prostate surgery comes with a trade-off, http://www.nbcnews.com/id/33291388/ns/health-cancer/t/robotic-prostate-surgery-comes-trade-off/#.U3PEdoFdXyM
- Da Vinci Surgery: Facing Prostate Cancer Surgery? http://www.davincisurgery.com/assets/docs/prostatectomy-prostate-cancer-en-870033.pdf
- Da Vinci Surgery: About Prostate Cancer, http://www.davincisurgery.com/da-vinci-urology/conditions/prostate-cancer/
- New York Daily News: Surgical robot da Vinci scrutinized by FDA after deaths, other surgical nightmares, http://www.nydailynews.com/life-style/health/surgical-robot-scrutinized-fda-deaths-nightmares-article-1.1311447