What Is the da Vinci Surgical System?
The da Vinci Surgical System is produced by Intuitive Surgical and is a robotic surgical system that is designed to be as minimally invasive as possible. This robotic surgical system is meant to assist surgeons and can be used in a variety of different surgeries. The robotic surgical system was named after Leonardo da Vinci
What Procedures Can Be Done With da Vinci Robotic Surgery?
The da Vinci robotic surgery system is used for conditions that affect soft tissue and organs. The FDA approval for the da Vinci robotic surgery system includes general laparoscopic surgery, gynecological surgery, urological surgery, general non-cardiovascular thoracic surgical procedures, and thoracoscopically assisted cardiotomy procedures.
Da Vinci can be used to treat:
- Kidney disorders
- Kidney cancer
- Bladder cancer
- Coronary artery disease
- Colorectal cancer
- Uterine disorders
- Gynecologic cancer
- Prostate cancer
- Throat cancer
- Mitral valve prolapse
- Uterine prolapse
- Uterine fibroids
The Da Vinci robotic surgical system can also be used to perform hysterectomies and prostatectomies.
How Does the da Vinci Robotic Surgery Work?
The da Vinci surgical system uses robot-assist technology to perform complicated surgical procedures through a small incision. The system is operated by the surgeon through a console that controls the robot arm. After a small surgical incision is made, the surgeon inserts long, delicate instruments into the area to be operated on. The tools include an endoscopic camera with magnification, lighting, and temperature control on a control arm which allows the surgeon to see inside of the body. The camera along with other instruments, such as a scalpel, is manipulated through small hand movements on the control panel.
Because the surgery is being performed through a small incision rather than a large, open wound, there is much less bleeding and trauma than in traditional surgery procedures. When compared to open surgery, da Vinci robotic surgery leaves a much smaller scar, may reduce the risk of infection through exposure to air, hands, and surgical devices like suction and sponges, and may reduce the overall recovery time after surgery.
How Much Does a da Vinci Robotic Surgery Cost?
The cost of using the da Vinci robotic surgery system can be high. For the patient, it is not less expensive than other surgeries but is generally $3,000 to $6,000 more than laparoscopic procedures. It becomes even more expensive if complications arise and additional procedures such as open surgery are required.
For the hospital or surgical center, the da Vinci system is a large expenditure. Each machine may cost upwards of $2 million, with yearly maintenance costs of $100 thousand or more and each surgeon is required to undergo extensive training which may be costly. It can take years for hospitals to recover the costs of investment in a da Vinci system. In addition, many of the surgical procedures which resulted in patient injury have cited improper training of the operating surgeon as a cause, making the hospital and surgeon at least partially liable for potential lawsuits.
Despite the challenges regarding costs and liability for injuries, Intuitive Surgical, the da Vinci manufacturer is selling more units and has upwards of $700 million in annual revenue. The company is still facing many lawsuits regarding injuries caused by the devices and as the number of da Vinci procedures continues to rise, additional lawsuits may be expected.
How Much Does a da Vinci Hysterectomy Cost?
Da Vinci robotic hysterectomy is perceived as being safer and a more efficient form of surgery. Many women may also believe that it is less expensive than traditional surgery but this is not often the case. Da Vinci robot surgeries are generally more expensive than regular laparoscopic procedures and may be more expensive than vaginal hysterectomy. In addition, if the patient requires conversion to an abdominal hysterectomy, the costs may be incrementally higher.
Surprisingly, the da Vinci system which is used for robot-assisted hysterectomy costs the hospital upwards of $2 million and requires a commitment to yearly maintenance costs of more than $100 thousand. The training of surgeons may also be a significant expense as many physicians have stated that they are not comfortable with the minimum training offered and require additional training sessions to become proficient.
What Is a Hysterectomy?
A hysterectomy is a surgery to remove a woman’s uterus. It is the second most common type of surgery for women in the United States today and is surpassed only by cesarean section surgery Approximately 600,000 hysterectomies are performed each year.
Da Vinci hysterectomy is performed as an alternative to traditional methods which may include open surgery, laparoscopic surgery, or vaginal hysterectomy. It uses robot-assisted technology in which a console is used by the surgeon who can perform precise and complex manipulations of instruments through wrist action.
In ideal circumstances, however, the da Vinci robotic technology may offer an improvement over open abdominal surgery, but it still poses a risk of complications, some of which are new and unique to the procedure. When compared to traditional laparoscopic surgery, it may not offer improvement and is considerably more expensive.
What Are the Reasons for a Hysterectomy?
Hysterectomy involves surgical removal of the uterus and may be done for many reasons. It may be performed to improve a patient’s medical condition or may be required as part of life-saving treatment.
Da Vinci hysterectomy surgery is used to correct or treat:
- Prolapse of the uterus
- Cancer of the cervix, ovaries, endometrium, or uterus
- Severe pelvic pain or vaginal bleeding
What Types of Hysterectomy Are There?
There are three main types of hysterectomies:
What Is a Radical Hysterectomy?
A radical hysterectomy is most often performed to eliminate cancer. It involves the removal of the entire uterus, cervix, and upper part of the vaginal canal, as well as the ovaries and the fallopian tubes.
What Is a Total Hysterectomy?
A total hysterectomy involves removing the uterus and cervix. It often also includes the removal of the fallopian tubes and ovaries.
What Is a Partial Hysterectomy?
A partial hysterectomy involves the removal of the uterus either in part or in full but leaves the cervix intact.
What da Vinci Hysterectomy Complications Can Occur?
Several complications have been reported after undergoing da Vinci hysterectomy surgery. Some of the complications are the same as other types of hysterectomy, but others are only experienced during a da Vinci procedure.
What Is Vaginal Cuff Dehiscence?
During a radical or total hysterectomy procedure, both the uterus and the cervix are removed. This requires closure of the upper portion of the vagina, where the cervix used to be. Da Vinci hysterectomy may result in vaginal cuff tear or vaginal cuff dehiscence which occurs at the area where the vaginal cuff was closed. Vaginal cuff dehiscence occurs more frequently following hysterectomies that are performed through laparoscopic incisions like the da Vinci procedure than through abdominal or vaginal hysterectomy.
Vaginal cuff dehiscence should be treated as a medical emergency. If left untreated it may result in bowel evisceration in which the intestines fall through the opening.
Symptoms of vaginal cuff dehiscence may include:
- Abdominal pain
- Pelvic pain
- Vaginal discharge or bleeding
- Fluid rush out of the vagina
- The feeling of a large mass in the vaginal or pelvic area
- A sensation of pressure in the vaginal or pelvic region
How Can a da Vinci Hysterectomy Cause Severe Bleeding?
Open surgery may hold a higher risk for significant blood loss in a hysterectomy, however, severe bleeding may still be of significant concern in a da Vinci procedure. It is often necessary for the surgeon to cut into veins or blood vessels to remove the uterus, cervix, and ovaries. This may result in internal bleeding which requires cauterization, sutures, or other methods to control. If bleeding goes unnoticed or occurs after the procedure, significant blood loss may occur and the risk of infection or other complications may increase.
How Can a da Vinci Hysterectomy Cause Organ Perforation?
During a hysterectomy, other abdominal organs may be punctured or perforated. Hysterectomies performed with the da Vinci robotic surgery system may be done at an increased risk of organ perforation than open or abdominal surgery, as the space and vision field of operation may be limited during the procedure. In addition, inadvertent movement with the robot-assisted control arm may result in nicks or cuts to organs which can result in complications beyond what is intended.
How Could a da Vinci System Cause a Need for an Open Hysterectomy?
If complications occur during a da Vinci hysterectomy, or the machinery malfunctions, the surgeon may be forced to convert the procedure into a traditional open or abdominal surgery. This will expose the patient to more risks than simply performing the abdominal hysterectomy would have caused. The patient will face the risk of bleeding, increased anesthesia time, significant abdominal scarring, internal scar tissue, and significant recovery time.
Da Vinci robotic surgery procedures generally require that patients are placed in a head-down position which may result in fluid accumulation in the lungs. Due to the fluid buildup, the patient may require intubation to provide proper oxygenation. Patients who have da Vinci hysterectomy may be at increased risk for pneumonia due to fluid accumulation and intubation equipment.
Is There Compensation for da Vinci Hysterectomy Injuries?
While most da Vinci-assisted hysterectomy surgeries may be completed successfully, there have also been many incidents reported to the FDA. Most of these had to do with either product malfunction or surgeon inexperience. People who have been harmed by a da Vinci robotic hysterectomy may be eligible for compensation for their injuries and should seek legal advice.
What Are the Drawbacks of a da Vinci Surgery?
Da Vinci surgery may have revolutionized invasive surgery, but it has also created unique problems. With the only vision allowed through the endoscopic camera, the surgeon’s field of vision may be limited. This may impede the surgeon’s ability to maneuver and may fail to identify additional issues that may have been obvious in another type of surgery.
The da Vinci robotic surgery system requires a period of training and may be difficult for some surgeons to become proficient at. This may be particularly true of older surgeons who are not accustomed to technological advances. Consequently, the vast experience that more established surgeons have may be lost to the patient.
What Are the Side Effects of a da Vinci Surgery?
Robot-assisted surgical technology like the da Vinci robotic surgery system allows the surgeon to perform precise, complex movements through wrist movements using an electronic console. It was designed to reduce the risks inherent in a traditional open surgery by operating through a small incision; reducing infection risk, blood loss, and recovery time.
Unfortunately, robot surgery is not without risks and a da Vinci robotic surgery may cause serious side effects, complications, and injuries.
What Complications Can Occur With a da Vinci Surgery?
The following are complications that can occur when the da Vinci system is used in surgery:
- Bowel tear or perforation
- Bladder perforation
- Punctured uterus
- Perforation or puncture of other organs
- Electrocution or electrical burns
- Severe bleeding
- Increased anesthesia time
- Internal scarring
- Required conversion to traditional surgery
What Are the Most Common da Vinci Surgery Injuries?
Between 2000 and 2013, 10,624 reports for injuries or adverse events associated with the da Vinci robotic surgery system were listed in the FDA’s MAUDE database. These reports included 8,061 device malfunctions, 1,391 injuries, and 144 deaths associated with the da Vinci system.
Though it represents only a fraction of the 1.5 million surgeries that were performed in the same period, some experts believe that the number of serious adverse events may be severely underreported. In addition, many of these events may have been preventable.
The most common da Vinci robot injuries include:
- Bowel or bladder injuries
- Punctured or cut ureters
- Perforations or tears in organs
- Burns to organs
Many of these issues may be attributable to either a lack of proper training or Da Vinci robot malfunctions.
How Can Surgeon Inexperience Cause a da Vinci Surgery Injury?
Surgeon inexperience has been cited as a major cause of da Vinci robot injuries. The use of robot-assisted technology may not come naturally to all physicians. It requires the surgeon to become comfortable operating on a patient using an electronic control panel and hand/wrist controls that may be similar to a joystick. The company requires only a few sessions for training but many have said this is inefficient.
Surgeons must complete the following steps to use the device:
- Complete one hour of online instructional training
- Watch two complete da Vinci robotic procedures (four hours)
- Spend at least seven hours in practice operation (on a pig)
- Perform at least two surgeries under the supervision of an experienced robotic surgeon
Some hospitals or healthcare groups may require more training but few require more than five supervised surgeries and some company sales representatives may have tried to get hospitals to lower their requirements.
How Can da Vinci Device Malfunction Cause Injury?
Device malfunction has also been cited as a major cause of negative outcomes. One series of events was caused by a device accessory which was ultimately recalled. The da Vinci EndoWrist Monopolar Curved Scissors attachment developed invisible cracks in several cases. This allowed electricity to arc, resulting in internal burns to the patient. In other cases, a robotic arm broke free of control and hit a patient in the face.
In cases where device malfunction or other complications result in long surgery or a requirement to convert the procedure to open surgery, the patient may be placed at added risk and may have resulted in at least one death. Many patients have decided to seek restitution for their injuries, and families of patients that have died as a result of da Vinci-related injuries are also seeking compensation for their loss.
How Often Are Adverse Effects From da Vinci Reported?
A study authored by a Johns Hopkins Hospital physician showed that many cases of da Vinci robot injury are incorrectly reported or simply, not reported at all. Many injuries and deaths that may be linked to da Vinci robot-assisted surgery may not occur during the patient’s hospital stay but may be delayed for weeks, months, or even years before requiring treatment.
When symptoms occur after the patient has returned home, both the patient and their primary care physician may be unaware that an illness or event is related to the surgery. The operating surgeon may not be informed of the event if the illness is treated only by the primary physician and no report is ever filed with the FDA. FDA adverse event reporting is voluntary and though the agency recommends that they be notified, there are no regulations that require reporting.
Has the FDA Recalled the da Vinci Surgical System?
In July of 2013, the Food and Drug Administration (FDA) issued a warning letter regarding the da Vinci robotic surgery system.
The letter stated that Intuitive Surgical, Inc. was subject to several violations including:
- Misbranding of device components due to improper labeling
- Refusal or failure to provide certain information
- Failure to submit reports regarding corrective actions
In 2015, the FDA noted that an increased number of adverse event reports had been received by the agency. Most of the reports involved complaints about device malfunction, mechanical issues, component breakage, and computer display issues, however, a number of the reports indicated severe injuries or even deaths that had been caused by the devices.
What da Vinci Lawsuit Settlements Have There Been?
In 2013, Intuitive announced they were setting $67 million aside to be used for 3,000 complaints that had been filed against the company. Rather than going to court, the company decided to offer settlements. This allowed them to avoid costly litigation and deny responsibility while still compensating the complainants.
The first jury trial involving da Vinci robot surgery was conducted in May of 2013. The plaintiff was the family of a prostatectomy patient who had died four years after the surgery from complications associated with the procedure. The jury ruled in favor of Intuitive Surgical, finding that the company was not negligent in training the surgeon involved in the case. Intuitive Surgical placed the blame for the negative outcome on the surgeon who had allegedly ignored guidelines despite numerous health concerns with the patient.
In April 2016, the second of the da Vinci robot injury trials went to court. The plaintiff was a woman who claimed that she had been injured during a hysterectomy procedure. The case was settled while the jury was in deliberations, for a total of $30 million offered to the plaintiff.
What da Vinci Lawsuits Are There?
More recently, Intuitive Surgical has faced lawsuits from anti-trust organizations as well as class-action lawsuits from hospitals. These lawsuits have claimed that Intuitive has a virtual monopoly on robotic surgical aids and that the company has threatened to brick hospitals’ da Vinci systems if they seek services or repair for the machines from a company other than Intuitive.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.