Da Vinci Lawsuit News

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Investors Alarmed over da Vinci Surgical Robot’s Drop in Sales

Investors of Intuitive Surgical became concern on the decline of sales of the company’s flagship medical device. According to an article published online, the sale of da Vinci surgical robot dropped to 22.8 percent selling only 138 units in 2013 compared to 175 in 2012. Each robotic device cost a staggering $1.5 million.   Da Vinci surgical robot has been under controversy due to its serious side effects that puts the lives of patients in danger. It was alleged that the company failed to informed potential patients and doctors alike of the possible side effects caused by the device. Da Vinci is popularly used in procedures, such as hysterectomies, prostatectomies, gall bladder removal and lobectomies.     READ MORE: Intuitive Surgical’s Earning Down Due to Slowing da Vinci Robot Sales

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Serious Harm Caused by Robotic Surgery

Despite being popular, there have been reports of patients complaining that robotic surgery has caused them serious injuries during or after the surgery. Regulators have already taken note of the complaints. The Food and Drug Administration (FDA) opened an inquiry this year into the safety of the da Vinci system following numerous adverse event reports. Federal regulators are looking into a sharp rise in injury and death reports in da Vinci surgeries. At least 71 people have died since 2000, according to a recent study. The reports include severe burns to internal tissue, pierced arteries and organs, and internal bleeding that is not discovered for days. Intuitive faces lawsuits from dozens of patients who say they were harmed.

The da Vinci system is branded as a minimally invasive alternative to many forms of laparoscopic and traditional abdominal and pelvic surgery. To use it, a surgeon watches a computer monitor displaying images from inside the body and manipulates the robot's arms through a console of hand controls and foot pedals.

Patients are now choosing hospitals because they offer robotic surgery, which makes them come across as more technologically advanced even though some critics say there's no evidence to suggest the robots or the hospitals have better outcomes than their competitors. However, many of the reported injuries at other hospitals appear as if they could have been caused by surgeons' inexperience.

The FDA has advised potential patients are suggested to consult their respective doctors and gather some information in order to determine if robotic surgery is the best for them.

References:

modernhealthcare.com/article/20130525/MAGAZINE/305259977

ocregister.com/articles/robot-527186-ahlering-company.html

bloomberg.com/news/2013-03-20/robot-surgery-risk-needs-disclosure-as-injuries-rise.html

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Robot-Assisted Hysterectomies More Costly

 Although hysterectomy is considered to be one of the most regularly performed procedures in women, the need for such procedure often lies in question, health care providers say. Several major procedures are now being offered by hospitals and surgeons with robotic-assistance. However, the use of robots during hysterectomy may not be cost-effective and may have the same results as that of minimally invasive techniques already in use, according to Dr James Breeden, president of the American Congress of Obstetricians and Gynecologists (ACOG). The number of hysterectomies performed with robots continue to rise but the importance of such operation is still being questioned.

The second most performed surgical procedure in women in the United States alone is the surgical removal of the uterus which may include the cervix, fallopian tubes and ovaries, according to the data from the Centers for Disease Control and Prevention (CDC). The thrust in avoiding hysterectomies is to prevent diseases that may lead to this surgical procedure. The minimally invasive procedure may be performed  among women who are free from complications. Hysterectomies and other major operations are now making use of these surgical robots.

A hysterectomy is medically necessary if it has the following characteristics:

- Unmanageable infection and bleeding - Cancer in the uterus, cervix, vagina, fallopian tubes or ovaries that are invasive - Complication in childbirth endangering the mother’s life

Health care providers are advised by the National Women’s Health Network (NWHN) to try other means first before resulting to this surgical procedure. Complications may arise when the surgical removal of women’s reproductive organs is done when it is not needed. Hysterectomies performed with robotic assistance did not provide any clear advantage on minimally invasive hysterectomies but was seen to be more expensive, findings from a recent study published in the Journal of American Medical Association (JAMA) show.

The findings of the study question the use of robots in regular hysterectomy, especially if they are not making any significant change in performance and result. The learning curve in the use of this technology may also be seen as a disadvantage because only a handful of surgeons are able of properly mastering its use. Studies regarding the use of these robots and their short- and long-term effects may be needed to ensure feasibility and safety in suing such technology.

  URL References:

nwhn.org/hysterectomy cdc.gov/reproductivehealth/WomensRH/Hysterectomy.htm jama.jamanetwork.com/article.aspx?articleid=1696087 usatoday.com/story/news/nation/2013/02/19/robotic-hysterectomy-jama-laparoscopic/1928689/

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Is Da Vinci System the Future of Surgery?

 The number of Da Vinci Surgical System increases as hospitals across the United States are slowly adding it in the services they offer, online sources say. The Food and Drug Administration (FDA) has permitted the use of the Da Vinci Surgical System in various surgical procedures, according to the manufacturer Intuitive Surgical. The numerous benefits it may offer makes the robotic system something that health care providers dream for the future of surgery. Several hospitals have already invested in robotics to provide better services to their patients.

This is the first of its kind and patients are lining up to feel the difference. The design of the robot has been found to be greatly beneficial and makes performing procedures easy for health care providers. However, this technology is still new and may have other safety concerns that are not yet seen or known and continuous observation is being done by the FDA.

Benefits of patients may include:

- Enjoy short stays in the hospital

- Blood loss is lessened

- Risk of infection is decreased

- There may be little to none scaring

- Return to normal activities is achieved in the soonest time possible due to faster healing

- Decreases the number of transfusions needed - Post-operative pain is lessened

Health care providers share the impression that they, too, have seen the differences between robotic-assisted surgery and the traditional way. Surgeons were able to experience the following during robotic-assisted surgery:

- Increased self-confidence after completing each operation

- Precise cutting and suturing

- Removes tremors and unsteady hand movements

- Enhanced dexterity in handling instruments

- Better visualization through 3-dimensional view with depth perception that is controlled by the surgeon

There are several areas that may lead to long-term effects, according to some critics. The cost of these machines also makes it inaccessible to other hospitals. Already crowded operating rooms will also find it hard to fit the massive size of the surgical robot and its system. It will only be feasible if the rooms are made larger or the robot is made into smaller versions, health care providers say. Compatible instruments with the robot are also limited.

Although several of the problems may be remedied through time, current safety issues need an immediate response from the manufacture. Reports have been documented as regard the link of robots with the some of the incidences in operating rooms.

URL References: ncbi.nlm.nih.gov/pmc/articles/PMC1356187/ mhyork.org/Documents/News/MedLine February 2011.pdf intuitivesurgical.com/company/regulatory-clearance.html