Intuitive Surgical Perspective on da Vinci® Surgery Safety, Clinical Data and Marketing
For more than 15 years, Intuitive Surgical has focused on advancing surgical technology while consistently maintaining a “patients first” philosophy. The da Vinci Surgical System has brought minimally invasive surgery to more than two million patients worldwide.
Safety & Efficacy
The most appropriate way to evaluate safety and efficacy of any surgical approach is through clinical data. The clinical literature (peer-reviewed publications written by surgeons) for robotic-assisted surgery is extensive.
Recent clinical literature includes several studies that use national databases to evaluate thousands of patient outcomes. These studies compare da Vinci Surgery to non-robotic-assisted approaches for specific procedures, such as prostatectomy (removal of the prostate) and hysterectomy (removal of the uterus).
For prostatectomy, two of the larger studies 1,2 demonstrate that da Vinci Prostatectomy is safer than the prior standard of open surgery. Complications, death, blood loss, and length of hospital stay are all substantially better (statistically significant margin) for da Vinci Prostatectomy patients.
For hysterectomy, two representative studies3,4 show that da Vinci Hysterectomy is as safe as laparoscopy and also reduces the length of hospital stays.
Marketing & Patient Education
We believe in educating hospitals, surgeons, and patients about the existence of da Vinci Surgery, its use and potential benefits, as well as the risks and alternatives. Intuitive is an industry leader in providing a fair and appropriate discussion of these points in our marketing and promotional materials.
Selection of a surgical or treatment approach requires a detailed dialogue between the physician and patient about the specific condition(s) and the surgeon's experience with all types of surgery. Although we believe marketing plays a role in educating patients and surgeons about surgical options, the ultimate decision must always be made by the patient and surgeon through their personal consultation.
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The links below lead to material relevant to media professionals.
1 Liu et. al., "Perioperative Outcomes for Laparoscopic and Robotic Compared with Open Prostatectomy Using the
National Surgical Quality Improvement Program (NSQIP) Database", European Urology (2013),
2 Kowalczyk et. al., "Temporal National Trends of Minimally Invasive and Retropubic Radical Prostatectomy Outcomes from2003 to 2007: Results from the 100% Medicare Sample", European Urology (2011), doi:10:1016/j.eurouro.2011.12.020
3 Lau et. al. "Outcomes and Cost Comparisons After Introducing a Robotics Program for Endometrial Cancer Surgery", Obstetrics & Gynecology (2012), DOI: 10.1097/AOG.ob013e31824c0956
4 Wright et. al. "Robotically Assisted vs Laparoscopic Hysterectomy Among Women With Benign Gynecologic Disease", JAMA 2013;309(7):689-698
Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Examples of serious or life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to, one or more of the following: injury to tissues/organs, bleeding, infection and internal scarring that can cause long-lasting dysfunction/pain. Risks of surgery also include the potential for equipment failure and/or human error. Individual surgical results may vary.
Risks specific to minimally invasive surgery, including da Vinci Surgery, include but are not limited to, one or more of the following: temporary pain/nerve injury associated with positioning; temporary pain/discomfort from the use of air or gas in the procedure; a longer operation and time under anesthesia and conversion to another surgical technique. If your doctor needs to convert the surgery to another surgical technique, this could result in a longer operative time, additional time under anesthesia, additional or larger incisions and/or increased complications.
Patients who are not candidates for non-robotic minimally invasive surgery are also not candidates for da Vinci® Surgery. Patients should talk to their doctor to decide if da Vinci Surgery is right for them. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed decision. For Important Safety Information, including surgical risks, indications, and considerations and contraindications for use, please also refer to http://www.intuitivesurgical.com/safety. Unless otherwise noted, all people depicted are models.
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