We invite you to learn more about laparoscopic procedures, trocars and related issues in this section. Included here are summaries of published reports and journal articles, along with links to websites that will provide you with more information about these issues.
As of 2003, there were more than 2 million laparoscopic procedures performed in the United States and that number continues to rise. As the popularity of laparoscopic surgery has increased, so has the injury rate related to the use of trocars. The U.S. Food and Drug Administration collects information on reported injuries from medical devices, including trocars. The FDA did a special study on trocars from 1997 to mid-2002, and noted more than 1300 laparoscopic trocar-associated injury reports, including reports of approximately 30 deaths. (1) Hemorrhage due to blood vessel injury and infection secondary to bowel injury, especially when diagnosis is delayed, are the most serious complications and the most likely to result in death. The FDA made several recommendations on managing this risk associated with trocar use that will hopefully reduce injuries in the future. These included better training on new devices, selecting patients more carefully, applying ergonomic principles to allow better control of instruments and patient education. However, even with the newer trocars that have safety shields, injuries can still occur. In 1996, an analysis of trocar injuries found that 29-39% of the cases involved shielded trocars. It is suggested that even though the shielded trocars provide an additional margin of safety, the shield may create a false sense of security for the surgeon, leading to over-reliance on it. (1) So even with improvements in trocar design, the risks continue.
Trocar injuries are the subject of many malpractice lawsuits. In cases of serious injury or a fatality, the jury verdicts can be quite large. Here are a few cases and their outcomes from the last few years, taken from various public information sources:
- New York: Jury awarded $2.5 million to a patient whose aorta and vena cava were transected during trocar insertion; the patient survived but suffered a major hemorrhage
- Pennsylvania: Jury awarded $5 million to a patient whose bladder was perforated by a trocar and suffered a serious infection but recovered
- Illinois: Jury awarded $2 million to survivors of a woman who died after her liver was lacerated during a trocar insertion
- New York: The family of a woman sued when the woman's sigmoid colon was perforated during a laparoscopic procedure; they settled for $1 million
- Pennsylvania: Jury awarded $1.2 million to a patient whose iliac vein was lacerated during trocar insertion, resulting in vascular congestion and nerve compression
- New York: A woman settled for $700,000 for peritonitis resulting from a perforated colon during a laparoscopic procedure
- Illinois: A jury awards $409,090 to a patient whose bladder perforation and resulting peritonitis occurred during laparoscopic surgery
What can surgeons and malpractice insurers do? In defending these cases, surgeons are measured as to whether they met the 'standard of care' within the community. To meet the standard of care, surgeons should be aware of the available trocar systems and their safety features, and selection of which one to use should not always be based on personal preference but the inherent risk of each needs to be considered. The surgeon must also use the trocar system that another surgeon in the same situation would have selected. Additionally, the surgeon's level of expertise and the patient's history should be considered. Even in the best of circumstances, however, surgeons are still found medically liable for an injury in malpractice cases because the plaintiff's attorney could argue that sharp trocars are inherently dangerous and therefore not defensible. (2) Until and unless risks are reduced through widespread use of additional safety devices, the rate of malpractice cases due to trocar-related injuries will likely continue.
Cited references and links:
1.Laparoscopic Trocar Injuries: A report from a U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Systematic Technology Assessment of Medical Products (STAMP) Committee, November 7, 2003.
2.Liability Risks Associated with Trocar Selection During Laparoscopy, by Brad L. Hilaman, M.D., J.D, Department of Legal Medicine, Armed Forces Institute of Pathology, 2002.
The following article also addresses trocar injuries:
"The Trouble with Trocars", by Linda Carroll and Alfred Lubrano, Smart Money, November 2001.http://www.taut.com/SmartMoney%20Reprint-2.pdf