BACKGROUND: Procedure-based surveys oflaparoscopic entry access injuries show a reassuringly low incidence, varying from 5 per 10,000 to 3 per 1,000, and, consequently, can provide only limited specific injury data. The current study uses existing injury-based reporting systems to access a uniquely large number of entry injuries to define the nature and outcomes of such events. STUDY DESIGN: Claims arising from US and non-US entry access injuries, between 1980 and 1999, reported to the Physicians Insurers Association of America by their member and affiliate companies and entry-injury medical device reports to the US FDA, from 1995 through October 1997, were analyzed to determine operative procedures, physician specialties, entry devices, and techniques associated with specific injuries. Individual injuries were analyzed for their relative incidence and potential to cause disability and death. RESULTS: Five hundred ninety-four structures or organs were injured in 506 patients, resulting in 65 deaths (13%). General surgical procedures made up at least 67% of combined medical device reports and US Physicians Insurers Association of America cases, and gynecologic procedures accounted for 63% of non-US claims. Bowel and retroperitoneal vascular injuries comprised 76% of all injuries incurred in the process of establishing a primary port. Nearly 50% of both small and large bowel injuries were unrecognized for 24 hours or longer. Delayed recognition, along with age greater than 59 years and major visceral vascular injuries, were each independent significant predictors of death. CONCLUSIONS: No entry technique or device is absolutely safe. Avoidance of entry injuries depends on patient-specific anatomic orientation and control of entry axial force. Certain entry devices can be facilitating in controlling axial force. Overall, this large aggregate of entry access injuries shows them to be more serious and, along with other data, implies that they might be more common than reported in procedure-based studies.
BACKGROUND: Procedure-based surveys oflaparoscopic entry access injuries show a reassuringly low incidence, varying from 5 per 10,000 to 3 per 1,000, and, consequently, can provide only limited specific injury data. The current study uses existing injury-based reporting systems to access a uniquely large number of entry injuries to define the nature and outcomes of such events. STUDY DESIGN: Claims arising from US and non-US entry access injuries, between 1980 and 1999, reported to the Physicians Insurers Association of America by their member and affiliate companies and entry-injury medical device reports to the US FDA, from 1995 through October 1997, were analyzed to determine operative procedures, physician specialties, entry devices, and techniques associated with specific injuries. Individual injuries were analyzed for their relative incidence and potential to cause disability and death. RESULTS: Five hundred ninety-four structures or organs were injured in 506 patients, resulting in 65 deaths (13%). General surgical procedures made up at least 67% of combined medical device reports and US Physicians Insurers Association of America cases, and gynecologic procedures accounted for 63% of non-US claims. Bowel and retroperitoneal vascular injuries comprised 76% of all injuries incurred in the process of establishing a primary port. Nearly 50% of both small and large bowel injuries were unrecognized for 24 hours or longer. Delayed recognition, along with age greater than 59 years and major visceral vascular injuries, were each independent significant predictors of death. CONCLUSIONS: No entry technique or device is absolutely safe. Avoidance of entry injuries depends on patient-specific anatomic orientation and control of entry axial force. Certain entry devices can be facilitating in controlling axial force. Overall, this large aggregate of entry access injuries shows them to be more serious and, along with other data, implies that they might be more common than reported in procedure-based studies.