Historical Example of Surgical Innovation 1:
Laparoscopic Cholecystectomy
Cholecystectomy used to be a relatively invasive operation, performed as an open surgical procedure. Technological and surgical advances, however, have outdated this technique and instead replaced it with a laparoscopic procedure that permits shorter post-op stays and reduced discomfort for patients. This progress involved the combination of two relatively established techniques, each with a proven safety record: open cholecystectomy, a method trusted for more than a hundred years, and laparoscopic surgery, which had also been in use for many years. To the chagrin of patients eager for the benefits of laparoscopy, the marriage of these two technologies resulted in unforeseen safety problems. Initially, the rate of biliary tract injury in the United States increased from 1,500 to 4,000 instances per year. These complications often involved complex injuries that required difficult biliary reconstructions and prolonged hospitalizations. Many cases have ended in subsequent litigation.
Laparoscopic cholecystectomy was rapidly disseminated across the United Stated, rarely being subjected to IRB evaluation by individual institutions. Many surgeons did not recognize the need for IRB approval or formal research on the technique prior to its use. Some randomized trials pointed to discrepancies in the two procedures, but the scale of these experiments was too narrow to detect differences in fairly sporadic outcomes such as biliary tract injuries. It was only through scrutiny of a series of cases involving biliary injuries in a New York registry system that surgeons became aware of the larger problem associated with the procedure.
The hurried implementation of laparoscopic cholecystectomy demonstrates that innovative techniques may seem benign and reliable when in fact they are harmful to patients. This procedure, which involved the combination of two established techniques, had effects that were unexpectedly flawed and unsafe. It highlights how innovative procedures can be hastily incorporated into mainstream clinical practice despite potentially harmful consequences for patients. It also emphasizes the need for effectively evaluating how much research on an innovative technique is necessary before its introduction, and why performing an appropriate investigation is absolutely essential to detect shortcomings.