Extracorporeal Shock-Wave Biliary Lithotripsy

To the Editor: Multiple treatment options should be available for patients with symptomatic gallstones — traditional and laparoscopic cholecystectomy, oral bile acids, biliary lithotripsy, contact dissolution agents, and percutaneous cholecystolithotomy. Unfortunately, some of these treatments may never truly be options. In the case of biliary lithotripsy, approval is stalled in the regulatory process. In 1989 the Food and Drug Administration denied premarket approval to two lithotripsy companies, and there was resultant confusion about how to correct the "deficiencies" identified by the panel. On August 2, 1990, two years after clinical trials had begun and 10 months after the first panel . . .