The authors reviewed treatments performed worldwide using extracorporeal shock wave lithotripsy since its introduction in West Germany in 1980 to determine the efficacy of this treatment modality and its potential risks. The prevention of complications related to patients or shock wave energy are discussed, as well as the cardiovascular complications related to immersion, prevention of lesions to nearby organs, treatment of ESWL-induced bleeding, treatment of post-ESWL ureteral obstruction, prevention and treatment of infection, and long-term biological effects. Currently, less than 5% of patients are excluded from treatment with ESWL due to technical reasons or increased risk of periprocedural complications. Patients with cardiac pacemakers have been treated safely. Calcifications of the ipsilateral renal artery or aorta are considered only relative contraindications. However, certain technical limitations exist; i.e., the Dornier HM-3 cannot support patients weighing more than 135 kg., and patient height is also a limiting factor. There is an impressively low incidence of complications related to the energy of the shock wave. The severity and extent of damage are dose- and pressure-dependent. The potential for induction of cardiac arrhythmias secondary to the shock wave exists; however, effective prevention is achieved by coupling the shock wave discharge to the electrocardiogram. Complications of immersion are also extremely rare and can be avoided by careful preoperative evaluation. Damage to nearby organs such as pulmonary, gastric, duodenal or colonic contusions, constitute a very infrequent complication. Elevations of liver enzymes have also been noted post-lithotripsy. However, all these changes were transient and had no significant clinical consequences. Management of post-ESWL ureteral obstruction is by endourological procedures.(ABSTRACT TRUNCATED AT 250 WORDS)