Physicians, health plans, hospitals, pharmaceutical companies, and medical device manufacturers have all recognized the benefits of marketing their products and services directly to the end user. As a result, there has been tremendous growth of direct-to-consumer advertising (DTCA), illustrated by the increase in spending on DTCA related to prescription drugs from an estimated $55 million in 1991 to $3.2 billion in 2003. This increase in DTCA has sparked vigorous debate among the major stakeholders in healthcare over the benefits and drawbacks of advertising directly to the healthcare consumer. Issues with DTCA include its impact on the doctor-patient relationship, patient education, inappropriate resource utilization, healthcare costs, healthcare quality, and overall patient wellbeing. Orthopaedic surgery is no longer insulated from this expanding trend in DTCA, as orthopaedic surgeons and hospitals are responsible for a substantial portion of DTCA related to orthopaedic devices and procedures. The Food and Drug Administration has a limited regulatory role and limited power related to DTCA due to considerable inefficiencies in its review and disciplinary processes. Therefore, physicians, including orthopaedic surgeons, must take a leadership role on this issue to ensure the integrity of information provided to patients and to protect the sanctity of the doctor-patient relationship.