Retention of medical records of patients with high-risk medical devices

Legislation mandates that all adult medical records be retained for a minimum of 7 years from the time of last patient contact, after which they can be destroyed. Exceptions to this requirement exist for young patients, and there are state-by-state variations, but there is no legislative requirement to retain records of patients who have implantable, high-risk devices. This is disturbing because many of these devices have an in vivo lifespan that exceeds 7 years. Of particular concern are patients with breast implants whose records may have been destroyed before a diagnosis of breast implant-associated anaplastic large cell lymphoma, which has an average latency period from implant to diagnosis of 9 years.1 Later presentations of this lymphoma are not uncommon, with latency intervals up to 23 years;2 therefore, it is imperative that implant details are retained to enable us to better understand the pathophysiology of this potentially fatal disease, which has been strongly associated with deeply textured surface implants. While the Australian Breast Device Registry (ABDR) is a safe repository for secure information on patients who are registered, those patients who are not may be at risk of losing important information about their implants. Furthermore, the expected lifespan of in vivo breast implants is at least a decade,3 so records may have been discarded at the time of patients presenting with serious implant-related problems. In our efforts to improve the safety of patients with breast implants, 30% of whom are breast reconstruction cases for cancer or congenital deformities, we encourage all practitioners to ensure that their patients are registered with the ABDR so their implant details are securely stored.4 In an effort to preserve the details of all Australian patients with breast implants, the ABDR can also store patient implant details retrospectively and will accept information from Australian patients having cosmetic tourism surgery overseas, after which significant complications can arise.5 It may be time, however, for legislation to be enacted to lengthen the mandatory retention period for patients with high-risk devices or to make it legally compulsory for practitioners inserting high-risk devices to enrol all patients into a clinical quality registry such as the ABDR.