Does Electronic Identification Enablement for Silicone Gel Implants Impact Patient Safety?

Life-Cycle traceability for medical devices is critical for assurance of patient safety and of great concern for manufacturers, healthcare providers and global regulatory authorities. Electronic tracking technologies are relied upon to maintain traceability integrity throughout the supply chain until device use, or in the case of implantable medical devices, placement in the patient. Active implantable medical devices, such as cardiac pacemakers can be identified in vivo but passive medical device traceability post-implantation must rely on patient registration cards and patient history records. Motiva Implants® with Q Inside Safety Technology™ silicone gel-filled breast implants contain a radiofrequency identification device and are the first passive devices that can be identified in vivo, but its presence creates an artifact during MRI, raising the concern of possibly missing a cancer diagnosis during surveillance of high-risk patients. Dual-modality imaging, using MRI and ultrasonography when the artifact is present is essentially equivalent to MRI alone when the artifact is not present, based on a number of potentially missed cancer detections per 1,000 screening exams. The Number Needed to Harm (NNH) with MRI with artifact present and obstructing 5.37% of the breast implant image indicates one high-risk patient with a cancer reoccurrence would likely be missed for every 596 high-risk patient screening exams performed. Likewise, when dual modality of MRI and ultrasonography are used to study the high-risk patient group, it would take 17,892 screening exams before a patient with cancer recurrence is likely to be missed (false negative). The addition of ultrasonography to the artifact void area mitigates the impact of the artifact quite substantially. Concerning traceability, the ratio of electronic in vivo assures a 100% traceability benefit (high-risk patients with cancer not missed in imaging studies) to the harm caused by the artifact (high-risk patients with cancer missed in imaging studies). Even for the MRI study alone with the artifact, 100% traceability finds a 22.84-fold increase in the number of patients benefiting over the number of patients harmed. Dual-modality improves this ratio up to a 710.96-fold increase of the number of patients benefiting over the number of patients harmed.