Alerta De Seguridad para Metal-metal prostheses

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

1. The ANVISA Technovigilance Unit is following the discussions; 2. the registry holders of products in Brazil were contacted, who informed that they did not receive complaints involving their products; 3. The NOTIVISA database, adverse event notification or technical complaint involving this technology has not been included so far; 4. Publication available on the FDA website on the internet reinforces some of the care already applied to patients who need implants or who have undergone orthopedic implant surgeries: (i). To choose the type of implant, a physician should choose to use a metal-to-metal hip implant only after determining that the benefit-risk of using one metal to metal exceeds the use of another type of technology; (ii). Patients implanted should be monitored periodically, through physical and imaging exams; (iii). The decision to review a metal-to-metal hip implant should be made according to the patient's clinical situation.