Safety Alert for (i). Breast Implant PIP: Mammary Implant filled with high rotation gel cohesiveness - Registration No. 80152300006; (ii). Breast Implant ROFIL: (1). M-Implant Breast Implant - Registration No. 80413800002; (2). ROFIL silicone breast prosthesis - Registration No. 80168150006; (3). Hydrogel Breast Implant ROFIL - Registration No. 80168150007; (4). ROFIL Mamária cohesive gel prosthesis - Registration No. 10438690002

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.

Within the research process of the problems presented by the breast implants described above, ANVISA, in partnership with other entities of the SNVS, carried out tax collection of several batches of breast implants for analysis in a specialized laboratory. These analyzes need to be performed in intact samples, so that the items in standards are observed. Products removed in the surgical process are considered health care waste and do not need to be submitted to laboratory analysis in this investigation. RDC No. 306, of December 07, 2004, which provides for the Technical Regulation for the management of health services waste, defines that health services are responsible for the correct management of all wastes generated by it, legal requirements, which will apply to the prostheses explanted. According to RDC No. 306/2004, breast implants fall into the Group A4 - Wastes with the possible presence of biological agents that, due to their characteristics, may present a risk of infection, such as containers and materials resulting from the health care process , which do not contain blood or body fluids in the free form. These residues may be disposed, without previous treatment, in a place duly licensed for final disposal of Health Services Waste and must be disposed of according to item 1.2 of RDC No. 306/2004, that is, in a milky white bag, to be replaced when (i). 2% of its capacity or (ii). at least once every 24 hours. For its identification, it complies with the requirements set forth in item 1.3.3 of the Resolution (as set forth in item 8 of the resolution). The surgically removed breast implants can be delivered to the patient at the request of the patient. However, the health service must proceed with the sterilization of the device and the sterilization package must be broken before delivering to the user. The interested party must sign a receipt and responsibility (guidelines according to Technical Opinion No. 06/2009 / CINFS / GGTES / ANVISA, dated March 27, 2009).