Alerta De Seguridad para MAMMARY IMPLANT FILLED WITH HIGH COESIVITY GEL (Anvisa reg.: 80152300001); MENTAL IMPLANT FILLED WITH HIGH ROTATION GEL COESIVITY (reg. Anvisa: 80152300006).

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.

Anvisa decided to suspend the marketing, distribution, importation and use of breast implants manufactured by the French company Poly Implant Prothese (PIP) through Resolution RE 1558/2010 (of April 1, 2010) throughout Brazil. The suspension was due to the risk associated with the products mentioned. The holder of the registration in Brazil is the company EMI Importação e Distribuição Ltda. Over the past three years, the French Agency for Sanitary Safety of Health Products (AFFSAPS) has seen an increase in reports of rupture of breast implants manufactured by Poly Implant Prothese. The rupture of the envelope of a mammary prosthesis can lead to local complications in the patients, often requiring surgery to correct the problem. After an inspection at the Poly Implant Prothese plant, AFSSAPS found that the gel filled the prosthesis manufactured by the company was different from that reported in the technical documentation of the product - documentation sent to AFSSAPS at the time of CE certification of the products. Therefore, prostheses do not comply with Directive 93/42 / EC (European Community). In addition, the AFSSAPS identified that the prostheses manufactured by the company are in disagreement with the ASTM F 703 standard, presenting a greater probability of diffusion of silicone through the prosthesis membrane. According to the French agency, this may explain the increase in the number of reports of rupture associated with these breast implants. Regarding Brazil, Anvisa has not, to the present moment, reports of adverse events or technical complaints involving these breast implants in its database of notifications (NOTIVISA). The Technovigilance Unit is following this case with the registration holder. #### Update: AFSSAPS announced on September 28, 2010 a statement on the test results, performed between June and September 2010, regarding the silicone gel used in PIP prostheses. According to the statement from the French agency: (1) Cytotoxicity tests have shown that the silicone gel of PIP prostheses has no toxic effect on tissues; (2) Intradermal irritation tests showed that the gel of PIP prostheses is more susceptible to causing intradermal irritations in patients when compared to other brands of silicone prosthesis; (3) One of the tests of mechanical resistance (elongation to rupture) performed for the envelope (external material of the prosthesis) showed an out-of-specification test, showing that it was a more fragile material than usual; (4) Genotoxicity tests have not yet been finalized by the French agency - the disclosure of results by AFSSAPS is scheduled for early 2011. For people who have PIP implants implanted and who, in the last 6 (six) months, have not undergone examinations ultrasound monitoring, it is recommended to perform this type of examination (ultrasound) to check the state of the implanted prosthesis. The remaining recommendations for users are retained (see the Action Description field in this alert). #### Update: The results of the genotoxicity tests performed by AFSSAPS were released on 04/14/2011 and no cytotoxic or genotoxic effects were observed in the in vitro tests. The results of genotoxic effects tests were not conclusive in in vivo tests. The in vivo intradermal irritation assessment tests for the PIP silicone gel showed that it has a higher irritating power relative to other silicone gel brands. For more recent information on the case, consult the Alert of Technovigilância n ° 1107, available at http://www.anvisa.gov.br/sistec/alerta/RelatorioAlerta.asp?ComeName=CO_SEQ_ALERTA&Parametro;=1107.