The Court of Cundinamarca ordered the Regulatory Authority (INVIMA in Spanish) to pay a woman compensation of 40 monthly minimum wages , for irregularities in the health registration of the PIP breast implants (Poly Implant Prothèse). Apparently, the implants did not fulfill quality standards for their use given there was not enough information submitted to warrant their safety and nevertheless, registration was granted.
The Court took into consideration a Technical Monitoring report from November of 2010, which states that “the Colombian importer Medical International S.A. did not submit relevant or sufficient information in order to warrant the safety of the components in PIP breast implants”. The Court reminded that all necessary tasks that the INVIMA must carry out before registration can be granted must be rigorously meticulous and not limited to sole documentary review.
Original source in Spanish: http://bit.ly/2Tjs42o
