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  • Regulatory NewsRegulatory News

    Fallout Continues from MHRA Suspension of Brazilian Manufacturer's Implants

    Two days since the UK's Medicines and Healthcare products Regulatory Agency (MHRA) halted all sales of Silimed's silicone implants, and at least two other regulators have followed suit, while Silimed insists its devices are safe and has criticized MHRA's criteria for particle levels. Background MHRA on Wednesday suspended the CE certificates of the Brazilian device manufacturer Silimed, which claims to be the largest manufacturer of silicone implants and the largest b...
  • Brazil: New Brazilian Standards For Breast Implants

    The new Conformity Assessment standards for silicone in breast implants were released on 9 April by the Brazilian National Institute of Metrology, Quality and Technology (Inmetro). The standards permit a company to choose between two different routes for obtaining Conformity Assessment.  The first involves manufacturing site certification of the Quality Management System through audits and testing of samples. The second provides for lot-by-lot certification a...
  • British Government Launches Investigation of PIP Implants

    UK Health Secretary Andrew Lansley launched an investigation in to breast implants made by the now-bankrupt French Poly Implant Prothese (PIP) on 31 December, saying that he wants to " reassure women […] that we will act swiftly to help them ." Some 40,000 British women have the implants, which reports have claimed are rupturing at excessively high rates.  Britain's Medicines and Healthcare Products Regulatory Agency (MHRA) is now slated to re-review the devi...