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  • Regulatory NewsRegulatory News

    Dutch Report Finds Silimed Breast Implants Carry Little Risk to Patients

    Particle contamination on the surface of breast implants made by Brazilian devicemaker Silimed poses, at worst, a "one in a million" risk to patients, according to a report released on Monday by the Dutch National Institute for Public Health and the Environment (RIVM). Background Last fall, EU regulators suspended all CE certificates for Silimed devices after German notified body TÜV SÜD found man-made fibers on the surface of the company's implants. After the inspec...
  • Regulatory NewsRegulatory News

    MHRA Calls for Continued Quarantine of Silimed Implants

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Friday reiterated its call to quarantine implants manufactured by Brazil’s Silimed, saying it’s still trying to determine if there are potential health risks associated with particles found on the surface of the devices. The caution from MHRA comes a day after Jeffrey Nugent, Sientra chairman and CEO, a US-based supplier of Silimed products, sent a letter to plastic surgeons informing them that an indep...
  • Regulatory NewsRegulatory News

    FDA Calls for 'Cautionary Approach' on Brazilian Manufacturer's Suspended Implants

    The US Food and Drug Administration (FDA) told RAPS' Regulatory Focus that it concurs with breast implant provider Sientra's caution in voluntarily placing a temporary hold on the US sales of all devices from Brazilian implant manufacturer Silimed. "We concur with Sientra’s recommendations to take a cautionary approach until more is known, and we are actively working with the company and other international regulators to investigate the issue. The FDA is in close c...
  • 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...
  • Regulatory NewsRegulatory News

    MHRA Suspends All Devices from Largest South American Silicone Implant Manufacturer

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA), alongside EU member state regulators, announced Wednesday the suspension of all CE certificates for medical devices made by Brazilian manufacturer Silimed. The suspension comes as a German notified body recently inspected one of the Brazilian manufacturing sites of Silimed, which claims to be the largest manufacturer of silicone implants and the largest breast implant manufacturer in South America, and ...