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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...
  • Amidst European PIP Scandal, FDA Approves New Breast Implant Product

    The US Food and Drug Administration (FDA) approved Sientra, Inc.'s breast implant product on 9 March, making Sientra the third approved marketer for breast implant products in the US. The approval comes amidst a world-wide scandal about breast augmentation products manufactured by French company Poly Implant Prothese (PIP), which has been under fire for manufacturing implants using industrial grade silicone. PIP's products have also been the subject of concerns of abnorm...