Boston Scientific Urogynaecological Surgical MeshesAdvantage/Advantage Fit, Transvaginal Sling, Lynx, Suprapubic Sling, Obtryx, Transobturator Sling (Curved/Halo), Obtryx II with PrecisionBlue Design, Solyx SIS, Single Incision Sling; Uphold LITE Vaginal Support with Capio SLIM Pinnacle LITE Pelvic Floor Repair Kit, Posterior with Capio SLIM, Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device; XenformTM Soft Tissue Repair Matrix

Fabricante

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA