Advantage and Advantage Fit System (Transvaginal Sling) / Lynx System (Suprapubic Sling) / Obtryx System (Curved or Halo; Transobturator Sling) / Obtryx II System with PrecisionBlue Design (Curved or Halo; Transobturator Sling) / Solyx SIS System (Single Incision Sling) / Uphold LITE Vaginal Support System with Capio SLIM / Pinnacle LITE Pelvic Floor Repair Kit (Posterior with Capio SLIM) / Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device
“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.”