Events

Recall of 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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Boston Scientific Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00120-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00120-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The tga carried out a clinical review of urogynaecological surgical mesh implants which have highlighted the importance of:- appropriate patient selection;- surgeon experience; and- the need for fully informed patient consent.Boston scientific (bsc) has made important updates to the directions for use (dfu) for the meshes. these updates are based on bsc’s review, as well as input from the tga. contraindications, precautions, and adverse events have been updated to present the most comprehensive and up to date information available.
  • Action
    The DFU for all Boston Scientific's surgical meshes were reviewed and updated to ensure consistency and alignment of language across the product lines. The customer letter identifies what amendments have to made to the DFU. This action has been closed-out on 27/01/2017.

Device

Boston Scientific Urogynaecological Surgical MeshesAdvantage/Advantage Fit, Transvaginal Sling, L...
  • Model / Serial
    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 SlingARTG 104326Uphold LITE Vaginal Support with Capio SLIM Pinnacle LITE Pelvic Floor Repair Kit, Posterior with Capio SLIM, Upsylon Y Mesh Kit with Colpassist Vaginal Positioning DeviceARTG 150342XenformTM Soft Tissue Repair MatrixARTG 174878
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “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