Events

Safety Alert Or Field Safety Notices for All Bard urogynaecological mesh

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by C.R. Bard.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2018-03-07
  • Event Date Posted
    2019-03-07
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/all-bard-urogynaecological-mesh-voluntary-product-withdrawal-implanted-devices-do-not-need-to-be-removed-mda-2019-014
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
    Bard has chosen to stop production and distribution of these devices. They are removing all urogynaecological mesh products from hospitals and distribution centres.Bard has taken the decision to stop production of these devices as part of its business strategy. We understand from Bard’s explanation that they are stopping production rather than continuing to invest in clinical data to support additional EU requirements. Therefore, implanted devices don’t need to be removed and no additional follow-up is required for patients implanted with these devices.We have continued to work closely with NHS England, NICE and professional bodies, and we are all committed to helping address the serious concerns raised by women who have experienced complications with mesh devices.We encourage anyone – patient, carer or healthcare professional – who is aware of a complication after a medical device is implanted, to report to us via the Yellow Card scheme, regardless of how long ago the implant was inserted.
  • Reason
    Manufactured by c.R. bard (becton, dickinson and company (bd)) – surgical mesh for stress urinary incontinence (sui) and pelvic organ prolapse (pop) is being withdrawn from hospitals and distribution centres.
  • Action
    If you work in procurement or are a healthcare professional:Identify and quarantine affected, unused devices listed in the manufacturer notice from BARD Ensure, in cooperation with implanting surgeons, that suitable alternative devices are available Follow the actions listed in the manufacturer notice from BARD Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do notIf you are a patient and have this device implanted:You don’t need to have the device removed or have any extra follow-up checks Read the manufacturer notice from BARD If you have any concerns about your implanted device, contact your GP or healthcare professional Report any problems you have with the mesh to the Yellow Card Scheme in England or the appropriate authority in Scotland, Northern Ireland and Wales

Device

All Bard urogynaecological mesh
  • Model / Serial
  • Product Description
    All urogynaecological mesh products for SUI and POP manufactured by C.R. Bard. See the manufacturer notice from BARD for a full table of devices affected
  • Manufacturer
    C.R. Bard

Manufacturer

C.R. Bard