Events

Alerte Ou Avis De Sécurité sur All Bard urogynaecological mesh

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par C.R. Bard.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Date
    2018-03-07
  • Date de publication de l'événement
    2019-03-07
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    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 / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    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