Medical Device Alert issued for urogynaecological mesh manufactured by C.R. Bard
A Medical Device Alert has been issued on C.R. Bard removing all surgical mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) from the market.
We are aware C.R. Bard have decided to stop selling all urogynaecological mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) and intend to withdraw remaining supply EU-wide.
It’s important to note, there are no specific safety concerns associated with this recall and there is no need for people to have the device removed or have any extra follow-up checks.
If you have any questions about your implanted device, please speak to your implanting surgeon or clinic.
Further information
The safety and efficacy for the use of these products, and the associated surgical procedures to implant them, has not changed.
This product withdrawal only affects Bard’s urogynaecological mesh products, this withdrawal will not create a supply issue.
We encourage anyone, patient, carer or healthcare professional, who is aware of a complication or adverse event associated with a medical device, to report to us via the Yellow Card scheme.
MHRA have issued a Medical Device Alert.
For our media statement and further information, please contact newscentre@mhra.gov.uk