Vaginal mesh from Bard removed from the EU markets

12 March 2019

The company Bard has decided to stop the sale of vaginal mesh implants on the markets in the EU. The decision is based on commercial reasons according to Bard.

The mesh concerned is used in surgery for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) and comes from the company C.R. Bard (Becton, Dickinson & Company (BD).

The products have been reported in both Danish and international media, for instance, in connection with a Danish DR documentary on medical devices which aired in autumn 2018. 

According to the information that we have received from Bard and the Danish Urogynaecological Society, the products being removed from the markets in the EU are not marketed in Denmark. However, the products have been used before, and there are Danish women who have had vaginal mesh from Bard implanted. According to Bard, the decision to remove the products from the market is not related to any safety concerns. Women who have a vaginal mesh implanted therefore do not need to do anything as a result of the product withdrawal.

Bard has issued a so-called Field Corrective Action to its customers and users. You can read it here: Notice to customers and users about Pelvic Organ Prolapse and Stress Urinary Incontinence Mesh Devices from C. R. Bard, Inc.