01.04.2019
Discontinuation of sale of mesh produced by C.R. Bard, Inc. for pelvic organ prolapse and stress urinary incontinence, and its removal from hospitals and distribution centres
Affected products
Products for the treatment of pelvic organ prolapse: Alyte® Y-Mesh, Nuvia® SI prolapse repair system, Avaulta® Solo mesh and Avaulta® Plus mesh
Products for the treatment of stress urinary incontinence: Ajust® single-incision vaginal sling, Ajust® helical single-incision sling, Align® urethral support system, Align® trans-obturator urethral support system
A list of the product codes concerned is contained in the appended letter from the manufacturer.
Manufacturer
C. R. Bard, Inc., a wholly owned subsidiary of Becton, Dickinson and Company (BD)
Reason for publication
Swissmedic was informed by the manufacturer regarding its decision to discontinue production and distribution of the above-mentioned products and to remove the products from hospitals and distribution centres.
This action has not been taken because of safety concerns regarding these products, nor are patients required to take any further precautionary measures. You can obtain further information about this in the manufacturer's information letter.
Swissmedic is publishing this decision because of the interest currently being shown by the media in the use of pelvic floor meshes and incontinence slings.
Notice for patients: If you have health concerns connected with your implants, please consult a healthcare professional.
Description of the risk
This action is not being taken because of safety concerns regarding these products.
Recommended action
Swissmedic recommends:
- Follow the manufacturer's instructions (see attached information letter from the manufacturer).
Contact
Swissmedic
Swiss Agency for Therapeutic Products
Medical Devices Division
Hallerstrasse 7
3012 Bern / Switzerland
Tel.: +41 58 462 02 23
Fax: +41 58 462 76 46
Internet: www.swissmedic.ch/md
E-mail: medical.devices@swissmedic.ch