The CE certificate for textured breast implants and tissue expanders manufactured by Allergan (Microcell ® and Biocell ®) expired on 16 December 2018.
The MHRA has advised that Allergan has stopped selling these implants and expanders, and intends to withdraw all remaining supply in European markets.
ABS advises that any of these implants manufactured from 17 December 2018 onwards must not be used.
Implants manufactured before 17 December 2018 remain CE marked and therefore could be used. However, before doing so, you should consider if it is wise to use an implant or expander that is no longer being manufactured and is being withdrawn.
You must discuss the issue with any patient in whom you are considering using one of these textured expanders or implants, and should give them the choice of using another implant or postponing their surgery.
Smooth implants and expanders manufactured by Allergan still have a CE mark.
The MHRA advises that patients who have already Allergan breast implants or expanders do not need to have them removed or replaced.
ABS continues to work with the MHRA about this issue, and the Association's advice will be updated if further information becomes available.
Mark Sibbering
President