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MHRA statement on Allergan

Statement from the Medicines and Healthcare products Regulatory Agency on Allergan suspending sales of textured breast implants and tissue expanders in Europe.

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We are aware Allergan have stopped selling textured breast implants and tissue expanders and intend to withdraw remaining supply in European markets.

There is currently no evidence of an increased risk to patients and there is no need for people who have Allergan breast implants to get them removed or have any additional clinical follow-up.

We are monitoring the situation closely and will provide updates as necessary.

If you have any questions about your implants, please speak to your implanting surgeon or clinic.

Further information

The CE certificate for textured breast implants and tissue expanders manufactured by Allergan expired as of 16 December.

Allergan are working with their notified body GMED, based in France, to resolve the issue. In the interim, they have stopped selling textured breast implants and tissue expanders and intend to withdraw any remaining supply in European markets.

MHRA is acting as lead co-ordinator to make sure Allergan takes a consistent EU-wide approach.

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.

Allergan have issued a Field Safety Notice.

Published 19 December 2018
Last updated 24 December 2018 + show all updates
  1. Updated to include a link to the Yellow Card Scheme.
  2. Updated to include link to Field Safety Notice from Allergan.
  3. First published.