The reason for this measure is new safety data regarding the rare cases of anaplastic large cell lymphoma associated with breast implants.
Allergan, UK products are in the market: 'Breast implant filled with gel, Natrelle' (registration certificate 26.02.2018 N2 FSZ 2009/05895), 'Natrelle 133 Plus tissue expander' (registration certificate 14.02.2017 FSH 2010/06196), 'Breast implant filled with saline gel, additionally filled with saline, injection port, Natrelle 150' (registration certificate of 26 February 2014, FSH 2010/06197).
"This action is a precautionary measure against recently updated global safety data obtained and published by the US Food and Drug Administration (FDA) on rare cases of anaplastic large breast lymphoma associated with breast implants," the company explained.
Allergan ceases distribution and sale of textured breast implants and tissue extensions of Biocell in all markets where the product is present. With the immediate effect of this decision, healthcare professionals no longer have to use textured breast implants and tissue extensions of Biocell, and unused products must be returned to Allergan.
It is emphasized that the FDA does not recommend the prophylactic removal or replacement of textured breast implants in asymptomatic patients. In case of concern, patients are advised to contact their plastic surgeon.