Solicitors who represent 20 women who have been diagnosed with or investigated for Breast Implant Associated Lymphoma, known as BIA-ALCL, have welcomed the news that the Medicine and Healthcare Authority (MHRA) has finally published a field safety notice regarding ‘Allergan Textured Breast Implants and Tissue Expanders’.
A field safety notice (FSN) is an important communication about the safety of a medical device that is sent to customers by a device manufacturer, or their representative. The purpose of a FSN is to outline actions to be taken in relation to specified risks of using a medical device. When a product is suspected or known to pose a risk the UK regulator, the MHRA, works with manufacturers and wholesalers on the most appropriate action to take. In the case of Allergan Biocell textured implants this has been Allergan’s recall and removal of the implants from the supply chain.
The FSN follows Allergan’s voluntary worldwide recall of Biocell textured breast implants and Biocell textured tissue expanders following notification by the US Food and Drug Administration (FDA) of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The FDA's notification to Allergan came as a result of analysing worldwide reports of a total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis. In addition, 12 out of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan breast implant at the time of their diagnosis. The manufacturer and/or texture is unknown for the remaining 20 reported deaths from BIA-ALCL.
Based on the currently available information, the FDA concluded that its analysis demonstrated that the risk of BIA-ALCL with Allergan Biocell textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. It also concluded that continued distribution of Allergan's Biocell textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.
Allergan has therefore now recommended that healthcare providers globally cease implanting Biocell textured breast implants and Biocell textured tissue expanders. They have requested that all unused product be returned to Allergan. The recall does not affect Allergan’s smooth breast implants and tissue expanders.
The MHRA FSN confirms that this action has already been completed for CE Mark governed countries in Europe. It also notes that the FDA and other global health authorities recommend not removing or replacing textured breast implants or textured tissue expanders in patients that are not showing any symptoms.
Zahra Nanji, who represents 20 women who have been diagnosed with or investigated for BIA-ALCL, alongside solicitor Sarah Moore, said:
“It is good to see that the FDA has taken the lead in analysing the worldwide data as it emerges surrounding the incidence of BIA-ALCL, after previously only requiring a ‘Black Box Warning’ but no ban on the Allergan textured implants in the US in May 2019. It reinforces our view that there needs to be proper regulation and ongoing monitoring of products by our own regulator, the MHRA, so that when worrying trends in data arise, the UK regulator can be proactive rather than reactive in their approach. This will allow any risks posed by a product to be dealt with swiftly to ensure that people are protected from avoidable risk.”