Permanent Allergan textured implant ban recommended
French regulator recommends a permanent ban on the sale of Allergan textured breast implants
Posted on 14 February 2019
On Friday, 8 February 2019, after two days of evidential hearings, an expert committee convened by the French regulator Agence Nationale de Securitie du Medicament (ANSM), recommended a permanent ban on the sale of Allergan textured breast implants across Europe.
The French regulator initially announced the temporary suspension of the Allergan CE mark during December 2018. At a public hearing, in Paris last week, the expert committee referenced concerns about the adverse health effects associated with breast implants, including a rare form of cancer known as BI-ALCL: BI-ALCL is associated with textured breast implants in general and a growing body of research now indicates a link with Allergan implants in particular.
As of 10 February 2019, the UK regulator, the MHRA, has yet to respond to the recommendations made by the French expert committee.
Leigh Day has been approached by a large group of women across the UK, all of whom have been implanted with textured Allergan implants, and many of whom are now concerned about potential health risks relating to their implants. In the last two weeks more than 150 women in the UK have been in touch with us, four of whom have been confirmed with ALCL diagnoses.
Zahra Nanji, Leigh Day solicitor, commented: “This latest intervention by the ANSM is to be welcomed. Based on available research, by banning textured Allergan implants from the European market, ANSM will be better protecting women across Europe from the rare, but potentially fatal, risk of BI-ALCL.
“According to our own regulator, the MHRA, there are currently just 47 confirmed cases of BI-ALCL in the UK. Experts suspect that number is likely to underestimate the real incidence rate of ALCL because the data is based upon the voluntary reporting of ALCL cases by surgeons and patients.”
The US regulator, the FDA, will meet next month to discuss implants safety. Further updates will follow.
Read the guidance from the MHRA for clinicians and patients on breast implants and ALCL.