ALLERGAN breast implants
The firm Allergan has marketed various types of textured breast prosthesis models since 1984.
In 2009, the first cases of anaplastic large cell lymphoma (ALCL) were identified on women wearing this type of breast implants. The number of cases of ALCL subsequently increased sharply from 2011 onwards.
The CE marking of these implants – a mandatory prerequisite for their marketing – expired on 16 December 2018.
On 2 April 2019, the French National Agency for the Safety of Medicines and Health Products (ANSM) banned the marketing, distribution, advertising and use of the macrotextured implants and implants with a texture equivalent to the envelope of the implants that were marketed by the company Allergan. This decision came into force on 5 April 2019.
The ANSM considered that:
‘it results from all the scientific data acquired, that breast implants with a macro-textured envelope as well as polyurethane breast implants present a risk of occurrence of LAGC-AIM; that by their implantation, these breast implants, are likely to constitute a rare but serious danger;’
‘that in view of the rare but serious danger that their implantation is likely to present, it is also appropriate to withdraw them from the market;’
This withdrawal decision concerns, in particular, the following Allergan brand implants:
- Natrelle 110
- Natrelle 110 Soft Touch
- Natrelle 120
- Natrelle 120 Soft Touch
- Natrelle 410 FL, FM, FF, FX, ML, MM, MF, LL, LM, LF, LX
- Natrelle 410 Soft Touch FL, FM, FF, FX, ML, MM, MF, LL, LM, LF, LX
- Natrelle 510 Dual Gel LX, MX, FX
- Natrelle INSPIRA TRX, TRF, TRM, TRL, TRLP
- Natrelle INSPIRA TSX, TSF, TSM, TSL, TSLP
What the firm does :
Le Tutour Avocats represent several women, French and foreign. They wear Allergan textured breast implants object of the ANSM withdrawal decision.
A pre-trial discovering proceedings is underway before the Paris Court of Justice. It aims at obtaining the communication of documents of the notified body that certified the breast implants as well as of Allergan’s French subsidiary.
This summary procedure will be pleaded in May 2023.
Contact : Solenn Le Tutour, avocate au barreau de Paris and Solicitor of England & Wales (NP)