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Context
Since 1984, Allergan has marketed various models of textured breast implants.
In 2009, the first cases of anaplastic large cell lymphoma (ALCL) were identified in women with this type of breast implant. The number of ALCL cases then rose sharply from 2011 onwards.
The CE marking for these implants a mandatory requirement for their marketing expired on December 16, 2018.
On April 2, 2019, the French National Agency for Medicines and Health Products Safety (ANSM) banned the marketing, distribution, advertising, and use of macrotextured implants and implants with a texture equivalent to the shell of implants marketed by Allergan. This decision came into effect on April 5, 2019.
Consideration by the ANSM
On the basis of all available scientific data, it follows that macrotextured breast implants, as well as polyurethane-coated breast implants, present a risk of developing breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). By virtue of their implantation, such breast implants may therefore constitute a rare but serious hazard. In light of the rare yet serious risk that their implantation is liable to pose, it is accordingly appropriate to withdraw these breast implants from the market.
Implants subject to the withdrawal
This withdrawal decision applies in particular to the following breast implants manufactured by Allergan
- 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
Action by Le Tutour Avocats
Le Tutour Avocats represents several women, both French and foreign nationals, who have received textured Allergan breast implants subject to the ANSM’s withdrawal decision.
Ongoing Legal Proceedings
Pre-discovery proceedings are currently pending before the Paris Judicial Court. Their purpose is to obtain disclosure of documents held by the notified body that certified the breast implants, as well as by Allergan’s French subsidiary.
These summary proceedings are scheduled to be heard in May 2023.