Taking into account both the scientific data currently available regarding BIA-ALCL (breast implant-associated anaplastic large cell lymphoma) and the ethical principles governing the practice of medicine, the Professional Board of Plastic Surgeons, convened under the aegis of the SoFCPRE, now recommends no longer placing macrotextured breast implants of the Biocell® type from the Allergan® brand, due to the over-representation of these implants in this condition.
The Board remains cautious regarding other macrotextured implants and polyurethane-coated implants, for which work is continuing to determine any possible exposure to risk.
Regarding women with Biocell®-type macrotextured breast implants, the Board does not recommend systematic preventive removal, as the risk of BIA-ALCL occurring is extremely low.
As with all women with breast implants, the Board recommends, together with its regulatory bodies, annual monitoring with their surgeon, gynecologist or primary care physician (clinical examination, ultrasound and MRI at the slightest doubt).
In the event of significant effusion, increase in volume, pain, inflammation, or any abnormality affecting the breast, regardless of when it occurs, or in the event of trauma to the breast, a medical consultation is essential.
In the absence of clinical or radiological abnormalities, however, there is no need to change the frequency or methods of annual monitoring.
In the event of implant removal or replacement, samples of the peri-prosthetic capsule or of any effusion should systematically be taken for the Lymphopath network.
Deeply concerned about the health of their patients, French plastic surgeons have been focused on the issue of BIA-ALCL since January 2011 and work closely with their regulatory bodies (DGS, ANSM, InCA) and with international scientific societies (ASAPS) toward this end.
Despite the large number of unknowns, it now appears that implant texturing could play a significant role in the occurrence of BIA-ALCL. Thanks to its Lymphopath network, unique in the world, France has been able to record 50 cases of BIA-ALCL from 2009 to July 2018. In most of these cases, the implants involved had a textured surface. In this regard, French plastic surgeons issued a recommendation for caution in 2017 regarding the use of macrotextured implants and the relative nature of their indication. Since then, following the conclusions of work commissioned by the ANSM and published in July 2018, breast implants are now classified into 4 categories according to the nature of their surface: smooth, microtextured, macrotextured, and polyurethane-coated.
While France is the only country in the world to have a network of expert "Lymphopath" centers, it is nonetheless behind in setting up a national breast implant monitoring registry. In collaboration with the Federation of Medical Specialties (FSM) and the ANSM, the Professional Board of Plastic Surgeons has nevertheless developed such a registry, which has been operational for 3 years, but whose implementation has unfortunately been hindered to date by CNIL administrative procedures.
While the topic is concerning, a sense of proportion must be kept, and the public should not be needlessly alarmed. BIA-ALCL is so rare that the risk is still very difficult to quantify. For the same reason, it is not possible to precisely identify the risk factors associated with this condition, which are likely multiple. Alongside implant surface texturing, the role of certain microbes and genetic predisposition have also been implicated, and these too require further study.
Whether in reconstructive surgery (breast reconstruction) or cosmetic surgery (breast augmentation with prostheses or implants), and when no reasonable alternative solution exists, the Board emphasizes that the benefits that breast implants provide to patients currently far outweigh the risk of BIA-ALCL.
For the Professional Board of Plastic Surgeons, November 22, 2018
Catherine BRUANT-RODIER, President of the SoFCPRE and of section 50 of the CNU
Gilbert VITALE, President of the SoFCEP
Véronique MARTINOT-DUQUENNOY, President of the College
Sébastien GARSON, President of the Union and of the Plastirisq accreditation body
Stéphane de MORTILLET, Secretary of the SoFCPRE's breast surgery and oncoplasty chapter
Marc REVOL, Secretary General of the SoFCPRE
Michel ROUIF, Secretary General of the SoFCEP
Richard ABS, Secretary General of the Union and Secretary of the SoFCPRE's aesthetics chapter
Eric ARNAUD, Secretary General of the College and of the Plastirisq accreditation body
