In March 2017, the FDA finally issued a warning confirming that breast implants cause BIA-ALCL cancer (LAGC in FRANCE) but the history of breast implants causing lymphoma cancer associated with breast implants goes back much further. The first case of lymphoma due to breast implants was reported in 1997, and for many years many cases of BIA-ALCL have occurred and have been reported, but there appears to have been a rejection of BIA-ALCL and other cancers by regulators. breast implants and associations of plastic surgeons and plastic surgeons. Despite all these cases of BIA-ALCL and other cancers occurring and being reported, FDA and FDA-approved manufacturers have approved more textured implants for sale as late as September 23, 2016 knowing that textured implants are particularly related and responsible of BIA-ALCL. In fact, the incidence rate of BIA-ALCL for Allergan textured implants (old and new) is about 1 in 4,000 from American and Australian studies, but other types of implants also cause BIA- ALCL. Women have difficulty in having the plastic surgeon recognize the importance of BIA-ALCL and the need to test it. If you have textured implants and symptoms of BIA-ALCL, you must push for tests at the time of your explant.
LYMPHOMA ASSOCIATED WITH BIA-ALCL BREAST IMPLANTS is a type of non-Hodgkin’s lymphoma, a cancer of the immune system cells (not the breast) that can be caused by breast implants. The main symptoms of BIA-ALCL are persistent swelling or pain in the vicinity of the breast implant, seroma, breast mass, capsular contracture, swollen lymph nodes and are usually associated with textured implants but not always. These symptoms may appear after healing of the surgical incision of the implant and may often appear several years after the implant is placed. If you have swelling, pain, seroma, breast mass, capsular contracture or swollen lymph nodes and especially if you have textured implants, please push hard for BIA-ALCL tests. Surgeons should consider the possibility of ALCL when they have a patient with a late onset and persistent fluid around the implant (peri-implant seroma) before and / or during the explant or have symptoms after the implant. explant. In the analysis of ALCL at the time of the explant, surgeons must collect fresh liquid serum and representative portions of the capsule and send pathology tests. The test is called CD-30 and CD-20 immunochemistry and few plastic surgeons are familiar with BIA-ALCL at this stage, it will be up to you to educate your plastic surgeon and persist in getting the test if you have symptoms and / or textured implants.
Anaplastic large cell lymphoma associated with breast implants: an infectious origin?
31 JAN 2017
Evaluation Question: The number of reported cases of anaplastic large cell lymphoma in women with breast implants (LAGC-AIM) has increased in recent years. The link between breast implants and the occurrence of LAGC-AIM is now clearly established. The aim of this study is to search for a biofilm on the surface of the implants breast implants. The bacterial species constituting it are then characterized in order to compare them with the flora found on breast implants incriminated in cases of capsular contractures (CC).
Type of study: Comparative prospective bacteriological study of breast prostheses associated with cases of LAGC and those responsible for CC.
– Patients with LAGC-AIM and CC;
– Collection of different explanted prostheses; biofilm research, estimation of the bacterial load and characterization of bacterial species in presence via molecular biology techniques (PCR, pyrosequencing, FISH);
– Observation of the surface of implants by scanning electron microscopy (SEM).
Prospective collection of 26 implants (n = 22 patients) of LAGC-AIM patients plus 3 contralateral implants in 4 centers, and 62 implants (n = 62 patients) of patients with high grade DC in 6 centers for 5 years ,
Bacterial burden: higher (p = 0.035) in LAGC and CC cases compared to contralateral implants. No difference between LAGC and CC populations.
Nature of the bacteria:
Prevalence of Ralstonia spp. on LAGC-associated implants (p <0.05) Prevalence of Staphylococcus spp. on implants associated with CC (p <0.001) SEM: visualization of a biofilm and lymphoma cells on LAGC-associated implants and a biofilm on CC-associated implants. Highlights: This study is the first to look for a biofilm on LAGC-associated breast implants and to characterize the bacterial species that constitute it. For the first time, the hypothesis of an infectious etiology is advanced to explain the occurrence of this rare form of lymphoma. Weak points : Ralstonia spp. not found on the surface of half of the implants associated with LAGC (9/19). This point is not discussed by the authors. Biofilm studied on a reduced number of implants associated with DC (12/62) without justification of the authors, with in some cases the presence of Ralstonia spp. Periods and locations of prosthesis collection are not detailed, as are local flora, including Ralstonia spp., Sites of intervention. Pretreatment of collected biological samples (non-fresh tumor material, search for biofilm applied to a limited portion of tissue). Conclusion: This study demonstrates the almost systematic presence of bacterial colonization on breast prostheses. This biofilm has a proven role in the occurrence of capsular contractures or anaplastic large cell lymphomas. Although it is neither necessary nor sufficient, the demonstration of Ralstonia spp. implies, according to the authors, the need to develop and disseminate a prevention strategy concerning the bacterial colonization of such implants. More generally, the reason for the development of the biofilm and the type of bacteria involved must be explored. Written by Jean-Baptiste Pain & Lionel Tortolano According to Hu et al .: Bacterial Biofilm Infection Detected in Breast Implant-Associated Anaplastic Large-Cell Lymphoma. Plast Reconstr Surg, 2016 Jun; 137 (6): 1659-69 Position of the ANSM on the LAGC.
http://ansm.sante.fr/S-informer/Points-d-information-Points-d-information/Lymphome-Anaplasique-a-Grandes-Cellules-associe-aux-implants-mammaires-LAGC-AIM-Point-sur-les-investigations-en-cours-Point-d-InformationIn March 2015, the group of experts convened by the National Cancer Institute (INCA) concluded that there is a clear link between the occurrence of anaplastic large cell lymphoma and the wearing of a breast implant.
ANSM then created a temporary specialized scientific committee composed of experts in hematology, plastic surgery, immunology, biocompatibility, toxicology and tribology to understand the causes of this pathology. Investigations have led to the implementation of studies aimed in particular to understand the immunological mechanisms involved in contact of the surface of the breast implant with the tissues. These studies are currently underway on different types of implant surfaces.
In parallel, an in-depth review of the materiovigilance data was carried out, both on the basis of the LAGC-AIM cases reported in France, and on the basis of data collected during the manufacturers’ inspections or transmitted directly by these manufacturers.
This review confirms the risk of developing a LAGC-AIM associated with one or more implants of sometimes different brands.
This pathology remains rare compared to the number of breast implants placed each year. The increase in LAGC is regular in France.
Of the 29 cases diagnosed to date in France  Allergan brand textured breast implants are currently overrepresented. This numerical over-representation is also found in LAGC-AIM cases reported around the world.
The ANSM is continuing its investigations and continues to carry out an in-depth analysis of each new declared case of LAGC-AIM for all brands of breast implants.
The Inca has also been very recently seized by the Ministry of Social Affairs and Health on this subject to update the opinion of its expert group in March 2015. The information on the LAGC-AIM will be supplemented from the conclusions of this referral.
Follow-up of patients with breast implants
For women who have breast implants and no clinical breast signs, the Inca expert group recommends, in its opinion of March 4, 2015, a follow-up identical to that which currently exists for all women and men. does not recommend the use of a LAGC-AIM risk-based explantation for women with any breast implant.
Clinical signs that should encourage consultation
In cases of heavy effusion, increased volume, pain, inflammation, mass, ulceration (lesion of the skin) in the breast, it is necessary to consult a doctor. Any other abnormality evoking a complication related to the implant requires consultation.
It is recommended to perform an ultrasound. If this examination is not sufficient, an MRI is recommended as second line.
Anyway, as a preventive measure, it is important that the implanted person be followed regularly by a doctor.
Information before implantation
ANSM reminds professionals of their obligation to provide complete information to the women concerned. The choice of placing a breast implant, whether in an esthetic context or in the context of a breast reconstruction, must be able to be evaluated and decided knowing the associated risks.