Breast implants are used in both breast augmentation surgery (to increase the breast size) and in breast reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality).
Allergan Inc.’s breast implants include saline and silicone devices used in breast augmentation and reconstruction. The company is one of the largest breast implant manufacturers in the world and started selling breast implants in 2006. Allergan’s flagship breast implant brand is Natrelle, but it also sells implants under its subsidiaries Inamed and McGhan. The manufacturer received approval from the FDA on 11/17/2006.
The popular product, its textured implants, is linked to a rare type of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. The disease is a type of non-Hodgkin lymphoma.
What Is BIA-ALCL?
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare form of T-cell lymphoma that occurs in some people who have had breast implants. It is not breast cancer but rather is a cancer of the immune system. The disease may affect a very small number of women who have received breast implants, primarily of the textured (rough) type. The lymphoma occurs in the scar tissue (fibrous capsule) that surrounds the implant, and in more advanced cases, may spread to lymph nodes that are near the breast.
Women who have undergone a mastectomy to treat breast cancer go on to have one or both breasts reconstructed, which can be done in two ways: using tissue transplanted from another part of your body, or inserting an implant that's filled with saline (saltwater) or silicone gel.
A saline implant consists of a silicone shell that is filled with saline and silicone gel implants are filled with firm silicone gel, which is believed to have more like natural breast tissue.
Once a breast implant is in place, scar tissue forms around it, creating what's called a tissue capsule. ALCL can develop in and around the tissue capsule.
According to the FDA, the risk of ALCL is higher in women with textured implants, which have a bumpy surface, as opposed to smooth implants.
The recalled Allergan products include:
- Natrelle saline breast implant styles 168, 363, 468.
- Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX.
- Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX.
- Natrelle 510 Dual-Gel styles LX, MX, FX.
- Natrelle Inspira breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX.
- Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch.
- Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM.
- Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM.
- Natrelle 150 Full Height and Short Height double lumen implants.
- Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T.
- Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T.
The recall does not affect Allergan’s Natrelle smooth or Microcell breast implants and tissue expanders.