Breast Implant Recall
FDA Recall on Allergan BIOCELL® Breast Implants
The FDA has requested that the pharmaceutical company Allergan recall its BIOCELL textured breast implants and tissue expanders. This request was issued after the FDA concluded that individuals who had the implants were six times more likely to develop anaplastic large cell lymphoma (BIA-ALCL), an uncommon form of lymphoma.
While the FDA did decline to impose an outright ban on BIOCELL implants, despite information indicating that 84% of reported cases of breast implant related BIA-ALCL involved Allergan implants, regulators in other countries have already put a ban in place on textured breast implants.
In response to the mounting information BIA-ALCL, Allergan has notified healthcare providers that they should no longer implant silicone-filled and saline-filled new BIOCELL textured breast implants and tissue expanders. The pharmaceutical company had previously pulled the BIOCELL implants from European markets in late 2018.
Most incidences of BIA-ACL related to Allergan breast implants have been successfully treated through the removal of the breast implant and accompanying scar tissue capsule. Additional treatment is recommended in some cases.
Symptoms Caused by BIOCELL Breast Implants
If you have breast implants and are worried that your BIOCELL implants were used in your procedure, do not hesitate to contact our office to discuss your concerns. Definitely contact a medical professional if you discover you have problems with your implants, such as:
- Pain
- Lumps
- Swelling.
The recalled Allergan breast implant and tissue expander 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
Schedule a Consultation with Dr. Diaco
If you want to discuss the status of your breast implants, we can schedule a consultation in Tampa at the Diaco Institute of Plastic Surgery. During your meeting with Dr. Dan Diaco, he will evaluate your concerns regarding your breast implants, before preparing a personalized plan to return your peace of mind.