Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
— Global Action Follows Notification of Updated Safety Information from the U.S. Food and Drug Administration (FDA)
— FDA Does Not Recommend Removal or Replacement of Textured Breast Implants in Asymptomatic Patients —
— Smooth and MICROCELL® Breast Implants and Tissue Expanders Not Impacted —
Allergan plc announced a voluntary worldwide recall of BIOCELL® textured breast implants and tissue expanders. Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA).
Patient safety is a priority for Allergan. Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns.
Importantly, the FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients.
This global recall does not affect Allergan’s NATRELLE® smooth or MICROCELL® breast implants and tissue expanders.
The recalled products concerning patients who have had breast augmentation under my care include the following:
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 INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
If you are one of my patients and have had any of the above implants inserted and are concerned in any way or would like further advice please contact Karen Lance on 07480 125890 or email: email@example.com