Allergan Withdraws Textured Breast Implants Due to Safety Concerns

Wednesday, July 24, 2019 | Healthcare Trends , Personnel/Company News , Allergan


Just days after surgeons from the British Association of Aesthetic Plastic Surgeons (BAAPS) and elsewhere called for warnings on silicone-filled breast implants due to risk of “breast implant illness,” Allergan has announced a voluntary worldwide recall of Biocell textured breast implants and tissue expanders due to concerns of another health concern --breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Breast Implant Illness is an umbrella term for a constellation of symptoms including tiredness, “brain fog”, joint aches, immune-related symptoms and sleep disturbance that women feel are directly connected to silicone implants.

Allergan is taking this action as a precaution because this rare form of cancer has been linked to textured implants. The FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients. 

Biocell saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available. Effective immediately, healthcare providers should no longer implant new Biocell textured breast implants and tissue expanders and unused products should be returned to Allergan. Allergan will provide additional information to customers about how to return unused products.

This global recall does not affect Allergan's Natrelle smooth or Microcell breast implants and tissue expanders.

The recalled 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

 

Next Story

Comments

You must be logged in to leave a comment.