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Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA product code FTR · Class 3 · General, Plastic Surgery

2,388
Registered devices
229,168
Adverse events
14
Recalls
0
510(k) clearances

Devices with this code

Motiva® SmoothSilk® Round Ergonomix Breast Implant — Establishment Labs S.A.SIENTRA Silicone Gel Breast Implant — Sientra, Inc.OPUS Silicone Gel Breast Implant — Sientra, Inc.Motiva® SmoothSilk® Round Ergonomix Breast Implant — Establishment Labs S.A.Silicone Gel Sizer — Sientra, Inc.Natrelle Inspira Cohesive Breast Implants — Allergan, Inc.NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants — Allergan, Inc.SIENTRA Silicone Gel Breast Implant — Sientra, Inc.Motiva® SmoothSilk® Round Ergonomix Breast Implant — Establishment Labs S.A.OPUS Silicone Gel Breast Implant — Sientra, Inc.Silicone Gel Sizer — Sientra, Inc.SIENTRA Silicone Gel Breast Implant — Sientra, Inc.MENTOR MemoryGel Breast Implant — MENTOR TEXAS L.P.MENTOR MemoryShape Breast Implant — MENTOR TEXAS L.P.MENTOR MemoryGel BOOST Breast Implant — MENTOR TEXAS L.P.MENTOR MemoryShape Breast Implant — MENTOR TEXAS L.P.MENTOR MemoryGel Xtra Breast Implant — MENTOR TEXAS L.P.Natrelle Inspira Cohesive Breast Implants — Allergan, Inc.Natrelle Inspira Cohesive Breast Implants — Allergan, Inc.SIENTRA Silicone Gel Breast Implant — Sientra, Inc.SIENTRA Silicone Gel Breast Implant — Sientra, Inc.SIENTRA Silicone Gel Breast Implant — Sientra, Inc.SIENTRA Silicone Gel Breast Implant — Sientra, Inc.Silicone Gel Sizer — Sientra, Inc.

Recent recalls

DateFirmReason
2019-11-06Allergan PLCThe firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separa
2019-11-06Allergan PLCThe firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separa
2019-07-24Allergan PLCThe action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplast
2019-07-24Allergan PLCThe action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplast
2019-07-24Allergan PLCThe action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplast
2019-07-24Allergan PLCThe action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplast
2019-07-24Allergan PLCThe action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplast
2019-07-24Allergan PLCThe action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplast
2019-07-24Allergan PLCThe action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplast
2019-07-24Allergan PLCThe action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplast

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.