Natrelle Inspira SoftTouch Breast Implants TSM-375Recalls & reported problems
Allergan, Inc. · Natrelle Inspira TSM 375cc Moderate profile BIOCELL |textured|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle Inspira SoftTouch Breast Implants (195)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888628033955), received between Apr 13, 2021 and Jun 10, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Material Rupture” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (P020056); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Jul 24, 2019Class IOpen, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Z-2453-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Rupture3
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
- Swollen Lymph Nodes/Glands1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RUPTURE", "IMPLANT INTEGRITY VIOLATION" AND "HYPERPLASIA OF PARAMAMMARY LYMPH NODE". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE OF THE IMPLANT SHELL" AND "CAPSULAR CONTRACTURE BAKER GRADE II". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25465819 ↗InjuryJun 2, 2026Material Rupture
PATIENT REPORTED "RUPTURE", "MIGRATION OF SILICONE GEL", "VISIBLE AXILLARY LYMPH NODES UP TO 15X5 MM IN SIZE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25363283 ↗InjuryApr 13, 2021Material Rupture; Migration; Material Rupture; Migration
PHYSICIAN REPORTED RIGHT SIDE "EXTRACAPSULAR RUPTURE, SILICOMATOSIC ADENOPATHIES AND ALSO INTRACAPSULAR RUPTURE" CONFIRMED BY MRI. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant; Swollen Lymph Nodes/Glands
MAUDE report 11657082 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.
- Z-0701-2020 · Nov 6, 2019 · TerminatedNatrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
- Z-0700-2020 · Nov 6, 2019 · TerminatedNatrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod
- Z-2454-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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