Natrelle INSPIRA Breast Implants TRM-520Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty TRM-520 Low Plus profile BIOCELL |textured|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle INSPIRA Breast Implants (197)
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
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10888628008168), received between Jul 17, 2019 and Feb 23, 2023 — classified as 15 injuries.
The most frequently reported specific device problem is “Material Rupture” (12 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.
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 Rupture12
- Adverse Event Without Identified Device or Use Problem1
- Device Appears to Trigger Rejection1
- No Apparent Adverse Event1
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant11
- Seroma3
- Capsular Contracture2
- Granuloma1
- Necrosis1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED, PROMINENT FOLDS VIA MRI. CAPSULECTOMY TREATMENT. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 16430666 ↗InjuryFeb 20, 2023Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE "RUPTURE". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16406038 ↗InjuryDec 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERNS OF THE PRODUCT AND RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV WITH FLUID. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 15965651 ↗InjuryAug 10, 2022Material Rupture; Material Rupture
PATIENT REPORTED SWELLING IN THE BREAST AND PAIN. PATIENT IS WORRIED IF THIS IS THE IMPLANT WHICH COULD CAUSE CANCER. THE PATIENT UNDERWENT AN ULTRASOUND WHICH CONFIRMED THE LEFT SIDE DEVICE WAS RUPTURED AND FLUID WAS PRESENT. DIAGNOSTIC REPORTS STATE: RUPTURED DEVICE, STRONG CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, AND SCAR TISSUE WITH GRANULATION TISSUE OF THE FOREIGN BODY. HEALTHCARE PROFESSIONAL FURTHER REPORTED ¿DOUBLE CAPSULATION¿, ¿INTENSE PAIN¿, ¿INTERMITTENT SWELLING AND REDDENING¿, ¿BREASTS APPEAR SWOLLEN¿, ¿FLUID FORMATION UP TO 1 CM WIDE AROUND THE LEFT BREAST IMPLANT, ACCENTUATED IN THE LOWER BREAST SECTION¿, ¿NUMEROUS FOREIGN-BODY GIANT CELLS¿, ¿GRANULATION TISSUE [AND] SCAR TISSUE WITH FOREIGN-BODY TYPE GRANULATION TISSUE¿, AND ¿SOME NECROTIC MATERIAL¿, ¿FATTY TISSUE NECROSIS¿. ADDITIONALLY REPORTED WAS THAT THE ¿PATIENT ALSO FEELS LANGUOROUS AND EXHAUSTED¿ WHICH HAS BEEN DEEMED NOT RELATED TO THE DEVICE. AFFECTED SIDE IS LEFT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Granuloma; Necrosis; Seroma
MAUDE report 15199147 ↗InjuryMay 25, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "EXCHANGE DUE TO PATIENT¿S CONCERNS WITH THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE DEVICE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 14498118 ↗InjuryApr 18, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED "IMPLANTS ARE RUPTURED." THIS IS THE LEFT SIDE RECORD. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14138988 ↗InjuryApr 16, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED "IMPLANTS ARE RUPTURED." THIS IS THE RIGHT SIDE RECORD. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14132065 ↗InjuryApr 8, 2022Material Rupture; Material Rupture
HEALTH CARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14054810 ↗InjuryApr 8, 2022Material Rupture; Material Rupture
HEALTH CARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14052544 ↗InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE PERIPROSTHETIC EFFUSION, PAIN AND DOUBLE CAPSULE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 11422528 ↗InjurySep 8, 2020Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE RUPTURE. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10503574 ↗InjuryFeb 7, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED RIGHT SIDE "PAIN, TENDERNESS, SWOLLEN; CAUSING NERVE PAIN AND RADIATING PAIN". ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9682462 ↗InjuryDec 17, 2019Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE "FELL COMPLETELY" AND RUPTURED. HEALTHCARE PROFESSIONAL ADDITIONAL REPORTED LEFT SIDE RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9482069 ↗InjuryJul 17, 2019Material Rupture; Material Rupture
InjuryJul 17, 2019Material Rupture; Material Rupture
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-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-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-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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