Natrelle INSPIRA Breast Implants TRM-445Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty TRM-445 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.
Quick summary
This Natrelle INSPIRA silicone gel-filled breast implant is a textured, round implant. The 43 reports mostly describe implants that rupture or harden into tight scar tissue around the implant (capsular contracture), often severe enough that the implant had to be removed; all 43 involve injuries and no deaths. One recall, open since July 2019, concerns a type of rare lymphoma linked to textured breast implants.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10888628008144), received between Oct 30, 2017 and Aug 26, 2026 — classified as 42 injuries.
The most frequently reported specific device problem is “Material Rupture” (27 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 Rupture27
- Device Appears to Trigger Rejection10
- Patient-Device Incompatibility7
- Adverse Event Without Identified Device or Use Problem2
- No Apparent Adverse Event1
Patient problems
- Failure of Implant21
- Capsular Contracture17
- Swollen Lymph Nodes2
- Edema1
- Lymphoma1
- Pain1
- Seroma1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50456051 ↗InjuryAug 26, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50455739 ↗InjuryJun 5, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25408656 ↗InjurySep 6, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20164643 ↗InjurySep 6, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, VIA NBIR RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20164642 ↗InjuryJul 27, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE IMPLANT EXCHANGE DUE TO CONCERNS WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE DETECTED DURING EXPLANT SURGERY. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17407426 ↗InjuryJul 24, 2023Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17381411 ↗InjuryMay 10, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED RIGHT SIDE EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT. HEALTHCARE PROFESSIONAL CONFIRMED PREVIOUS EVENT AND FURTHER REPORTED CAPSULAR CONTRACTURE BAKER GRADE III AND RUPTURE DISCOVERED DURING EXPLANT SURGERY. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16903830 ↗InjuryApr 12, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND TEXTURED IMPLANT CONCERN. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16728009 ↗InjuryMar 6, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, A LEFT-SIDE RUPTURE. VIA MRI. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16491434 ↗InjuryJan 23, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "HOLE, NON-SPECIFIC" OBSERVED DURING SURGERY VIA RGA. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16223360 ↗InjuryJan 23, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "HOLE, NON-SPECIFIC" OBSERVED DURING SURGERY VIA RGA. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16223221 ↗InjuryDec 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE PAIN AND PATIENT REPORTED THAT THEY EXPERIENCED ¿PAIN¿, ¿ THREE AUTOIMMUNE DISORDERS" AND "THEY ARE CAUSING CANCER IN SOME PATIENTS AND WANTS TO GET THEM OUT¿. LATER, HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15900687 ↗InjuryDec 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE PAIN AND PATIENT REPORTED THAT THEY EXPERIENCED ¿PAIN¿, ¿ THREE AUTOIMMUNE DISORDERS" AND "THEY ARE CAUSING CANCER IN SOME PATIENTS AND WANTS TO GET THEM OUT¿. LATER, HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15900431 ↗InjuryNov 17, 2022Material Rupture; Material Rupture
PATIENT REPORTED BILATERAL EXCHANGE FROM TEXTURED IMPLANTS DUE TO CONCERN WITH THE PRODUCT. PATIENT LATER REPORTED "FEEL FATIGUE, ALL OVER BODY PAIN, NECK, ARMS AND JOINT PAIN" AND "RUPTURE". DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Failure of Implant
MAUDE report 15812783 ↗InjuryAug 18, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. PHYSICIAN LATER REPORTED RUPTURE. THE DEVICE WAS REPLACED.
Patient problems: Failure of Implant
MAUDE report 15255898 ↗InjuryJul 18, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/ TEXTURE" AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15045469 ↗InjuryJul 7, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 14951171 ↗InjuryJul 7, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 14949907 ↗InjuryJun 3, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING, RIGHT SIDE "RUPTURE." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 14594659 ↗InjuryMay 23, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "TEXTURE/RUPTURE." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14469818 ↗InjuryMar 1, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PATIENT'S CONCERN WITH PRODUCT." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11393224 ↗InjuryDec 5, 2020Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE AND PAIN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10950232 ↗InjuryOct 20, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PATIENT'S CONCERN WITH PRODUCT." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10705709 ↗InjuryJun 10, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE AND EXCHANGE DUE TO ANXIETY WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Failure of Implant
MAUDE report 10138462 ↗
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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