Natrelle INSPIRA Breast Implants TRM-240Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty TRM-240 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 is a Natrelle INSPIRA textured silicone gel breast implant from Allergan. Most of the 34 reports describe implants that ruptured or caused the surrounding scar tissue to tighten, often needing surgery to remove or replace them; a few mention swollen lymph nodes and one mentions a rare lymphoma. There are no deaths, and all 34 reports involve injuries. One open recall, started in July 2019, follows FDA safety information on the higher incidence of that lymphoma in patients with 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
- 36
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10888628008045), received between Apr 2, 2019 and Sep 10, 2026 — classified as 36 injuries.
The most frequently reported specific device problem is “Material Rupture” (24 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 Rupture24
- Device Appears to Trigger Rejection14
- Patient-Device Incompatibility4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Contracture18
- Failure of Implant16
- Swollen Lymph Nodes3
- Seroma2
- Anaplastic Large Cell Lymphoma1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Material Rupture
Healthcare professional reported "Rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721311 ↗InjuryAug 20, 2026Device Appears to Trigger Rejection
Healthcare professional reported via regulatory agency "stage 3 shell". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50354535 ↗InjuryJun 25, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE" AND "RUPTURE". THIS RECORD IS FOR LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25621214 ↗InjuryJun 25, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE", THIS RECORD IS FOR LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25621061 ↗InjurySep 9, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23005663 ↗InjurySep 4, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" VIA MRI. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22968340 ↗InjuryMay 9, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE CONFIRMED VIA MAMMOGRAM AND ULTRASOUND AND "EXCHANGE FROM TEXTURED TO SMOOTH". DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.
Patient problems: Failure of Implant
MAUDE report 21997384 ↗InjuryMay 1, 2025Material Rupture; Material Rupture
InjuryJun 20, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA REGULATORY AGENCY RIGHT SIDE INTRACAPSULAR RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 19575823 ↗InjuryJan 4, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED "GLOBAL RUPTURE" AND "HOLE IN RADIUS" OBSERVED DURING SURGERY. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16095805 ↗InjuryNov 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT- SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15804702 ↗InjuryOct 18, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15621363 ↗InjuryOct 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15621360 ↗InjuryJun 17, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE III, AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14739165 ↗InjuryJun 17, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III WITH TEXTURED IMPLANTS. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 14732750 ↗InjuryMar 31, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH AND RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13965751 ↗InjuryMar 31, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH AND CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13965586 ↗InjuryMar 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13945721 ↗InjuryDec 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13062816 ↗InjuryDec 21, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13052448 ↗InjuryJul 28, 2021Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 12240396 ↗InjuryJun 14, 2021Material Rupture; Material Rupture
PATIENT REPORTED "I ALREADY KNOW THAT ALLERGAN IS NOT PAYING FOR REMOVAL. I DON'T THINK IT'S REASONABLE TO WAIT AROUND 8 TO 10 YEARS TO SEE IF I DEVELOP LYMPHOMA. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Failure of Implant
MAUDE report 11992611 ↗InjuryFeb 23, 2021Material Rupture; Material Rupture
InjuryFeb 23, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL 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 11366810 ↗InjuryJun 13, 2020Material Rupture; Material Rupture
HEALTHCARE PROVIDER REPORTED LEFT SIDE RUPTURE. PATIENT REPORTED "SWELLING ALL THE WAY UP SHOULDER WITH 400CC'S OF SEROMA." DEVICE WAS EXPLANTED.
Patient problems: Seroma
MAUDE report 10151389 ↗
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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