Natrelle INSPIRA Breast Implants TRM-485Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty TRM-485 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 Allergan Natrelle INSPIRA textured silicone breast implant has 24 adverse event reports that mostly describe tearing with holes and implant failure leading to removal or replacement with smooth implants, along with tightening scar tissue and fluid buildup. The 24 reports mention no deaths and 24 injuries. There is 1 open recall started in July 2019 about a higher occurrence of an immune-system cancer in people with textured 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
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10888628008151), received between Apr 24, 2019 and Jun 24, 2025 — classified as 24 injuries.
The most frequently reported specific device problem is “Material Rupture” (16 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 Rupture16
- Device Appears to Trigger Rejection4
- Patient-Device Incompatibility3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Failure of Implant16
- Capsular Contracture6
- Seroma2
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE REPLACEMENT FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERN OF THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED ¿HOLE, NON-SPECIFIC¿ OBSERVED DURING SURGERY. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22322246 ↗InjuryJun 9, 2025Material Rupture; Material Rupture
HEALTHCARE PROVIDER REPORTED A LEFT SIDE RUPTURE AND REPLACEMENT FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERN OF THE PRODUCT. HEALTHCARE PROVIDER ADDITIONALLY REPORTED ¿OBSERVATIONS MADE DURING SURGERY¿ OF ¿HOLE, NON-SPECIFIC¿. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22165746 ↗InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANT DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT." PATIENT LATER REPORTED "PAIN, FLUID BUILD UP, AND RASH." DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 18747332 ↗InjurySep 22, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, A LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17800666 ↗InjuryAug 22, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT." HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17599074 ↗InjuryAug 21, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT." HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE." DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 17582572 ↗InjuryJul 6, 2023Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE "I BELIEVE THAT THEY ARE TEXTURED IMPLANTS." ADDITIONALLY, PATIENT REPORTED RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17268712 ↗InjuryNov 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTH CARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15805310 ↗InjuryNov 14, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED REPLACED.
Patient problems: Failure of Implant
MAUDE report 15788547 ↗InjuryMay 16, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTION BAKER GRADE III/IV PLUS EXCHANGE DUE TO PATIENT¿S CONCERNS WITH THE PRODUCT" HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "HOLE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14414264 ↗InjuryMay 6, 2022Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE "SOMETHING SUSPICIOUS ON YEARLY MAMMOGRAM.¿ HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE DUE TO PATIENT¿S CONCERN WITH THE PRODUCT" AND "RIGHT SIDE RUPTURE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14311653 ↗InjuryApr 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III/IV" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14214599 ↗InjuryApr 13, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14109419 ↗InjuryApr 11, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14075118 ↗InjuryOct 21, 2021Material Rupture; Material Rupture
InjuryAug 20, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE REMOVED DUE TO "RUPTURE". REMOVAL WAS ALSO DUE TO CONCERN WITH THE PRODUCT BEING TEXTURED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12349054 ↗InjuryFeb 8, 2021Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE "RANDOM SHOOTING PAIN." HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11298617 ↗InjuryNov 25, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10900221 ↗InjuryOct 26, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED ¿LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENT CONCERN WITH THE PRODUCT AND CAPSULAR CONTRACTURE, BAKER GRADE IV¿. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10732749 ↗InjuryJul 23, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED LEFT SIDE "HARDENING", "SWELLING" WITH "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND EXCHANGE DUE TO CONCERN WITH TEXTURED PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10318240 ↗InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED AN UNKNOWN SIDE "HAD THE FLUID BUILD UP AROUND THEIR IMPLANTS," "HAD EXTREME SWELLING," "HAD THE ENLARGEMENT, THE HARDENING AND THE FLUID," AND "EXPERIENCING PERSISTENT PAIN OVER THE PAST THREE MONTHS." DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Seroma
MAUDE report 10017820 ↗InjuryFeb 25, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9751617 ↗InjuryAug 9, 2019Material Rupture; Material Rupture
InjuryApr 24, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, AND "CONTINUOUS PAIN". PATIENT ALSO INDICATED THEY WANTED TO "INITIATE DIAGNOSTIC TESTING FOR THE CANCER RELATED TO THESE IMPLANTS". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8546658 ↗
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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