Natrelle INSPIRA Breast Implants TRM-275Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty TRM-275 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 made by Allergan. Most of the 30 reports describe the implant rupturing or leaking silicone, along with hardening of the surrounding scar tissue and swollen lymph nodes; 30 reports involved injuries and no deaths. One open recall, started in July 2019, relates to FDA safety information about a rare blood cancer of the scar tissue seen 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
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10888628008069), received between Jun 5, 2019 and Sep 9, 2026 — classified as 29 injuries.
The most frequently reported specific device problem is “Material Rupture” (19 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 Rupture19
- Device Appears to Trigger Rejection6
- Gel Leak2
- Patient-Device Incompatibility2
- Migration1
- No Apparent Adverse Event1
Patient problems
- Failure of Implant19
- Capsular Contracture8
- No Clinical Signs, Symptoms or Conditions3
- Swollen Lymph Nodes1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Gel Leak
Healthcare professional reported in the French National Agency for Medicines and Health Products Safety (ANSM) "silicone perspiration" and capsular contracture Baker grade I. This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50690260 ↗InjuryJul 27, 2026Material Rupture
Healthcare Professional reported ¿signs of intracapsular rupture. No signs of free silicone" and "A 13 mm cystic image is observed" which is not device related. This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50012886 ↗InjuryAug 13, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED. HEALTHCARE PROFESSIONAL LATER REPORTED DEVICES WERE EXPLANTED AND REPLACE.
Patient problems: Failure of Implant
MAUDE report 22800353 ↗InjuryJul 21, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22561439 ↗InjuryApr 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 21876974 ↗InjuryApr 18, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE "INTACT TEXTURED SILICONE IMPLANT WAS ENCOUNTERED" AND "NO SIGN OF RUPTURE OR LEAK" OBSERVED DURING SURGERY. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 21866653 ↗InjuryOct 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryOct 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III, PAIN, AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17864443 ↗InjuryMar 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16482851 ↗InjuryJul 27, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED" AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15114412 ↗InjuryJul 27, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15114267 ↗InjuryJul 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15069911 ↗InjuryJul 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15069787 ↗InjuryMar 31, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13970692 ↗InjuryJan 12, 2022Gel Leak; Gel Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE OF TEXTURED DEVICES DUE TO GEL BLEED AND PATIENT'S CONCERN WITH PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13239102 ↗InjuryNov 23, 2021Material Rupture; Material Rupture
PHYSICIAN REPORTED RIGHT SIDE RUPTURE AND "ANY CREASES ASSOCIATED WITH HOLE." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12865410 ↗InjuryDec 30, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11097228 ↗InjuryDec 30, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11097112 ↗InjuryDec 16, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED THE EVENT.
Patient problems: Failure of Implant
MAUDE report 11023585 ↗InjuryNov 3, 2020Material Rupture; Material Rupture
InjurySep 24, 2020Material Rupture; Material Rupture
InjurySep 9, 2020Material Rupture; Material Rupture
InjuryFeb 26, 2020Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 9759086 ↗InjuryFeb 26, 2020Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE, LEFT SIDE "LOOKS SLIGHTLY MORE DEFLATED AND HAS CAPSULE", AND BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 9755947 ↗InjurySep 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9042256 ↗
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-
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
- MENTOR MemoryGel Breast Implant 3503501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,167 reports
- MENTOR MemoryGel Breast Implant 3504001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,130 reports
- MENTOR MemoryGel Breast Implant 3504004BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
- MENTOR MemoryGel Breast Implant 3503251BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,684 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page