Natrelle INSPIRA Breast Implants TRM-310Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty TRM-310 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 textured silicone gel breast implant appears in 30 adverse event reports, all describing injuries and no deaths. Most reports describe the implant rupturing or leaking gel, with the silicone traveling to nearby lymph nodes, along with hard scar tissue tightening around the implant (capsular contracture); several patients had the implants removed and replaced with smooth ones. One open recall, started in July 2019, relates to updated FDA information on a higher rate of a rare breast implant-related lymphoma 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 10888628008083), received between Jul 29, 2019 and Sep 17, 2026 — classified as 29 injuries.
The most frequently reported specific device problem is “Material Rupture” (20 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 Rupture20
- Device Appears to Trigger Rejection7
- Patient-Device Incompatibility4
- Adverse Event Without Identified Device or Use Problem1
- Device Handling Problem1
Patient problems
- Failure of Implant16
- Capsular Contracture11
- Seroma3
- Hypersensitivity/Allergic reaction1
- No Clinical Signs, Symptoms or Conditions1
- 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 17, 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 50802270 ↗InjuryApr 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH AND CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21858871 ↗InjuryMay 21, 2024Material Rupture; Device Handling Problem; Material Rupture; Device Handling Problem
HEALTHCARE PROFESSIONAL REPORTED ¿R IMPLANT RUPTURED PRIOR TO PROCEDURE¿ IS NOT DEVICE RELATED. UN-REPORTING RUPTURE, ADDING USE-ERROR.
Patient problems: Failure of Implant
MAUDE report 19363099 ↗InjuryOct 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED A CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17958703 ↗InjuryOct 17, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "LUMP, EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED A RUPTURED DEVICE AND HAD TO REMOVE SILICONE FROM LYMPH NODES. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17950171 ↗InjurySep 13, 2023Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE IMPLANT REMOVAL DUE TO THE CONCERNS OF THE PRODUCT. LATER, HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE EXCHANGE DUE TO CONCERNS WITH THE PRODUCT AND RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17738024 ↗InjuryJun 9, 2023Material Rupture; Material Rupture
InjuryFeb 9, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE RUPTURE. "TEXTURED", AND "SMALL AMOUNT OF PERIIMPLANT FLUID". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; Seroma
MAUDE report 16337032 ↗InjuryOct 26, 2022Device 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 REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AS WELL AS EXCHANGE FROM TEXTURED TO SMOOTH. PATIENT FURTHER REPORTED RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15677080 ↗InjuryOct 4, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED LEFT SIDE "HARDENING AND EXCHANGE FROM TEXTURED TO SMOOTH." ADDITIONALLY HEALTHCARE PROFESSIONAL REPORTED "A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III" AS WELL AS A BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT". PATIENT FURTHER REPORTED RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15538028 ↗InjurySep 28, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT AND LATER REPORTED A "RIGHT SIDE RUPTURE WAS FOUND DURING THE PATIENT'S SURGERY". THE DEVICE AS BEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15495731 ↗InjurySep 14, 2022Material Rupture; Material Rupture
PATIENT REPORTED A LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT AND RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED .
Patient problems: Failure of Implant
MAUDE report 15421994 ↗InjuryMar 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13865599 ↗InjuryFeb 26, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT RUPTURE CONFIRMED BY MRI. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13608363 ↗InjuryFeb 14, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13529420 ↗InjuryFeb 4, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13455565 ↗InjuryDec 16, 2021Material Rupture; Material Rupture
PHYSICIAN REPORTS A SUSPECTED RUPTURE DIAGNOSED WITH AN MRI. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. THIS RECORD RELATES TO THE RIGHT SIDE.
Patient problems: Failure of Implant
MAUDE report 13020512 ↗InjuryDec 13, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE INTRACAPSULAR RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 12984445 ↗InjuryNov 3, 2021Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE RUPTURE AND PAIN. PATIENT ADDITIONALLY REPORTED "PEA SIZE LUMP"; THIS EVENT IS NOT RELATED TO THE DEVICE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12748984 ↗InjuryOct 28, 2021Material Rupture; Material Rupture
PHYSICIAN REPORTED, RUPTURE ON THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 12715617 ↗InjuryMay 5, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTH PROFESSIONAL REPORTED A RIGHT SIDE EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL ADDED CAPSULAR CONTRACTURE, BAKER GRADE NOT SPECIFIED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11777077 ↗InjuryMar 31, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED A RIGHT SIDE "A LOT HARDER AND LARGER THAN THEIR LEFT BREAST " AND " PAINFUL". HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III AND "SEROMA FLUID". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 11596880 ↗InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED RIGHT SIDE "SEVERE ALLERGIC REACTION TO THE BREAST IMPLANTS AND ALMOST DIED". DEVICE REMAINS IMPLANTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 10466774 ↗InjuryJun 19, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant; Swollen Lymph Nodes
MAUDE report 10175448 ↗InjuryFeb 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9688442 ↗
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-
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