Natrelle INSPIRA Breast Implants TRF-365Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty TRF-365 Full 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. The 27 reports mostly describe the scar tissue tightening around the implant (capsular contracture), implant rupture, fluid collection behind the breast, and swollen lymph nodes; all 27 were injuries and no deaths were reported. One recall remains open, started in July 2019, after FDA updated safety information on a 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
- 27
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10888628008311), received between Jun 11, 2019 and Aug 24, 2026 — classified as 27 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (12 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
- Device Appears to Trigger Rejection12
- Material Rupture8
- Patient-Device Incompatibility5
- Adverse Event Without Identified Device or Use Problem2
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture17
- Failure of Implant6
- Seroma4
- No Clinical Signs, Symptoms or Conditions3
- Cellulitis2
- Swollen Lymph Nodes2
- Swollen Lymph Nodes/Glands1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2026Material Rupture
Patient and patient representative reported: "rupture". This record is for the left-side device. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50411666 ↗InjuryMay 7, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED THROUGH SALES REPRESENTATIVE "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113139 ↗InjuryMar 11, 2026Material Rupture
HEALTHCARE PROFESSIONAL THROUGH SALES REPRESENTATIVE REPORTED "TEXTURED". HEALTHCARE PROFESSIONAL REPORTED "RUPTURED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24575305 ↗InjurySep 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV (WITH PAIN). THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22939009 ↗InjuryMay 26, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22084860 ↗InjuryApr 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED A LEFT SIDE EXCHANGE DUE TO PATIENT¿S CONCERN WITH PRODUCT. DEVICE REMAINS IMPLANTED. LATER, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN.
Patient problems: Capsular Contracture
MAUDE report 16675319 ↗InjuryNov 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, SWOLLEN LYMPH NODES" AND ""BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT". DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands
MAUDE report 15868356 ↗InjuryAug 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15147095 ↗InjuryJul 25, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED PATIENT IS EXPERIENCING MILD CELLULITIS, PAIN, REDNESS, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, PERIPROSTHETIC FLUID, IMPLANT MALPOSITION, INFERIOR DISPLACEMENT, AND QUESTIONING AS TO WHETHER THIS IS RELATED TO TEXTURED IMPLANTS. THE FOLLOWING REPORTED EVENTS HAVE BEEN DEEMED NOT RELATED TO THE DEVICE: WEIGHT LOSS, NOT FEELING NORMAL SELF, MORE ILLNESSES, GENERALIZED MALAISE, AND AUTOIMMUNE ISSUES. AFFECTED SIDE IS RIGHT. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Cellulitis; Seroma
MAUDE report 15097486 ↗InjuryJul 25, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED PATIENT IS EXPERIENCING MILD CELLULITIS, PAIN, REDNESS, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, PERIPROSTHETIC FLUID, IMPLANT MALPOSITION, INFERIOR DISPLACEMENT, AND QUESTIONING AS TO WHETHER THIS IS RELATED TO TEXTURED IMPLANTS. THE FOLLOWING REPORTED EVENTS HAVE BEEN DEEMED NOT RELATED TO THE DEVICE: WEIGHT LOSS, NOT FEELING NORMAL SELF, MORE ILLNESSES, GENERALIZED MALAISE, AND AUTOIMMUNE ISSUES. AFFECTED SIDE IS LEFT. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Cellulitis; Seroma
MAUDE report 15095707 ↗InjuryMay 6, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT AGAINST THE RIGHT SIDE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED DEFLATION. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14307451 ↗InjuryJan 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13315700 ↗InjuryDec 16, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 13022321 ↗InjuryJun 18, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT" AND ¿RIGHT-SIDE RUPTURE, CONFIRMED DURING SURGERY.¿ DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12025967 ↗InjuryApr 29, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryApr 29, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 11749368 ↗InjuryApr 5, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11615874 ↗InjuryMar 17, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
LATER HEALTHCARE PROFESSIONAL REPORTED VIA PORTAL "TEXTURED IMPLANTS". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 11505165 ↗InjuryJul 30, 2020Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10347112 ↗InjuryJul 21, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10305267 ↗InjuryMay 5, 2020Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE "RUPTURE." DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10026985 ↗InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "FLUID AND ENLARGED LYMPH NODES". DEVICE REMAINS IMPLANTED.
Patient problems: Seroma; Swollen Lymph Nodes
MAUDE report 9226674 ↗InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "FLUID AND ENLARGED LYMPH NODES". DEVICE REMAINS IMPLANTED.
Patient problems: Seroma; Swollen Lymph Nodes
MAUDE report 9226647 ↗InjuryAug 4, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8858341 ↗InjuryJun 24, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8729710 ↗
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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