Natrelle INSPIRA Breast Implants TRF-385Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty TRF-385 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 Natrelle INSPIRA breast implant is a textured, silicone gel-filled implant. The 25 reports mostly describe implant rupture or breakage, tightening of scar tissue around the implant, and implant failure; they include 25 injuries and no deaths. One open recall started in July 2019 over updated information about higher rates of a rare lymphoma in patients with textured breast implants. Reports fell from 5 in the previous 12 months to 2 in the most recent 12 months.
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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10888628008328), received between Oct 10, 2017 and Sep 25, 2026 — classified as 26 injuries.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture12
- Device Appears to Trigger Rejection6
- Patient-Device Incompatibility5
- Adverse Event Without Identified Device or Use Problem2
- Migration or Expulsion of Device1
Patient problems
- Capsular Contracture11
- Failure of Implant10
- Seroma4
- No Clinical Signs, Symptoms or Conditions2
- Anaplastic Large Cell Lymphoma1
- Cyst(s)1
- Lymphoma1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Material Rupture
Healthcare professional reported "'Rupture" against the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894952 ↗InjuryJul 28, 2026Material Rupture
Healthcare professional reported of the right side device: "prosthesis broken". The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060540 ↗InjuryFeb 18, 2026Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24382076 ↗InjuryJul 8, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE CONFIRMED VIA MRI". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22435195 ↗InjuryJun 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III-IV AND REPLACEMENT FROM TEXTURED TO SMOOTH DUE TO THE PATIENT'S CONCERN OF THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22171549 ↗InjuryJun 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryMar 24, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE II, SUSPECTED RUPTURE, CHANGE SHAPE/SIZE/STYLE, PTOSIS". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 21675361 ↗InjuryMar 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III, CHANGE SHAPE/SIZE/STYLE, PTOSIS". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 21632683 ↗InjuryAug 22, 2024Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE "PAIN IN THE BREAST ABOUT 6 MONTHS AGO". PATIENT LATER REPORTED "POSSIBLE RUPTURE", "WEIGHT GAIN", "SKIN RASH", "INFLAMMATION IN LEGS", "AUTO IMMUNE DISEASE" AND REMOVAL OF THE TEXTURED BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. THE EVENTS OF AUTO IMMUNE DISEASE AND INFLAMMATION IN LEGS ARE NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 20037692 ↗InjuryJan 31, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE IMPLANT. HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE WAS DISCOVERED DURING SURGERY." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16272050 ↗InjuryJan 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CONTRACTURE BAKER GRADE II/III". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16099599 ↗InjuryOct 11, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15577327 ↗InjuryOct 11, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15577317 ↗InjuryAug 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" AND ANXIETY AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15147360 ↗InjuryJun 25, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12071884 ↗InjuryFeb 24, 2021Device 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 11373028 ↗InjuryDec 14, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "DOUBLE CAPSULE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11003673 ↗InjuryNov 5, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10792997 ↗InjuryNov 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryNov 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT CALLED TO REPORT LEFT SIDE "HARDENING", "SWOLLEN", "BUMP BY ARMPIT", AND "CONCERN WITH THE PRODUCT." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED SEROMA. DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 10719241 ↗InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE SEROMA AND EXCHANGE FROM TEXTURED TO SMOOTH. DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 10018190 ↗InjuryMar 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND SEROMA. HEALTH PROFESSIONAL ADDITIONALLY REPORTED REMOVAL DUE TO EXCHANGE OF TEXTURED IMPLANT FOR SMOOTH. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 9786142 ↗InjuryNov 13, 2019Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "ANY CREASES ASSOCIATED WITH HOLE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9317692 ↗InjuryMay 21, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
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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