Natrelle INSPIRA Breast Implants SRX-375Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRX-375 Extra Full profile |smooth|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
Quick summary
This Allergan Natrelle INSPIRA breast implant has 144 FDA adverse event reports, with no deaths and 144 injuries. Most mention capsular contracture, which is hardening of the scar tissue around the implant. Many describe the body seeming to reject the implant, and many say it was removed. No recalls name this device.
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
- 145
- Deaths reported
- 0
- Injuries reported
- 145
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 10888628007499), received between May 20, 2019 and Sep 30, 2026 — classified as 145 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (99 reports).
4 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
Most reported problems
Device problems
- Device Appears to Trigger Rejection99
- Patient-Device Incompatibility27
- Material Rupture20
- Adverse Event Without Identified Device or Use Problem3
- Break1
- Fluid/Blood Leak1
Patient problems
- Capsular Contracture124
- Failure of Implant17
- Impaired Healing2
- Swollen Lymph Nodes/Glands2
- Foreign Body Reaction1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 145 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50952789 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported through National Breast Implant Registry "Capsular Contracture Baker Grade III" against the left side record. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50047764 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported Capsular Contracture Baker grade III. This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50001801 ↗InjuryJul 8, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture, Baker grade unknown¿. Later the Healthcare professional reported "capsular contracture, Baker grade III". This record is for the left side. Device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 25756771 ↗InjuryJul 5, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25712780 ↗InjuryJun 8, 2026Device Appears to Trigger Rejection
PATIENT REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25437354 ↗InjuryJun 4, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25393995 ↗InjuryMay 15, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25186534 ↗InjuryApr 29, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25034932 ↗InjuryJan 30, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR)"CAPSULAR CONTRACTURE BAKER GRADE III, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24221211 ↗InjuryDec 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23861334 ↗InjurySep 4, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 22968144 ↗InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. MEDICATION PRESCRIBED TO TREAT THE CAPSULAR CONTRACTURE. THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22909838 ↗InjuryJul 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
LATER HEALTHCARE PROFESSIONAL REPORTED "BAKER GRADE- 3". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22584244 ↗InjuryJun 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22330195 ↗InjuryJun 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22318678 ↗InjuryJun 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22306635 ↗InjurySep 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR A RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20306239 ↗InjurySep 20, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR A LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20268070 ↗InjuryJan 5, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 18454046 ↗InjuryNov 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18237654 ↗InjuryNov 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18205897 ↗InjuryNov 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL CALLED TO REPORT A CAPSULAR CONTRACTURE BAKER GRADE III/IV ON UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18119367 ↗InjuryOct 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "RUPTURE AND PAIN." HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND "NO RUPTURE." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17996494 ↗InjurySep 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL VIA SALES REP REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17784839 ↗
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-2453-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TR
- 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
- 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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