Natrelle INSPIRA Breast Implants SRM-445Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRM-445 Moderate 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 424 reports, all listed as injuries, and no deaths. Most reports describe capsular contracture, where scar tissue tightens around the implant, and many say the implant appears to trigger rejection. Some implants were 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
- 434
- Deaths reported
- 0
- Injuries reported
- 434
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 434 adverse event reports that list this exact device (DI 10888628007147), received between May 13, 2019 and Sep 21, 2026 — classified as 434 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (239 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 Rejection239
- Patient-Device Incompatibility113
- Material Rupture89
- Adverse Event Without Identified Device or Use Problem10
- No Apparent Adverse Event6
- Device Handling Problem4
- Fluid/Blood Leak2
- Material Protrusion/Extrusion1
Patient problems
- Capsular Contracture348
- Failure of Implant62
- No Clinical Signs, Symptoms or Conditions16
- Unspecified Infection10
- Foreign Body Reaction3
- Seroma3
- Swollen Lymph Nodes2
- Abscess1
Recent adverse event reports
The 25 most recent of 434 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50849267 ↗InjurySep 21, 2026Material Rupture
Healthcare professional reported "ruptured" and "heard a pop". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50844466 ↗InjurySep 16, 2026Device Appears to Trigger Rejection; Material Rupture
Later healthcare professional reported "radial folds". This record is for left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796368 ↗InjurySep 8, 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 50671200 ↗InjurySep 7, 2026Material Rupture
Patient problems: Breast Mass
MAUDE report 50651340 ↗InjurySep 4, 2026Material Rupture
Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50622342 ↗InjurySep 2, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture Baker grade IV", "pain". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50569206 ↗InjurySep 2, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569128 ↗InjuryAug 6, 2026Material Rupture
Patient reported "Rupture". Later healthcare professional reported "Rupture" against the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160126 ↗InjuryJul 29, 2026Device Appears to Trigger Rejection
Healthcare profession reported Capsular Contracture Baker grade unknown. This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50068479 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported ¿psb infection¿. This record is for the right side. Device was explanted.
Patient problems: Unspecified Infection
MAUDE report 50045965 ↗InjuryJul 6, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE LLL". THIS RECORD IS RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25717122 ↗InjuryJun 3, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "RUPTURE/DEFLATION ". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25373861 ↗InjuryJun 2, 2026Material Rupture
Patient reported "rupture", "lumps" and "a year after revision started feeling problems and something was up with the implant". Later Healthcare professional reported rupture. This record is for the right side. The device was explanted.
Patient problems: Failure of Implant
MAUDE report 25369154 ↗InjuryJun 2, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. LATER PATIENT REPORTED "RUPTURE" AND "LUMPS". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 25368784 ↗InjuryMay 27, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED OF THE RIGHT SIDE DEVICE: "RUPTURE". THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310753 ↗InjuryMay 18, 2026Material Rupture
Patient reported "rupture". Later healthcare professional reported "implant rupture". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203788 ↗InjuryMay 18, 2026Material Rupture
Patient reported "rupture". Later healthcare professional reported "implant rupture". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203756 ↗InjuryMay 11, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25145548 ↗InjuryMay 4, 2026Device Appears to Trigger Rejection
Healthcare Professional reported "Capsular Contracture Baker grade IV". This record is for the right side. Device has been explanted and replaced.
Patient problems: Capsular Contracture
MAUDE report 25072120 ↗InjuryApr 7, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "SUSPECTED/ACTUAL RUPTURE/DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24808323 ↗InjuryApr 7, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY "CAPSULAR CONTRACTURE BAKER GRADE IV, CORRECTION OF ASYMMETRY, CHANGE SHAPE/SIZE/STYLE, PTOSIS". PTOSIS IS NOT CONSIDERED DEVICE RELATED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24801020 ↗InjuryFeb 25, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24445269 ↗InjuryFeb 23, 2026Material Rupture
InjuryFeb 9, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE FOUND ON MRI". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24298512 ↗
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-
- 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
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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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