Natrelle INSPIRA Breast Implants SRX-420Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRX-420 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 133 reports, most describing capsular contracture, where scar tissue around the implant tightens, and some implants were removed. The reports mention 132 injuries and no deaths, and 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
- 137
- Deaths reported
- 0
- Injuries reported
- 136
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 10888628007512), received between Feb 5, 2018 and Sep 30, 2026 — classified as 136 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (86 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 Rejection86
- Patient-Device Incompatibility32
- Material Rupture19
- Adverse Event Without Identified Device or Use Problem5
- Malposition of Device2
- No Apparent Adverse Event2
- Device Handling Problem1
- Fluid/Blood Leak1
Patient problems
- Capsular Contracture117
- Failure of Implant11
- No Clinical Signs, Symptoms or Conditions4
- Seroma3
- Unspecified Infection3
- Erosion1
- Foreign Body Reaction1
- Sepsis1
Recent adverse event reports
The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade IV". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50945816 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade IV". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50945747 ↗InjurySep 22, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861876 ↗InjuryAug 25, 2026Device Appears to Trigger Rejection
Healthcare professional reported ¿Capsular Contracture Baker grade III¿. Patient undergone capsulectomy. This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50422123 ↗InjuryAug 18, 2026Device 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 50297941 ↗InjuryAug 16, 2026Device Appears to Trigger Rejection
Patient reported "capsular contracture baker grade unknown with "pain" "redness, burning feeling internal, it went up high". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50268301 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker Grade III" via the National Breast Implant Registry (NBIR). This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50047862 ↗InjuryMay 21, 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 25244626 ↗InjuryMay 21, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25244361 ↗InjuryApr 20, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III, CHANGE SHAPE/SIZE/STYLE" THROUGH THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24922862 ↗InjuryFeb 17, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "BREAST HAS DEVELOPED CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24364003 ↗InjurySep 23, 2025Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT AGAINST THE RIGHT SIDE DEVICE. THE RECORD IS NO LONGER DEEMED TO BE REPORTABLE TO THE FDA AND WILL BE UN-REPORTED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 23122359 ↗InjurySep 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV" AND "HARDER" THAN CONTRALATERAL SIDE. TREATMENT: MONTELUKAST. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23083530 ↗InjuryAug 13, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22793500 ↗InjuryAug 12, 2025Malposition of Device; Malposition of Device
PATIENT REPORTED LEFT SIDE "DROPPED". THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22781297 ↗InjuryAug 8, 2025Malposition of Device; Malposition of Device
PATIENT REPORTED RIGHT SIDE "ROTATED", "IMPLANT PUSHING TOWARDS ARMPIT". THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22755343 ↗InjuryJul 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22636535 ↗InjuryMay 12, 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 22007208 ↗InjuryMay 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE RECEIVED AT THE DAL WITHOUT A COMPLAINT AGAINST IT. HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21976780 ↗InjuryApr 10, 2025Device Appears to Trigger Rejection; Material Rupture; Patient-Device Incompatibility; Device Appears to Trigger Rejection; Material Rupture; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE IV, PAIN AND EXPOSED IMPLANT COMING THROUGH THE INCISION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Foreign Body Reaction
MAUDE report 21812672 ↗InjuryJun 10, 2024Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED LEFT SIDE "RUPTURE PLUS EXTRUSION/LEAKAGE THRU SKIN IMPLANT EXCHANGE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Erosion
MAUDE report 19499829 ↗InjuryNov 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 18124905 ↗InjuryNov 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE REPORTED, "RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18062412 ↗InjuryOct 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III, AND EXCHANGE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17950952 ↗InjuryOct 12, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. HEALTHCARE PROFESSIONAL, LATER REPORTED, "RUPTURE FOUND, DURING EXPLANT SURGERY". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17927969 ↗
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-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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