Natrelle INSPIRA Breast Implants SRM-560Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRM-560 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 is a smooth, round, silicone gel-filled implant. Of the 161 reports, most describe capsular contracture (hardening of the scar tissue around the implant), and some describe ruptures or the body appearing to reject the implant. The reports include no deaths and 161 injuries, and reports fell to 3 in the last 12 months from 12 before. 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
- 162
- Deaths reported
- 0
- Injuries reported
- 162
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 10888628007178), received between May 21, 2019 and Aug 20, 2026 — classified as 162 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (78 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 Rejection78
- Patient-Device Incompatibility47
- Material Rupture43
- Adverse Event Without Identified Device or Use Problem6
- Fluid/Blood Leak1
Patient problems
- Capsular Contracture123
- Failure of Implant32
- Seroma4
- Unspecified Infection3
- Fluid Discharge1
- Foreign Body Reaction1
- No Clinical Signs, Symptoms or Conditions1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 162 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare Professional reported "Capsular Contracture Baker grade IV". Healthcare Professional later reported "rupture". This record is for the left side. Device was explanted. Patient received Accolate as treatment.
Patient problems: Capsular Contracture
MAUDE report 50359332 ↗InjuryAug 10, 2026Device Appears to Trigger Rejection
Healthcare professional reported a Capsular Contracture, Baker Grade IV. This record is for the right side. The device was explanted. Singulair was prescribed.
Patient problems: Capsular Contracture
MAUDE report 50200068 ↗InjuryJul 27, 2026Material Rupture
Healthcare professional reported a rupture. This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50031653 ↗InjuryJun 12, 2026Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 25491433 ↗InjurySep 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23136915 ↗InjurySep 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "NO COMPLAINT AGAINST THE DEVICE VIA MAMMOGRAM AND MRI". HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE, AND SUSPECTED CAPSULAR CONTRACTURE BAKER GRADE II". HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "LEFT SIDE WAS NOT CONFIRM TO BE RUPTURE, FOUND TO BE INTACT DURING THE SURGERY". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23058797 ↗InjuryAug 14, 2025Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE "TISSUE DAMAGE." LATER REPORTED "RUPTURE". THIS RELATES TO THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22808668 ↗InjuryAug 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22767688 ↗InjuryAug 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22718925 ↗InjuryJul 24, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE DIAGNOSED VIA ULTRASOUND. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22596704 ↗InjuryJul 24, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22591761 ↗InjuryJul 15, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS IS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22512243 ↗InjuryJul 14, 2025Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE POSSIBLE RUPTURE AND SORENESS. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22491345 ↗InjuryJul 12, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22490207 ↗InjuryApr 28, 2025Material Rupture; Material Rupture
PATIENT REPORTED "MALFUNCTION, LOOKS LIKE THE INNER LAYER IS BURSTING INTO THE OUTER LAYER." THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21923296 ↗InjuryJan 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III" AND "APPEARANCE, PALPATION, PATIENT WITH DISCOMFORT". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21183681 ↗InjuryApr 26, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 19195011 ↗InjuryNov 30, 2023Device 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 18243061 ↗InjurySep 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17815343 ↗InjurySep 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17785002 ↗InjuryAug 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE REMOVAL NOTED AS ¿CAPSULE" LATER REPORTED TO BE A CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17651800 ↗InjuryAug 9, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE AND PAIN. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17490559 ↗InjuryAug 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17447669 ↗InjuryJul 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryJul 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17278678 ↗
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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