Natrelle INSPIRA Breast Implants SRM-640Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRM-640 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 Natrelle INSPIRA silicone gel breast implant is used in breast reconstruction or augmentation. The 65 reports mostly describe the scar tissue around the implant tightening and contracting so the breast becomes hard and misshapen, sometimes with the implant rupturing or breaking down and needing surgical removal. There are 64 reports of injury and no deaths. 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
- 66
- Deaths reported
- 0
- Injuries reported
- 66
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10888628007192), received between May 22, 2019 and Sep 17, 2026 — classified as 66 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (33 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 Rejection33
- Material Rupture16
- Patient-Device Incompatibility16
- No Apparent Adverse Event3
- Device Handling Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Contracture48
- Failure of Implant15
- No Clinical Signs, Symptoms or Conditions3
- Unspecified Infection2
- Abscess1
- Foreign Body Reaction1
- Seroma1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture grade 3" against the right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50805242 ↗InjuryJun 29, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker Grade III". Patient was prescribed Accolate. This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 25662031 ↗InjuryApr 24, 2026Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED THE CAPSULAR CONTRACTURE IS BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24987207 ↗InjuryApr 22, 2026No Apparent Adverse Event
PATIENT REPORTED "POSSIBLE RUPTURE, PAIN, DIFFERENT IN TEXTURE AND DIFFERENT IN DROOPINESS". LATER HEALTHCARE PROFESSIONAL REPORTED POSSIBLE RUPTURE. LATER HEALTHCARE PROFESSIONAL REPORTED THAT THE REASON FOR REMOVAL WAS AN EVENT ON THE CONTRALATERAL SIDE. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960733 ↗InjuryMar 17, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "BAKER GRADE 4 CAPSULAR CONTRACURE". "PATIENT HAS BEEN ON ORAL MEDICATIONS AS SINGULAIR, CELEBREX, MILK THISTLE AND HAS IMPROVED TO CAPSULAR CONTRACTURE BAKER GRADE 3". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24619225 ↗InjuryOct 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE¿. BAKER GRADE NOT SPECIFIED". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23392326 ↗InjurySep 24, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23133249 ↗InjurySep 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23111186 ↗InjurySep 12, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE". DIAGNOSED VIA MRI. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23045310 ↗InjuryJul 18, 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 AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22543077 ↗InjuryJul 18, 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 22541098 ↗InjuryJun 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "IMPLANT EXCHANGE DUE TO ¿ENCAPSULATION¿ BAKER GRADE UNKNOWN AND ¿IT LOOKS TERRIBLE.¿". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22136833 ↗InjuryMay 22, 2025Material Rupture; Material Rupture
InjuryNov 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryNov 1, 2023Material Rupture; Material Rupture
PATIENT REPORTED RUPTURE. THE DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Failure of Implant
MAUDE report 18048783 ↗InjurySep 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17668317 ↗InjuryJul 21, 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 17370600 ↗InjuryMay 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16899402 ↗InjuryApr 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16662767 ↗InjuryFeb 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16405962 ↗InjuryFeb 3, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND DISCARDED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Failure of Implant
MAUDE report 16294831 ↗InjuryJan 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16107034 ↗InjuryDec 20, 2022Device 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 16018340 ↗InjuryNov 11, 2022Device 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 15784425 ↗InjuryOct 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE REMOVAL NOTED AS "EXPOSED TO ELEMENTS¿. DEVICE HAS BEEN EXPLANTED.
Patient problems: Foreign Body Reaction
MAUDE report 15658071 ↗
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-
- 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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