Natrelle INSPIRA Breast Implants SRLP-440Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRLP-440 Low Plus 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 silicone gel-filled implant placed inside the breast. Reports mostly describe hardening and tightening around the implant and the implant tearing open, often leading to removal or replacement. There are 25 reports naming its identifier, with no deaths and 25 injuries. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10888628006959), received between Aug 1, 2019 and Dec 29, 2025 — classified as 24 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (13 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 Rejection13
- Material Rupture9
- Patient-Device Incompatibility8
Patient problems
- Capsular Contracture20
- Failure of Implant7
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryDec 29, 2025Material Rupture; Material Rupture
PATIENT REPORTED "INTRACAPSULAR RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23918697 ↗InjuryOct 2, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED SILICONE IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23206674 ↗InjurySep 16, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". MRI CONFIRMED INTRACAPSULAR RUPTURE ON (B(6) 2025. PROVIDER LATER NOTED "BAKER GRADE IV" CAPSULAR CONTRACTURE VIA OP. REPORT. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23069387 ↗InjuryDec 4, 2024Material Rupture; Material Rupture
HEALTHCARE PROVIDER REPORTED A LEFT SIDE EXCHANGE WITH NO COMPLAINTS AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 20841540 ↗InjuryNov 10, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE VIA MRI. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 18112420 ↗InjurySep 29, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 17843826 ↗InjuryAug 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17552954 ↗InjuryJul 5, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 17256936 ↗InjuryMar 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16541682 ↗InjuryOct 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV." THIS IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15613114 ↗InjuryOct 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV." THIS IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15613112 ↗InjuryJan 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13168444 ↗InjuryJan 4, 2022Device 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 13154819 ↗InjuryMar 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE II". ADDITIONALLY, HEALTHCARE PROVIDER REPORTS CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11543226 ↗InjuryFeb 11, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. HEALTHCARE PROFESSIONAL REPORTED AND CONFIRMED THE EVENT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11315115 ↗InjuryDec 21, 2020Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 11047187 ↗InjuryDec 21, 2020Device Appears to Trigger Rejection; Material Rupture; Patient-Device Incompatibility; Device Appears to Trigger Rejection; Material Rupture; Patient-Device Incompatibility
ADDITIONALLY, HEALTHCARE PROFESSIONAL CONFIRMS RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11047166 ↗InjuryNov 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryNov 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTION, BAKER GRADE "III/IV.¿ DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10828076 ↗InjuryOct 20, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10707671 ↗InjuryJun 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10121256 ↗InjuryJan 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9581955 ↗InjuryAug 4, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8858335 ↗InjuryAug 1, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8851630 ↗
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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