Natrelle INSPIRA Breast Implants SRLP-190Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRLP-190 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. Reports mostly describe hardening and tightening around the implant and rupture, often with removal or replacement mentioned. There are 25 reports that name 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
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10888628006836), received between Sep 6, 2019 and Sep 10, 2025 — classified as 23 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (18 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 Rejection18
- Material Rupture4
- Patient-Device Incompatibility3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Contracture20
- Failure of Implant3
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" VIA " MRI AND MAMMOGRAM". HEALTHCARE PROFESSIONAL REPORTED "PTOSIS". THIS RECORD IS FOR THE "LEFT" SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23016254 ↗InjuryMay 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PHYSICIAN REPORTED VIA NBIR RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19311025 ↗InjuryMay 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PHYSICIAN REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19310926 ↗InjuryMay 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16907888 ↗InjuryApr 13, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT-SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16737095 ↗InjuryApr 13, 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 16730302 ↗InjuryMar 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTION, BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16499111 ↗InjuryFeb 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16378805 ↗InjuryFeb 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 16364180 ↗InjuryNov 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15839005 ↗InjuryNov 11, 2022Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, AND RIPPLING. DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Capsular Contracture; Skin Inflammation/ Irritation
MAUDE report 15785010 ↗InjuryOct 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE GRADE II/III AND "COSMETIC DISSATISFACTION WITH THE APPEARANCE OF THE BREAST" AND "SLIGHTLY FOLDED". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15628973 ↗InjuryOct 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE GRADE III ,"COSMETIC DISSATISFACTION WITH THE APPEARANCE OF THE BREAST", AND "SLIGHTLY FOLDED" DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15628776 ↗InjuryAug 3, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE INTRACAPSULAR RUPTURE CONFIRMED VIA MRI. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15156350 ↗InjuryMay 10, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III." THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14349273 ↗InjuryMay 9, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PHYSICIAN REPORTED PATIENT "PRESENTED WITH EARLY CAP CON (BAKER GRADE UNKNOWN) AGAIN ON RIGHT SIDE," PATIENT "RECALLED FALLING WHILE TRAIL RUNNING, LANDING ON CHEST," AND THERE "MAY ALSO BE ANOTHER RUPTURE." THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14342316 ↗InjuryApr 13, 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 14105900 ↗InjuryDec 20, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13048229 ↗InjuryMar 7, 2021Device 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 11426471 ↗InjuryJan 8, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11139813 ↗InjuryJul 10, 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 10259776 ↗InjuryMar 25, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9879503 ↗InjurySep 6, 2019Device Appears to Trigger Rejection; Patient-Device Incompatibility; Device Appears to Trigger Rejection; Patient-Device Incompatibility
DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Capsular Contracture
MAUDE report 8972899 ↗
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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