Natrelle INSPIRA Breast Implants SRLP-235Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRLP-235 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 Natrelle INSPIRA silicone gel breast implant is a smooth, round, low-plus-profile implant made by Allergan. The 28 reports mostly describe the scar tissue tightening around the implant (capsular contracture), often to a severe, painful, distorted grade, along with reports of the implant shell rupturing and the body reacting to it. All 28 reports involve injuries, with 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
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10888628006867), received between Aug 7, 2019 and Jul 21, 2026 — classified as 29 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 Incompatibility7
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Capsular Contracture20
- Failure of Implant6
- Hematoma1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2026Material Rupture
Healthcare professional reported "rupture" confirmed with MRI. This record is for the left side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25899355 ↗InjurySep 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV (FIRM, PAINFUL, AND SIGNIFICANTLY DISTORTED). THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22988965 ↗InjuryAug 20, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" DIAGNOSED VIA MRI AND LATER REPORTED "ANY CREASES". THIS RECORD IS FOR THE RIGHT-SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22849576 ↗InjuryJun 23, 2025Device 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 22308032 ↗InjuryJun 4, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT CALLED TO REPORT LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22141869 ↗InjuryNov 20, 2023Device Appears to Trigger Rejection; Device 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 18176574 ↗InjuryNov 20, 2023Device Appears to Trigger Rejection; Device 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 18175978 ↗InjuryAug 24, 2023Device 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 17618643 ↗InjuryJun 7, 2023Device 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 17080459 ↗InjuryFeb 22, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16423116 ↗InjuryFeb 21, 2023Material Rupture; Material Rupture
InjuryNov 24, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV AND A POSSIBLE BILATERAL RUPTURE". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15862168 ↗InjuryOct 27, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15685174 ↗InjuryOct 27, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15684440 ↗InjuryOct 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15638295 ↗InjuryOct 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15638238 ↗InjuryJun 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14880682 ↗InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "INFECTION." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 12281746 ↗InjuryApr 19, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 11691145 ↗InjuryApr 19, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryOct 30, 2020Material Rupture; Material Rupture
InjuryOct 8, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED ¿LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III¿. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10652512 ↗InjuryAug 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10398897 ↗InjuryMar 25, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9877960 ↗InjuryFeb 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9720860 ↗
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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