Natrelle INSPIRA Breast Implants SRLP-360Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRLP-360 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 is a Natrelle INSPIRA silicone gel breast implant made by Allergan. The 50 reports mostly describe the scar tissue around the implant tightening and contracting, which can make the breast feel hard and change shape, along with the implant shell breaking or leaking inside the chest. All 50 reports describe injuries, and no deaths were reported. There are no recalls naming 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
- 52
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10888628006935), received between May 7, 2019 and Sep 18, 2026 — classified as 52 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (20 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 Rejection20
- Patient-Device Incompatibility19
- Material Rupture13
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Contracture39
- Failure of Implant7
- No Clinical Signs, Symptoms or Conditions6
- Seroma1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831493 ↗InjurySep 9, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700486 ↗InjurySep 9, 2026Material Rupture
Healthcare professional reported a "Rupture". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692547 ↗InjuryAug 25, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture, Baker II-III" against the Right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50440103 ↗InjuryJul 20, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25882274 ↗InjuryJun 8, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25434545 ↗InjuryJun 7, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25422157 ↗InjuryAug 22, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR REPORTED " SUSPECTED/ACTUAL RUPTURE/DEFLATION, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22873107 ↗InjuryDec 9, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE "RUPTURE." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 20880221 ↗InjurySep 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, A LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17786182 ↗InjurySep 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, CAPSULAR CONTRACTURE, BAKER GRADE III. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17769887 ↗InjuryAug 25, 2023Device 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 LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE "IV."
Patient problems: Capsular Contracture; Seroma
MAUDE report 17627172 ↗InjuryMay 18, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT BREAST PAIN AND INCIDENTAL RIGHT INTRACAPSULAR RUPTURE SHOWN BY CT SCAN. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16957389 ↗InjuryMay 4, 2023Material Rupture; Material Rupture
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE RUPTURE CONFIRMED BY AN MRI. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16872866 ↗InjuryApr 24, 2023Material Rupture; Material Rupture
InjuryApr 11, 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 16718145 ↗InjuryMar 17, 2023Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE NO COMPLAINT AGAINST THE DEVICE. LATER, PATIENT REPORTED "COLLAPSE." HEALTHCARE PROFESSIONAL REPORTED "BOTTOMING OUT." LATER, PATIENT ADDITIONALLY REPORTED RIGHT SIDE "POSSIBLY RUPTURED." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16566583 ↗InjuryMar 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16542289 ↗InjuryJan 12, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE NOTICED AT THE TIME OF EXPLANT SURGERY." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16153272 ↗InjuryNov 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 15870771 ↗InjuryNov 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 15870436 ↗InjuryNov 25, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTH CARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15866218 ↗InjuryOct 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15656475 ↗InjuryMay 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14517419 ↗InjuryMay 10, 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 14346326 ↗
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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- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
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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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