Natrelle INSPIRA Breast Implants SRLP-320Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRLP-320 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 implant used in breast reconstruction or augmentation. The 47 reports mostly describe the scar tissue around the implant tightening and contracting (capsular contracture), which can make the breast feel hard and painful, and the implant shell breaking or rupturing, in some cases requiring surgical removal and replacement. There were 46 injuries 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
- 46
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10888628006911), received between May 22, 2019 and Sep 25, 2026 — classified as 45 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (22 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 Rejection22
- Patient-Device Incompatibility12
- Material Rupture11
- Adverse Event Without Identified Device or Use Problem3
- Device Handling Problem1
Patient problems
- Capsular Contracture34
- Failure of Implant9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fluid Discharge1
- Impaired Healing1
- Seroma1
- Unspecified Infection1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture" Baker grade IV. This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50899845 ↗InjurySep 25, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture" Baker grade IV. This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50899620 ↗InjuryJun 10, 2026Device Appears to Trigger Rejection
Healthcare professional reported a "Capsular contracture, Grade 4". This record is for the left side. Device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 25462631 ↗InjuryJun 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE "2 OR 3" AND "PATIENT DISSATISFACTION". HEALTHCARE PROFESSIONAL ALSO REPORTED "IMPLANTS WERE REMOVED DUE TO BREAST CANCER", WHICH IS NOT DEVICE-RELATED. DEVICE WAS EXPLANTED VIA DEEP INFERIOR EPIGASTRIC PERFORATOR (DIEP) PROCEDURE.
Patient problems: Capsular Contracture
MAUDE report 22332984 ↗InjuryJun 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE "2 OR 3" AND "PATIENT DISSATISFACTION". HEALTHCARE PROFESSIONAL ALSO REPORTED "IMPLANTS WERE REMOVED DUE TO BREAST CANCER", WHICH IS NOT DEVICE-RELATED. DEVICE WAS EXPLANTED VIA DEEP INFERIOR EPIGASTRIC PERFORATOR (DIEP) PROCEDURE.
Patient problems: Capsular Contracture
MAUDE report 22332982 ↗InjuryJun 3, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "POSSIBLE RUPTURE". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22137583 ↗InjuryMay 28, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22102183 ↗InjuryJan 25, 2024Material Rupture; Material Rupture
COMPANY REPRESENTATIVE REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 18584971 ↗InjuryOct 24, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "I HAVE BEEN TRYING TO START A DIGITAL WARRANTY CLAIM FOR PATIENT REDACTED. WHEN I HIT SUBMIT IT JUST SAYS UPLOAD AND NEVER FULLY SUBMITS". HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE CONFIRMED BY ULTRASOUND. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17996255 ↗InjuryOct 23, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE CONFIRMED BY ULTRASOUND. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17988043 ↗InjuryOct 19, 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 17969546 ↗InjuryJul 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryJul 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17313379 ↗InjuryMay 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III/IV. THE DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 16887472 ↗InjuryApr 27, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16826438 ↗InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE INFECTION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 16769065 ↗InjuryMar 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER CALLED TO REPORT RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16503508 ↗InjuryMar 7, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
InjuryNov 23, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "A RIGHT SIDE RUPTURE." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15854617 ↗InjuryOct 25, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE III." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15667764 ↗InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE SEROMA. DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 15650388 ↗InjurySep 14, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15419835 ↗InjuryJul 25, 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 15093499 ↗InjuryJul 5, 2022Device 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 14914623 ↗InjuryJun 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14672382 ↗
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-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-
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
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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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