Natrelle INSPIRA Breast Implants SRLP-220Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRLP-220 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-filled breast implant made by Allergan. The 28 reports mostly describe the scar tissue around the implant tightening and hardening (capsular contracture), which can make the breast firm, painful or misshapen, and sometimes requires surgery to remove or replace the implant; a smaller number describe the implant shell breaking or leaking. All 28 reports involved injuries, and no deaths were reported. 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 10888628006850), received between Jun 7, 2019 and Sep 15, 2026 — classified as 29 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
- Material Rupture7
- Patient-Device Incompatibility4
Patient problems
- Capsular Contracture24
- Failure of Implant4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Material Rupture
Healthcare professional reported a "rupture". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50769960 ↗InjuryAug 18, 2026Device Appears to Trigger Rejection
Healthcare professional reported ¿Capsular Contracture Baker grade IV¿. Later healthcare professional reported through the National Breast Implant Registry (NBIR) ¿Capsular Contracture Baker Grade III, Correction of Asymmetry and Ptosis¿. Capsulectomy/Capsulotomy was performed. This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50293158 ↗InjuryAug 18, 2026Device 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 50293092 ↗InjuryApr 9, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24835781 ↗InjuryJan 28, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE, III/IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24198413 ↗InjurySep 2, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURE.¿ THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22937696 ↗InjuryJun 4, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED AND HEALTHCARE PROFESSIONAL CONFIRMED RIGHT SIDE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22146739 ↗InjuryNov 29, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 18230578 ↗InjuryAug 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17494104 ↗InjuryJul 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III/IV . DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 17374786 ↗InjuryApr 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
COMPANY REPRESENTATIVE REPORTED, ON BEHALF OF PHYSICIAN, A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16685180 ↗InjuryMar 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 16538337 ↗InjuryJan 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND LATER REPORTED BAKER GRADE IV. THIS RELATES TO THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16268814 ↗InjuryDec 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE BREAST PAIN AND CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15971244 ↗InjuryDec 12, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿RUPTURE/DEFLATION' AND "CAPSULAR CONTRACTURE, BAKER GRADE III'' DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15963535 ↗InjuryDec 9, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE "EXTRACAPSULAR SILICONE." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15947867 ↗InjuryNov 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE CAPSULAR CONTRACTION BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15804297 ↗InjurySep 12, 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 15407151 ↗InjuryAug 29, 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 15311044 ↗InjuryOct 29, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryOct 28, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjurySep 8, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12442225 ↗InjuryJun 29, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 12087990 ↗InjuryFeb 5, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryJan 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9585802 ↗
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-
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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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