Natrelle INSPIRA Breast Implants SRX-285Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRX-285 Extra Full 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-filled breast implant (SRX-285, extra full profile) is made by Allergan. The 53 reports to FDA mostly describe the scar tissue around the implant tightening and hardening, which can make the breast feel firm, painful or distorted, and in some cases the implant has been removed along with the surrounding capsule. Reports also mention rupture of the implant shell and erosion of the tissue pocket. There were 53 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
- 50
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10888628007468), received between Jun 20, 2019 and Aug 6, 2026 — classified as 50 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (33 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 Rejection33
- Patient-Device Incompatibility11
- Material Rupture9
Patient problems
- Capsular Contracture42
- Failure of Implant6
- Pocket Erosion2
- Seroma1
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade IV." This record is for the left side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50164346 ↗InjuryAug 3, 2026Device Appears to Trigger Rejection
Healthcare professional reported Capsular Contracture Baker grade III. This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50119504 ↗InjuryJun 4, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25389426 ↗InjuryMay 14, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. PATIENT UNDERGO A CAPSULECTOMY.
Patient problems: Capsular Contracture
MAUDE report 25167303 ↗InjuryMay 14, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. PATIENT UNDERGO A CAPSULECTOMY.
Patient problems: Capsular Contracture
MAUDE report 25167290 ↗InjuryFeb 6, 2026Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III AND "POSSIBLE RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24282719 ↗InjuryAug 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURES, BAKER GRADE III", "REALLY BOTHERING" AND "INFLAMMATION". HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE IN BOTH OF BREASTS, BAKER GRADE 3. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22685548 ↗InjuryJul 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "CAPSULAR CONTRACTURES BAKER GRADE III", "REALLY BOTHERING" AND "INFLAMMATION". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22591261 ↗InjuryJun 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT'S REPRESENTATIVE REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22353086 ↗InjuryMay 12, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE¿ AND "BAKER GRADE 3". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22007254 ↗InjuryMay 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED A RIGHT-SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, "SAGGING UNDERNEATH" AND DOUBLE BUBBLE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21995864 ↗InjuryFeb 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21428640 ↗InjuryNov 1, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III-IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18051026 ↗InjuryOct 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjurySep 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17695669 ↗InjurySep 6, 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 17692023 ↗InjuryAug 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA COMPANY REPRESENTATIVE RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17638555 ↗InjuryApr 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED THE EVENT OF LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16765849 ↗InjuryApr 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16732715 ↗InjuryApr 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURES, BAKER GRADE IV. PATIENT HAD IMPLANT PUT IN ON (B)(6) 2021. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16714883 ↗InjuryApr 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURES, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16709336 ↗InjuryJan 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED THE EVENT OF RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16235607 ↗InjuryNov 22, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15842782 ↗InjuryNov 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15839939 ↗InjuryNov 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15743878 ↗
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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