Natrelle INSPIRA Breast Implants SRF-520Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRF-520 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 Allergan Natrelle INSPIRA breast implant is a silicone gel-filled implant placed in the breast. Most of its 473 reports mention hardening of the scar tissue around the implant, with others describing the body reacting against it, the implant failing, and the shell breaking. The reports include 471 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
- 479
- Deaths reported
- 0
- Injuries reported
- 477
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 479 adverse event reports that list this exact device (DI 10888628007369), received between May 13, 2019 and Sep 28, 2026 — classified as 477 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (290 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 Rejection290
- Patient-Device Incompatibility128
- Material Rupture66
- Adverse Event Without Identified Device or Use Problem9
- Device Handling Problem2
- Break1
- Difficult to Open or Remove Packaging Material1
- Gel Leak1
Patient problems
- Capsular Contracture407
- Failure of Implant51
- Unspecified Infection10
- No Clinical Signs, Symptoms or Conditions7
- Erosion3
- Foreign Body Reaction3
- Pocket Erosion3
- Seroma3
Recent adverse event reports
The 25 most recent of 479 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50924079 ↗InjurySep 21, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade III". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50841303 ↗InjurySep 18, 2026Device Appears to Trigger Rejection; Material Rupture
Later reported "rupture". Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50831116 ↗InjurySep 16, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796816 ↗InjurySep 15, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50766003 ↗InjurySep 11, 2026Material Rupture
Patient reported "implant rupture". Later healthcare professional reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738237 ↗InjurySep 11, 2026Device Appears to Trigger Rejection; Material Rupture
Patient reported "rupture" and "higher". Later, patient reported "went higher, the difference is very noticeable, I don't like it", "I heard something popped" and "capsular contracture baker grade unknown". Later, healthcare professional reported "raising", "hardening", "capsular contracture Baker grade IV", "sits higher", "rupture" and ¿the inner silicone touched the patient¿. This record is for the left side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50735236 ↗InjurySep 10, 2026Material Rupture
Patient reported "rupture/leak" and "pain". Additionally reported were "inflammation", "autoimmune issues, dry eyes, thyroid disease, Rheumatoid Arthritis, Sjrogen Syndrome" which are not device related. This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722160 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported ¿Infection¿ and " Infection surrounding area". This record is for the right side. The device has been explanted.
Patient problems: Unspecified Infection
MAUDE report 50717789 ↗InjurySep 9, 2026Device Appears to Trigger Rejection
Healthcare professional reported ¿Capsular Contracture Baker Grade III/IV¿. Singular, prednisone and minicyclin were prescribed. This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50695781 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "overlying wound". This record is for the right side. Device has been explanted.
Patient problems: Impaired Healing
MAUDE report 50681648 ↗InjurySep 1, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50546913 ↗InjuryAug 25, 2026Device Appears to Trigger Rejection
Healthcare Professional reported "Capsulectomy" and Capsular Contracture, Baker Grade IV. Later patient reported "had a lot of pain" and "encapsulated". This record is for the right side. Device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50422369 ↗InjuryAug 21, 2026Device Appears to Trigger Rejection
InjuryAug 19, 2026Device Appears to Trigger Rejection
Healthcare Professional reported "Capsulectomy" and Capsular Contracture, Baker Grade IV. This record is for the left side. Device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50323486 ↗InjuryAug 13, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture baker grade III". Patient received Singulair as treatment. This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50241301 ↗InjuryAug 13, 2026Patient-Device Incompatibility
Healthcare professional reported "Breast implant replacement due to trauma induced rupture in the contralateral breast". Later Healthcare professional reported "breast wound dehiscence with skin/soft tissue necrosis and exposed implant". This record is for the left side. The device has been explanted.
Patient problems: Foreign Body Reaction; Necrosis
MAUDE report 50240816 ↗InjuryAug 11, 2026Device Appears to Trigger Rejection
Healthcare professional reported a Capsular Contracture, Baker Grade "III/IV". This record is for the left side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50210092 ↗InjuryAug 7, 2026Patient-Device Incompatibility
Healthcare professional reported "implant exposed thru the skin". This record is for the left side. Device was explanted.
Patient problems: Foreign Body Reaction
MAUDE report 50169255 ↗InjuryAug 3, 2026Device Appears to Trigger Rejection
Healthcare professional reported "exchange with no complaint against the device". Later healthcare professional reported Capsular Contracture Baker Grade Unknown. This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50117917 ↗InjuryJul 13, 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 25807592 ↗InjuryJun 18, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25555026 ↗InjuryJun 11, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25470156 ↗InjuryJun 8, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25429820 ↗InjuryMay 1, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25057333 ↗
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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