Natrelle INSPIRA Breast Implants SRF-220Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRF-220 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 is made by Allergan. The 58 reports mostly describe the scar tissue around the implant tightening and hardening (capsular contracture), which can make the breast feel firm and sometimes painful, along with reports of the implant rupturing or sitting in the wrong position. All 58 reports involve injuries, and no deaths are described. No recalls name this device, and reports have dropped from 6 in the prior12 months to 1 in the past year.
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
- 59
- Deaths reported
- 0
- Injuries reported
- 59
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10888628007246), received between May 9, 2019 and Sep 30, 2026 — classified as 59 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (36 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 Rejection36
- Patient-Device Incompatibility13
- Material Rupture8
- Adverse Event Without Identified Device or Use Problem2
- Malposition of Device2
- Improper or Incorrect Procedure or Method1
Patient problems
- Capsular Contracture49
- Failure of Implant7
- Unspecified Infection3
- No Clinical Signs, Symptoms or Conditions1
- Swollen Lymph Nodes/Glands1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Fibrous capsule", "Encapsulation". Later, healthcare professional reported " Fibrous capsule", " Capsular contracture Baker grade IV". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50941714 ↗InjuryAug 3, 2026Malposition of Device
Patient reported "is higher". Patient later reported "moved up, bothering me, uncomfortable, and having pain" and "it's outside of the breast, it's in the chest, above the breast, had to change the bra, the bra hurts when I put it on, the arm is bothering, I am worried". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50116473 ↗InjurySep 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE III¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. IT WAS RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23149884 ↗InjurySep 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22990430 ↗InjuryAug 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22843085 ↗InjuryJun 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22308866 ↗InjuryJun 17, 2025Device Appears to Trigger Rejection; Malposition of Device; Device Appears to Trigger Rejection; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III, DEVICE MIGRATION/IMPLANT MALPOSITION, CORRECTION OF ASYMMETRY". THIS RELATES TO THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22235849 ↗InjuryJun 4, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22142037 ↗InjuryOct 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE II. HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17934733 ↗InjuryOct 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE II. HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17922907 ↗InjuryJun 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17242816 ↗InjuryJun 29, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND NOT REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17232311 ↗InjuryJun 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE OF CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND NO REPLACEMENT.
Patient problems: Capsular Contracture
MAUDE report 17222294 ↗InjuryMay 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULOTOMY. HEALTHCARE PROFESSIONAL LATER REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16856523 ↗InjuryMay 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT HAS BEEN IDENTIFIED THAT THIS RECORD IS A DUPLICATE OF MRN 9617229-2023-06511.
Patient problems: Capsular Contracture
MAUDE report 16845447 ↗InjuryApr 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16781572 ↗InjuryApr 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16781571 ↗InjuryJan 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA OPERATIVE REPORT BAKER GRADE IV. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16140130 ↗InjuryJan 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16137326 ↗InjuryNov 29, 2022Material Rupture; Material Rupture
HEALTH CARE PROFESSIONAL REPORTING A RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15883667 ↗InjuryNov 29, 2022Material Rupture; Material Rupture
HEALTH CARE PROFESSIONAL REPORTING A LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15881667 ↗InjuryOct 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED. TREATMENT NOTED AS "SINGULAIR, VITAMIN E, DOXYCYCLINE."
Patient problems: Capsular Contracture
MAUDE report 15565464 ↗InjurySep 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15510873 ↗InjurySep 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED A RIGHT CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15354124 ↗InjuryAug 25, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV AND PAIN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15298552 ↗
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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