Natrelle INSPIRA Breast Implants SRL-260Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRL-260 Low 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 silicone breast implant has 24 adverse event reports that mention tightening of scar tissue around the implant and ruptures, with some implants removed and replaced. The reports include no deaths and 24 injuries. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10888628006706), received between Aug 2, 2019 and Jan 9, 2026 — classified as 24 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (14 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 Rejection14
- Material Rupture6
- Patient-Device Incompatibility3
- No Apparent Adverse Event2
- Adverse Event Without Identified Device or Use Problem1
- Malposition of Device1
- Migration1
Patient problems
- Capsular Contracture16
- Failure of Implant8
- No Clinical Signs, Symptoms or Conditions2
- Impaired Healing1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEVICE MIGRATION/IMPLANT MALPOSITION, PTOSIS". THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 24028379 ↗InjuryMay 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22086277 ↗InjuryNov 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18210175 ↗InjuryNov 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18210174 ↗InjurySep 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III" AND "BREAST MASS." THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17758003 ↗InjuryJul 7, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 17278342 ↗InjuryApr 28, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16832229 ↗InjuryMar 21, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
PHYSICIAN REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 16584431 ↗InjuryJan 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THIS RECORD IS FOR RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16273089 ↗InjuryOct 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED RIGHT CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15633230 ↗InjuryOct 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED LEFT CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15633140 ↗InjurySep 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15486576 ↗InjurySep 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND A PERMANENT CREASE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15358611 ↗InjuryAug 10, 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 15198345 ↗InjuryJul 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III AGAINST LEFT DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14936068 ↗InjuryOct 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III, "RIPPLES", AND "CAPSULE THAT WAS CAUSING SOME AREAS TO KIND OF FOLD THE IMPLANT". THE DEVICE HAS BEEN REPLACED.
Patient problems: Failure of Implant
MAUDE report 12682767 ↗InjuryJun 14, 2021Device 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 11995602 ↗InjuryMar 5, 2021Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Impaired Healing
MAUDE report 11423526 ↗InjuryJul 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryJul 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND PAIN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10257756 ↗InjuryDec 11, 2019Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9453207 ↗InjuryAug 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8887590 ↗InjuryAug 4, 2019Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 8858349 ↗InjuryAug 2, 2019Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE, "PAIN" AND "BREAST LUMP." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 8856496 ↗
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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