Natrelle Inspira Cohesive Breast Implants SCM-295Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCM 295cc Moderate profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle Inspira Cohesive Breast Implants (192)
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. Reports mostly describe tightening of tissue around the implant, often leading to removal or replacement, and mention rupture, infection, pain and implants sitting out of position. There are 25 reports naming its identifier, with no deaths and 25 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
- 27
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10888628029866), received between Jun 14, 2019 and Sep 15, 2026 — classified as 27 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (15 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 Rejection15
- Patient-Device Incompatibility5
- Adverse Event Without Identified Device or Use Problem4
- Material Rupture3
- No Apparent Adverse Event2
- Device Handling Problem1
- Malposition of Device1
Patient problems
- Capsular Contracture19
- Failure of Implant3
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Breast Discomfort/Pain1
- Foreign Body Reaction1
- Impaired Healing1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50782204 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 50764289 ↗InjuryJul 27, 2026Patient-Device Incompatibility
Healthcare professional reported "Exposure". This record is for the left side. Device was explanted.
Patient problems: Foreign Body Reaction
MAUDE report 50042855 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED A "SIZE EXCHANGE¿ AND ¿PATIENT CHEST DISCOMFORT, IMPLANT TOO LARGE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Breast Discomfort/Pain
MAUDE report 24756768 ↗InjuryFeb 16, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED OF THE RIGHT SIDE DEVICE: "BAKER GRADE IV CAPSULE". THE PATIENT WAS PRESCRIBED STEROIDS. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24345169 ↗InjurySep 6, 2025Device Appears to Trigger Rejection; Malposition of Device; Device Appears to Trigger Rejection; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III AND MALPOSITION. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22988979 ↗InjuryJul 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE INFECTION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 22284852 ↗InjuryMay 15, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
THIS REPORT HAS BEEN CONFIRMED AS A DUPLICATE OF MRN 9617229-2024-24074 AND WILL NOT LONGER BE CONSIDERED REPORTABLE.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22029385 ↗InjuryMay 14, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED ¿EXCHANGE DUE TO A RUPTURE.¿ HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE II. THIS IS FOR THE RIGHT-SIDE DEVICE THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22018123 ↗InjuryApr 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". DIAGNOSED VIA PHYSICAL EXAM. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21802537 ↗InjuryNov 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. HEALTHCARE PROFESSIONAL LATER REPORTED "ANY CREASES." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 18084065 ↗InjuryApr 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PHYSICIAN REPORTED LEFT SIDE CAPSULAR CONTRACTURES, BAKER GRADES UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16690745 ↗InjuryMar 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16577771 ↗InjuryFeb 14, 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 16375464 ↗InjuryNov 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III." THIS IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15749722 ↗InjuryNov 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III." THIS IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15749422 ↗InjuryJun 15, 2022Device Appears to Trigger Rejection; Device Handling Problem; Device Appears to Trigger Rejection; Device Handling Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14704679 ↗InjuryFeb 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE NOT SPECIFIED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13571739 ↗InjuryFeb 17, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13553097 ↗InjuryDec 23, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 13078919 ↗InjuryJun 24, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN REMOVED.
Patient problems: Capsular Contracture
MAUDE report 12063596 ↗InjuryNov 16, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryOct 1, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE REMOVAL WAS NOTED AS "REVISION-RUPTURED UPON REMOVAL". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10617241 ↗InjuryMar 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9786196 ↗
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-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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