Natrelle Inspira Cohesive Breast Implants SCM-310Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCM 310cc 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 Natrelle Inspira cohesive breast implant is a smooth, round, silicone gel-filled implant made by Allergan. The 36 reports mostly describe the scar tissue around the implant tightening and contracting, sometimes severe enough to change its shape, plus a smaller number of ruptures and skin infections; all 36 involved injuries and no deaths were reported. 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
- 39
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10888628029873), received between Aug 1, 2019 and Jul 27, 2026 — classified as 39 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (25 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 Rejection25
- Material Rupture6
- Adverse Event Without Identified Device or Use Problem4
- Patient-Device Incompatibility4
Patient problems
- Capsular Contracture29
- Failure of Implant5
- Cellulitis2
- Foreign Body Sensation in Eye1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. The device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50006345 ↗InjuryJul 17, 2026Device Appears to Trigger Rejection
InjuryJul 14, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 3". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25812289 ↗InjuryJul 13, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE LLL". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25807834 ↗InjuryJul 13, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade lll". This record is for left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 25804114 ↗InjurySep 15, 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 REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23052174 ↗InjuryJun 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
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 22255423 ↗InjuryJun 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR BAKER GRADE III/IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22248305 ↗InjuryMay 14, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE, BRAIN TUMOR, NEUROLOGICAL ISSUES, AND NUMB TO THE TOUCH" CONFIRMED VIA MRI. LATER HEALTHCARE PROFESSIONAL CONFIRMED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22021101 ↗InjuryJun 28, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "CAPSULAR CONTRACTURE BAKER GRADE III" AND "CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19632358 ↗InjurySep 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
COMPANY REPRESENTATIVE REPORTED ON BEHALF OF THE HEALTHCARE PROFESSIONAL A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17717130 ↗InjuryJan 17, 2023Device 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 16186926 ↗InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING LEFT SIDE "CELLULITIS WITH FLUID COLLECTION TO LEFT BREAST". DEVICE HAS BEEN EXPLANTED.
Patient problems: Cellulitis
MAUDE report 16052739 ↗InjuryNov 15, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15801145 ↗InjuryNov 15, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15801057 ↗InjuryOct 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15621128 ↗InjuryOct 2, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING "RUPTURE" "ANY CREASES" FOLDED OVER AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15526287 ↗InjuryAug 31, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15332613 ↗InjuryJul 10, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14973909 ↗InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE "WOUND HEALING". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Wound Dehiscence
MAUDE report 14380351 ↗InjuryMay 12, 2022Device Appears to Trigger Rejection; Device 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 14371332 ↗InjuryFeb 24, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13592381 ↗InjuryDec 21, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING THE RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13056214 ↗InjuryDec 17, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING "CONTRACTURE BAKER GRADE UNKNOWN". DEVICE HAS BEEN EXPLANTED. LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 13029215 ↗InjuryDec 9, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 12971995 ↗
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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