Natrelle Inspira Cohesive Breast Implants SCM-360Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCM 360cc 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 is a Natrelle Inspira silicone gel breast implant. The 50 reports mostly describe capsular contracture — the scar tissue around the implant tightening and hardening, sometimes causing pain — along with a few cases of fluid buildup (seroma) and implant rupture found on MRI. No deaths were reported, and all 50 reports were 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
- 49
- Deaths reported
- 0
- Injuries reported
- 49
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10888628029903), received between Jun 4, 2019 and Jun 11, 2026 — classified as 49 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (32 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 Rejection32
- Patient-Device Incompatibility11
- Adverse Event Without Identified Device or Use Problem4
- Material Rupture4
Patient problems
- Capsular Contracture41
- Failure of Implant3
- Seroma3
- Foreign Body Sensation in Eye1
- Impaired Healing1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2026Device Appears to Trigger Rejection
SALES REPRESENTATIVE ON BEHALF OF HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED "GRADE 3 CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25476611 ↗InjuryApr 3, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24776245 ↗InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SEROMA". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Seroma
MAUDE report 23078481 ↗InjuryJun 4, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" DIAGNOSED VIA MRI. LATER HEALTHCARE PROFESSIONAL REPORTED "SCAR TISSUE MILD CAPSULAR CONTRACTURE" (BAKER GRADE UNKNOWN) AND "ANY CREASES". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22146817 ↗InjuryApr 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE MILD CAPSULAR CONTRACTURE BAKER III WITH NARROWING OF THE IMPLANT AND FIRMNESS, PAIN, WHICH MAY MAKE IT A BAKER IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21922539 ↗InjuryApr 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER III WITH NARROWING OF THE IMPLANT AND FIRMNESS. PATIENT ALSO COMPLAINS OF PAIN, WHICH MAY MAKE IT A BAKER IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21919945 ↗InjurySep 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ALLERGAN AESTHETICS RECEIVED, A REPORT VIA NBIR OF A RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE IV". THE DEVICE HAS BEEN EXPLANTED AND REPLACED. "CAPSULECTOMY/CAPSULOTOMY" WAS PERFORMED.
Patient problems: Capsular Contracture
MAUDE report 20232060 ↗InjuryNov 30, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 18241852 ↗InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE SEROMA. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Seroma
MAUDE report 17967021 ↗InjuryOct 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17951019 ↗InjurySep 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17727665 ↗InjurySep 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17727612 ↗InjuryAug 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryAug 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17494374 ↗InjuryAug 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17484566 ↗InjuryJun 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17075924 ↗InjuryJun 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, A LEFT-SIDE CAPSULAR CONTRACTION, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17050941 ↗InjuryMar 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTION, BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16462045 ↗InjuryMar 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTION, BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16461563 ↗InjuryJan 10, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE I. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16131570 ↗InjuryDec 1, 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 15899183 ↗InjuryNov 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15886693 ↗InjuryNov 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III." AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15744672 ↗InjuryNov 4, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15726954 ↗InjuryNov 3, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15719787 ↗
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-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-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-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-
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
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- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
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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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