Natrelle Inspira Cohesive Breast Implants SCM-345Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCM 345cc 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 silicone breast implant has 51 adverse event reports, with no deaths, 50 injuries and 1 malfunction report. The reports mostly describe capsular contracture, where hard scar tissue tightens around the implant, along with some implants rupturing and a few packaging problems. 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
- 50
- Deaths reported
- 0
- Injuries reported
- 49
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10888628029897), received between May 17, 2019 and Nov 6, 2025 — classified as 49 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (31 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 Rejection31
- Patient-Device Incompatibility9
- Material Rupture5
- Difficult to Open or Remove Packaging Material2
- Adverse Event Without Identified Device or Use Problem1
- Device Contamination with Chemical or Other Material1
- Device Handling Problem1
Patient problems
- Capsular Contracture40
- Failure of Implant5
- No Clinical Signs, Symptoms or Conditions3
- Impaired Healing1
- No Patient Involvement1
- Unspecified Infection1
- Wrinkling1
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "ISSUE WITH THE TYVEK PAPER". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23486330 ↗InjurySep 29, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "TORN IN 2 PLACES". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23175249 ↗InjurySep 16, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "TYVEK PAPER DIDN¿T COME OFF" AND "ENDED UP BREAKING STERILE FIELD". THE DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23069556 ↗InjuryJul 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED
Patient problems: Capsular Contracture
MAUDE report 22510924 ↗InjuryJul 14, 2025Device 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 WAS EXPLANTED AND REPLACED
Patient problems: Capsular Contracture
MAUDE report 22497394 ↗InjuryMay 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22066474 ↗InjuryMay 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22064146 ↗InjuryOct 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED AND REPLACED .
Patient problems: Capsular Contracture
MAUDE report 17959799 ↗InjuryAug 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17552274 ↗InjuryJun 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 17209406 ↗InjuryMay 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16918763 ↗InjuryMay 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16907314 ↗InjuryMay 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16856996 ↗InjuryFeb 2, 2023Device 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 16287003 ↗InjuryDec 27, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16057549 ↗InjuryNov 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 15852707 ↗InjuryNov 10, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15777280 ↗InjuryNov 10, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15777150 ↗InjuryOct 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15621219 ↗InjurySep 19, 2022Device 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 15447834 ↗InjurySep 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15403050 ↗InjuryAug 4, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AGAINST LEFT DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15167661 ↗InjuryJun 27, 2022Device Handling Problem; Device Handling Problem
HEALTHCARE PROFESSIONAL REPORTED "PUNCTURED BY SUTURE" AGAINST DEVICE. THE DEVICE WAS NOT IMPLANTED. SURGERY WAS COMPLETED WITH A BACKUP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14836942 ↗InjuryApr 27, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "REPORTED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE IV." DEVICE EXPLANTED. LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 14215754 ↗InjuryApr 25, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE IV." DEVICE EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14192446 ↗
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-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
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
- MENTOR MemoryGel Breast Implant 3503501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,167 reports
- MENTOR MemoryGel Breast Implant 3504001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,130 reports
- MENTOR MemoryGel Breast Implant 3504004BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- 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
- MENTOR MemoryGel Breast Implant 3503251BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,684 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page