Natrelle Inspira SoftTouch Breast Implants SSM-345Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSM 345cc Moderate profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle Inspira SoftTouch Breast Implants (195)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Allergan Natrelle Inspira breast implant has 178 adverse event reports, with no deaths and 178 injuries. The reports mostly describe hardening of scar tissue around the implant, ruptures, and implants shifting or sitting in the wrong position, and several describe the implant being removed. No recalls name this device, and reports fell to 8 in the latest 12 months from 16 in the prior 12 months.
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
- 179
- Deaths reported
- 0
- Injuries reported
- 179
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 10888628032934), received between Jun 25, 2019 and Sep 15, 2026 — classified as 179 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (128 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 Rejection128
- Patient-Device Incompatibility34
- Material Rupture16
- Adverse Event Without Identified Device or Use Problem7
- Malposition of Device2
- Device Handling Problem1
- Gel Leak1
- Improper or Incorrect Procedure or Method1
Patient problems
- Capsular Contracture160
- Failure of Implant10
- Unspecified Infection5
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body Reaction1
- Impaired Healing1
- Necrosis1
- Seroma1
Recent adverse event reports
The 25 most recent of 179 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Device Appears to Trigger Rejection
Healthcare Professional reported "Capsular Contracture Baker grade IV". This record is for the left side. Device remains implanted. Patient received Singulair as treatment.
Patient problems: Capsular Contracture
MAUDE report 50766427 ↗InjuryAug 21, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported persistent "breast pain" and "concern for capsular contracture versus implant rupture". Later reported Capsular Contracture, Baker "Grade IV". This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50381023 ↗InjuryAug 20, 2026Device 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 50355132 ↗InjuryJun 3, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "STIFF", "FIRMER" AND "SITTING HIGHER". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25386244 ↗InjuryMay 1, 2026Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "NOT POSITIONED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25061996 ↗InjuryApr 17, 2026Material Rupture; No Apparent Adverse Event
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24915846 ↗InjuryApr 1, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" THROUGH THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24758001 ↗InjuryJan 28, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN" AND "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24200973 ↗InjuryJan 28, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN" AND "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24199676 ↗InjurySep 25, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23144182 ↗InjurySep 9, 2025Malposition of Device; Malposition of Device
PATIENT REPORTED RIGHT SIDE FLIPPED (CAPTURED AS MALPOSITION). REVISION PROCEDURE TOOK PLACE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23000532 ↗InjuryAug 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE "RIGHT" SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22892599 ↗InjuryAug 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22693304 ↗InjuryJul 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "INTACT, BAKER GRADE 3". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22579243 ↗InjuryJul 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE "RIGHT" SIDE. THE DEVICE REMAINS IMPLANTED. TREATMENT: SINGULAIR WAS PRESCRIBED.
Patient problems: Capsular Contracture
MAUDE report 22577622 ↗InjuryJul 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22536367 ↗InjuryJul 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND FAT NECROSIS. EXCISION OF FAT NECROSIS PERFORMED." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Necrosis
MAUDE report 22490287 ↗InjuryJun 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" VIA NBIR. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22286189 ↗InjuryMay 27, 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 HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22093409 ↗InjuryMay 27, 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 HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22087175 ↗InjuryMay 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22054097 ↗InjuryMay 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. HEALTHCARE PROFESSIONAL CONFIRMED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22029830 ↗InjuryMay 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21955804 ↗InjuryApr 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 21877356 ↗InjuryApr 10, 2025Device 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 21819139 ↗
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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