Natrelle Inspira SoftTouch Breast Implants SSF-450Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSF 450cc Full 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 SoftTouch is a silicone gel-filled breast implant. Its 334 reports mostly describe hardening of the scar tissue around the implant, known as capsular contracture, and implants that rupture or sit out of place. The reports mention 332 injuries and no deaths. 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
- 348
- Deaths reported
- 0
- Injuries reported
- 346
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 348 adverse event reports that list this exact device (DI 10888628033177), received between May 28, 2019 and Sep 30, 2026 — classified as 346 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (236 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 Rejection236
- Patient-Device Incompatibility66
- Material Rupture28
- Adverse Event Without Identified Device or Use Problem16
- Malposition of Device6
- Migration5
- No Apparent Adverse Event2
- Device Contamination with Chemical or Other Material1
Patient problems
- Capsular Contracture295
- Failure of Implant21
- Unspecified Infection12
- No Clinical Signs, Symptoms or Conditions10
- Seroma6
- Foreign Body Reaction3
- Foreign Body Sensation in Eye3
- Impaired Healing2
Recent adverse event reports
The 25 most recent of 348 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50952822 ↗InjurySep 24, 2026Device 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 50880884 ↗InjurySep 23, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50875998 ↗InjurySep 23, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50875994 ↗InjurySep 19, 2026Malposition of Device; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831631 ↗InjurySep 15, 2026Device Appears to Trigger Rejection
Healthcare professional reported "exchange with no complaint against the device". Later healthcare professional reported Capsular Contracture Baker grade IV. This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50766165 ↗InjurySep 14, 2026Malposition of Device; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765805 ↗InjurySep 12, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50744786 ↗InjurySep 10, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade 4". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50717695 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "rippling". This record is for the right side. Device was explanted.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50717356 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "Infection". Healthcare professional later reported "event not confirmed: culture negative". This record is for the left side. The device was explanted. Patient was prescribed Bactrim.
Patient problems: Unspecified Infection
MAUDE report 50691442 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50678950 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50678646 ↗InjuryAug 27, 2026Material Rupture; Malposition of Device
Healthcare professional reported "rupture noticed during surgery for a scar revision". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476506 ↗InjuryAug 25, 2026Device Appears to Trigger Rejection
Patient reported "capsular contracture Baker grade unknown". Later healthcare professional reported "capsular contracture Baker grade unknown". This record is for the left side. Device remains implanted. Patient was prescribed Accolate.
Patient problems: Capsular Contracture
MAUDE report 50435628 ↗InjuryAug 21, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture". This record is for the right side. Device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50381041 ↗InjuryAug 20, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker Grade III"; Accolate prescribed. This record is for the left side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50358925 ↗InjuryAug 18, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50290653 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker Grade III." This record is for the right side. The device was explanted. Patient was prescribed Singulair.
Patient problems: Capsular Contracture
MAUDE report 50038635 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker Grade III". This record is for the left side. The device was explanted. Patient was prescribed Singulair.
Patient problems: Capsular Contracture
MAUDE report 50038562 ↗InjuryJul 20, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25883762 ↗InjuryJul 15, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25827817 ↗InjuryJul 1, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURE¿. LATER HEALTHCARE PROFESSIONAL REPORTED ¿MALPOSITION¿ AND ¿IMPLANT WAS SITTING VERY FAR LATERALLY¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25685023 ↗InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED ¿INFECTION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 25658751 ↗InjuryJun 16, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25527436 ↗
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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