Natrelle Inspira SoftTouch Breast Implants SSF-365Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSF 365cc 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 breast implant. Most of its 208 reports describe capsular contracture, a tightening of the scar tissue around the implant, and some describe ruptures. The reports include 205 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
- 212
- Deaths reported
- 0
- Injuries reported
- 209
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 212 adverse event reports that list this exact device (DI 10888628033146), received between May 22, 2019 and Sep 22, 2026 — classified as 209 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (139 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 Rejection139
- Patient-Device Incompatibility36
- Material Rupture22
- Adverse Event Without Identified Device or Use Problem12
- Migration5
- Malposition of Device3
- Difficult to Open or Remove Packaging Material2
- No Apparent Adverse Event2
Patient problems
- Capsular Contracture172
- Failure of Implant19
- Unspecified Infection13
- No Clinical Signs, Symptoms or Conditions9
- Seroma4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Foreign Body Reaction1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 212 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862157 ↗InjurySep 22, 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 50859409 ↗InjurySep 22, 2026Biofilm coating in Device; Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade lll/IV" and "Biofilm on the implant that causes chronic inflammation". This record is for left side. The device was explanted. Patient receive Singulair treatment.
Patient problems: Capsular Contracture; Subclinical Infection
MAUDE report 50849853 ↗InjurySep 21, 2026Malposition of Device; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848842 ↗InjurySep 21, 2026Malposition of Device; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848841 ↗InjurySep 17, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture" Baker Grade III. This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50809245 ↗InjurySep 15, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture" Baker Grade III. This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50766303 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "asymmetry". This record is for the right side. Device has been explanted.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50756296 ↗InjurySep 14, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade lll". This record is for right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50752936 ↗InjurySep 11, 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 problems: Capsular Contracture
MAUDE report 50736524 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "asymmetry". This record is for the left side. Device has been explanted.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50676812 ↗InjuryAug 11, 2026Device Appears to Trigger Rejection
Healthcare professional reported Capsular Contracture Baker Grade IV. This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50202668 ↗InjuryAug 4, 2026Material Rupture
Healthcare professional reported "Implants were extremely cloudy". Healthcare professional then reported "Suspect occult rupture". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50134255 ↗InjuryJun 18, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. PATIENT WAS PRESCRIBED WITH SINGULAIR. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25548519 ↗InjuryMay 21, 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 problems: Capsular Contracture
MAUDE report 25247352 ↗InjuryApr 9, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24831208 ↗InjuryApr 6, 2026Migration
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT DROPPED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24795692 ↗InjuryApr 3, 2026Material Deformation; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED "BREAST DEFORMITY IS MILD IN SEVERITY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 24781059 ↗InjuryApr 1, 2026Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24757319 ↗InjuryMar 25, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24684956 ↗InjuryFeb 20, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 4". LATER HEALTHCARE PROFESSIONAL REPORTED "PERFORMED CAPSULAR WORK AND RE-IMPLANTED THE SAME IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED. PATIENT WAS PRESCRIBED MONTELUKAST.
Patient problems: Capsular Contracture
MAUDE report 24402823 ↗InjuryJan 21, 2026Migration
HEALTHCARE PROFESSIONAL VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24130087 ↗InjuryJan 14, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III". PATIENT UNDERGONE CAPSULECTOMY. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24073599 ↗InjuryJan 5, 2026Device Appears to Trigger Rejection; Improper or Incorrect Procedure or Method
THE DEVICE HAS BEEN EXPLANTED AND WILL NOT BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23966158 ↗MalfunctionNov 14, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "TIVEK PAPER ISSUE". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICES REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555615 ↗
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