Natrelle Inspira SoftTouch Breast Implants SSF-520Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSF 520cc 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. It has 198 adverse event reports, with no deaths and 197 injuries, plus 1 malfunction. Most describe hardening of the scar tissue around the implant, and some describe the implant rupturing. 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
- 200
- Deaths reported
- 0
- Injuries reported
- 199
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 200 adverse event reports that list this exact device (DI 10888628033191), received between Jun 6, 2019 and Sep 29, 2026 — classified as 199 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (135 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 Rejection135
- Patient-Device Incompatibility30
- Material Rupture21
- Adverse Event Without Identified Device or Use Problem13
- No Apparent Adverse Event3
- Malposition of Device2
- Device Contaminated During Manufacture or Shipping1
- Device Handling Problem1
Patient problems
- Capsular Contracture163
- Failure of Implant20
- No Clinical Signs, Symptoms or Conditions6
- Unspecified Infection5
- Seroma4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Wound Dehiscence3
- Foreign Body Sensation in Eye2
Recent adverse event reports
The 25 most recent of 200 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 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 50934674 ↗InjurySep 23, 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 50865297 ↗InjurySep 16, 2026Device Appears to Trigger Rejection
Healthcare professional reported "breast hardness and pain consistent with capsular contracture". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50785827 ↗InjurySep 11, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50744200 ↗InjuryAug 25, 2026Device Appears to Trigger Rejection
InjuryAug 14, 2026Device Appears to Trigger Rejection
HealthCare professional reported "Capsular Contracture" against the right side device. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50262397 ↗InjuryJun 30, 2026Device Appears to Trigger Rejection
InjuryJun 23, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". PATIENT WAS PRESCRIBED SINGULAIR. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25593919 ↗InjuryJun 21, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III¿. PATIENT WAS PRESCRIBED SINGULAIR. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25572270 ↗InjuryJun 12, 2026Difficult to Open or Remove Packaging Material
COMPANY REPRESENTATIVE REPORTED ¿DEFECTIVE BOX DURING A SURGERY, ADHESIVE NOT COMPLETELY COMING OFF¿. DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488452 ↗InjuryJun 10, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25465282 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "PATIENT FELT ASYMMETRIC." THIS RECORD IS FOR THE LEFT SIDE. DEVICE EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24968320 ↗InjuryApr 11, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24852534 ↗InjuryApr 7, 2026Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 24810193 ↗InjuryApr 6, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24794629 ↗InjuryApr 3, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) CAPSULAR CONTRACTURE BAKER GRADE III / "SUSPECTED/ACTUAL RUPTURE/DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24784313 ↗InjuryMar 6, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture baker grade lll". This record is for right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 24539225 ↗InjuryFeb 2, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "SPONTANEOUS RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24236065 ↗InjuryDec 22, 2025Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED. DEVICE RETURN STATUS UNKNOWN.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 23873307 ↗InjuryDec 17, 2025Migration; Migration
HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION", "WRINKLING/RIPPLING", "CHANGE SHAPE/SIZE/STYLE" AND "STAGED RECONSTRUCTION" VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER´S DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23825762 ↗InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "WRINKLING/RIPPLING", "CORRECTION OF ASYMMETRY", "CHANGE SHAPE/SIZE/STYLE" AND "STAGED RECONSTRUCTION" VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER´S DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23779967 ↗InjuryOct 15, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23302371 ↗InjuryOct 6, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT FLIPPED". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23229507 ↗InjurySep 29, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT FLIPPED". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23168091 ↗InjurySep 19, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". ADDITIONALLY REPORTED WAS CAPSULAR CONTRACTURE, BAKER GRADE III. THIS RECORD IS FOR THE LEFT-SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 23103376 ↗
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
- 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