Natrelle Inspira SoftTouch Breast Implants SSM-485Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSM 485cc 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 SoftTouch breast implant is a silicone gel-filled implant. Most of the 126 reports describe capsular contracture, where scar tissue tightens around the implant, and some describe ruptures. The reports include no deaths and 125 injuries. Reports fell to 9 in the last 12 months from 18 in the previous 12. 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
- 125
- Deaths reported
- 0
- Injuries reported
- 124
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 10888628032989), received between Jul 11, 2019 and Sep 30, 2026 — classified as 124 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (83 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 Rejection83
- Patient-Device Incompatibility20
- Adverse Event Without Identified Device or Use Problem12
- Material Rupture9
- No Apparent Adverse Event2
- Device Damaged Prior to Use1
- Fluid/Blood Leak1
- Malposition of Device1
Patient problems
- Capsular Contracture102
- Unspecified Infection11
- Failure of Implant10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Clinical Signs, Symptoms or Conditions2
- Seroma2
- Bacterial Infection1
Recent adverse event reports
The 25 most recent of 125 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 50941462 ↗InjurySep 13, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50746940 ↗InjurySep 11, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Infection" and Capsular Contracture Baker Grade Unknown. This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture; Unspecified Infection
MAUDE report 50729962 ↗InjurySep 10, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade IV". This record is for the right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50721411 ↗InjuryApr 21, 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 AND HEMATOMA". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24942359 ↗InjuryApr 9, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24836003 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY "WRINKLING/RIPPLING". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24605110 ↗InjuryJan 27, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24188478 ↗InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "INFECTION". THIS RECORD IS FOR THE LEFT SIDE. PATIENT RECEIVED MEDICATION AS TREATMENT. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL NOT BE RETURNED.
Patient problems: Unspecified Infection
MAUDE report 23440044 ↗InjurySep 11, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND "MAYBE A RUPTURE". LATER, HEALTHCARE PROFESSIONAL REPORTED "BREAST HYPOPLASIA", "IMPLANT FOLDED ON ITSELF" AND "THICKENED CAPSULE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23033717 ↗InjuryAug 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER, HEALTHCARE PROFESSIONAL REPORTED BAKER GRADE IV. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22914309 ↗InjuryAug 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III", PRESCRIBED SINGULAR BID. PATIENT UNDERGONE CAPSULECTOMY. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22853833 ↗InjuryAug 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
COMPANY REPRESENTATIVE REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE IV¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22850451 ↗InjuryJul 29, 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.
Patient problems: Capsular Contracture
MAUDE report 22652861 ↗InjuryJul 25, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RUPTURE" CONFIRMED VIA CT SCAN AND MRI. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22620920 ↗InjuryJul 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22559671 ↗InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED "INFECTION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 22502469 ↗InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED "INFECTION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE IS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 22496769 ↗InjuryJul 7, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22413307 ↗InjuryMay 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22072600 ↗InjuryMay 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "BAKER GRADE: 4 - CAP CON". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22022693 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "INFECTION" VIA NBIR. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 21988078 ↗InjuryMay 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PHYSICIAN REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 21968532 ↗InjuryApr 11, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED RIGHT SIDE RUPTURE. PATIENT ADDITIONALLY REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. HEALTHCARE PROFESSIONAL LATER CONFIRMED THE ONLY DOCUMENTED EVENT IS THE RUPTURE DIAGNOSED VIA MRI. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21825250 ↗InjuryApr 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21809336 ↗
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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