Natrelle Inspira SoftTouch Breast Implants SSX-420Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSX 420cc Extra 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 is a Natrelle Inspira SoftTouch silicone gel breast implant. The 46 reports mostly describe the scar tissue around the implant tightening and shrinking the breast (capsular contracture), sometimes with pain, swelling or a reported rupture; all 46 involve injuries and none report a death. No recalls name this device. Reports have slowed in the past 12 months, with 4 compared to 8 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
- 46
- Deaths reported
- 0
- Injuries reported
- 46
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10888628033344), received between Sep 4, 2019 and Sep 30, 2026 — classified as 46 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (31 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 Rejection31
- Patient-Device Incompatibility8
- Adverse Event Without Identified Device or Use Problem4
- Material Rupture4
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Capsular Contracture39
- Granuloma2
- No Clinical Signs, Symptoms or Conditions2
- Swollen Lymph Nodes2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
- Pain1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Material Rupture
Patient reported ¿rupture¿ and ¿device was setting higher and didn't drop". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946720 ↗InjurySep 29, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50938586 ↗InjuryJul 14, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED OF THE LEFT SIDE DEVICE: "IMPLANT RUPTURE, IMPLANT RIPPLING". THE DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 25820750 ↗InjuryMay 20, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 3". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25230975 ↗InjuryAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
HEALTHCARE PROFESSIONAL REPORTED "PAIN, SWELLING? INTEGRITY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Pain; Swelling/ Edema
MAUDE report 22923059 ↗InjuryAug 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22900831 ↗InjuryJun 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULECTOMY AND IMPLANTS REPLACEMENT SURGERY". PATIENT LATER REPORTED: "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN", "BREAST IMPLANT WHICH IS QUITE SOFT", "DISCOMFORT ASSOCIATED WITH MAMMOGRAM", "INFRAMAMMARY FOLDS ARE SLIGHTLY DIFFERENT" AND "DENSITY CATEGORY D" DIAGNOSED VIA MAMMOGRAM. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22283471 ↗InjuryJun 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED¿ CAPSULAR CONTRACTURE BAKER GRADE IV¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22177245 ↗InjuryJun 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22157776 ↗InjuryMay 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III". DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22109432 ↗InjuryApr 24, 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. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21902298 ↗InjuryApr 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE "BAKER III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 21860433 ↗InjuryAug 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17476434 ↗InjuryAug 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17465805 ↗InjuryDec 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 16004638 ↗InjuryNov 22, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV AND "IMPLANT SITTING HIGHER THAN NORMAL." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15841088 ↗InjuryNov 21, 2022Device 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 15840114 ↗InjuryNov 17, 2022Device 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 15815850 ↗InjuryNov 4, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15725977 ↗InjuryNov 1, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15712564 ↗InjuryOct 27, 2022Device 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 15684343 ↗InjuryOct 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. PHYSICIAN FURTHER REPORTED "SILICONE GRANULOMAS PRESENT IN THE IMPLANT CAPSULE". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Granuloma
MAUDE report 15631046 ↗InjuryOct 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV AND "SILICONE GRANULOMAS PRESENT IN THE IMPLANT CAPSULE". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Granuloma
MAUDE report 15621156 ↗InjurySep 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15519775 ↗InjurySep 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15452222 ↗
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-
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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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