Natrelle Inspira SoftTouch Breast Implants SSF-385Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSF 385cc 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 is a silicone gel breast implant. The 285 reports mostly describe capsular contracture, where scar tissue tightens around the implant, and some describe the body appearing to reject it or the material rupturing. The reports include 279 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
- 289
- Deaths reported
- 0
- Injuries reported
- 284
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 289 adverse event reports that list this exact device (DI 10888628033153), received between May 22, 2019 and Sep 29, 2026 — classified as 284 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (198 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 Rejection198
- Patient-Device Incompatibility45
- Material Rupture27
- Adverse Event Without Identified Device or Use Problem16
- Break3
- Device Handling Problem2
- Difficult to Open or Remove Packaging Material2
- No Apparent Adverse Event2
Patient problems
- Capsular Contracture241
- Failure of Implant23
- Unspecified Infection12
- No Clinical Signs, Symptoms or Conditions10
- Fluid Discharge3
- Peripheral Edema2
- Seroma2
- Wound Infection2
Recent adverse event reports
The 25 most recent of 289 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50939767 ↗InjurySep 18, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50812829 ↗InjurySep 7, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50658786 ↗InjurySep 7, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50656802 ↗InjuryAug 26, 2026Material Rupture
The device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456929 ↗InjuryAug 24, 2026Device Appears to Trigger Rejection
InjuryAug 23, 2026Device Appears to Trigger Rejection
Healthcare professional reported ¿capsular contracture Baker grade III/IV¿. This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50395683 ↗InjuryAug 19, 2026Device Appears to Trigger Rejection; Material Rupture
Patient reported "Rupture". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 50323620 ↗InjuryAug 7, 2026Device Appears to Trigger Rejection
Healthcare professional reported Capsular Contracture Baker Grade IV. This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50176618 ↗InjuryAug 4, 2026Device Appears to Trigger Rejection
Healthcare Professional reported "mastopexy". Healthcare Professional later reported "Capsular Contracture Baker grade III". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50136335 ↗InjuryAug 4, 2026Device Appears to Trigger Rejection
Healthcare Professional reported "mastopexy". Healthcare Professional later reported "Capsular Contracture Baker grade III". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50129097 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture -Baker grade IV". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50006394 ↗InjuryJul 17, 2026Device Appears to Trigger Rejection
Healthcare professional reported Capsular Contracture Baker Grade IV. This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 25855288 ↗InjuryJul 14, 2026Material Rupture
PATIENT REPORTED A "RUPTURE WITH LUMP". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25814141 ↗InjuryJul 2, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A CAPSULAR CONTRACTURE, BAKER GRADE III. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25695647 ↗InjuryJun 30, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULE CONTRACTURE GRADE 3". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25665927 ↗InjuryJun 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsule contracture grade 3". This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 25665727 ↗InjuryJun 11, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE IMPLANT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25477195 ↗InjuryJun 10, 2026Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "REMOVING THE IMPLANT FROM ITS STERILE PACKAGING AND HOW THIS HAS BECOME SUCH A PROBLEM FOR HIM. HE CAN'T RELY ON THE IMPLANT BEING REMOVED IN A STERILE MANNER". THIS RECORD IS FOR UNKNOWN SIDE. THE DEVICE STATUS IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25462562 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "LYMPHEDEMA AND AL AMYLOIDOSIS NOT DEVICE RELATED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Peripheral Edema
MAUDE report 25454457 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "LYMPHEDEMA AND AL AMYLOIDOSIS NOT DEVICE RELATED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Peripheral Edema
MAUDE report 25452313 ↗InjuryApr 16, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade III". This record is for the right side. Device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 24899808 ↗InjuryMar 24, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24683331 ↗InjuryMar 17, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III. PATIENT WAS PRESCRIBED SINGULAIR". THIS RECORD IS FOR THE RIGHT SIDE. DEVICES REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24620950 ↗InjuryFeb 17, 2026Device Appears to Trigger Rejection
PHYSICIAN REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE NOT SPECIFIED. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24364298 ↗
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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