Natrelle INSPIRA Breast Implants SRF-385Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRF-385 Full profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle INSPIRA Breast Implants (197)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Allergan Natrelle INSPIRA breast implant is a silicone gel implant used in breast surgery. Its 492 reports most often describe capsular contracture, where scar tissue tightens around the implant, and reports of the body appearing to reject it. Recent reports describe ruptured implants and severe capsular contracture. The reports include 488 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
- 499
- Deaths reported
- 0
- Injuries reported
- 495
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 499 adverse event reports that list this exact device (DI 10888628007321), received between Dec 28, 2017 and Sep 30, 2026 — classified as 495 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (316 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Appears to Trigger Rejection316
- Patient-Device Incompatibility113
- Material Rupture84
- Adverse Event Without Identified Device or Use Problem9
- No Apparent Adverse Event6
- Break4
- Gel Leak2
- Malposition of Device2
Patient problems
- Capsular Contracture421
- Failure of Implant59
- No Clinical Signs, Symptoms or Conditions14
- Unspecified Infection10
- Seroma3
- Foreign Body Reaction2
- Foreign Body Sensation in Eye2
- Granuloma2
Recent adverse event reports
The 25 most recent of 499 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Material Rupture
Healthcare professional reported "possible rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947563 ↗InjurySep 21, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture" Baker Grade III/IV. This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50840888 ↗InjurySep 14, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765914 ↗InjurySep 8, 2026Material Rupture
Healthcare professional reported "Droopy" which is not device related, "rupture" and "pain". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672545 ↗InjurySep 7, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50656914 ↗InjurySep 7, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50651181 ↗InjurySep 7, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50649642 ↗InjurySep 2, 2026Material Rupture
Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573108 ↗InjuryAug 21, 2026Device Appears to Trigger Rejection; Material Rupture
Patient reported "intracapsular rupture". Later healthcare professional reported "discomfort, Capsular Contracture, Baker Grade Unknown, and intracapsular rupture" and "patient fell off of a jet ski". This record is for the left side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50380125 ↗InjuryAug 14, 2026Device Appears to Trigger Rejection
Healthcare Professional reported "pain, pressure elevated and Capsular Contracture Baker grade IV". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50255741 ↗InjuryAug 14, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture" Baker Grade IV. This record is for the left side. Device remains implanted. Patient was prescribed Gabapetin.
Patient problems: Capsular Contracture
MAUDE report 50254962 ↗InjuryAug 12, 2026Material Rupture
Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50224087 ↗InjuryAug 6, 2026Device Appears to Trigger Rejection
Patient reported "Capsular contracture Baker grade unknown". Later, healthcare professional reported "Capsular contracture Baker grade lll", "hematoma". Patient was prescribed with Singulair and Vitamin E. This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50160942 ↗InjuryJul 30, 2026Device Appears to Trigger Rejection
Patient reported "capsular contracture Baker grade III" and "very high, itching, pain, uncomfortable, very hard". Later healthcare professional reported "capsular contracture Baker grade III". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50091019 ↗InjuryJul 30, 2026Device Appears to Trigger Rejection
Patient reported "capsular contracture, baker grade unknown, nipple tenderness, "small and tight", "achy" and "feels like a bruise". Later, patient reported "Capsular Contracture Baker grade III, pain and exchange". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50090238 ↗InjuryJul 30, 2026Device Appears to Trigger Rejection
Patient reported "Capsular Contracture Baker grade Unknown". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50087148 ↗InjuryJul 27, 2026Malposition of Device; Migration
Healthcare professional reported "Device Migration/Implant Malposition". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50039749 ↗InjuryJul 20, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker grade III". Patient was prescribed Celebrex. This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 25881220 ↗InjuryJul 13, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". DUE TO CONFLICTING AVAILABLE INFORMATION REGARDING RUPTURE, RUPTURE IS BEING KEPT CONSERVATIVELY IN THIS RECORD. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25804702 ↗InjuryJul 7, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25742455 ↗InjuryJul 6, 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 25728350 ↗InjuryJul 5, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25712400 ↗InjuryJun 29, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "Baker grade 4 capsular contracture" and "firm and mildly tender to palpitation". Later Healthcare professional reported "Rupture". Later Healthcare professional reported "Rupture silicone implant" against the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 25651625 ↗InjuryJun 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 25580886 ↗InjuryJun 16, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT AGAINST THE DEVICE. LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25524857 ↗
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 108
- 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, 110-210,
- 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,TRL-
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- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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