Natrelle INSPIRA Breast Implants SRM-405Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRM-405 Moderate profile |smooth|round|silicone · Class 3 · Implant
Quick summary
This Natrelle INSPIRA breast implant from Allergan is a silicone gel implant. The FDA database holds 539 reports for it, 538 of them describing injuries and no deaths. Most reports mention capsular contracture, in which scar tissue around the implant tightens, and some describe ruptures. No recalls name this device. Reports fell from 59 in the previous 12 months to 29 in the last 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
- 546
- Deaths reported
- 0
- Injuries reported
- 545
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 546 adverse event reports that list this exact device (DI 10888628007130), received between May 17, 2019 and Sep 30, 2026 — classified as 545 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (314 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Appears to Trigger Rejection314
- Patient-Device Incompatibility145
- Material Rupture94
- Adverse Event Without Identified Device or Use Problem10
- Device Handling Problem5
- Improper or Incorrect Procedure or Method3
- Migration3
- No Apparent Adverse Event3
Patient problems
- Capsular Contracture453
- Failure of Implant71
- No Clinical Signs, Symptoms or Conditions13
- Unspecified Infection8
- Pocket Erosion3
- Extreme Exhaustion2
- Headache2
- Neck Pain2
Recent adverse event reports
The 25 most recent of 546 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 50951318 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture" Baker Grade IV. This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50941611 ↗InjurySep 23, 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 50863384 ↗InjurySep 21, 2026Material Rupture
Healthcare professional reported "ruptured" and "heard a pop". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843287 ↗InjurySep 18, 2026Material Rupture
Healthcare professional reported "Rupture" and "Ptosis". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817307 ↗InjurySep 17, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker grade IV" against the left side. Patient was prescribed a 3 month course of Singulair. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50804676 ↗InjurySep 16, 2026Device Appears to Trigger Rejection; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796360 ↗InjurySep 15, 2026Material Rupture; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781869 ↗InjurySep 15, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781731 ↗InjurySep 10, 2026Device Appears to Trigger Rejection
Healthcare professional reported "exchange with no complaint against the device". Later healthcare professional reported "Capsular contracture" Baker grade unknown. This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50717029 ↗InjuryAug 30, 2026Device Appears to Trigger Rejection
Healthcare professional later reported "any creases." Device has been explanted and replaced.
Patient problems: Capsular Contracture
MAUDE report 50512498 ↗InjuryAug 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade unknown". Later 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 50485528 ↗InjuryAug 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Baker Grade 4 Cap. Con.". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50478466 ↗InjuryAug 21, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture baker grade III maybe IV". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50381071 ↗InjuryAug 19, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332110 ↗InjuryJul 30, 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 50093725 ↗InjuryJul 30, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50089614 ↗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 and returned.
Patient problems: Capsular Contracture
MAUDE report 50031633 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Possible capsular contracture (baker grade unknown)". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50025275 ↗InjuryJul 10, 2026Material Rupture
Healthcare professional reported "suspected rupture". Later healthcare professional reported "failure". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25780725 ↗InjuryJun 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade III". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 25674173 ↗InjuryJun 29, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND "STIFF, IMMOBILE AND HIGH IMPLANT". LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. SINGULAIR WAS PRESCRIBED AS TREATMENT. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25658822 ↗InjuryJun 15, 2026Material Rupture
Patient reported "rupture, pain and itching". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25504522 ↗InjuryJun 1, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25350459 ↗InjuryMay 25, 2026Migration
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25272348 ↗
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-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-
- 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,
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.