Natrelle INSPIRA Breast Implants SRM-685Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRM-685 Moderate profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle INSPIRA Breast Implants (197)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Natrelle INSPIRA silicone gel breast implant is a soft, round implant used in breast surgery. Most of the 48 reports describe the scar tissue around the implant tightening and contracting (capsular contracture), which can make the breast feel hard, or the implant shell breaking and leaking gel. All reports describe injuries, with no deaths reported, and several implants were removed and replaced. 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
- 50
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10888628007208), received between May 30, 2019 and Jul 1, 2026 — classified as 50 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (25 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 Rejection25
- Material Rupture14
- Patient-Device Incompatibility10
- Device Handling Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Contracture35
- Failure of Implant13
- No Clinical Signs, Symptoms or Conditions2
- Necrosis1
- Seroma1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25685999 ↗InjuryJun 30, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". PATIENT WAS PRESCRIBED ACCOLATE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25665194 ↗InjuryOct 7, 2025Material Rupture; Material Rupture
PREVIOUS MEDWATCH SUBMISSION NOTED RUPTURE. UPON RECEIVING CORRECT DEVICE INFORMATION FOR THIS RECORD, ABBVIE HAS DETERMINED THAT THIS RECORD IS A DUPLICATE RECORD AND IS BEING UNREPORTED. PLEASE REFER MRN# 9617229-2025-16824 AS THE OPERATING RECORD RELATED TO THIS COMPLAINT.
Patient problems: Failure of Implant
MAUDE report 23238191 ↗InjuryOct 2, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23206018 ↗InjurySep 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23103364 ↗InjurySep 12, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE". DIAGNOSED VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23040024 ↗InjuryAug 25, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED BY COSTUMER PORTAL "RUPTURE/DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22883171 ↗InjuryApr 2, 2024Material Rupture; Material Rupture
InjuryNov 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjurySep 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17795886 ↗InjuryMay 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED A RIGHT-SIDE NO COMPLAINT AGAINST THE DEVICE. LATER, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16990008 ↗InjuryApr 24, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16800585 ↗InjuryMar 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III/IV." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16469540 ↗InjuryFeb 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III/IV." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16309286 ↗InjuryJan 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORT A LEFT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16244921 ↗InjuryJan 4, 2023Device 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 16098782 ↗InjuryNov 14, 2022Material Rupture; Material Rupture
PATIENT REPORTED A RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15787695 ↗InjuryNov 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15713911 ↗InjuryOct 31, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15704411 ↗InjurySep 9, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15391386 ↗InjuryAug 31, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15332558 ↗InjuryAug 25, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15295217 ↗InjuryAug 24, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE OFFICIAL REPORTED RIGHT CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15287698 ↗InjuryJul 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REREPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15129367 ↗InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING "NECROSIS AROUND INCISION SITE" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Necrosis
MAUDE report 14704559 ↗
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-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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