Natrelle INSPIRA Breast Implants SRF-605Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRF-605 Full 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 Allergan Natrelle Inspira silicone breast implant has 294 reports, all listed as injuries, and no deaths. Most describe hardening scar tissue around the implant, and many describe the body appearing to reject the implant. Reports fell to 6 in the latest 12 months from 28 in the 12 months before. 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
- 297
- Deaths reported
- 0
- Injuries reported
- 297
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 297 adverse event reports that list this exact device (DI 10888628007383), received between Dec 21, 2018 and Sep 29, 2026 — classified as 297 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (186 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 Rejection186
- Patient-Device Incompatibility67
- Material Rupture52
- Adverse Event Without Identified Device or Use Problem11
- Device Handling Problem1
- Fluid/Blood Leak1
- Malposition of Device1
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture250
- Failure of Implant32
- No Clinical Signs, Symptoms or Conditions4
- Seroma4
- Unspecified Infection4
- Impaired Healing3
- Abscess2
- Breast Discomfort/Pain1
Recent adverse event reports
The 25 most recent of 297 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Material Rupture
Patient reported "Rupture". This record is for the right side. The device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936377 ↗InjurySep 24, 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 50885669 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Abscess
MAUDE report 50848209 ↗InjurySep 15, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "Capsular contracture Baker grade IV" ,"Rupture". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50777943 ↗InjurySep 10, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722886 ↗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 25734803 ↗InjuryJul 3, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "SEROMA". THIS RECORD IS FOR THE LEFT SIDE RECORD. DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 25704914 ↗InjuryMar 9, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24547512 ↗InjuryJan 27, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24189565 ↗InjuryOct 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 9617229-2025-16948, IS A DUPLICATE OF MRN 9617229-2025-16834. PLEASE SEE MRN 9617229-2025-16834 FOR REPORTABLE EVENTS.
Patient problems: Capsular Contracture
MAUDE report 23222903 ↗InjuryOct 2, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED "RIPPLING". LATER PATIENT REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". LATHER HEALTHCARE PROFESSIONAL REPORTED "RIPPLING". THIS RECORD IS FOR THE RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23206618 ↗InjurySep 29, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV WITH A POSSIBLE RUPTURE AND BILATERAL RIPPLING". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23174472 ↗InjurySep 27, 2025Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event
PATIENT REPORTED "CAPSULAR CONTRACTURES BAKER GRADE IV". TREATMENT PLAN: MONTELUKAST. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 23162307 ↗InjurySep 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THIS RECORD RELATED TO THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23075642 ↗InjurySep 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22956651 ↗InjuryAug 21, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT-SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22862178 ↗InjuryAug 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22743454 ↗InjuryJul 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULE AND INTERNAL MAMMARY LYMPNODE." HEALTHCARE PROFESSIONAL LATER CONFIRMED ACHED. CAPSULAR CONTRACTURE BAKER GRADE IV, INFLAMED LYMPH NODES AS WELL AS PAIN IN THE LEFT BREAST IMPLANT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands
MAUDE report 22476305 ↗InjuryJul 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "INFLAMMATION, PAIN, HEADACHES AND SWELLING OF ANKLES AND FEET...CAPSULE AND INTERNAL MAMMARY LYMPH NODE" AND "MRI SHOWS INFLAMED LYMPH NODES, CONFIRMED RIGHT SIDE INTACT". HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22475725 ↗InjuryJul 8, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22437197 ↗InjuryJul 7, 2025Material Rupture; Material Rupture
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22431456 ↗InjuryJul 7, 2025Material Rupture; Malposition of Device; Material Rupture; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PAIN, MALPOSITIONED IMPLANT AND GROSSLY RUPTURED". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Breast Discomfort/Pain
MAUDE report 22423417 ↗InjuryJul 5, 2025Material Rupture; Material Rupture
HEALTHCARE PROVIDER REPORTED A LEFT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22407100 ↗InjuryJul 4, 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. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22403639 ↗InjuryJun 26, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE IV. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22333870 ↗
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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