Natrelle INSPIRA Breast Implants SRX-310Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRX-310 Extra 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 Natrelle INSPIRA silicone gel breast implant is a soft, rounded implant used for breast reconstruction or augmentation. The 65 reports mostly describe capsular contracture — the scar tissue around the implant tightening and hardening, causing pain, swelling and a misshapen or displaced implant — often severe enough that the implant was removed or replaced. There are 64 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
- 61
- Deaths reported
- 0
- Injuries reported
- 60
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10888628007475), received between Jun 5, 2019 and Sep 10, 2026 — classified as 60 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (36 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 Rejection36
- Patient-Device Incompatibility16
- Material Rupture4
- Adverse Event Without Identified Device or Use Problem2
- Device Handling Problem2
- No Apparent Adverse Event2
- Break1
- Fracture1
Patient problems
- Capsular Contracture51
- Failure of Implant6
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body Reaction1
- Swelling/ Edema1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade lll". This record is for right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50715228 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
SALES REPRESENTATIVE REPORTED "VERY ODD SHAPE". LATER THE HEALTHCARE PROFESSIONAL REPORTED "PATIENT COMPLAINING OF SEVERE PAIN AND THINKS IT HAS BECOME MORE SWOLLEN SINCE SURGERY. UNABLE TO MOVE THEIR ARM MUCH". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Swelling/ Edema
MAUDE report 24652550 ↗InjuryNov 5, 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 WILL BE RETURNED. THE PATIENT TRIED MASSAGING AND ACCOLATE BUT THE ISSUES ARE STILL ONGOING. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23477202 ↗InjuryOct 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III, IMPLANT MALPOSITION, DEVICE MIGRATION" VIA NBIR. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED WITH NON-ABBVIE DEVICES.
Patient problems: Capsular Contracture
MAUDE report 23333994 ↗InjurySep 25, 2025Device Handling Problem; Device Handling Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "LIFT ON THE PATIENT AND THE DEVICE WAS REMOVED AND REIMPLANTED THAT DAY". THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23151441 ↗InjurySep 22, 2025Device Handling Problem; Device Handling Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "LIFT ON THE PATIENT AND THE DEVICE WAS REMOVED AND REIMPLANTED THAT DAY". THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23110287 ↗InjurySep 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23053236 ↗InjuryJul 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22645864 ↗InjuryJun 14, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22208513 ↗InjuryMay 27, 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. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22087287 ↗InjuryMay 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III (CONFIRMED BY PHYSICIAN). THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22022764 ↗InjuryMay 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". HEALTHCARE LATER CONFIRMED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22010119 ↗InjuryApr 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III AND TENDERNESS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21819767 ↗InjuryApr 4, 2025Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event
PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III AND TENDERNESS; IMPLANTS WERE NOT COMING DOWN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 21778037 ↗InjuryMar 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. HEALTHCARE PROFESSIONAL LATER CONFIRMED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21598950 ↗InjuryNov 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL CALLED TO REPORT A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18069736 ↗InjuryMay 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16981409 ↗InjuryMay 22, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT-SIDE RUPTURE, PAIN AND " LOOKED ODD." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16971597 ↗InjuryMay 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16873010 ↗InjuryMar 31, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "IMPLANT EXPOSURE." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Foreign Body Reaction
MAUDE report 16659367 ↗InjuryMar 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryJan 19, 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 16211843 ↗InjuryDec 21, 2022Break; Break
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE DEVICE RUPTURED UP ON INSERTION WITH FUNNEL. IT IS UNKNOWN IF A BACK-UP DEVICE WAS USED. DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 16023754 ↗InjuryOct 25, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15668789 ↗InjuryOct 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15524238 ↗
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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