Natrelle INSPIRA Breast Implants SRLP-300Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRLP-300 Low Plus 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 smooth, round breast prosthesis made by Allergan. The 54 reports mostly describe the implant breaking or leaking (rupture), scar tissue tightening around it so the breast becomes hard and painful (capsular contracture), and infections, including one where a blood clot after surgery led to a bacterial infection and the implant being removed. 53 people reported injuries and no deaths were reported. No recalls name this device, and reports held steady at 6 in each of the last two 12-month periods.
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
- 54
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10888628006904), received between May 9, 2019 and Sep 1, 2026 — classified as 53 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (22 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 Rejection22
- Material Rupture20
- Patient-Device Incompatibility9
- Adverse Event Without Identified Device or Use Problem6
- Break1
Patient problems
- Capsular Contracture31
- Failure of Implant14
- Unspecified Infection5
- No Clinical Signs, Symptoms or Conditions2
- Bacterial Infection1
- Hematoma1
- No Consequences Or Impact To Patient1
- Swollen Lymph Nodes/Glands1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2026Material Rupture
The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548056 ↗InjuryAug 28, 2026Material Rupture
Patient reported "rupture". This record is for right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506528 ↗InjuryAug 27, 2026Device Appears to Trigger Rejection
Device has been explanted. Patient received a capsulectomy.
Patient problems: Capsular Contracture
MAUDE report 50481701 ↗InjuryMar 16, 2026Material Rupture
HEALTHCARE PROFESSIONAL THROUGH THE NATIONAL BREAST IMPLANT REGISTRY REPORTED "SUSPECTED/ACTUAL RUPTURE/DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24604273 ↗InjuryMar 13, 2026Material Rupture
HEALTHCARE PROFESSIONAL THROUGH THE NATIONAL BREAST IMPLANT REGISTRY REPORTED "SUSPECTED/ACTUAL RUPTURE/DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24596001 ↗InjuryNov 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER III". THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23640419 ↗InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "HEMATOMA THEN INFECTION". LATER HEALTHCARE PROFESSIONAL REPORTED "PATIENT DEVELOPED A HEMATOMA 2 WEEKS POST OP, THEN SHE HAD A BACTERIAL INFECTION WHICH LED TO THE IMPLANT BEING REMOVED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Bacterial Infection; Hematoma
MAUDE report 23064127 ↗InjurySep 4, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE¿ VIA MAMMOGRAM AND ULTRA SOUND. LATER HEALTHCARE PROFESSIONAL REPORTED "PROMINENT IMPLANT FOLD" AND "CYSTS" VIA ULTRASOUND AND MAMMOGRAM. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22974088 ↗InjuryAug 25, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT TOWARDS THE DEVICE¿. LATER HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE AND IMPLANT FOLD" VIA MAMMOGRAM AND ULTRASOUND. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22885151 ↗InjuryJun 2, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22124528 ↗InjuryApr 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 21853261 ↗InjuryApr 9, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED " RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE IV". CONFIRMED VIA MAMMOGRAM AND CT.THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 21806709 ↗InjuryAug 14, 2024Device 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 HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 19983647 ↗InjuryAug 14, 2024Device 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 HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19983283 ↗InjuryNov 2, 2023Material Rupture; Material Rupture
InjuryOct 5, 2023Material Rupture; Material Rupture
InjuryAug 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17500124 ↗InjuryJul 14, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT AGAINST RIGHT DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE "HOLE, NON-SPECIFIC." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17329721 ↗InjuryJul 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17256063 ↗InjuryJun 7, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED RIGHT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. LATER, HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE DISCOVERED DURING SURGERY. HEALTHCARE PROFESSIONAL ADDITIONALLY NOTED THEIR BELIEF THAT THE "RUPTURED DEVICE ON THE RIGHT SIDE WAS LIKELY RESPONSIBLE FOR CAPSULAR CONTRACTURE [BAKER GRADE UNKNOWN] ON THAT SIDE." TOTAL CAPSULECTOMY WAS PERFORMED ON THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17083030 ↗InjuryApr 28, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16839332 ↗InjuryMar 23, 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 16600547 ↗InjuryMar 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16600535 ↗InjuryFeb 21, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16411466 ↗InjuryFeb 21, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16409464 ↗
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-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-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-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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