NATRELLE Silicone-Filled Breast Implants 10-240Recalls & reported problems
Allergan, Inc. · NATRELLE Style 10-240 Moderate profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · NATRELLE Silicone-Filled Breast Implants (128)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Natrelle silicone gel-filled breast implant. Reports mostly describe implant rupture and capsular contracture (scar tissue hardening around the implant), often with the implant later explanted. The FDA has 41 adverse event reports naming this implant's identifier, with no deaths and 41 injuries. 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
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10888628001220), received between Feb 21, 2020 and Sep 22, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Material Rupture” (27 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
- Material Rupture27
- Device Appears to Trigger Rejection18
- Patient-Device Incompatibility3
Patient problems
- Capsular Contracture21
- Failure of Implant18
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857151 ↗InjuryMar 30, 2026Device Appears to Trigger Rejection
PATIENT REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN¿ ON AN UNKNOWN SIDE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24732659 ↗InjuryMar 30, 2026Device Appears to Trigger Rejection
PATIENT REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN¿ ON AN UNKNOWN SIDE. LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24729920 ↗InjuryFeb 17, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "CAPSULAR CONTRACTURE (UNKNOWN BAKER GRADE)". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24365865 ↗InjuryJan 28, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED BY MRI. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24198745 ↗InjuryJan 21, 2026Device Appears to Trigger Rejection; Material Rupture
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 24132203 ↗InjuryDec 21, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RUPTURE". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23861378 ↗InjuryOct 23, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT AGAINST THE DEVICE. LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL "IS SOFT AND MOBILE". LATER, HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "CAPSULAR CONTRACTURE BAKER GRADE III" THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23368931 ↗InjuryOct 15, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
LATER HEALTHCARE PROFESSIONAL REPORTED "GROSSLY RUPTURE", "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN, "MALPOSITION" AND "SUPEROMEDIAL DISPLACEMENT OF IMPLANT".
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 23278927 ↗InjurySep 30, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "RUPTURE". DEVICE HAS BEEN EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23187201 ↗InjuryJul 30, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT ASSOCIATED WITH THE PRODUCT. HEALTHCARE LATER REPORTED "RUPTURE" THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22667334 ↗InjuryMay 28, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN WITH A RUPTURE CONFIRMED VIA MRI". HEALTHCARE PROFESSIONAL LATER REPORTED "IMPLANT FAILURE" AND "CAPSULAR CONTRACTURE BAKER GRADE I". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22095577 ↗InjuryApr 28, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND ANXIETY. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 21923322 ↗InjuryFeb 19, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA LEFT SIDE RUPTURE. IT WAS LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE II AND FOLDS. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21412029 ↗InjurySep 25, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "IMPLANT RUPTURE". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 20306118 ↗InjuryOct 20, 2023Material Rupture; Material Rupture
InjuryAug 8, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE PER MRI. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 17478128 ↗InjuryAug 7, 2023Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE PAIN. LATER, HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. PATIENT LATER REPORTED "POSSIBLE CYST". PATIENT ADDITIONALLY REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17469291 ↗InjuryJul 18, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED, LEFT SIDE PAIN. HEALTHCARE PROFESSIONAL, LATER REPORTED, CAPSULAR CONTRACTURE, BAKER GRADE III. PATIENT REPORTED, LEFT SIDE RUPTURE. CONFIRMED MY MRI. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17346843 ↗InjuryMar 17, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16567865 ↗InjuryJan 31, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16274683 ↗InjuryJan 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16126395 ↗InjuryJan 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE GRADE 3. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16098862 ↗InjuryDec 2, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT CALLED TO REPORT A LEFT SIDE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN.
Patient problems: Capsular Contracture
MAUDE report 15910042 ↗InjuryOct 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15656594 ↗
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-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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