NATRELLE Silicone-Filled Breast Implants 10-210Recalls & reported problems
Allergan, Inc. · NATRELLE Style 10-210 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 Allergan Natrelle silicone breast implant is a smooth, round implant filled with silicone gel. The 24 reports mostly describe the implant rupturing, scar tissue tightening around it, and implants being removed or replaced; there were no deaths and 24 injuries. No recalls name this device. Reports increased from 3 in the previous 12 months to 7 in the last 12 months.
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
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10888628001213), received between May 21, 2019 and Jul 28, 2026 — classified as 24 injuries.
The most frequently reported specific device problem is “Material Rupture” (16 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 Rupture16
- Device Appears to Trigger Rejection7
- Patient-Device Incompatibility3
Patient problems
- Failure of Implant13
- Capsular Contracture10
- Impaired Healing1
- No Clinical Signs, Symptoms or Conditions1
- Wound Dehiscence1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060148 ↗InjuryJan 1, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE RUPTURE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23939539 ↗InjuryDec 17, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "FRANK RUPTURE OF IMPLANT". LATER HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE", "COLLECTION OF SILICONE ABUTTING THE SUPERIOR IMPLANT" AND "CIRCUMSCRIBED ENHANCING MASS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23830014 ↗InjuryDec 9, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND IT'S UNKNOWN IF REPLACED. THE DEVICE WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23761394 ↗InjuryDec 1, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE", "DELAYED HEALING AND WOUND DEHISCENCE NOT RELATED TO THE DEVICE". THIS RECORD IS FOR THE RIGHT SIDE. IT WAS EXPLANTED AND REPLACED. IT WILL BE RETURNED.
Patient problems: Failure of Implant; Impaired Healing; Wound Dehiscence
MAUDE report 23689071 ↗InjuryNov 6, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23486633 ↗InjuryNov 3, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23452016 ↗InjuryOct 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" AND "FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23363437 ↗InjuryOct 15, 2025Material Rupture; Material Rupture
DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23293957 ↗InjuryOct 8, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. DEVICE WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23251120 ↗InjuryJan 18, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE FOUND DURING SURGERY. DEVICE HAS BEEN EXPLANTED AND REPLACED .
Patient problems: Failure of Implant
MAUDE report 18536872 ↗InjuryOct 23, 2023Material Rupture; Material Rupture
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17986161 ↗InjurySep 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17835746 ↗InjuryMar 1, 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 16462146 ↗InjuryJan 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE GRADE 3. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16098910 ↗InjuryOct 18, 2022Material Rupture; Material Rupture
PATIENT REPORTED A RIGHT SIDE DEVICE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15628404 ↗InjuryOct 10, 2022Material Rupture; Material Rupture
PATIENT REPORTED A LEFT SIDE "DEVICE RUPTURE". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15570462 ↗InjuryApr 22, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 14187939 ↗InjuryApr 7, 2022Material Rupture; Material Rupture
PHYSICIAN REPORTED LEFT SIDE "SUSPECTED INTRACAPSULAR RUPTURE.", "MULTIPLE IMPLANT FOLDS.", AND BILATERAL TEXTURED TO SMOOTH IMPLANT EXCHANGE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14046317 ↗InjuryOct 23, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A "RIGHT SIDE RUPTURE". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12686642 ↗InjuryMar 1, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11393275 ↗InjuryDec 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9425009 ↗InjuryJul 12, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROVIDER REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8784453 ↗InjuryMay 21, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV AND RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8628445 ↗
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
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
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- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
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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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