NATRELLE Silicone-Filled Breast Implants 10-300Recalls & reported problems
Allergan, Inc. · NATRELLE Style 10-300 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 Style 10-300 moderate profile silicone gel-filled breast implant from Allergan. The 43 reports mostly describe implants rupturing or leaking gel, along with hardening and tightening of the surrounding scar tissue (capsular contracture) that can make the breast feel firm or lumpy; 43 injuries and no deaths were reported. No recalls name this device. Reports have risen sharply, from 9 in the prior 12 months to 23 in the most recent 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
- 47
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10888628001244), received between Aug 13, 2019 and Sep 21, 2026 — classified as 47 injuries.
The most frequently reported specific device problem is “Material Rupture” (35 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 Rupture35
- Device Appears to Trigger Rejection15
- Patient-Device Incompatibility2
- Fluid/Blood Leak1
- Gel Leak1
- No Apparent Adverse Event1
Patient problems
- Failure of Implant19
- Capsular Contracture17
- No Clinical Signs, Symptoms or Conditions14
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Device Appears to Trigger Rejection
Healthcare professional reported "exchange with no complaint against the device". Later 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 50842579 ↗InjurySep 18, 2026Material Rupture
Healthcare professional reported "Rupture." This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823608 ↗InjurySep 15, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775575 ↗InjurySep 11, 2026Material Rupture
Healthcare professional reported "no complaint against the device¿. Healthcare professional reported later "broken implant". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735592 ↗InjuryAug 16, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. the device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50268617 ↗InjuryAug 14, 2026Device Appears to Trigger Rejection
Healthcare Professional reported "exchange with no complaint against device". Later Healthcare Professional reported "Capsular Contracture", Baker Grade Unknown. This record is for the left side. Device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50252261 ↗InjuryAug 13, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture" Baker Grade IV. This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50239141 ↗InjuryJul 27, 2026Material Rupture
Patient reported "Rupture". Later Healthcare Professional reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50015509 ↗InjuryJul 20, 2026Material Rupture
Healthcare professional reported of the right side device: "rupture". The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25881526 ↗InjuryJul 8, 2026Material Rupture
PATIENT REPORTED " RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25747555 ↗InjuryJul 3, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¿SILICONE RUPTURE¿. LATER HEALTHCARE PROFESSIONAL REPORTED ¿HOLE NON-SPECIFIC¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25707156 ↗InjuryJun 9, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED THROUGH COMPANY REPRESENTATIVE "IMPLANT RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25447952 ↗InjuryJun 5, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE ". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 25416452 ↗InjuryJun 3, 2026Material Rupture
Healthcare professional reported "rupture¿. This record is for the right side. Device has been explanted.
Patient problems: Failure of Implant
MAUDE report 25376865 ↗InjuryApr 22, 2026Material Rupture
PATIENT REPORTED "RUPTURE, CALCIFICATION ON IMPLANT, SMALL PERICARDIAL EFFUSION, INDENTATION ON IMPLANT AND LOW WHITE BLOOD CELL COUNT". SMALL PERICARDIAL EFFUSION AND LOW WHITE BLOOD CELL COUNT ARE CONSIDERED NOT DEVICE RELATED. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955897 ↗InjuryApr 7, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. The device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24798384 ↗InjuryMar 13, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24589043 ↗InjuryJan 4, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INNER AND OUTER CAPSULAR RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED AND IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23954377 ↗InjuryDec 28, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23903962 ↗InjuryDec 19, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23853463 ↗InjuryDec 10, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. DEVICE WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23771511 ↗InjuryDec 5, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III AND MODERATE CALCIFICATION, PER DR´S OFFICE CALCIFICATION IS NOT DEVICE RELATED". HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURED FOUND DURING SURGERY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23728386 ↗InjuryDec 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 was explanted.
Patient problems: Capsular Contracture
MAUDE report 23724324 ↗InjuryNov 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND "CHANGE SHAPE/SIZE/STYLE" VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23646765 ↗InjuryNov 25, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23642135 ↗
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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- 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
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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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