NATRELLE Silicone-Filled Breast Implants 20-475Recalls & reported problems
Allergan, Inc. · NATRELLE Style 20-475 High 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-filled breast implant from Allergan. The 56 reports mostly describe the implant rupturing or breaking inside the body, along with the surrounding scar tissue tightening around it (capsular contracture), sometimes with blotchy skin, itching or burning; the 56 reports all involve injuries and none involve deaths, and many mention the implant being surgically removed. There are no recalls naming this device. In the past 12 months 11 reports were filed, up from 4 in the earlier 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
- 56
- Deaths reported
- 0
- Injuries reported
- 56
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10888628001732), received between Aug 10, 2015 and Sep 11, 2026 — classified as 56 injuries.
The most frequently reported specific device problem is “Material Rupture” (34 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 Rupture34
- Device Appears to Trigger Rejection16
- Patient-Device Incompatibility9
- Adverse Event Without Identified Device or Use Problem3
- Gel Leak1
- No Apparent Adverse Event1
Patient problems
- Failure of Implant26
- Capsular Contracture25
- No Clinical Signs, Symptoms or Conditions4
- Seroma1
- Swollen Lymph Nodes1
- Teratogenic Effects1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Device Appears to Trigger Rejection; Material Rupture
Patient problems: Capsular Contracture
MAUDE report 50743948 ↗InjuryAug 13, 2026Material Rupture
Healthcare professional reported "rupture". This record is for unknown side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236270 ↗InjuryAug 13, 2026Material Rupture
Healthcare professional reported "rupture". This record is for unknown side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236099 ↗InjuryJul 1, 2026Gel Leak; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RUPTURE. LATER THROUGH RETURN PAPERWORK NOTED "GEL BLEED". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25676860 ↗InjuryApr 13, 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 24861187 ↗InjuryMar 26, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "FOLD FLAW". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24708462 ↗InjuryDec 22, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE", "EXPERIENCING BLOTCHINESS, DEEP ITCHING, AND A BURNING SENSATION IN BREAST, WHICH BECOME SORE WHEN SLEEPING ON THE SIDE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23865075 ↗InjuryDec 12, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "ANY CREASES." THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23790124 ↗InjuryDec 4, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23716702 ↗InjuryNov 21, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED. IT WILL BE RETURNED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 23618975 ↗InjuryNov 13, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "UNCOMFORTABLE, SITTING DIFFERENT" AND "RUPTURES". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23544829 ↗InjuryOct 26, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23387973 ↗InjurySep 11, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA MAMMOGRAM AND ULTRASOUND. THIS RECORD IS FOR LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23023986 ↗InjuryAug 14, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22812563 ↗InjuryApr 24, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21902568 ↗InjuryJul 29, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, "INTRACAPSULAR RUPTURE". RECORD IS FOR LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 19856080 ↗InjuryMar 6, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED, A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. HEALTHCARE PROFESSIONAL, LATER CONFIRMED, EVENT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18851918 ↗InjuryNov 17, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, A RIGHT SIDE RUPTURES. PER, MAMMOGRAM IMPLANT EXCHANGE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 18160798 ↗InjuryNov 13, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A BILATERAL -SIDE RUPTURES PER MAMMOGRAM IMPLANT EXCHANGE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18125729 ↗InjurySep 19, 2023Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE. LATER HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND "THE LEFT BREAST IMPLANT APPEARS SOMEWHAT LOBULATED". LATER, PATIENT REPORTED "REMOVAL OF BOTH IMPLANTS DUE TO RUPTURE. DUE TO RUPTURE IT IS MEDICALLY NECESSARY DUE TO SILICONE LEAKING INTO BODY. THE IMPLANTS ARE ALSO PART OF THE RECALL GROUP." LATER, HEALTHCARE PROFESSIONAL REPORTED "NO EVENT - MRI CONFIRMED", BUT LATER CONFIRMED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17775562 ↗InjuryAug 24, 2023Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE RUPTURE CONFIRMED WITH A MAMMOGRAM AND "BOTH FLAT ON TOP AND SAG". ADDITIONAL REPORT OF LOST WEIGHT, DEEMED NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17619617 ↗InjuryJul 13, 2023Material Rupture; Material Rupture
DEVICE WAS EXPLANTED. HEALTHCARE PROFESSIONAL REPORTED, DEPRESSION. AND EXCHANGE FROM TEXTURED TO SMOOTH, DUE TO THE PATIENT¿S CONCERN ABOUT THE PRODUCT.
Patient problems: Failure of Implant
MAUDE report 17322017 ↗InjuryMay 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A POSSIBLE CAPSULAR CONTRACTURE UNKNOWN BAKER GRADE ON AN UNKNOWN SIDE. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16875151 ↗InjuryMay 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A POSSIBLE CAPSULAR CONTRACTURE UNKNOWN BAKER GRADE ON AN UNKNOWN SIDE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16874622 ↗InjuryApr 18, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORT RIGHT-SIDE "ENCAPSULATION", "POTENTIALLY/POSSIBLE RUPTURE", AND " MIGHT APPEAR HAIRAGEOUS WITH STEPLADDER SIGN AND INTER-CAPSULAR RUPTURE" AND CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16762469 ↗
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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