NATRELLE Silicone-Filled Breast Implants 115-272Recalls & reported problems
Allergan, Inc. · NATRELLE St 115-272 Moderate plus profile BIOCELL |textured|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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Allergan Natrelle textured silicone breast implant is a gel-filled implant. Most of the 81 reports describe the implant rupturing, and some describe scar tightening around the implant or fluid build-up. The reports include 81 injuries and no deaths. One recall, still open, began in July 2019 after the FDA warned about a rare lymphoma linked to textured implants.
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
- 80
- Deaths reported
- 0
- Injuries reported
- 80
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10888628002364), received between May 23, 2019 and Sep 24, 2026 — classified as 80 injuries.
The most frequently reported specific device problem is “Material Rupture” (65 reports).
1 FDA recall record name this device's identifier, 1 still open.
3 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
Recalls naming this device
- Jul 24, 2019Class IOpen, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Z-2454-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Rupture65
- Device Appears to Trigger Rejection8
- Adverse Event Without Identified Device or Use Problem5
- Patient-Device Incompatibility5
- Migration2
- Device Handling Problem1
- Fluid/Blood Leak1
- Improper or Incorrect Procedure or Method1
Patient problems
- Failure of Implant54
- Capsular Contracture13
- Seroma9
- No Clinical Signs, Symptoms or Conditions7
- Swollen Lymph Nodes/Glands2
- Abscess1
- Lymphoma1
- Pain1
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Material Rupture
Healthcare professional "rupture", "Mechanical complications" and silicone touched the patient. This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882963 ↗InjurySep 23, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869303 ↗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 50859457 ↗InjurySep 22, 2026Material Rupture; Improper or Incorrect Procedure or Method
Healthcare professional, through distributor, reported "implant rupture". The inner silicone gel came into contact with the patient. This record is for the right side. Device was explanted. Capsulotomy treatment was performed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859411 ↗InjurySep 13, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747546 ↗InjuryJul 20, 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 25873851 ↗InjuryJul 16, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25840824 ↗InjuryJul 15, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED OF THE RIGHT SIDE DEVICE: "EXTRACAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURED, BIOCELL, GRADE 3 CAPSULAR CONTRACTURE". THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25821851 ↗InjuryApr 14, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED THROUGH DISTRIBUTOR A "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.
Patient problems: Failure of Implant
MAUDE report 24878594 ↗InjuryApr 9, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED THROUGH DISTRIBUTOR ¿PROSTHESIS RUPTURED¿. LATER HEALTHCARE PROFESSIONAL REPORTED ¿BREAST PAIN¿. CAPSULECTOMY WAS PERFORMED. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829952 ↗InjuryFeb 13, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24330865 ↗InjuryFeb 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "EXTRACAPSULAR RUPTURE" AND "MULTIPLE LYMPH NODE REPLACED WITH A SNOWSTORM APPEARANCE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24283561 ↗InjuryJan 22, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24149592 ↗InjuryJan 20, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR BREAST IMPLANT RUPTURE" CONFIRMED BY MRI AND ULTRASOUND. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24122279 ↗InjuryJan 16, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR BREAST IMPLANT RUPTURE" CONFIRMED BY MRI AND ULTRASOUND. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24095963 ↗InjuryJan 15, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "COMPLEX RUPTURE WITH MULTIPLE FOLDS" AND "MIXED CYSTIC COMPONENTS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24086153 ↗InjuryNov 24, 2025Material Rupture; Migration; Material Rupture; Migration
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "MORE SUPERIOR IN THE AXILLA, THERE IS AT LEAST ONE AREA OF SILICONE WITHIN A NORMAL LYMPH NODE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23631587 ↗InjuryOct 23, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT-SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23373345 ↗InjuryOct 15, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" DIAGNOSED VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23286102 ↗InjuryOct 9, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE. LATER, HEALTHCARE PROFESSIONAL REPORTED IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23263126 ↗InjurySep 30, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT-SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23180741 ↗InjurySep 29, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CYST, FLUID BUILD UP, AND RUPTURE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23167361 ↗InjuryAug 28, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "PATIENT VISITED THE EMERGENCY ROOM OF THE HOSPITAL AFTER BEING INJURED WHILE TRIPPING OVER A STONE ON THE BEACH", "DAMAGE TO THE RIGHT PROSTHESIS INSERTED FOR BREAST SURGERY WAS PERFORMED ON THE CHEST CT PERFORMED AT THE HOSPITAL". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE BRAND AND IT WILL BE RETURN.
Patient problems: Failure of Implant
MAUDE report 22910995 ↗InjuryAug 1, 2025Material Rupture; Migration; Material Rupture; Migration
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE", "DISPLACED LATERALLY" AND "COMPLETE RUPTURE WITH MULTIPLE DISCONTINUITIES" CONFIRMED VIA MRI AND ULTRASOUND. THE DEVICE HAS BEEN EXPLANTED AND NOT REPLACED.
Patient problems: Failure of Implant
MAUDE report 22690348 ↗InjuryJul 17, 2025Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL CONFIRMED THE EVENT OF RUPTURE VIA ULTRASOUND. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22536495 ↗
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
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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 · each recall links to the FDA recall notice
- 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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