NATRELLE Silicone-Filled Breast Implants 115-378Recalls & reported problems
Allergan, Inc. · NATRELLE St 115-378 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 is a Natrelle BIOCELL textured silicone gel-filled breast implant from Allergan. The 58 reports mostly describe implants rupturing or leaking, along with the surrounding scar tissue tightening hard around the implant (capsular contracture), sometimes needing removal or replacement. No deaths were reported, and all 58 reports involved injuries. One recall names this device; it began in July 2019 and remains open, after FDA raised concerns about a rare lymphoma linked to textured implants. Reports in the past 12 months (12) were higher than the 5 in the prior12 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
- 63
- Deaths reported
- 0
- Injuries reported
- 63
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10888628002401), received between Jun 14, 2019 and Sep 16, 2026 — classified as 63 injuries.
The most frequently reported specific device problem is “Material Rupture” (45 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 Rupture45
- Device Appears to Trigger Rejection13
- Patient-Device Incompatibility9
- Adverse Event Without Identified Device or Use Problem1
- Malposition of Device1
- Migration1
Patient problems
- Failure of Implant33
- Capsular Contracture22
- No Clinical Signs, Symptoms or Conditions5
- Seroma3
- Breast Mass2
- Swollen Lymph Nodes/Glands2
- Anxiety1
- Pain1
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Material Rupture
Patient reported "They had chronic pain and tightness everywhere". Patient then reported "I have a tear/leak" and "Recall". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791228 ↗InjurySep 14, 2026Material Rupture
Patient reported "lump", " intracapsular implant rupture" and "extracapsular silicone leakage". This record is for the left side. The device remains implanted.
Patient problems: Breast Mass
MAUDE report 50754966 ↗InjurySep 14, 2026Material Rupture
Patient reported "lump", " intracapsular implant rupture" and "extracapsular silicone leakage". This record is for the right side. The device remains implanted.
Patient problems: Breast Mass
MAUDE report 50753712 ↗InjurySep 7, 2026Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50650984 ↗InjurySep 2, 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 50569502 ↗InjuryAug 21, 2026Material Rupture
Healthcare professional reported "I discovered a rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50383463 ↗InjuryJul 21, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AS WELL A EXCHANGE FROM TEXTURED TO SMOOTH". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25896024 ↗InjuryMar 13, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "PAIN". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Pain
MAUDE report 24591855 ↗InjuryMar 6, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24530923 ↗InjuryMar 6, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24530787 ↗InjuryFeb 16, 2026Material Rupture
PATIENT REPORTED "RUPTURE" AND "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24344158 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED RAYNAUD¿S PHENOMENON. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Pallor
MAUDE report 24323509 ↗InjuryFeb 9, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURE¿ AND ¿BIOCELL¿. LATER HEALTHCARE PROFESSIONAL REPORTED ¿HOLE NON-SPECIFIC¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24293612 ↗InjuryDec 9, 2025Device Appears to Trigger Rejection; Material Rupture; Migration; Device Appears to Trigger Rejection; Material Rupture; Migration
Patient reported right side "lump under her right arm pit", "plastic surgeon said it was like seepage", "they have a leakage or something", "silicone was gathering in the right armpit", and "concern with the product". Then healthcare professional reported "Pain", "Leaking", "Capsular Contracture Baker Grade III" and "Exchange from textured to smooth device due to the patients concern with the product". Device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 23759557 ↗InjuryDec 3, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE AND "TEXTURED". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23706788 ↗InjuryNov 24, 2025Material Rupture; Material Rupture
InjuryNov 24, 2025Material Rupture; Material Rupture
DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.
Patient problems: Failure of Implant
MAUDE report 23631744 ↗InjuryOct 27, 2025Material Rupture; Material Rupture
InjuryOct 9, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "REPLACEMENT DUE TO RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.
Patient problems: Failure of Implant
MAUDE report 23255265 ↗InjuryJul 31, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22676860 ↗InjuryJun 12, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "TEXTURED IMPLANTS". HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22193829 ↗InjuryJun 11, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "TEXTURED IMPLANTS". ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22188125 ↗InjuryNov 8, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE CONFIRMED BY AN MRI. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 18096598 ↗InjuryNov 2, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18056868 ↗InjuryOct 10, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. HEALTHCARE PROFESSIONAL REPORTED "HOLE, NON-SPECIFIC." DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.
Patient problems: Failure of Implant
MAUDE report 17906622 ↗
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
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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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