NATRELLE Silicone-Filled Breast Implants 115-222Recalls & reported problems
Allergan, Inc. · NATRELLE St 115-222 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 silicone-filled breast implant. Most of the 49 reports describe the implant rupturing or leaking, often with the shell breaking down and the scar tissue around it tightening enough to distort the breast; several implants were removed and replaced. There are no deaths, and 49 injuries. One open recall, started in July 2019, concerns a rare lymphoma risk in patients with textured breast 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
- 52
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10888628002340), received between May 17, 2019 and Sep 14, 2026 — classified as 52 injuries.
The most frequently reported specific device problem is “Material Rupture” (36 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 Rupture36
- Patient-Device Incompatibility11
- Device Appears to Trigger Rejection6
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant33
- Capsular Contracture17
- Seroma5
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Device Appears to Trigger Rejection
Healthcare professional reported through company representative "capsular contracture (Baker grade: 3)". This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50757306 ↗InjurySep 10, 2026Device Appears to Trigger Rejection
Healthcare professional reported through company representative "capsular contracture (Baker grade: 3)". This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50721035 ↗InjuryJul 10, 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 25787535 ↗InjuryJul 2, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE", "BREAST SWELLING", "PAIN" AND "SEROMA¿. LATER HEALTHCARE PROFESSIONAL REPORTED "LYMPHOCYTES AND A FEW HISTIOCYTES, NEGATIVE FOR MALIGNANCY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Seroma
MAUDE report 25691573 ↗InjuryJan 7, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED DEVICE" AND "UNSPECIFIED BREAST NODULE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.
Patient problems: Failure of Implant
MAUDE report 23989085 ↗InjuryNov 27, 2025Material Rupture; Material Rupture
PATIENT REPORTED "GROIN PAIN AND PELVIC PAIN", "FEVER AND BREAST SIZE ARE CLEARLY DIFFERENT", "THE SIZE GOT BIGGER AND BIGGER" AND "RUPTURE". THE EVENT "GROIN PAIN AND PELVIC PAIN" IS NOT DEVICE RELATED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED. THE PATIENT WAS PRESCRIBED MEDICATION AND ANTIBIOTICS.
Patient problems: Failure of Implant
MAUDE report 23667719 ↗InjuryOct 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE "TEXTURE TO SMOOTH" AND CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE REMAINS IMPLANTED. IT IS UNKNOWN IF THE DEVICES WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23407146 ↗InjuryOct 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "TEXTURE TO SMOOTH" AND CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE REMAINS IMPLANTED. IT IS UNKNOWN IF THE DEVICES WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23407143 ↗InjuryAug 8, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE; ULTRASOUND PERFORMED. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22751048 ↗InjuryAug 1, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22686557 ↗InjuryMay 9, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL LATER REPORTED SEROMA-LATE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant; Seroma
MAUDE report 16894707 ↗InjuryFeb 2, 2023Material Rupture; Material Rupture
PATIENT REPORTED, RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16284033 ↗InjuryJan 19, 2023Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE. THE PATIENT UNDERWENT A CAPSULECTOMY. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16206121 ↗InjuryJan 16, 2023Material Rupture; Material Rupture
PATIENT REPORTED, LEFT RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16174470 ↗InjuryJan 10, 2023Material Rupture; Material Rupture
PATIENT REPORTED, RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16132754 ↗InjuryDec 22, 2022Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16034154 ↗InjuryDec 5, 2022Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE "RUPTURE." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; Seroma
MAUDE report 15917683 ↗InjuryOct 19, 2022Material Rupture; Material Rupture
PATIENT REPORTED "CHANGE IN SIZE OF RIGHT CHEST" AND LATER REPORTED RIGHT RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15631593 ↗InjuryMay 16, 2022Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14408697 ↗InjuryApr 27, 2022Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant; Seroma
MAUDE report 14223591 ↗InjuryApr 25, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant; Seroma
MAUDE report 14198034 ↗InjuryMar 24, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "A RIGHT SIDE RUPTURE AS WELL AS BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13876962 ↗InjuryMar 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13654079 ↗InjuryJan 18, 2022Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13286951 ↗InjuryJan 12, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "RUPTURE." DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13236818 ↗
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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