NATRELLE Silicone-Filled Breast Implants 115-401Recalls & reported problems
Allergan, Inc. · NATRELLE St 115-401 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 Natrelle BIOCELL textured silicone breast implant from Allergan appears in 43 adverse event reports, all describing injuries, with no deaths. Most describe the implant rupturing, along with pain, hardening of the surrounding tissue (capsular contracture) and fluid buildup. One open recall, started in July 2019, follows FDA safety information about a higher rate of a rare breast implant-related lymphoma in patients with 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
- 44
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10888628002418), received between Jul 9, 2019 and Sep 28, 2026 — classified as 44 injuries.
The most frequently reported specific device problem is “Material Rupture” (32 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 Rupture32
- Device Appears to Trigger Rejection8
- Patient-Device Incompatibility6
- Adverse Event Without Identified Device or Use Problem1
- Loss of or Failure to Bond1
Patient problems
- Failure of Implant24
- Capsular Contracture14
- Seroma7
- Swollen Lymph Nodes/Glands3
- Lymphoma2
- No Clinical Signs, Symptoms or Conditions2
- Swelling/ Edema1
- Swollen Lymph Nodes1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923786 ↗InjuryJul 21, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AS WELL A EXCHANGE FROM TEXTURED TO SMOOTH". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25895933 ↗InjuryApr 20, 2026Material Rupture
PATIENT REPORTED "RUPTURE & PAIN". THIS RECORD RELATES TO THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24929233 ↗InjuryMar 11, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURED¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24573373 ↗InjuryMar 10, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURED¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24565511 ↗InjuryJan 29, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24213451 ↗InjuryJan 28, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24202941 ↗InjuryDec 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT MENTIONED IMPLANTS BEING UNDER RECALL. THEN HEALTHCARE PROFESSIONAL REPORTED "PAIN", "CAPSULAR CONTRACTURE BAKER GRADE III" AND "EXCHANGE FROM TEXTURED TO SMOOTH DEVICE DUE TO THE PATIENTS CONCERN WITH THE PRODUCT". DEVICE REMAINS IMPLANTED. DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23791685 ↗InjuryNov 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV, WRINKLING/RIPPLING, PTOSIS, OTHER" VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR). SURGICAL INTERVENTION: CAPSULOTOMY AND MASTOPEXY. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23585472 ↗InjurySep 25, 2025Material Rupture; Material Rupture
InjurySep 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER HEALTHCARE PROFESSIONAL REPORTED "SMALL RADIAL FOLDS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23097277 ↗InjuryFeb 27, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE OF TEXTURED DEVICES DUE TO PRODUCT CONCERN. LATER, HEALTHCARE PROFESSIONAL REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21479526 ↗InjurySep 11, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED, LEFT SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL, LATER REPORTED,D LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. AND EXCHANGE FROM A TEXTURED TO SMOOTH BREAST IMPLANT, DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20189304 ↗InjuryApr 22, 2024Material Rupture; Material Rupture
PATIENT REPORTED A LEFT IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 19158239 ↗InjuryJan 12, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE REPLACEMENT FROM TEXTURED TO SMOOTH DUE TO THE PATIENT CONCERN OF THE IMPLANT. LATER, HEALTHCARE PROFESSIONAL REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 18504616 ↗InjuryDec 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
CAPSULAR CONTRACTURE HAS NOW BEEN CONFIRMED AS BAKER GRADE IV. FURTHER REPORTED WAS LEFT BREAST SEROMA/HEMATOMA AND "FLUID SENT FOR ALCL TESTING;" MARKERS CONFIRMING THIS EVENT HAVE NOT BEEN REPORTED.
Patient problems: Capsular Contracture; Lymphoma; Seroma
MAUDE report 18364509 ↗InjuryOct 6, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17885178 ↗InjuryMay 17, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED BILATERAL EXCHANGE DUE TO PATIENT¿S CONCERNS WITH THE PRODUCT. THIS RECORD REPRESENTS THE RIGHT SIDE. HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE TO RIGHT IMPLANT WAS NOTED AT THE TIME OF SURGERY". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16946383 ↗InjuryFeb 20, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, SEROMA (NOT TESTED YET), AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PRODUCT CONCERN. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 16404181 ↗InjuryJan 30, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16269285 ↗InjuryOct 21, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE RUPTURE AND REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE PATIENT'S CONCERN WITH THE DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15655180 ↗InjuryOct 19, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¿HOLE, NON SPECIFIC¿ AND PATIENT'S CONCERN FOR TEXTURED IMPLANT DEVICE. ADDITIONALLY REPORTED WAS "GREATER SAPHENOUS VEIN INSUFFICIENCY¿ WHICH HAS BEEN DEEMED NOT RELATED TO THE DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15633786 ↗InjuryOct 12, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "LATE SEROMA", RUPTURE, "PAIN", "IMPLANT LOOKS HIGHER", "SWELLING FOR FIVE DAYS", "ENLARGED, TIGHTNESS, HARD", AND "SEVERAL SMALL AXILLARY LYMPH NODES". DEVICE REMAINS IMPLANTED.
Patient problems: Seroma; Swollen Lymph Nodes/Glands
MAUDE report 15591478 ↗InjurySep 23, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15474162 ↗InjuryAug 17, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15245978 ↗
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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