NATRELLE Silicone-Filled Breast Implants 110-150Recalls & reported problems
Allergan, Inc. · NATRELLE Style 110-150 Moderate 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 Style 110-150 BIOCELL textured silicone breast implant by Allergan is used for breast reconstruction or augmentation. The 30 reports mostly describe the implant breaking (rupture) and scar tissue tightening around it (capsular contracture), with some fluid collection and pain. All 30 involve injuries, and no deaths are reported. One open recall, started in July 2019, followed FDA notice of a higher rate of a rare lymphoma 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
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10888628002173), received between May 16, 2019 and Dec 16, 2025 — classified as 29 injuries.
The most frequently reported specific device problem is “Material Rupture” (15 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 Rupture15
- Patient-Device Incompatibility9
- Device Appears to Trigger Rejection7
- Adverse Event Without Identified Device or Use Problem1
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture16
- Failure of Implant11
- Seroma2
- No Clinical Signs, Symptoms or Conditions1
- Swollen Lymph Nodes/Glands1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2025Material Rupture; Material Rupture
PATIENT REPORTED "PAIN", "LUMP" AND "RUPTURE". HEALTHCARE PROFESSIONAL CONFIRMED RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23815207 ↗InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "SEROMA". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.
Patient problems: Seroma
MAUDE report 23812853 ↗InjuryNov 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED ¿PAIN¿, ¿CAPSULAR CONTRACTURE BAKER GRADE IV¿ AND ¿IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23656070 ↗InjuryNov 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED ¿PAIN¿, ¿CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN¿ AND ¿IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23656029 ↗InjuryJun 6, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
PATIENT REPORTED UNKNOWN SIDE RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22159992 ↗InjuryOct 19, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED RIGHT SIDE RUPTURE. HEALTH PROFESSIONAL REPORTED COMPLICATIONS SUCH AS RETHORACIC ABNORMAL MOVEMENT AND CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) DEFORMATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17965380 ↗InjuryJun 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.
Patient problems: Capsular Contracture
MAUDE report 17139252 ↗InjuryMay 22, 2023Material Rupture; Material Rupture
PATIENT REPORTED A RIGHT SIDE RUPTURE CONFIRMED VIA MRI. THE NON-DEVICE RELATED EVENT OF "MALIGNANT NEOPLASM OF BREAST UNKNOWN" WAS REPORTED. THE DEVICE HAS BEEN EXPLANTED, REPLACED AND A CAPSULECTOMY WAS PERFORMED.
Patient problems: Failure of Implant
MAUDE report 16979946 ↗InjuryMar 10, 2023Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16526748 ↗InjuryFeb 7, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16315407 ↗InjuryNov 23, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE RUPTURE AND TEXTURED. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15858297 ↗InjuryNov 15, 2022Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE RECALL AND RUPTURE. FURTHER REPORTED WAS "INTRAUTERINE CARCINOMA OF BREAST" WHICH HAS BEEN DEEMED NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15798309 ↗InjuryMar 29, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE BIOCELL REPLACEMENT, "MULTIPLE ENLARGED LYMPH NODES IN RIGHT AXILLA.", AND RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 13935579 ↗InjuryJan 20, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED RIGHT SIDE RUPTURE. HEALTHCARE PROFESSIONAL REPORTED ¿BREAST CANCER¿, ¿CAPSULAR CONTRACTURE OF BREAST IMPLANT¿, ¿SLIGHTLY INCREASED, SMALL AMOUNT OF FLUID COLLECTION AROUND THE IMPLANT BAG¿, ¿PROMINENT INTERNAL FOLDING¿. THE EVENT OF ¿MALIGNANT NEOPLASM¿ IS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 13309817 ↗InjuryJun 29, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12086549 ↗InjuryApr 7, 2021Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE (GRADE III) AND MRI CONFIRMED RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11629774 ↗InjuryMar 4, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED BILATERAL EXCHANGE FROM TEXTURED IMPLANTS DUE TO CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RUPTURE FOUND DURING EXPLANT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11416195 ↗InjuryFeb 17, 2021Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE "RUPTURE" AND "AFFECTED DEVICE INFORMATION WAS TEXTURED DEVICE IMPLANTED". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11336607 ↗InjuryOct 15, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED FOR RIGHT SIDE, CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10682816 ↗InjuryOct 15, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED FOR LEFT SIDE, CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10682766 ↗InjuryAug 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III ON RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10396331 ↗InjuryJun 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10149421 ↗InjuryJun 5, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE GRADE 3" ASSOCIATED WITH LEFT SIDE DEVICE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10122202 ↗InjuryApr 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9975771 ↗InjuryJan 30, 2020Material Rupture; Material Rupture
¿MALICIOUS NEOPLASMS OF THE BREAST¿ WERE REPORTED BUT NOT CONSIDERED DEVICE RELATED.
Patient problems: Failure of Implant
MAUDE report 9647449 ↗
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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