NATRELLE Silicone-Filled Breast Implants 115-469Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10888628002432), received between Jul 24, 2019 and Aug 23, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Material Rupture” (8 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.

Recalls naming this device

1. 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

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2026Material Rupture

  Healthcare professional reported ¿textured/ruptured¿. Later, healthcare professional reported ¿severely ruptured", ¿Hole, non-specific¿ and ¿intracapsular rupture¿. This record is for the left side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50395928 ↗
• InjuryApr 29, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient reported "rupture". Later Healthcare professional reported "rupture" and "capsular contracture". This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25037616 ↗
• InjuryJul 1, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE". DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22375814 ↗
• InjuryMay 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND RECALL. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ABBVIE PRODUCT.

  Patient problems: Capsular Contracture

  MAUDE report 21998943 ↗
• InjuryNov 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE DEVICE EXCHANGE. HEALTHCARE PROFESSIONAL REPORTED "REASON FOR EXCHANGE: BIOCELL / BAKER GRADE III." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10854126 ↗
• InjuryFeb 14, 2020Material Rupture; Migration; Material Rupture; Migration

  PATIENT REPORTED RIGHT SIDE RUPTURE AND BREAST "DOUBLED IN SIZE, IS HARD, AND SILICONE IN LYMPH NODE." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant; Seroma; Swollen Lymph Nodes

  MAUDE report 9711481 ↗
• InjuryFeb 11, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE IMPLANT RUPTURE, AND BILATERAL IMPLANT EXCHANGE DUE TO VOLUNTARY RECALL (ASYMPTOMATIC PATIENT). DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9694784 ↗
• InjuryJan 29, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9645017 ↗
• InjuryDec 16, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9475623 ↗
• InjuryDec 13, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9469790 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TESTING HAS BEEN CONDUCTED FOR ALCL AND NO MALIGNANCY WAS FOUND.

  Patient problems: Inflammation; Lymphoma; Seroma

  MAUDE report 9257138 ↗
• InjuryOct 15, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9194435 ↗
• InjuryOct 15, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9193670 ↗
• InjuryAug 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, AND PAIN. PATIENT ADDITIONALLY REPORTED "TIREDNESS," "NIGHT SWEAT," "DEPRESSION" "TO THE POINT OF THINKING OF COMMITTING SUICIDE," "NO APPETITE," "ANAPHYLACTIC SHOCK" FROM "ANTIBIOTICS AND PAIN MEDS," "DRY, CANNOT PRODUCT TEARS"; THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 8926212 ↗
• InjuryAug 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, PAIN, "LYMPH NODE ISSUES," AND "A LYMPH NODE UNDER MY RIGHT ARM." PATIENT ADDITIONALLY REPORTED "NIGHT SWEATS," "NO APPETITE," "DEPRESSION TO THE POINT OF THINKING OF COMMITTING SUICIDE," "FOGGY BRAIN," "DRY, CANNOT PRODUCE TEARS," "TIREDNESS," "ANAPHYLACTIC SHOCK" FROM "ANTIBIOTICS AND PAIN MEDS"; THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 8925662 ↗
• InjuryJul 24, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RUPTURE CONFIRMED VIA MRI AND CAPSULAR CONTRACTURE, BAKER GRADE III.

  Patient problems: Capsular Contracture

  MAUDE report 8822272 ↗

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 · Terminated
  Natrelle 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 · Terminated
  Natrelle 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, Classified
  Natrelle 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