NATRELLE Silicone-Filled Breast Implants 120-260Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888628002524), received between Nov 15, 2013 and Jul 27, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Material Rupture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Material Rupture

  Healthcare professional reported "Rupture". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50015610 ↗
• InjuryJan 8, 2026Material Rupture

  LATER HEALTHCARE PROFESSIONAL REPORTED "AFTER SURGERY, SUSPECTED FINDINGS OF ALCL WERE OBSERVED". CAPSULE SPECIMEN WAS FOUND NEGATIVE FOR ALCL MALIGNANCY. TREATMENT: DEVICE REMOVAL, CAPSULECTOMY.

  Patient problems: Failure of Implant

  MAUDE report 24006941 ↗
• InjuryJan 7, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 3". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23995427 ↗
• InjuryOct 15, 2024Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE "RUPTURE". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20455960 ↗
• InjuryDec 9, 2022Material Rupture; Material Rupture

  PATIENT REPORTED "SOME PAIN OFF AND ON OVER THE LAST YEAR OR SO", RUPTURE, CONCERN WITH THE PRODUCT, AND SWELLING. ADDITIONALLY REPORTED WAS "A POSITIVE AUTO-IMMUNE DISEASE" WHICH HAS BEEN DEEMED NOT RELATED TO THE DEVICE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15951370 ↗
• InjuryJan 12, 2022Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant; Seroma

  MAUDE report 13239920 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE SEROMA. DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 11122917 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE "IMPLANT NEVER WENT DOWN INTO THE POCKET." ADDITIONALLY, PATIENT REPORTED "CONSTANT PAIN". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Pain

  MAUDE report 10640913 ↗
• InjuryNov 15, 2013No Apparent Adverse Event

  ALLERGAN'S LEGAL DEPARTMENT RECEIVED A LETTER REPORTING A PATIENT HAD "BILATERAL BREAST AUGMENTATION WITH SILICON BREAST IMPLANTS AND WAS DIAGNOSED WITH LYMPHOMA OF THE ANTERIOR MEDIASTINUM." FOLLOW UP INFO INDICATES THAT THIS IS A SYSTEMIC LYMPHOMA. IT IS NOTED PRIMARY LARGE B-CELL LYMPHOMA; THAT IMMUNOSTAINS SHOW THE ATYPICAL LYMPHOID CELLS TO BE POSITIVE.

  Patient problems: Chest Pain; Itching Sensation; Lymphoma; Malaise; Respiratory Distress

  MAUDE report 3523589 ↗

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