NATRELLE Silicone-Filled Breast Implants 120-650Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888628002609), received between Dec 5, 2019 and Sep 29, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Material Rupture” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926941 ↗
• InjuryApr 1, 2026Material Rupture

  PATIENT REPORTED OF THE RIGHT-SIDE DEVICE: "RUPTURE, IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT, WEAK IMMUNE SYSTEM, AND "HAVEN'T BEEN FEELING GOOD". THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760384 ↗
• InjuryDec 11, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURES" AND "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23783810 ↗
• InjuryDec 11, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURES" AND "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23783802 ↗
• InjuryJun 1, 2022Material Rupture; Material Rupture

  HEALTHCARE PROVIDER CALLED TO REPORT RIGHT SIDED FLUID, POSSIBLE RUPTURE, AND PAIN FOUND ON ULTRASOUND. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 14562329 ↗
• InjuryMay 25, 2022Material Rupture; Material Rupture

  HEALTHCARE PROVIDER REPORTED "LEFT SIDED SEROMA WITH BLOOD, PAIN, AND POSSIBLE RUPTURE FOUND ON AN ULTRASOUND." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Seroma

  MAUDE report 14495808 ↗
• InjuryJun 18, 2021Material Rupture; Material Rupture

  THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 12028933 ↗
• InjuryJun 16, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE AS BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 12013384 ↗
• InjuryNov 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL EXCHANGE TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERN WITH THE PRODUCT. PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10773259 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE PROVIDED FLOW CYTOMETRY AND SURGICAL PATHOLOGY RESULTS INDICATING THAT THE PATIENT EXPERIENCED A LATE SEROMA. THE RESULTS PROVIDED THE FOLLOWING DIAGNOSIS: "ABNORMAL CD30 POSITIVE T CELLS" AND "THESE FINDINGS ARE CONSISTENT WITH NON -HODGKIN LYMPHOMA IN THE APPROPRIATE CLINICAL AND MORPHOLOGIC CONTEXT. IN CONTEXT OF THE CLINICAL HISTORY, THIS IMMUNOPHENOTYPE SUGGESTS BREAST IMPLANT -ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL: PROVISIONAL ENTITY UNDER THE 2016 WHO CLASSIFICATION) BUT SHOULD BE CORRELATED IN CONTEXT OF THE CONCURRENT MORPHOLOGY AND POSSIBLY OTHER ANCILLARY STUDIES FOR DEFINITIVE DIAGNOSIS AND SUBCLASSIFICATION." WHILE THE MARKER OF CD30+ HAS BEEN REPORTED, THE MARKER OF ALK- HAS NOT. AFFECTED SIDE IS RIGHT. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Lymphoma; Seroma

  MAUDE report 9890749 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE PAIN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Pain

  MAUDE report 9419692 ↗

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