NATRELLE Silicone-Filled Breast Implants 110-270Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10888628002210), received between May 21, 2015 and Sep 4, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Material Rupture” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50622283 ↗
• InjuryJun 5, 2026Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED "RUPTURE". HEALTHCARE PROFESSIONAL THEN REPORTED "CAPSULAR CONTRACTURE CAUSING IMPLANT RUPTURE". HEALTHCARE PROFESSIONAL THEN REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25418121 ↗
• InjuryJan 22, 2026Material Rupture

  HEALTHCARE PROFESSIONAL THROUGH A DISTRIBUTOR REPORTED "PROSTHESIS RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24156029 ↗
• InjuryOct 23, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE", "CAPSULAR CONTRACTURE BAKER GRADE IV" AND "FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23375645 ↗
• InjuryOct 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "A LEFT SIDE CAPSULAR CONTRACTURE, CAPSULAR CONTRACTURE BAKER GRADE IV, PAIN, CHANGE IN LOOK, AND A ANXIETY TOWARDS THE PRODUCT." LATER HEALTHCARE PROFESSIONAL REPORTED "ANY CREASES". LATER HEALTHCARE PROFESSIONAL REPORTED "REMOVAL WITH NO COMPLAINT AGAINST DEVICE, DEVICE FOUND TO BE INTACT". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23327583 ↗
• InjuryOct 15, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE CONFIRMED WITH MRI" AND "IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". LATER, HEALTHCARE PROFESSIONAL REPORTED "TISSUE INGROWTH". THIS RELATES TO THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. DEVICE WAS RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23286713 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "FOLDS AND SEROMA" CONFIRMED VIA MRI. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Seroma

  MAUDE report 22143215 ↗
• InjuryApr 6, 2025Material Rupture; Material Rupture

  PATIENT REPORTED RUPTURE AND "MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF BREAST, BREAST CANCER" CONFIRMED BY ULTRASOUND. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21782649 ↗
• InjuryJan 5, 2024Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROVIDER REPORTED "PATIENT HAS TEXTURED MAMMARY IMPLANTS AND HAS RECENTLY NOTICED A CHANGE IN THE IMPLANTS AND BREAST ASYMMETRY. POSSIBLE RUPTURE OR LEAKAGE SUSPECTED. PATIENT WISHES TO HAVE THE IMPLANTS REMOVED". THIS IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 18457748 ↗
• InjuryJan 5, 2024Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROVIDER REPORTED LEFT SIDE POSSIBLE RUPTURE OR LEAKAGE SUSPECTED. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE III/IV. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 18457409 ↗
• InjuryApr 10, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 16708996 ↗
• InjuryApr 10, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  THIS IS A DUPLICATE FILE, HENCE UN-REPORTING RUPTURE. PLEASE REFER MRN#: 9617229-2020-10879 FOR THIS DEVICE.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708846 ↗
• InjuryAug 19, 2022Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE" AGAINST LEFT SIDE DEVICE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15261209 ↗
• InjuryAug 3, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10359539 ↗
• InjuryJul 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE GRADE III". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10257833 ↗
• InjuryJul 10, 2020Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 10257620 ↗
• InjuryJan 6, 2020Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 9553420 ↗
• InjuryMay 21, 2015No Apparent Adverse Event

  F/U CONFIRMED WITH THE PHYSICIAN THAT THE PT DOES NOT HAVE LYMPHOMA OR ALCL.

  Patient problems: Complaint, Ill-Defined; Lymphoma; Nausea; Pain

  MAUDE report 4791713 ↗
• InjuryMay 21, 2015Material Rupture

  F/U CONFIRMED WITH THE PHYSICIAN THAT THE PT DOES NOT HAVE LYMPHOMA OR ALCL.

  Patient problems: Complaint, Ill-Defined; Lymphoma; Nausea

  MAUDE report 4791712 ↗

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-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-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-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