NATRELLE Silicone-Filled Breast Implants 110-360Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10888628002241), received between Mar 27, 2020 and Sep 29, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Material Rupture” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Rupture

  Healthcare professional reported "exchange from textured to smooth implant". Healthcare professional later reported "rupture". This record is for the left side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936759 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "STAPH INFECTION". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 25073216 ↗
• InjuryFeb 6, 2026Material Rupture

  PATIENT REPORTED "RUPTURE". PATIENT LATER REPORTED "RUPTURE" AND "TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED "POSSIBLE RUPTURE" AND "PATIENT IS ALSO CONCERNED ABOUT THE TEXTURED BIOCELL PRODUCT". HEALTHCARE PROFESSIONAL LATER CONFIRMED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24278839 ↗
• InjuryFeb 2, 2026Material Rupture

  PATIENT REPORTED "TEXTURED IMPLANTS FROM TEXTURED TO SMOOTH DUE TO THE CONCERN", "BREAST IMPLANT ILLNESS" (NOT DEVICE RELATED) AND "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24234613 ↗
• InjuryJan 12, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "PERFORATION/ RECALL". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 24039439 ↗
• InjuryJan 12, 2026Material Rupture

  UN-REPORTING SINCE THIS IS A DUPLICATE RECORD.

  Patient problems: Failure of Implant

  MAUDE report 24039030 ↗
• InjuryMay 24, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 19393704 ↗
• InjuryApr 1, 2024Material Rupture; Material Rupture

  PATIENT REPORTED A RIGHT SIDE "MAMMOGRAPHY SHOWED RUPTURE OF IMPLANT". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19011096 ↗
• InjuryMar 25, 2024Material Rupture; Material Rupture

  PATIENT REPORTED A LEFT SIDE "MAMMOGRAPHY SHOWED RUPTURE OF IMPLANT". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18974341 ↗
• InjuryAug 10, 2023Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE VIA ULTRASOUND. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17504345 ↗
• InjuryDec 29, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE "BREAST DEFORMITY. WITH THE RIGHT IMPLANT APPEARING SMALLER THAN THE LEFT". BAKER GRADE II, CAPSULAR CONTRACTURE OF THE RIGHT BREAST". AND PATIENT ALSO, HAS TEXTURED MAMMARY IMPLANTS. HEALTHCARE PROFESSIONAL LATER REPORTED, "ANY CREASES" AND "HOLE, NON SPECIFIC" AND "HOLE IN RADIUS EDGE". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16075414 ↗
• InjuryJun 30, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 14880879 ↗
• InjuryMar 3, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 13663809 ↗
• InjuryMar 28, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE "III/IV", AND "PATIENT'S CONCERN WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11580255 ↗
• InjuryMar 27, 2020Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE RUPTURE. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED CAPSULAR CONTRACTURE, BAKER GRADE "III-IV" AND "PATIENT¿S CONCERN WITH THE PRODUCT". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9888619 ↗

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