NATRELLE Silicone-Filled Breast Implants 120-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10888628002579), received between Aug 7, 2013 and Aug 29, 2026 — classified as 41 injuries.

The most frequently reported specific device problem is “Material Rupture” (20 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular contracture" Baker Grade III and "exchange from textured to smooth". This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50510154 ↗
• InjuryAug 29, 2026Device Appears to Trigger Rejection

  Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50510150 ↗
• InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "TEXTURED IMPLANT, CAPSULAR CONTRACTURE BAKER GRADE III, AND MALPOSITION". THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23840533 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "SEROMA". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED AND WILL BE RETURNED.

  Patient problems: Seroma

  MAUDE report 23472657 ↗
• InjuryAug 7, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "HAVING PAIN ON RIGHT SIDE WITH POSSIBLE CAPSULAR CONTRACTURE GRADE UNKNOWN".

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 22742982 ↗
• InjuryJul 15, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE" CONFIRMED VIA MRI AND "CONCERNS OF THE PRODUCT". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22507761 ↗
• InjuryApr 22, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21886698 ↗
• InjuryApr 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "FLUID AROUND BREASTS" AND "EXCHANGE OF TEXTURED DEVICES DUE TO PRODUCT CONCERN". PATIENT LATER REPORTED "FLUID WITH STUFF IN THERE" VIA ULTRASOUND/MAMMOGRAM. PATIENT LATER REPORTED "LARGE AMOUNT OF FLUID OUTSIDE OF DEVICE, SHARP CHEST PAIN, SWOLLEN, AND TENDER". PATIENT LATER REPORTED "TIGHT, SWOLLEN AND TENDER". HEALTHCARE PROFESSIONAL LATER REPORTED AND CONFIRMED "FLUID COLLECTION AROUND IMPLANTS" AND "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". HEALTHCARE PROFESSIONAL LATER CONFIRMED "FLUID AROUND BREASTS", "EXCHANGE OF TEXTURED DEVICES DUE TO PRODUCT CONCERN", "LARGE AMOUNT OF FLUID OUTSIDE OF DEVICE, SHARP CHEST PAIN, SWOLLEN, AND TENDER", "TIGHT, SWOLLEN AND TENDER". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 21798958 ↗
• InjuryApr 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL LATER CONFIRMED "FLUID AROUND BREASTS", "EXCHANGE OF TEXTURED DEVICES DUE TO PRODUCT CONCERN", "LARGE AMOUNT OF FLUID OUTSIDE OF DEVICE, SHARP CHEST PAIN, SWOLLEN, AND TENDER", "TIGHT, SWOLLEN AND TENDER". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 21779578 ↗
• InjuryFeb 13, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED TEXTURED IMPLANT AND CAPSULAR CONTRACTURE, BAKER GRADE III. PATIENT LATER REPORTED RUPTURE. HEALTHCARE PROFESSIONAL LATER CONFIRMED RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 21373307 ↗
• InjuryJan 9, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. A DIFFERENT HEALTHCARE PROFESSIONAL REPORTED POSSIBLE RIGHT CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN OR POSSIBLE RUPTURE THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 21111645 ↗
• InjuryAug 15, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING LEFT SIDE ¿SIZE EXCHANGE; REMOVED BECAUSE OF REMOVAL OF RIGHT SIDE. UPON REMOVAL, FOUND IMPLANT TO BE GROSSLY RUPTURED.¿ DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17552198 ↗
• InjuryJul 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERNS WITH THE PRODUCT WITH "INCREDIBLE PAIN, HARDNESS" AND "MY BREAST WAS BLACK AT 2 WEEKS POST OP.'' HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE," BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17256487 ↗
• InjuryJul 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERNS WITH THE PRODUCT WITH "INCREDIBLE PAIN AND HARDNESS.'' HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE," BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17254552 ↗
• InjuryMar 16, 2023Material Rupture; Migration; Material Rupture; Migration

  HEALTHCARE PROFESSIONAL REPORTED ADDITIONAL EVENT OF "RIGHT AXILLA LEVEL 1 LYMPH NODES CONSISTENT WITH SILICONE LYMPHADENOPATHY" THROUGH MRI RESULTS. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant; Swollen Lymph Nodes/Glands

  MAUDE report 16558849 ↗
• InjuryMar 16, 2023Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16558658 ↗
• InjuryOct 14, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15608410 ↗
• InjuryOct 14, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "A LEFT SIDE RUPTURE AND A BILATERAL IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15608102 ↗
• InjuryJul 11, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE PAIN IN ARMPITS ON RIGHT-SIDE AND LYMPHADENOPATHY. DEVICE REMAINS IMPLANTED.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 14983218 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE LYMPHADENOPATHY. DEVICE REMAINS IMPLANTED.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 14983160 ↗
• InjuryMay 9, 2022Material Rupture; Material Rupture

  PATIENT REPORTED "SOME TINGLING". HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14342482 ↗
• InjuryFeb 10, 2022Material Rupture; Migration; Material Rupture; Migration

  HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 13506544 ↗
• InjuryJan 14, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "EXCHANGE OF TEXTURED DEVICE DUE TO PATIENT'S CONCERN WITH PRODUCT". HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "CAPSULAR CTX", BAKER GRADE NOT SPECIFIED. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 13261042 ↗
• InjuryOct 21, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12672322 ↗
• InjuryAug 19, 2021Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 12344408 ↗

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