NATRELLE Silicone-Filled Breast Implants 120-550Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10888628002586), received between Jun 7, 2019 and Aug 20, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Material Rupture” (12 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Material Rupture

  Healthcare professional reported "rupture and exchange from texture to smooth implant". This record is for the left side. The device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50349994 ↗
• InjuryJan 21, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURED". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND EXCHANGE OF TEXTURED DEVICE DUE TO PATIENT'S CONCERN WITH PRODUCT" THIS RECORD IS FOR THE RIGHT SIDE. CAPSULECTOMY WAS PERFORMED. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Anxiety

  MAUDE report 24136446 ↗
• InjuryJan 5, 2026Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED THAT THE PATIENT WANTS THEIR IMPLANT REMOVED DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. LATER, HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT.". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". CAPSULECTOMY WAS PERFORMED AS TREATMENT. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23969588 ↗
• InjuryDec 28, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPRESENTATIVE REPORTED THAT THE PATIENT WANTS THEIR IMPLANT REMOVED DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. LATER, HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT.". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "RUPTURED IMPLANT". CAPSULECTOMY WAS PERFORMED AS TREATMENT. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND IT IS UNKNOWN IF IT WAS REPLACED. DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23903966 ↗
• InjuryNov 17, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23575643 ↗
• InjurySep 2, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III-IV AND TEXTURED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 20117809 ↗
• InjuryAug 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND TEXTURED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 20026000 ↗
• InjuryJun 21, 2023Material Rupture; Material Rupture

  PHYSICIAN REPORTED RIGHT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17173134 ↗
• InjuryAug 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENTS CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15257605 ↗
• InjuryAug 16, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED RIGHT SIDE "HUGE AND HARD." PATIENT ADDITIONALLY REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 15237290 ↗
• InjuryJun 14, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14689521 ↗
• InjuryJun 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE "BILATERAL CAPSULAR CONTRACTURES, BAKER GRADES III AND EXCHANGE." THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14676763 ↗
• InjuryJun 6, 2022Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE ¿SIDE WALL OF IMPLANT PAIN, CHRONIC PAIN¿ AND ¿WANTING EXCHANGE FROM TEXTURED TO A SMOOTH BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN." HEALTHCARE PROFESSIONAL LATER REPORTED THAT THE DEVICE WAS FOUND TO BE RUPTURED DURING EXPLANT SURGERY. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 14603515 ↗
• InjuryApr 29, 2022Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE ¿SIDE WALL OF IMPLANT PAIN, CHRONIC PAIN¿ AND ¿WANTING EXCHANGE FROM TEXTURED TO A SMOOTH BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED THAT THE DEVICE WAS FOUND TO BE RUPTURED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14253035 ↗
• InjuryJun 17, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROVIDER REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENTS CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12018459 ↗
• InjuryFeb 23, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. ADDITIONALLY, THE HEALTHCARE PHYSICIAN OPERATIVE REPORT STATED "INTRACAPSULAR RUPTURE OF THE RIGHT SILICONE BREAST IMPLANT". DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 11365683 ↗
• InjuryFeb 19, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 11349410 ↗
• InjuryFeb 11, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT AND CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11314118 ↗
• InjuryFeb 10, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT AND CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11310801 ↗
• InjuryFeb 9, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANT EXCHANGE DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT AND RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11303132 ↗
• InjuryOct 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 10635790 ↗
• InjuryNov 22, 2019Material Rupture; Material Rupture

  PATIENT REPRESENTATIVE ALSO REPORTED PATIENT ¿SUFFERED PERSONAL INJURIES AND RELATED DAMAGES,¿ THIS EVENT IS NOT RELATED TO THE DEVICE. DEVICE WAS EXPLANTED.

  Patient problems: Lymphoma

  MAUDE report 9362881 ↗
• InjuryJun 11, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 8688259 ↗
• InjuryJun 7, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8680926 ↗

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