NATRELLE Silicone-Filled Breast Implants 115-290Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 10888628002371), received between May 22, 2019 and Sep 29, 2026 — classified as 151 injuries.

The most frequently reported specific device problem is “Material Rupture” (116 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 151 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Rupture

  Healthcare professional reported "textured implant/ruptured implant". This record is for the right side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935751 ↗
• InjurySep 28, 2026Material Rupture

  Healthcare professional through distributor reported "rupture". This record is for right side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912938 ↗
• InjurySep 28, 2026Material Rupture

  Healthcare professional through distributor reported "rupture". This record is for left side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912899 ↗
• InjurySep 25, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892545 ↗
• InjurySep 24, 2026Material Rupture

  Healthcare professional reported "rupture" and inner silicone gel touched the patient. This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883102 ↗
• InjurySep 14, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765915 ↗
• InjurySep 14, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50765825 ↗
• InjurySep 11, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50743426 ↗
• InjurySep 8, 2026Material Rupture

  Company Representative reported on behalf of patient no complaint against the device. Healthcare professional later reported "Intracapsular Rupture". Patient later reported through company representative "intracapsular rupture of breast implant", "textured implant included in the recall", "enlarged axillary lymph nodes are likely secondary to systemic process" and "Few breast cysts". This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675299 ↗
• InjurySep 8, 2026Material Rupture

  Company representative reported on behalf of patient "dull aching near the breast". Healthcare professional later reported "Rupture". Patient later reported through company representative "intracapsular rupture of breast implant", "textured implant included in the recall", "enlarged axillary lymph nodes are likely secondary to systemic process" and "Few breast cysts". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675121 ↗
• InjurySep 8, 2026Material Rupture

  Healthcare professional, through distributor, reported "rupture". This record is for the left side. Device was explanted. The inner silicone gel touch the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675031 ↗
• InjuryAug 21, 2026Material Rupture

  Healthcare professional reported ¿implant appears to be ruptured¿. This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50381854 ↗
• InjuryAug 21, 2026Material Rupture

  Healthcare professional reported ¿implant appears to be ruptured¿. This record is for the right side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50381106 ↗
• InjuryAug 12, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture" and Capsular Contracture Baker Grade IV with asymmetry. This record is for the left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50224957 ↗
• InjuryJul 16, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25840826 ↗
• InjuryMay 13, 2026Material Rupture

  PATIENT REPORTED "RUPTURE" AND "2 LUMPS WHICH A BIOPSY WAS DONE AND THE RESULTS ARE NEGATIVE FOR MALIGNANCY" AND "FLUID WAS FOUND AND 10 ML'S WAS TESTED WHICH CAME BACK DEGENERATING A-CELLULAR MATERIAL". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160624 ↗
• InjuryFeb 20, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "FIBROUS CAPSULE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24402298 ↗
• InjuryFeb 13, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "EXCHANGE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT" AND "PAIN". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV ". HEALTHCARE PROFESSIONAL LATER REPORTED "GRADE IV CAPSULAR CONTRACTURE", "TEXTURED" . THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24338328 ↗
• InjuryFeb 11, 2026Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED "EXCHANGE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT" AND "PAIN". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV". HEALTHCARE PROFESSIONAL LATER REPORTED "GRADE IV CAPSULAR CONTRACTURE", "TEXTURED" AND "IMPLANT RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24316965 ↗
• InjuryJan 27, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE. THE DEVICE WAS DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 24193015 ↗
• InjuryJan 27, 2026Material Rupture

  COMPANY DISTRIBUTOR, ON BEHALF OF HEALTHCARE PROFESSIONAL, REPORTED OF THE RIGHT SIDE DEVICE: "RUPTURE", AND "SMALL NODULE AT THE APEX OF THE RIGHT LUNG; MILD FIBROSIS IN SEGMENT S4 OF THE LEFT LUNG" ASSESSED AS NOT DEVICE RELATED. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24189076 ↗
• InjuryJan 8, 2026Material Rupture

  PATIENT REPORTED "RUPTURE" AND "ABNORMAL FINDING WAS DETECTED". THIS RECORD IS FOR LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 24011822 ↗
• InjuryJan 8, 2026Material Rupture

  LATER HEALTHCARE PROFESSIONAL REPORTED THE RUPTURE RELATED TO THE CONTRALATERAL SIDE AND "UNSPECIFIED BENIGN NEOPLASM OF BREAST". THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED. UN-REPORTING RUPTURE.

  Patient problems: Breast Mass; Failure of Implant

  MAUDE report 24011496 ↗
• InjuryDec 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "GRADE 3-4 CAPSULAR CONTRACTURE AND TEXTURED IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER´S DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23857788 ↗
• InjuryDec 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "GRADE 3-4 CAPSULAR CONTRACTURE AND TEXTURED IMPLANT". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER´S DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23857785 ↗

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