NATRELLE Silicone-Filled Breast Implants 115-203Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10888628002333), received between Dec 19, 2019 and Sep 2, 2025 — classified as 22 injuries.

The most frequently reported specific device problem is “Material Rupture” (16 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE "RUPTURE" DIAGNOSED VIA ULTRASOUND AND CONFIRMED VIA SURGERY. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ABBVIE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 22947944 ↗
• InjuryJun 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "GRADE 3 BILATERAL CAPSULAR CONTRACTURE OF BIOCELL IMPLANTS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22340494 ↗
• InjuryMay 14, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  IT HAS BEEN DETERMINED THAT THE DEVICE ASSOCIATED WITH THIS COMPLAINT IS NOT MANUFACTURED BY ALLERGAN/ABBVIE. THIS RECORD IS NO LONGER REPORTABLE TO THE FDA AND WILL BE UN-REPORTED.

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

  MAUDE report 22022012 ↗
• InjuryOct 10, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE CONFIRMED VIA MRI. LATER, PHYSICIAN REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III.DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 17903792 ↗
• InjuryJun 29, 2023Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17231197 ↗
• InjuryMar 29, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND RECALLED IMPLANTS. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 13944049 ↗
• InjuryMar 8, 2022Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 13695839 ↗
• InjuryOct 9, 2021Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "RUPTURE." HEALTHCARE PROFESSIONAL LATER REPORTED "BIOCELL REPLACEMENT." DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12601933 ↗
• InjuryMar 25, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTS LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11567702 ↗
• InjuryFeb 17, 2021Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE CONFIRMED THROUGH ULTRASOUND, PAIN, SHAPE CHANGE, PREVENTATIVE REPLACEMENT. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11336770 ↗
• InjuryDec 16, 2020Material Rupture; Material Rupture

  PATIENT REPORTED A LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11022154 ↗
• InjurySep 28, 2020Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE AND SEROMA-LATE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant; Seroma

  MAUDE report 10593475 ↗
• InjurySep 9, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 10506363 ↗
• InjuryJul 28, 2020Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE, SEROMA-LATE AND INFLAMMATION/IRRITATION. "FULL BOWEL" WAS REPORTED, BUT IS NOT RELATED TO THE DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 10333227 ↗
• InjuryMay 29, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PSYCHOLOGICAL ANXIETY" AND RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10102685 ↗
• InjuryApr 27, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE (BAKER GRADE III). THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10002733 ↗
• InjuryApr 8, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND "PATIENT'S CONCERN WITH THE PRODUCT". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9938029 ↗
• InjuryJan 20, 2020Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9608417 ↗
• InjuryJan 10, 2020Material Rupture; Material Rupture

  PATIENT REPORTS A RUPTURE, SIDE UNSPECIFIED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9574815 ↗
• InjuryJan 7, 2020Material Rupture; Material Rupture

  PATIENT REPORTS A RUPTURE, SIDE UNSPECIFIED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9558454 ↗
• InjuryDec 19, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTS LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9496681 ↗
• InjuryDec 19, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTH PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9496314 ↗

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