NATRELLE Silicone-Filled Breast Implants 15-213Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10888628001411), received between Jan 14, 2020 and Feb 7, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (11 reports).

4 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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED VIA BREAST IMPLANT FOLLOW-UP STUDY (BIFS), "EXPERIENCING HARD KNOTS OR LUMPS SURROUNDING THE IMPLANT OR IN THE ARMPIT, PAINFULLY HARD AND LOOKS ABNORMAL DUE TO CAPSULAR CONTRACTURE (BAKER GRADE IV) AND SEVERE PAIN". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Nodule

  MAUDE report 24285896 ↗
• InjuryFeb 7, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED VIA BREAST IMPLANT FOLLOW-UP STUDY (BIFS), "EXPERIENCING HARD KNOTS OR LUMPS SURROUNDING THE IMPLANT OR IN THE ARMPIT, PAINFULLY HARD AND LOOKS ABNORMAL DUE TO CAPSULAR CONTRACTURE (BAKER GRADE IV) AND SEVERE PAIN". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Nodule

  MAUDE report 24285875 ↗
• InjuryJan 13, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24052631 ↗
• InjuryDec 23, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED ¿SLIGHT CAP CON [BAKER GRADE] II¿. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

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

  MAUDE report 23884873 ↗
• InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "FIRM AND LOOKS ABNORMAL DUE TO CAPSULAR CONTRACTURE". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE II/III" AND "MODERATELY THICK CAPSULE". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23844052 ↗
• InjuryOct 30, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "ISSUES, POSSIBLE RUPTURE, FATTY OCULUS", "MASS AND T-CELLS WHICH IS NOT RELATED TO THE DEVICE" AND "CONFIRM IF IMPLANTS ARE TEXTURED OR SMOOTH". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23433349 ↗
• InjuryOct 30, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE CONFIRMED WITH ULTRASOUND. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23426255 ↗
• InjuryJun 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE III¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22160027 ↗
• InjuryApr 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 19131380 ↗
• InjuryApr 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE "RIPPLING, FOLDS, DISCOMFORT, PAIN LUMPS AND WHEN I PRESS THE IMPLANT MOVES." HEALTHCARE PROFESSIONAL LATER REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 19130336 ↗
• InjuryJun 26, 2023Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 17203943 ↗
• InjuryJun 20, 2023Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE ¿RUPTURE¿. THIS IS FOR THE LEFT SIDE DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17167131 ↗
• InjuryMay 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16853374 ↗
• InjuryJan 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE ON AN UNKNOWN SIDE WITH AN UNKNOWN BAKER GRADE." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16198893 ↗
• InjuryMar 31, 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 13965077 ↗
• InjuryNov 19, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV." DEVICE EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12848658 ↗
• MalfunctionNov 15, 2021Break; Break

  HEALTHCARE PROFESSIONAL REPORTED "LEAK" DURING IMPLANTATION. IMPLANT SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 12816394 ↗
• InjuryJan 13, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11165747 ↗
• InjuryJan 15, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED BILATERAL ¿CAPSULAR CONTRACTURE, GRADE III¿. THE DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 9591614 ↗
• InjuryJan 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PHYSICIAN REPORTED LEFT SIDE ¿CAPSULAR CONTRACTURE, GRADE III¿. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9587510 ↗

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-2454-2019 · Jul 24, 2019 · Open, Classified
  Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-
• 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