NATRELLE Silicone-Filled Breast Implants 10-450Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10888628001299), received between Jun 6, 2019 and Jun 8, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Material Rupture” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429109 ↗
• InjuryFeb 9, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24295408 ↗
• InjuryFeb 9, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24293565 ↗
• InjuryJan 9, 2026Material Rupture

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24031280 ↗
• InjuryJan 7, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23989504 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "MODERATE BREAST PAIN". PATIENT LATER REPORTED "RAYNAUD'S PHENOMENON" THAT HAVE BEEN DEEMED NOT DEVICE RELATED. PATIENT LATER REPORTED "ULNAR NERVE DAMAGE, CORPAL AND CARPEL TUNNEL DAMAGE RIGHT ARM, ELBOW AND WRIST" AND "RED SPOTS ON MY FOREARMS AND VULVAR SWELLING APPEAR THEN DISAPPEAR, BUT THE VULVAR ITCHING". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Arthritis; Nervous System Injury; Skin Inflammation/ Irritation

  MAUDE report 23960561 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT FOLDED" AND "CAPSULAR CONTRACTURE, BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23758269 ↗
• InjuryDec 8, 2025Material Rupture; Material Rupture

  PATIENT REPORTED REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23751123 ↗
• InjuryDec 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT FOLDED" AND "CAPSULAR CONTRACTURE, BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23745341 ↗
• InjuryDec 2, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR LEFT SIDE. THE DEVICE REMAINS IMPLANTED. DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23697139 ↗
• InjuryNov 25, 2025Material Rupture; Material Rupture

  PATIENT REPORTED SIDE UNSPECIFIC SIDE CONNECTIVE TISSUE DISEASE OR DISORDER WITHOUT ANY TREATMENT. FOLLOW UP FINDINGS REVEAL THAT THE REPORTED EVENT OF CONNECTIVE TISSUE DISEASE OR DISORDER WAS REPORTED IN ERROR. HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23647432 ↗
• InjuryNov 3, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "POSSIBLE RUPTURE". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23457839 ↗
• InjuryNov 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED ¿FIRM AND LOOKS ABNORMAL DUE TO CAPSULAR CONTRACTURE". PATIENT LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED, WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23452398 ↗
• InjuryOct 20, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23336196 ↗
• InjuryMay 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21980770 ↗
• InjuryOct 12, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17927779 ↗
• InjuryDec 14, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 13002685 ↗
• InjuryJun 12, 2020Gel Leak; Patient-Device Incompatibility; Gel Leak; Patient-Device Incompatibility

  HEALTHCARE PROVIDER ADDITIONALLY REPORTED "GEL BLEED." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10148178 ↗
• InjuryJan 23, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9624204 ↗
• InjuryNov 27, 2019Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE "LUMP". PATIENT ADDITIONALLY REPORTED RIGHT SIDE "RUPTURE" AND "LARGE FLUID ACCUMULATION." DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 9382693 ↗
• InjuryJun 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 8675311 ↗

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