NATRELLE Silicone-Filled Breast Implants 45-460Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10888628002081), received between Jan 6, 2020 and Sep 30, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Material Rupture” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950089 ↗
• InjuryJul 1, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25683219 ↗
• InjuryJul 1, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURE¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25675228 ↗
• InjuryMay 1, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25060316 ↗
• InjuryMar 25, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "BODY REJECTING BREAST IMPLANTS LEADING TO CAPSULAR CONTRACTURE", BAKER GRADE UNSPECIFIED. LATER HEALTHCARE PROFESSIONAL REPORTED "FULL BODY HIVES, JOINT ACHINESS, MALAISE, FEELING GENERALLY POOR AND LOCALIZED TENDERNESS AT THE VOLUMA¿ INJECTION SITES". MALAISE, POSSIBLE UNDIAGNOSED IMMUNE CONDITION, JOINT SWELLING, JOINT ACHINESS AND FEELING GENERALLY POOR ARE CONSIDERED NOT DEVICE RELATED. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24688326 ↗
• InjuryMar 21, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656712 ↗
• InjuryMar 16, 2026Device Appears to Trigger Rejection; Malposition of Device

  PATIENT REPORTED REOPERATION DUE TO "IMPLANT MALPOSITION". PATIENT ALSO REPORTED RAYNAUD'S PHENOMENON-NDR- WITH NO MENTION OF SURGICAL TREATMENT OR REOPERATION. DURING ANNUAL QUESTIONNAIRE FOLLOW UPS PATIENT REPORTED "NUMBNESS IN TOES", "CERTAIN FINGERS TURN WHITE AND SEEM TO LOSE BLOOD CIRCULATION IN VERY COLD TEMPERATURES" AND "VAGINAL DRYNESS"-NDR-. LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24609991 ↗
• InjuryJul 30, 2025Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE" VIA "CT SCAN". HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "CHEST PAIN". THE DEVICE HAS BEEN EXPLANTED, NOT REPLACED, AND DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 22671851 ↗
• InjuryMay 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22100606 ↗
• InjuryFeb 26, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 21474618 ↗
• InjuryApr 11, 2023Material Rupture; Material Rupture

  PATIENT REPORTED A POSSIBLE RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16718905 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED ¿FLUID POCKET WHICH IS CAUSING [THEM] A LOT OF PAIN¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 10859996 ↗
• InjuryAug 14, 2020Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 10409669 ↗
• InjuryApr 29, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10009271 ↗
• InjuryMar 31, 2020Patient-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 9905720 ↗
• InjuryFeb 7, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE IMPLANT RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9681750 ↗
• InjuryJan 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9553872 ↗

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
• 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-