NATRELLE Silicone-Filled Breast Implants 45-550Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10888628002104), received between Jul 30, 2019 and Sep 21, 2026 — classified as 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (22 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Material Rupture

  Patient reported "rupture". Later healthcare professional reported "animation deformity". Later patient reported "breast pain", "asymmetry", "inflammatory reaction", "seizure disorder", "headache", "numbness", "highly stressful life", "breast mass/ protrusion", "pleural calcifications", "cyst cluster", "unusual weight loss", "breast tenderness", "irregular menses" and "ptosis". Headaches, seizures, irregular menses and weight loss are considered not device related. Patient was prescribed with antibiotic and ibuprofen. This record is for the right side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841229 ↗
• InjurySep 18, 2026Material Rupture

  Patient reported "rupture" and "dentation". Later healthcare professional reported "animation deformity". Later patient reported "breast pain", "asymmetry", "inflammatory reaction", "seizure disorder", "headache", "numbness", "highly stressful life", "nipple discharge", "oval mass", "unusual weight loss", "breast tenderness", "breast mass/ protrusion", "irregular menses" and "ptosis". Headaches, seizures, irregular menses and weight loss are considered not device related. Patient was prescribed with antibiotic and ibuprofen. This record is for the left side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50821781 ↗
• InjurySep 11, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744085 ↗
• InjuryAug 25, 2026Material Rupture

  Healthcare professional reported "Rupture" against the right side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436405 ↗
• InjuryJul 27, 2026Material Rupture

  Patient reported ¿rupture¿. This record is for the right side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50038608 ↗
• InjuryJul 10, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" AND "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "NECROTIC CAPSULE, NECROTIC HEMATOMA WITHIN POCKET, THE CAPSULE WAS VERY ABNORMAL APPEARING IT WAS BLACK AND NECROTIC WITH VERY STRONG ODOR". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Necrosis

  MAUDE report 25785677 ↗
• InjuryMar 25, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "NODULES ON THE BREAST". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24689001 ↗
• InjuryFeb 3, 2026Material Rupture

  PATIENT REPORTED "OVARIAN CANCER, SLIGHT RUPTURE, PAIN, DON'T FEEL RIGHT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24248911 ↗
• InjuryFeb 2, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24231110 ↗
• InjuryDec 5, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE, ASYMMETRY AND PTOSIS. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 23733461 ↗
• InjuryDec 4, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "COMPLETE RUPTURE", "FREE SILICONE", "SILICONE EXTENDING SUPERIORLY AND UP INTO THE OLD TRANSAXILLARY PASSAGEWAY AND TOWARD THE ANTERIOR SHOULDER" AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED. PATIENT UNDERWENT CAPSULECTOMY.

  Patient problems: Capsular Contracture

  MAUDE report 23716985 ↗
• InjuryNov 7, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  DUPLICATE RECORD. THE EVENT OF RUPTURE IS NO LONGER REPORTABLE FOR THIS RECORD. ALL FUTURE INFORMATION WILL BE REPORTED UNDER MANUFACTURER REPORT NUMBER: 9617229-2025-20997.

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

  MAUDE report 23497883 ↗
• InjuryAug 25, 2025Material Rupture; Material Rupture

  PATIENT REPORTED RUPTURE DIAGNOSED VIA ULTRASOUND, MAMMOGRAM AND MRI. LATER HEALTHCARE PROFESSIONAL CONFIRMED THE EVENT. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22882315 ↗
• InjuryMar 4, 2025Material Rupture; Material Rupture

  COMPANY REPRESENTATIVE REPORTED "I'VE BEEN HAVING SOME ISSUES ". PATIENT LATER REPORTED "STARTING TO CAPSULIZE, HEADACHES, JOINT PAIN, TINGLY, SKIN CHANGES, RASHES AROUND MY EYES AND CHEST IN BETWEEN MY BREAST, SKIN ON CHEST HAS SUCKLING AND DISCOLORING, I HAVE ANXIETY, INFLAMMATION ON THE CHEST". PATIENT LATER REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21521236 ↗
• InjurySep 4, 2024Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 20136934 ↗
• InjuryDec 25, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT LATER REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 18390523 ↗
• InjuryOct 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE IV." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17912860 ↗
• InjuryJan 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16090137 ↗
• InjuryAug 24, 2021Device 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 12362756 ↗
• InjuryAug 23, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 12354604 ↗
• InjuryJul 9, 2021Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "PAIN UNDER HER LEFT BREAST AROUND THE ARMPIT AREA", " AND "MAMMOGRAM THAT DETECTS A POSSIBLE LEAK". PATIENT ADDITIONALLY REPORTED GETTING HEADACHES, AND NOTICING THAT SHE IS STARTING TO FORGET THINGS THAT WERE JUST TOLD TO HER"; THESE EVENTS ARE NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12147671 ↗
• InjuryMar 17, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. HEALTHCARE PROFESSIONAL CONFIRMED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11504625 ↗
• InjuryNov 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 10820315 ↗
• InjuryOct 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND MALPOSITION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10697013 ↗
• InjuryJun 17, 2020Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 10164948 ↗

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-