NATRELLE Silicone-Filled Breast Implants 10-390Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10888628001275), received between Jan 26, 2021 and Jul 17, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Material Rupture” (21 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional later reported "retroglandular glandular silicone implant demonstrates multiple helical size though somewhat obliquely signs indicating intracapsular rupture. No findings of extracapsular silicone".

  Patient problems: Capsular Contracture

  MAUDE report 25861081 ↗
• InjuryJul 17, 2026Device Appears to Trigger Rejection; Material Rupture

  Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25851615 ↗
• InjuryJun 29, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture". Later healthcare professional also reported "Capsular contracture" and "Baker 3". This record is for the right side. Device has been explanted.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25649551 ↗
• InjuryJun 26, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture". Later healthcare professional also reported "Capsular contracture" and "Baker 3". This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25643397 ↗
• InjuryJun 8, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429249 ↗
• InjuryFeb 6, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24283960 ↗
• InjuryDec 26, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED BY CT SCAN. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED AND WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23900806 ↗
• InjuryDec 26, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL LATER REPORTED "BREAST IMPLANT CAPSULE WITH SILICONE GRANULOMA" VIA PATHOLOGY REPORT DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant; Granuloma

  MAUDE report 23897386 ↗
• InjuryDec 18, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 23841854 ↗
• InjuryDec 18, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 23841717 ↗
• InjuryMar 5, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE". DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 21532114 ↗
• InjuryJan 7, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE CONFIRMED VIA MRI. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21089224 ↗
• InjuryDec 25, 2024Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV," AND "SUGGESTED EXTRACAPSULAR RUPTURE ON IMAGING." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21015398 ↗
• InjuryDec 10, 2024Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "HAVING SYMPTOMS OF BII FOR A FEW YEARS," "HAD A MAMMOGRAM AND IT WAS PROVEN THE IMPLANT IS RUPTURED," AND "RECALLED". PATIENT LATER REPORTED "ABOUT 3 YEARS AGO, I STARTED NOTICING MY HEALTH DETERIORATING. UNFORTUNATELY, I HAVE BII (BREAST IMPLANT ILLNESS) AND THESE ARE MY SYMPTOMS: BREAST PAIN AND SENSITIVITY, ENERGY LEVEL WAY DOWN, LACK OF SLEEP MAJOR HAIR LOSS, BLOATED, PSORIATIC ARTHRITIS, MEMORY ISSUES, FOGGY BRAIN, CAN'T FOCUS, DRY EYES, LIGHT SENSITIVITY, LIBIDO WAY DOWN, RASHES ONCE IN A WHILE, CAN'T SLEEP ON MY STOMACH ANYMORE, BREAST IS SORE AND BURNING SENSATION. IMPLANTS WERE PLACED IN 2010, THEY ARE BOTH RUPTURED AND I ALSO HAVE CAPSULECTOMY. DAILY MINIMUM TASKS ARE BECOMING MORE AND MORE DIFFICULT. I HAVE EXTREME FATIGUE AND BACK PAIN ON TOP OF IT ALL. I CAN'T WAIT TO REMOVE MY IMPLANTS SOON! 390 CC EACH SIDE. THE EVENTS OF "HAVING SYMPTOMS OF BII FOR A FEW YEARS," ¿BACK PAIN ON TOP OF IT ALL,¿ ¿PSORIATIC ARTHRITIS,¿ ¿DRY EYES,¿ "I HAVE EXTREME FATIGUE,¿ ¿ENERGY LEVEL WAY DOWN, LACK OF SLEEP MAJOR HAIR LOSS, BLOATED, MEMORY ISSUES, FOGGY BRAIN, LIGHT SENSITIVITY, LIBIDO WAY DOWN, CAN'T SLEEP ON MY STOMACH ANYMORE ¿HAVE BEEN DEEMED NOT RELATE

  Patient problems: Failure of Implant

  MAUDE report 20895823 ↗
• InjuryNov 27, 2024Material Rupture; Material Rupture

  PATIENT REPORTED, RIGHT SIDE "HAVING SYMPTOMS OF BII FOR A FEW YEARS". "HAD A MAMMOGRAM AND IT WAS PROVEN THE IMPLANT IS RUPTURED" AND "RECALLED". THE EVENT OF "HAVING SYMPTOMS OF BII FOR A FEW YEARS", HAS BEEN DEEMED NOT RELATED TO THE DEVICE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20802793 ↗
• InjuryMar 29, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED RUPTURE-NDR. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Capsular Contracture

  MAUDE report 16639758 ↗
• InjurySep 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED AGAINST RIGHT SIDE NO COMPLAINT, THEN LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15442235 ↗
• InjurySep 12, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15400808 ↗
• InjuryApr 14, 2022Material Rupture; Material Rupture

  PHYSICIAN REPORTED RIGHT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14116266 ↗
• InjuryApr 13, 2022Material Rupture; Material Rupture

  HEALTH CARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14107446 ↗
• InjuryJul 1, 2021Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 12100163 ↗
• InjuryJan 26, 2021Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11229861 ↗

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