NATRELLE Silicone-Filled Breast Implants 45-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10888628002074), received between May 24, 2019 and Sep 24, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Material Rupture” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890580 ↗
• InjurySep 15, 2026Material Rupture

  Patient reported "rupture". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779082 ↗
• InjuryAug 6, 2026Device Appears to Trigger Rejection; Material Rupture

  Device has been explanted and replaced.

  Patient problems: Capsular Contracture

  MAUDE report 50168195 ↗
• InjuryAug 6, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture" and "capsular contracture Baker grade IV". This record is for the right side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50165091 ↗
• InjuryJul 27, 2026Material Rupture

  Healthcare professional reported a intracapsular rupture. This record is for the left side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008377 ↗
• InjuryJul 27, 2026Material Rupture

  Healthcare professional reported a "probable intracapsular rupture". This record is for the right side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008309 ↗
• InjuryMar 20, 2026Device Appears to Trigger Rejection; Material Rupture

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

  Patient problems: Capsular Contracture

  MAUDE report 24652902 ↗
• InjuryOct 20, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿RUPTURE¿. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23338369 ↗
• InjuryJan 13, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED ¿HOLE NONSPECIFIC¿ VIA AN RGA FORM. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16158334 ↗
• InjuryOct 31, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE "HEADACHES, CAPSULAR CONTRACTURE BAKER GRADE IV, AND MIGRATION." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15699941 ↗
• InjuryOct 31, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE, "HEADACHES, CAPSULAR CONTRACTURE BAKER GRADE IV, AND MIGRATION." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15699913 ↗
• InjuryOct 23, 2020Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. PATIENT ADDITIONALLY REPORTED "RIGHT-SIDE RUPTURE AND CAPSULAR CONTRACTURE, THE BAKER GRADE IS UNKNOWN" DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10725453 ↗
• InjuryApr 21, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9983462 ↗
• InjuryJul 31, 2019Break; Break

  HEALTHCARE PROFESSIONAL REPORTED "NOTICED A "WEAK SPOT", AND AS HE REMOVED IT WITH HIS FINGER, IT BROKE." PATIENT CONTACT OCCURRED. DEVICE WAS NOT IMPLANTED. LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 8848531 ↗
• InjuryMay 26, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND "SHOULDER PAIN, BACK PAIN, AND ARM PAIN." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8643133 ↗
• InjuryMay 24, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND "SHOULDER PAIN, BACK PAIN, AND ARM PAIN." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8642841 ↗

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