NATRELLE Silicone-Filled Breast Implants 15-616Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10888628001541), received between May 9, 2019 and Sep 16, 2026 — classified as 16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 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 50793483 ↗
• InjuryAug 26, 2026Device Appears to Trigger Rejection

  Patient reported "Baker Grade IV capsular contracture". This record is for the right side. Device remain implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50458865 ↗
• InjuryAug 26, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient reported "Baker Grade IV capsular contracture" and a "possible rupture". This record is for the left side. Device remains impanted.

  Patient problems: Capsular Contracture

  MAUDE report 50458701 ↗
• InjuryFeb 9, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24299790 ↗
• InjuryJan 23, 2026Gel Leak; No Apparent Adverse Event

  PATIENT REPORTED "LEAK". THIS RECORD IS FOR UNKNOWN SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

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

  MAUDE report 24160569 ↗
• InjuryApr 30, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE DIAGNOSED VIA MRI. HEALTHCARE PROFESSIONAL LATER REPORTED "HOLE, NON-SPECIFIC." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 21939039 ↗
• InjuryOct 13, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE (CONFIRMED WITH MRI). DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17931696 ↗
• InjuryAug 2, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "TEXTURED IMPLANTS", "RUPTURE WITH GRADE III BAKER CONTRACTURE." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17441745 ↗
• InjuryMar 31, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 16659378 ↗
• InjuryJan 26, 2022Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 13361329 ↗
• InjuryNov 30, 2021Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE". PATIENT ALSO REPORTED "PULMONARY EMBOLISM", "KIDNEY DISEASE, JOINT PAIN, ECZEMA, WEIGHT GAIN AND ARTHRITIS". THESE EVENTS WERE DETERMINED NOT TO BE DEVICE-RELATED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Pulmonary Embolism

  MAUDE report 12903356 ↗
• InjuryNov 30, 2021Material Rupture; Material Rupture

  PATIENT REPORTED "RIGHT SIDE RUPTURE AS WELL AS KIDNEY DISEASE, PULMONARY EMBOLISM. JOINT PAIN, ECZEMA, WEIGHT GAIN AND ARTHRITIS." HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant; Pulmonary Embolism

  MAUDE report 12895418 ↗
• InjuryNov 7, 2021Material Rupture; Material Rupture

  HEALTH CARE PROFESSIONAL REPORTED A "RIGHT SIDE RUPTURE". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12760665 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROVIDER REPORTED RIGHT SIDE "CLOUDY SEROUS FLUID, INFECTION, MILD ERYTHEMA, SWELLING, PAIN, ELEVATED TEMPERATURE, AIR BUBBLES, AND NONVIABLE SOFT TISSUE." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "PREVIOUS BREAST CANCER;" THIS EVENT IS NOT DEVICE RELATED. DEVICE WAS EXPLANTED.

  Patient problems: Necrosis; Seroma; Unspecified Infection

  MAUDE report 9593002 ↗
• InjuryAug 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 8867301 ↗
• InjuryMay 9, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE POSSIBLE RUPTURE. ADDITIONAL EVENTS OF "PAIN AND HARDNESS" AND "DROOPY" STATING THAT IT MAY BE DUE TO THE IMPLANTING PHYSICIAN "NOT REMOVING ENOUGH TISSUE." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8595339 ↗

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