NATRELLE Silicone-Filled Breast Implants 10-650Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888628001343), received between Jul 15, 2020 and Jul 8, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Material Rupture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "ruptured implant found at surgery" and "capsular contracture Baker Grade III". Later, healthcare professional reported "inner silicone touched the patient". Capsulotomy and capsulectomy was performed as treatment. This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25745296 ↗
• InjuryApr 21, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24947924 ↗
• InjuryDec 1, 2025Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23688582 ↗
• InjuryNov 4, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 23468591 ↗
• InjuryDec 19, 2023Material Rupture; Material Rupture

  HEALTHCARE PROVIDER REPORTED "RIGHT BREAST CONFIRMED RUPTURE". HEALTHCARE PROVIDER ALSO NOTED "DAMAGE CAUSED BY EXPLANT SURGERY THAT "ONLY PART OF IMPLANT BEING RETURNED DUE TO BEING IN LAPS, ETC" THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18356955 ↗
• InjuryJul 15, 2020Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 10275030 ↗

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-