NATRELLE Silicone-Filled Breast Implants 40-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888628001930), received between Jun 11, 2019 and Sep 10, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Material Rupture

  Patient reported "lump or thickening" and "moderate pain". Later, Healthcare professional reported "rupture". This record is for the right side. Device was explanted. Capsulectomy treatment was performed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721997 ↗
• InjurySep 10, 2026Device Appears to Trigger Rejection

  Patient reported "Implant malposition" and "moderate pain". Later, Healthcare professional reported "capsular contracture, unknown Baker grade". Later, patient also reported "hard knots or lumps". This record is for the left side. Device was explanted. Reoperation was performed.

  Patient problems: Capsular Contracture

  MAUDE report 50721458 ↗
• InjuryApr 1, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 21747787 ↗
• InjuryAug 26, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTS RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10453712 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PAIN". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Pain

  MAUDE report 8687704 ↗

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-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-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-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-