NATRELLE Silicone-Filled Breast Implants 45-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10888628002098), received between Jun 21, 2019 and Sep 24, 2026 — classified as 17 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 17 most recent of 17 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 50892328 ↗
• InjurySep 24, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892327 ↗
• InjurySep 15, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture Baker grade unknown". Later healthcare professional reported "capsular contracture Baker grade III". This record is for the right side. The device was explanted. Patient received capsulectomy as treatment.

  Patient problems: Capsular Contracture

  MAUDE report 50766256 ↗
• InjurySep 15, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture Baker grade unknown". Later healthcare professional reported "capsular contracture Baker grade III". This record is for the left side. The device was explanted. Patient received capsulectomy as treatment.

  Patient problems: Capsular Contracture

  MAUDE report 50766199 ↗
• InjuryAug 31, 2026Gel Leak; Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture and exchange". Later healthcare professional reported "implants intact, gel bleed, capsular contracture grade 3 and severe calcified implant capsules". This record is for the left side. Device was explanted.

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

  MAUDE report 50525530 ↗
• InjuryAug 31, 2026Gel Leak; Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture and exchange". Later healthcare professional reported "implants intact, gel bleed, capsular contracture grade 3 and severe calcified implant capsules". This record is for the right side. Device was explanted.

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

  MAUDE report 50522100 ↗
• InjuryMar 25, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "BODY REJECTING BREAST IMPLANTS LEADING TO CAPSULAR CONTRACTURE", BAKER GRADE UNSPECIFIED. LATER HEALTHCARE PROFESSIONAL REPORTED "FULL BODY HIVES, JOINT ACHINESS, MALAISE, FEELING GENERALLY POOR AND LOCALIZED TENDERNESS AT THE VOLUMA¿ INJECTION SITES". MALAISE, POSSIBLE UNDIAGNOSED IMMUNE CONDITION, JOINT SWELLING, JOINT ACHINESS AND FEELING GENERALLY POOR ARE CONSIDERED NOT DEVICE RELATED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24688384 ↗
• InjuryMar 16, 2026Material Rupture

  PATIENT REPORTED RAYNAUD'S PHENOMENON, "NUMBNESS, PAIN, OR COLOR CHANGES IN THE FINGERS AND TOES OFTEN BROUGHT ON BY THE COLD OR EMOTIONAL DISTRESS"-NDR-, WITH NO MENTION OF SURGICAL TREATMENT OR REOPERATION. DURING ANNUAL QUESTIONNAIRE FOLLOW UPS PATIENT REPORTED "NUMBNESS IN TOES", "CERTAIN FINGERS TURN WHITE AND SEEM TO LOSE BLOOD CIRCULATION IN VERY COLD TEMPERATURES" AND "VAGINAL DRYNESS"-NDR-. LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURED". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24610933 ↗
• InjuryJun 5, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 22150009 ↗
• InjuryNov 21, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15838024 ↗
• InjuryAug 3, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15156177 ↗
• InjuryNov 30, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10920132 ↗
• InjuryNov 23, 2020Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 10885186 ↗
• InjuryAug 20, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10433024 ↗
• InjuryJul 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. PATIENT REPORTED SWELLING AND THE LEFT SIDE IS RIPPLED SO BAD THAT IT IS INDENTING SO THE NIPPLE HAS FOLDED OVER. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10261205 ↗
• InjuryJul 31, 2019Material Rupture; Migration; Material Rupture; Migration

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. PATIENT STATED THAT MAMMOGRAM SHOWED A "BUBBLE" WHICH IS "KIND OF RAISED". ADDITIONAL EVENT OF "EXTRAVASATED SILICONE" IN THE "AXILLARY TAIL". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8846471 ↗
• InjuryJun 21, 2019Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 8722650 ↗

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-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