Natrelle INSPIRA Breast Implants SRL-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10888628006683), received between Jul 1, 2020 and Sep 25, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Material Rupture” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Material Rupture

  Healthcare professional reported "leak", "rupture" and "unilateral exchange". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896690 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50860568 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50860496 ↗
• InjuryDec 22, 2025Malposition of Device; Migration; Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. IT IS UNKNOWN IF THE DEVICE WILL RETURN.

  Patient problems: Failure of Implant

  MAUDE report 23873863 ↗
• InjuryDec 22, 2025Malposition of Device; Migration; Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. IT IS UNKNOWN IF THE DEVICE WILL RETURN.

  Patient problems: Failure of Implant

  MAUDE report 23873862 ↗
• InjurySep 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23011435 ↗
• InjuryMay 13, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE" CONFIRMED VIA MRI AND US. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22015711 ↗
• InjuryApr 30, 2025Material Rupture; Material Rupture

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21931954 ↗
• InjuryApr 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III/IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21873489 ↗
• InjuryApr 11, 2025Adverse Event Without Identified Device or Use Problem

  AFTER HAVING A BILATERAL BREAST IMPLANT EXCHANGE FROM 375ML SALINE (IMPLANTED IN 1997) TO 200 ML SILICONE IMPLANTS, I BEGAN HAVING A MULTITUDE OF SYMPTOMS THAT I HAD NEVER EXPERIENCED BEFORE. SEVERE INSOMNIA, FATIGUE, MUSCLE AND JOINT PAIN, PALPITATIONS, TINNITUS, GASTRITIS, SHORTNESS OF BREATH, HAIR LOSS AND HAND TREMORS. I HAD A COMPLETE CARDIAC WORKUP INCLUDING BLOOD WORK, EKG(ELECTROCARDIOGRAM), ECHOCARDIOGRAM AND A HOLTER MONITOR. I ALSO HAD A GI WORKUP THAT INCLUDED ABDOMINAL AND PELVIC CT SCANS, BLOOD WORK AND AN EGD (ESOPHAGOGASTRODUODENOSCOPY). I SAW MULTIPLE PRIMARY CARE PHYSICIANS AND HAD MORE BLOODWORK AND EXAMS. ALL OF MY TESTING CAME BACK NORMAL. I REACHED OUT TO MY PLASTIC SURGEON IN (B)(6) 2025 AND SUBSEQUENTLY HAD THE IMPLANTS REMOVED ON (B)(6) 2025. SINCE THAT TIME MY SYMPTOMS HAVE EITHER DISAPPEARED OR IMPROVED GREATLY. REFERENCE REPORT#: MW5168869.

  Patient problems: Dyspnea; Fatigue; Gastritis; Hair Loss; Pain; Sleep Dysfunction; Tics/Tremor; Tinnitus

  MAUDE report 21825178 ↗
• InjuryApr 11, 2025Use of Device Problem

  AFTER HAVING A BILATERAL BREAST IMPLANT EXCHANGE FROM 375ML SALINE (IMPLANTED IN 1997) TO 200 ML SILICONE IMPLANTS, I BEGAN HAVING A MULTITUDE OF SYMPTOMS THAT I HAD NEVER EXPERIENCED BEFORE. SEVERE INSOMNIA, FATIGUE, MUSCLE AND JOINT PAIN, PALPITATIONS, TINNITUS, GASTRITIS, SHORTNESS OF BREATH, HAIR LOSS AND HAND TREMORS. I HAD A COMPLETE CARDIAC WORKUP INCLUDING BLOOD WORK, EKG(ELECTROCARDIOGRAM), ECHOCARDIOGRAM AND A HOLTER MONITOR. I ALSO HAD A GI WORKUP THAT INCLUDED ABDOMINAL AND PELVIC CT SCANS, BLOOD WORK AND AN EGD (ESOPHAGOGASTRODUODENOSCOPY). I SAW MULTIPLE PRIMARY CARE PHYSICIANS AND HAD MORE BLOODWORK AND EXAMS. ALL OF MY TESTING CAME BACK NORMAL. I REACHED OUT TO MY PLASTIC SURGEON IN (B)(6) 2025 AND SUBSEQUENTLY HAD THE IMPLANTS REMOVED ON (B)(6) 2025. SINCE THAT TIME MY SYMPTOMS HAVE EITHER DISAPPEARED OR IMPROVED GREATLY. REFERENCE REPORT#: MW5168870.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dyspnea; Fatigue; Gastritis; Hair Loss; Pain; Shaking/Tremors; Sleep Dysfunction; Tinnitus

  MAUDE report 21825137 ↗
• InjuryMar 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PHYSICIAN REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III, DEVICE MIGRATION/IMPLANT MALPOSITION, CORRECTION OF ASYMMETRY. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18922763 ↗
• InjuryOct 16, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. LATER HEALTHCARE PROFESSIONAL REPORTED RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17940441 ↗
• InjuryOct 16, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. LATER HEALTHCARE PROFESSIONAL REPORTED RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17940304 ↗
• InjurySep 26, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "POSSIBLE RUPTURE, SILICONE DOESN'T LEAK OUT BUT BUBBLES IN SILICONE". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17818016 ↗
• InjuryJun 16, 2023Material Rupture; Material Rupture

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17148443 ↗
• InjuryApr 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16746673 ↗
• InjuryMar 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SALES REPRESENTATIVE REPORTED, ON BEHALF OF PHYSICIAN, A "RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 13803615 ↗
• InjuryNov 12, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12807231 ↗
• InjuryNov 10, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12788292 ↗
• InjuryOct 29, 2021Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 12718826 ↗
• InjuryNov 30, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 10920634 ↗
• InjuryJul 15, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE DUE TO CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10274991 ↗
• InjuryJul 1, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 10217740 ↗

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