Natrelle INSPIRA Breast Implants SRX-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888628007437), received between Feb 16, 2018 and Jul 12, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture" and "capsular contracture, Baker grade III". This record is for the right side. The device was explanted and replaced.

  Patient problems: Capsular Contracture

  MAUDE report 25791354 ↗
• InjuryJul 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED, CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 17390513 ↗
• InjuryMay 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PHYSICIAN REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16935569 ↗
• InjuryNov 17, 2022Device 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 15818847 ↗
• InjuryApr 22, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 14187297 ↗
• InjuryFeb 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED " CAPSULAR CONTRACTURE, BAKER GRADE III ALMOST IV" AGAINST RIGHT DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 13574309 ↗
• MalfunctionSep 11, 2020Break; Break

  HEALTHCARE PROFESSIONAL INFORMED THAT ONE OF THE IMPLANT WAS RUPTURED, THE DOCTOR WAS GOING TO PLACE IT IN THE PATIENT. DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10520234 ↗
• InjuryFeb 16, 2018Material Rupture; Material Rupture

  PATIENT REPORTED 8 AMBULANCE EPISODES FOLLOWING IMPLANT SURGERY AND 6 WEEKS OF BEING GRAVELY ILL. PATIENT REPORTED CONTAMINATION. PATIENT ALSO REPORTED METALLIC TASTE IN MOUTH, SWOLLEN STOMACH, FLUID SWELLING, MASSIVE PAIN IN BOTH BREASTS, SEROMA FLUID BUILDUP, JOINT PAN IN LIGAMENTS OF LEGS, TOXIC SHOCK, BLURRY VISION, EXTREME EXHAUSTION, FATIGUE, SHOOTING PAIN IN LEGS, NUMBNESS IN ARMS, SHOULDER PAIN, DIFFICULTY SWALLOWING, FEVER/CHILLS, DIFFICULTY CONCENTRATING, AND CONFUSION. PATIENT ALSO STATED THAT [PATIENT] WAS INFORMED THAT [PATIENT] HAD A BREAST ABSCESS, CONTAMINATION, AND BACTERIA STAPH AND SEPSIS BLOOD POISONING. PATIENT ALSO REPORTED GETTING MRSA AND ANOTHER EMERGENCY A MONTH LATER FOR DRAINAGE OF INFECTION. PATIENT STATED THAT [PATIENT] LAID IN BED FOR 5 MONTHS GOING BACK AND FORTH TO WOUND BURN UNIT. PATIENT ADDITIONALLY REPORTED BEING TREATED FOR ALCL. PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED. PHYSICIAN HAS NOT CONFIRMED. THIS RECORD IS FOR THE LEFT SIDE. SEE MFR # 9617229-2018-00892 FOR THE RIGHT SIDE.

  Patient problems: Lymphoma; Seroma; Tingling; Wound Dehiscence

  MAUDE report 7276678 ↗

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-