Natrelle Inspira SoftTouch Breast Implants SSM-240Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 10888628032873), received between May 22, 2019 and Aug 22, 2026 — classified as 83 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (63 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 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular contracture, baker grade III". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50384344 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported a Capsular Contracture, Baker Grade IV. This record is for the left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50044310 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, Baker grade IV". This record is for the right side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50015397 ↗
• InjuryJun 3, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE UNKNOWN BAKER GRADE". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". PATIENT UNDERWENT CAPSULECTOMY. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25377143 ↗
• InjuryMay 29, 2026Device Appears to Trigger Rejection

  Device has been explanted and replaced.

  Patient problems: Capsular Contracture

  MAUDE report 25337904 ↗
• InjuryMay 11, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAP CON III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25136395 ↗
• InjuryMay 11, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAP CON III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25136382 ↗
• InjuryApr 6, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "NO REASON FOR REMOVAL". LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24794491 ↗
• InjurySep 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23130885 ↗
• InjuryJul 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22508615 ↗
• InjuryJun 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22164629 ↗
• InjuryMay 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22063740 ↗
• MalfunctionMay 12, 2025Improper or Incorrect Procedure or Method; Device Handling Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  PATIENT REPORTED "SURGEON PUT IN AN IMPLANT THEY DIDN'T CONSENT TO, CONSTANT PAIN IN BREASTS, STITCHES COMING OUT, IMPLANTS GOING DIFFERENT DIRECTIONS, CAN'T REACH UP OR BEND OVER, SURGEON DIDN'T PLACE THE IMPLANTS CORRECTLY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22005817 ↗
• InjuryMay 12, 2025Improper or Incorrect Procedure or Method; Malposition of Device; Device Handling Problem; Improper or Incorrect Procedure or Method; Malposition of Device; Device Handling Problem

  PATIENT REPORTED "SURGEON PUT IN AN IMPLANT THEY DIDN'T CONSENT TO, CONSTANT PAIN IN BREASTS, STITCHES COMING OUT, IMPLANTS GOING DIFFERENT DIRECTIONS, CAN'T REACH UP OR BEND OVER, SURGEON DIDN'T PLACE THE IMPLANTS CORRECTLY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22004300 ↗
• InjuryMay 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 21960923 ↗
• InjuryApr 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 21902041 ↗
• InjuryJan 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PHYSICIAN REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III, CORRECTION OF ASYMMETRY, CHANGE SHAPE/SIZE/STYLE, PTOSIS. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21208475 ↗
• InjuryNov 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV, DEFORMATION AND EXCHANGE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 18141772 ↗
• InjuryOct 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED, NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL, LATER REPORTED, CAPSULAR CONTRACTURE, BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17989478 ↗
• InjuryOct 19, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 17968524 ↗
• InjuryOct 19, 2023Gel Leak; Device Appears to Trigger Rejection; Gel Leak; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17968127 ↗
• InjuryOct 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Capsular Contracture

  MAUDE report 17963474 ↗
• InjuryOct 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17954024 ↗
• InjuryOct 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17953982 ↗
• InjuryOct 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE "FULLNESS AND HARDNESS," CAPSULAR CONTRACTURE BAKER GRADE I", AND "PAIN IN THE BACK AND NECK." HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17865597 ↗

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