Natrelle Inspira SoftTouch Breast Implants SSX-340Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10888628033313), received between Jul 16, 2019 and Jun 22, 2026 — classified as 34 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (25 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "GRADE IV CAPSULAR CONTRACTURE" AND "RUPTURED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25581379 ↗
• InjuryJun 9, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURED DURING BREAST PROCEDURE¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445881 ↗
• InjuryNov 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED THROUGH SALES REPRESENTATIVE "PATIENT HAVING PAIN IN BREAST", "CHEST TIGHTNESS", "MALPOSITION" AND "POTENTIAL CAPSULAR CONTRACTURE". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 4". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV", "PAIN", "FIRMNESS", "DISTORTION" AND "AESTHETIC DEFORMITY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23676838 ↗
• InjuryNov 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED THROUGH SALES REPRESENTATIVE "PATIENT HAVING PAIN IN BREAST", "CHEST TIGHTNESS", "MALPOSITION" AND "POTENTIAL CAPSULAR CONTRACTURE". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 4". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV", "PAIN", "FIRMNESS", "DISTORTION" AND "AESTHETIC DEFORMITY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23672190 ↗
• InjuryAug 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22724113 ↗
• InjuryJun 19, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22292927 ↗
• MalfunctionMay 16, 2025Component Missing; Component Missing

  COMPANY REPRESENTATIVE REPORTED "IMPLANT WAS OPENED AND DID NOT HAVE A FILL TUBE IN IT". THIS RECORD IS FOR LEFT SIDE. DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22040614 ↗
• InjuryMay 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 21957577 ↗
• InjuryApr 21, 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 WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21877268 ↗
• InjuryNov 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE III/IV. THIS RECORD IS FOR LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18115930 ↗
• InjurySep 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17703590 ↗
• InjurySep 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17688660 ↗
• InjuryAug 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17431598 ↗
• InjuryJul 27, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  PREVIOUS MEDWATCH SUBMISSION NOTED, RUPTURE. UPON FURTHER INFORMATION, ALLERGAN HAS DETERMINED, THAT THE EVENT OF RUPTURE DID NOT OCCUR.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410652 ↗
• InjuryMay 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 16988656 ↗
• InjuryOct 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15696443 ↗
• InjurySep 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15439595 ↗
• InjurySep 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA COMPANY REPRESENTATIVE UNKNOWN SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR LEFT SIDE. DEVICE STATUS UNKNOWN.

  Patient problems: Capsular Contracture

  MAUDE report 15411086 ↗
• InjurySep 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  COMPANY REPRESENTATIVE REPORTED CAPSULAR CONTRACTURE ON RIGHT SIDE. BAKER GRADE IS UNKNOWN. IT IS UNKNOWN WHETHER OR NOT THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15407573 ↗
• InjuryAug 10, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15204539 ↗
• InjuryAug 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTH CARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15189093 ↗
• InjuryJul 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL INITIALLY REPORTED NO COMPLAINT AGAINST LEFT DEVICE THEN LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15131004 ↗
• InjuryJul 19, 2022Material Rupture; Material Rupture

  PHYSICIAN REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15059897 ↗
• InjuryMay 11, 2022Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 14358635 ↗
• MalfunctionMay 10, 2022Break; Break

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE TEAR IN IMPLANT ON PLACEMENT. DEVICE WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347637 ↗

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-