Natrelle Inspira SoftTouch Breast Implants SSX-545Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10888628033399), received between May 13, 2019 and Sep 14, 2026 — classified as 57 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (37 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 58 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Patient-Device Incompatibility

  Healthcare professional reported "exposed implant". This record is for the left side. The device was explanted.

  Patient problems: Foreign Body Reaction

  MAUDE report 50761610 ↗
• InjurySep 8, 2026Device Appears to Trigger Rejection

  Healthcare professional reported: unspecified Baker grade capsular contracture. This record is for the left-side device. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50669177 ↗
• InjuryJul 7, 2026Device 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 was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25742134 ↗
• InjuryJul 4, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker Grade III. Patient was prescribed with Singulair and a breast band was applied. This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25710143 ↗
• InjuryJun 26, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV". HEALTHCARE PROFESSIONAL LATER REPORTED "NEAR EXPOLSION OF BREAST IMPLANT". HEALTHCARE PROFESSIONAL LATER REPORTED "NEAR EXPULSION" AND "IMPLANT WAS ALMOST EXPOSED" THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25635469 ↗
• InjuryJun 8, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 3". PATIENT WAS PROVIDED SINGULAIR AND OMEGA 3 FISH OIL DAILY. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25430892 ↗
• InjuryApr 9, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) "SKIN NECROSIS, DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Necrosis

  MAUDE report 24830061 ↗
• InjuryApr 3, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III". PATIENT UNDERGONE CAPSULECTOMY. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24784134 ↗
• InjuryJan 7, 2026Device Appears to Trigger Rejection; Material Rupture; No Apparent Adverse Event

  THE DEVICE WAS FOUND INTACT UPON EXPLANT AND THAT THE BAKER GRADE OF THE REPORTED CAPSULAR CONTRACTURE IS BAKER GRADE II. THIS RECORD IS NO LONGER REPORTABLE TO THE FDA AND WILL BE UN-REPORTED.

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

  MAUDE report 24000046 ↗
• InjuryJan 7, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III". HEALTHCARE PROFESSIONAL REPORTED LATER "BAKER III (CAPSULAR CONTRATURE), AND WATERFALL DEFORMITY". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23998199 ↗
• InjuryDec 9, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE". THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23761391 ↗
• InjuryDec 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORDS IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23717125 ↗
• InjurySep 30, 2025Device Appears to Trigger Rejection; Material Rupture; Migration; Device Appears to Trigger Rejection; Material Rupture; Migration

  PATIENT REPORTED ¿RUPTURE¿ DIAGNOSED VIA ULTRASOUND AND ¿SILICONE IN AXILLARY LYMPH NODE¿. LATER HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE". LATER PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER HEALTHCARE PROFESSIONAL REPORTED "IMPLANT INTACT" AND "CAPSULAR CONTRACTURE BAKER GRADE IV". CAPSULECTOMY WAS PERFORMED. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 23187293 ↗
• InjuryJul 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22512443 ↗
• InjuryMay 15, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED, REPLACED, AND DISCARDED. CAPSULECTOMY PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 22031081 ↗
• InjuryApr 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 21819100 ↗
• InjuryJan 11, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED BY NBIR RIGHT SIDE ¿CAPSULAR CONTRACTURE, BAKER GRADE III". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 18494177 ↗
• InjuryDec 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  NBIR REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 18369128 ↗
• MalfunctionOct 5, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17880149 ↗
• InjurySep 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17782519 ↗
• InjuryAug 22, 2023Device 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 REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17596882 ↗
• InjuryMay 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16963919 ↗
• InjuryMar 2, 2023Device 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 16475234 ↗
• InjuryFeb 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16422652 ↗
• InjuryJan 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16233432 ↗

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