Natrelle Inspira SoftTouch Breast Implants SSF-605Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSF 605cc Full profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle Inspira SoftTouch Breast Implants (195)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Allergan Natrelle Inspira SoftTouch breast implant is a silicone gel-filled implant. Its 151 adverse event reports include 150 injuries and no deaths, and many describe scar tissue tightening around the implant (capsular contracture), ruptures, and infections, with some implants removed. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 152
- Deaths reported
- 0
- Injuries reported
- 151
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 10888628033214), received between Jul 9, 2019 and Sep 14, 2026 — classified as 151 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (80 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.
Reports received per month
Most reported problems
Device problems
- Device Appears to Trigger Rejection80
- Patient-Device Incompatibility24
- Material Rupture23
- Adverse Event Without Identified Device or Use Problem22
- Device Handling Problem2
- Improper or Incorrect Procedure or Method2
- Break1
- Insufficient Device Problem Information1
Patient problems
- Capsular Contracture103
- Failure of Implant20
- Unspecified Infection15
- No Clinical Signs, Symptoms or Conditions7
- Seroma7
- Wound Dehiscence5
- Necrosis2
- Bacterial Infection1
Recent adverse event reports
The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Device Appears to Trigger Rejection
Healthcare Professional reported Capsular Contracture Baker grade III/IV. This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50762924 ↗InjuryJul 30, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50093145 ↗InjuryJul 30, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50090530 ↗InjuryJun 10, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "MAXTOPEXY REMOVAL OF RUPTURED BREAST IMPLANT". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464010 ↗InjuryMay 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25093274 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "SEROMA". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Seroma
MAUDE report 24956437 ↗MalfunctionMar 24, 2026Break
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS NOT IMPLANTED. PATIENT CONTACT IS UNKNOWN. SURGERY WAS COMPLETED WITH A BACK UP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24681364 ↗InjuryMar 2, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY CAPSULAR CONTRACTURE BAKER GRADE IV. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24486262 ↗InjuryNov 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III, DEVICE MIGRATION/IMPLANT MALPOSITION AND CHANGE SHAPE/SIZE/STYLE" THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED; IT IS UNKNOWN IF THE DEVICE WILL BE RETURN.
Patient problems: Capsular Contracture
MAUDE report 23598424 ↗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 RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22731722 ↗InjuryAug 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22712875 ↗InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "INFECTION". THIS RECORD IS FOR THE "LEFT" SIDE. THE DEVICE WAS EXPLANTED
Patient problems: Bacterial Infection
MAUDE report 22679658 ↗InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE [WOUND] DEHISCENCE OF SURGICAL INCISION WITH SUBSEQUENT INFECTION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 22589028 ↗InjuryJul 14, 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 22503769 ↗InjuryJun 24, 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. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22321260 ↗InjuryJun 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE. HEALTHCARE PROFESSIONAL LATER REPORTED "BAKER GRADE III" WITH MAMMOGRAM. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22207303 ↗InjuryMay 28, 2025Material Rupture; Material Rupture
PATIENT REPORTED "FLIPPED AND DEFLATED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22101824 ↗InjuryMay 28, 2025Material Rupture; Material Rupture
PATIENT REPORTED "FLIPPED AND DEFLATED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22096941 ↗InjuryMay 21, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" VIA ULTRASOUND AND MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22067076 ↗InjuryMay 12, 2025Device 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 22006893 ↗InjuryMay 12, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22004751 ↗InjuryApr 30, 2025Material Rupture; Material Rupture
PHYSICIAN REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21931955 ↗InjuryApr 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. PATIENT WAS TREATED WITH SINGULAIR. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21871321 ↗InjuryApr 17, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21860826 ↗InjuryOct 4, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, MIGRATION, AND MALPOSITION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20371575 ↗
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 · TerminatedNatrelle 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 · TerminatedNatrelle 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, ClassifiedNatrelle 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, ClassifiedNatrelle 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
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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