Natrelle Inspira SoftTouch Breast Implants SSX-750Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSX 750cc Extra 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 used in breast surgery. Most of the 47 reports describe the scar tissue around the implant tightening and contracting, which can make the breast feel hard, crease, or flip, and several of these implants were removed or replaced. Reports also mention infection, implant rupture, and one case of non-sterile packaging. No deaths were reported.
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
- 51
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10888628033450), received between May 21, 2019 and Sep 29, 2026 — classified as 48 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (26 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 Rejection26
- Patient-Device Incompatibility10
- Adverse Event Without Identified Device or Use Problem7
- Material Rupture6
- Malposition of Device3
- Break2
- Difficult to Open or Remove Packaging Material1
Patient problems
- Capsular Contracture36
- Unspecified Infection6
- Failure of Implant5
- No Clinical Signs, Symptoms or Conditions4
- Hematoma1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Device Appears to Trigger Rejection
Healthcare professional reporter "Baker grade 3 capsular contracture", "Pain" and "distortion" against the right side. Patient was prescribed with Vitamin E, Singulair, and Doxycycline. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50927245 ↗InjurySep 17, 2026Material Rupture; Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812342 ↗InjurySep 14, 2026Material Rupture; Malposition of Device
Healthcare professional reported "ruptured implant". Later healthcare professional reported "implant malposition". This record is for the left side. Device was explanted. Patient had a capsulorrhaphy, capsulotomy and a capsulectomy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755814 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture Baker grade Unknown." This record is for the left side. The device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50031736 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture Baker grade Unknown". This record is for the right side. The device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50031730 ↗InjuryJul 14, 2026Device Appears to Trigger Rejection
Device has been explanted and replaced.
Patient problems: Capsular Contracture
MAUDE report 25820739 ↗InjuryApr 21, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24948038 ↗MalfunctionJan 5, 2026Difficult to Open or Remove Packaging Material
SALES REPRESENTATIVE REPORTED "WE HAD AN ADVERSE EVENT ON AN IMPLANT. THE PACKAGING WAS NOT STERILE". DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23964311 ↗InjuryAug 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22883643 ↗InjuryAug 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". LATER, HEALTHCARE PROFESSIONAL REPORTED "CREASES". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22868719 ↗InjuryJul 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "MECHANICAL COMPLICATION", "FOLD FLAW FROM CAPSULAR CONTRACTURE GRADE UNKNOWN". THIS IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22508291 ↗InjuryMay 30, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED ¿RECURRENT FLIPPING OF IMPLANT¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22116234 ↗InjuryMay 30, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III AND RUPTURE". THIS RECORD IS FOR THE "LEFT" SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22113747 ↗InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE, 'POSSIBLE INFECTION'. DEVICE HAS BEEN EXPLANTED, REPLACED AND DISCARDED.
Patient problems: Unspecified Infection
MAUDE report 21929316 ↗InjuryApr 16, 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.
Patient problems: Capsular Contracture
MAUDE report 21852042 ↗InjuryJun 14, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 19542508 ↗InjuryNov 29, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 18226591 ↗InjuryNov 13, 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 18127992 ↗InjuryNov 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PHYSICIAN REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18117169 ↗InjuryOct 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryOct 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17971470 ↗InjuryOct 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17959588 ↗InjuryOct 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17906303 ↗InjurySep 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17784919 ↗InjuryAug 16, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, RIGHT CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17560806 ↗
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 · 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-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-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
- 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-
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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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