Natrelle Inspira SoftTouch Breast Implants SSF-770Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSF 770cc 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 Natrelle Inspira SoftTouch silicone breast implant from Allergan is a smooth, round, full-profile gel-filled implant. The 37 reports mostly describe the scar tissue tightening around the implant (capsular contracture), causing pain, hardening and deformity, along with leakage, rupture and skin damage; 36 reports involve injuries and no deaths. One malfunction report describes implant trays stuck together during shipping. Reports fell from 8 in the prior 12 months to 1 in the most recent 12 months, and 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
- 39
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10888628033252), received between Oct 2, 2019 and Sep 29, 2026 — classified as 37 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (19 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 Rejection19
- Material Rupture8
- Adverse Event Without Identified Device or Use Problem6
- Patient-Device Incompatibility6
- Difficult to Open or Remove Packaging Material2
- Device Handling Problem1
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture24
- Failure of Implant6
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body Reaction1
- Impaired Healing1
- Necrosis1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture baker grade III". This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50934231 ↗MalfunctionSep 9, 2026Difficult to Open or Remove Packaging Material; No Apparent Adverse Event
Sales representative reported "10x harder to get out than the one I took a video of" and "implant is very hard to get out of the packaging". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692469 ↗InjuryMar 4, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A "BAKER GRADE 4 CAPSULAR CONTRACTURE " AND PAIN. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24507212 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "WRINKLING/RIPPLING, CORRECTION OF ASYMMETRY, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23292146 ↗InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "SKIN INTEGRITY". LATER HEALTHCARE PROFESSIONAL REPORTED "SKIN NECROSIS REQUIRING EXCISION". THIS RECORD IS FOR THE "RIGHT" SIDE. THE DEVICE WAS "EXPLANTED.
Patient problems: Necrosis
MAUDE report 23015261 ↗InjurySep 3, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "LEAKAGE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22956188 ↗InjurySep 2, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "LEAKAGE". DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22944910 ↗InjuryAug 5, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". LATER HEALTHCARE PROFESSIONAL REPORTED "RIGHT SIDE IS TIGHT DEFORMED AND PUSHED UP AND PAINFUL. THEREFORE [PATIENT] HAS A BAKER GRADE 4 CAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "HOLE ON PATCH SIDE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22720006 ↗MalfunctionJun 6, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
SALES REPRESENTATIVE REPORTED "IMPLANT TRAYS WERE STUCK TOGETHER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22158545 ↗InjuryApr 9, 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 REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21810850 ↗InjuryApr 9, 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 21805717 ↗InjuryNov 16, 2023Device Handling Problem; Device Handling Problem
HEALTHCARE PROVIDER REPORTED A LEFT SIDE EXCHANGE ¿WAS CUT WITH KNIFE DURING SURGERY.¿ THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 18155583 ↗InjuryOct 31, 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 18044052 ↗InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED INFECTION (LATE ONSET). DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Unspecified Infection
MAUDE report 17997238 ↗InjuryMay 30, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, RUPTURE. HEALTHCARE PROFESSIONAL, LATER REPORTED, CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 17022530 ↗InjuryApr 17, 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 16758373 ↗InjuryJan 13, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED, LEFT- SIDE "EXPOSED.¿ DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Foreign Body Reaction
MAUDE report 16156356 ↗InjuryDec 22, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16037391 ↗InjuryNov 22, 2022Device 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 15843248 ↗InjurySep 15, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15429440 ↗InjuryApr 28, 2022Material Rupture; Material Rupture
HEALTHCARE PROVIDER CALLED TO REPORT A LEFT SIDE IMPLANT PAIN AND POSSIBLE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14247184 ↗InjuryApr 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING "CAP CON" AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14174538 ↗InjuryApr 11, 2022Material Rupture; Material Rupture
COMPANY REPRESENTATIVE REPORTED ON BEHALF OF THE HEALTH PROFESSIONAL, "RUPTURE" AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14079030 ↗InjuryJan 14, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 13257983 ↗InjuryJan 10, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE "CAPSULAR CONTRACTURE" BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13213904 ↗
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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