Natrelle Inspira SoftTouch Breast Implants SSM-405Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSM 405cc Moderate 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 silicone breast implant is a silicone gel-filled breast prosthesis. Most reports describe scar tissue tightening around the implant, some describe the body appearing to reject it, and others describe ruptures of the implant material. There are 260 reports, with no deaths and 260 injuries. Reports fell to 14 in the last 12 months from 41 in the year before. 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
- 266
- Deaths reported
- 0
- Injuries reported
- 266
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 266 adverse event reports that list this exact device (DI 10888628032965), received between May 23, 2019 and Sep 29, 2026 — classified as 266 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (184 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 Rejection184
- Patient-Device Incompatibility37
- Material Rupture31
- Adverse Event Without Identified Device or Use Problem19
- No Apparent Adverse Event3
- Device Dislodged or Dislocated2
- Break1
- Device Handling Problem1
Patient problems
- Capsular Contracture220
- Failure of Implant21
- Unspecified Infection16
- No Clinical Signs, Symptoms or Conditions8
- Seroma4
- Deformity/ Disfigurement2
- Impaired Healing2
- Necrosis2
Recent adverse event reports
The 25 most recent of 266 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937954 ↗InjurySep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846837 ↗InjurySep 11, 2026Material Rupture
Healthcare professional, through company representative, reported: "rupture". This record is for the left-side device. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50731985 ↗InjurySep 11, 2026Material Rupture
Healthcare professional, through company representative, reported: "rupture". This record is for the right-side device. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725344 ↗InjuryAug 30, 2026Device Appears to Trigger Rejection
InjuryAug 26, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture Baker grade lll". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50456518 ↗InjuryJul 31, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade III/IV". This record is for the left side. Device has been explanted. Patient was doing exercises and vitamin E.
Patient problems: Capsular Contracture
MAUDE report 50107545 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture Baker III"; Singulair prescribed. This record is for the left side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50012233 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture Baker III"; Singulair prescribed. This record is for the right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50011580 ↗InjuryJun 30, 2026Material Rupture
Healthcare professional reported "rupture". Later Healthcare professional reported "displacement", "ptosis recurrence" which is not device related and "rupture". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673665 ↗InjuryJun 4, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND DISCARDED.
Patient problems: Capsular Contracture
MAUDE report 25389113 ↗InjuryApr 10, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED INTACT DEVICE. LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24844282 ↗InjuryApr 9, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED INTACT DEVICE. LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24833355 ↗InjuryApr 6, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24794631 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "SKIN NECROSIS" AND "WOUND PROBLEMS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Impaired Healing; Necrosis
MAUDE report 24792049 ↗InjuryMar 6, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24534206 ↗InjuryMar 5, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24524442 ↗InjuryFeb 4, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". PATIENT WAS PRESCRIBED SINGULAIR AND RECEIVED 4 ROUNDS OF ULTRASOUND. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24260209 ↗InjuryDec 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE GRADE III CAPSULAR CONTRACTURE AND "BREAST PTOSIS". THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23826582 ↗InjuryDec 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE GRADE III CAPSULAR CONTRACTURE AND "BREAST PTOSIS". THE DEVICE WAS EXPLANTED AND REPLACED, AND WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23804707 ↗InjurySep 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III IMPLANT EXCHANGE". THIS RECORD RELATES TO THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23187699 ↗InjurySep 24, 2025Material Rupture; Material Rupture
LATER HEALTHCARE PROFESSIONAL REPORTED "FATIGUE, MALAISE, WEIGHT AND HAIR LOSS MYALGIAS, SKIN IRRITATION SYMPTOMS". THIS RECORD RELATES TO THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.
Patient problems: Failure of Implant
MAUDE report 23134280 ↗InjurySep 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22998621 ↗InjurySep 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22983694 ↗InjurySep 5, 2025Device 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 22983579 ↗
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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