IDEAL IMPLANT 47501Recalls & reported problems
Ideal Implant Incorporated · Round, smooth-surface, saline-filled breast implant. · Class 3
Quick summary
This Ideal Implant saline breast implant is a round, smooth-surface implant filled with saline solution. Of its 90 reports, 83 involve injuries and no deaths are recorded. Reports mostly describe implants that deflated or ruptured, sometimes noticed before implanting. There were no reports in the last 12 months, down from 6 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
- 90
- Deaths reported
- 0
- Injuries reported
- 83
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10851795006084), received between Jul 19, 2016 and Apr 1, 2025 — classified as 83 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (50 reports).
1 other recall cover devices cleared under the same FDA submission (P120011); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Deflation Problem50
- Material Rupture11
- Adverse Event Without Identified Device or Use Problem8
- Insufficient Device Problem Information8
- Unintended Deflation7
- Material Split, Cut or Torn3
- Burst Container or Vessel2
- Material Deformation2
Patient problems
- Insufficient Information29
- No Known Impact Or Consequence To Patient23
- Failure of Implant12
- Capsular Contracture10
- No Clinical Signs, Symptoms or Conditions10
- No Code Available5
- Deformity/ Disfigurement2
- No Information1
Recent adverse event reports
The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2025Unintended Deflation; Unintended Deflation
SUSPECTED LEAK OF BREAST IMPLANT. IT WAS NOTICED BEFORE IT WAS IMPLANATED.
Patient problems: Failure of Implant
MAUDE report 21743662 ↗InjuryFeb 8, 2025Unintended Deflation; Unintended Deflation
InjuryJan 6, 2025Unintended Deflation; Unintended Deflation
InjuryDec 13, 2024Unintended Deflation; Unintended Deflation
InjuryDec 11, 2024Unintended Deflation; Unintended Deflation
InjuryDec 6, 2024Unintended Deflation; Unintended Deflation
DEFLATION OF IMPLANT (RIGHT OR LEFT NOT REPORTED).
Patient problems: Failure of Implant
MAUDE report 20860629 ↗InjuryJun 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17132163 ↗InjuryMay 2, 2023Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16855923 ↗InjuryMar 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16600911 ↗InjuryMar 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16464401 ↗InjuryJan 15, 2023Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16172364 ↗InjuryJan 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16142361 ↗InjuryDec 13, 2022Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15973682 ↗InjuryOct 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15617377 ↗InjuryAug 16, 2022Material Rupture
InjuryJul 29, 2022Deflation Problem
InjuryJul 22, 2022Loss of or Failure to Bond; Material Rupture; Loss of or Failure to Bond
ALLEGED DEFLATION.
Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions
MAUDE report 15088979 ↗InjuryJul 14, 2022Material Deformation
InjuryJul 14, 2022Material Deformation
InjuryJul 13, 2022Deflation Problem
InjuryJun 24, 2022Unintended Deflation
InjuryJun 16, 2022Insufficient Device Problem Information; Deflation Problem; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14718142 ↗InjuryJun 7, 2022Deflation Problem
InjuryMay 13, 2022Deflation Problem
InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem
Recalls under the same FDA submission
These recalls involve devices cleared under P120011. One submission often covers many models, so check the product and lot details in each record.
- Z-2219-2019 · Mar 18, 2019 · TerminatedIDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc,
Other Prosthesis, Breast, Inflatable, Internal, Saline devices
- MENTOR Smooth Round Moderate Profile 3501650Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline2,187 reports
- MENTOR Smooth Round Moderate Profile 3501660Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,972 reports
- MENTOR Smooth Round Moderate Profile 3501670Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,899 reports
- MENTOR Smooth Round Moderate Profile 3501645Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,655 reports
- MENTOR Smooth Round Moderate Profile 3501655Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,534 reports
- MENTOR Smooth Round Moderate Profile 3501640Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,294 reports
- MENTOR Smooth Round Moderate Profile 3501680Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,095 reports
- MENTOR Smooth Round Moderate Profile 3501635Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline864 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.