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TPLC
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Device
prosthesis, breast, inflatable, internal, saline
Regulation Description
Silicone inflatable breast prosthesis.
Definition
Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99
Product Code
FWM
Regulation Number
878.3530
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
7
9
4
6
7
0
MDR Year
MDR Reports
MDR Events
2020
14021
14021
2021
11351
11351
2022
13654
13654
2023
11012
11012
2024
9944
9952
2025
771
771
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
22175
22175
Material Rupture
22082
22082
Adverse Event Without Identified Device or Use Problem
9232
9232
Device Appears to Trigger Rejection
5609
5609
Patient-Device Incompatibility
1459
1459
Deflation Problem
1162
1162
Migration
631
631
No Apparent Adverse Event
388
388
Insufficient Information
275
275
Appropriate Term/Code Not Available
173
173
Unintended Deflation
152
160
Peeled/Delaminated
142
142
Detachment of Device or Device Component
115
115
Device Handling Problem
95
95
Off-Label Use
79
79
Connection Problem
69
69
Use of Device Problem
66
66
Break
65
65
Microbial Contamination of Device
61
61
Patient Device Interaction Problem
48
48
Improper or Incorrect Procedure or Method
43
43
Loss of or Failure to Bond
41
41
Gel Leak
39
39
Failure to Fold
30
30
Defective Device
28
28
Material Split, Cut or Torn
27
27
Nonstandard Device
25
25
Material Perforation
24
24
Device Contamination with Chemical or Other Material
22
22
Difficult to Open or Remove Packaging Material
22
22
Air/Gas in Device
20
20
Material Deformation
19
19
Burst Container or Vessel
15
15
Material Discolored
15
15
Short Fill
13
13
Defective Component
13
13
Material Invagination
9
9
Malposition of Device
9
9
Material Integrity Problem
7
7
Device Dislodged or Dislocated
6
6
Infusion or Flow Problem
6
6
Device Damaged Prior to Use
6
6
Leak/Splash
6
6
Device Contaminated During Manufacture or Shipping
6
6
Contamination of Device Ingredient or Reagent
6
6
Contamination /Decontamination Problem
5
5
Migration or Expulsion of Device
5
5
Unsealed Device Packaging
5
5
Delivered as Unsterile Product
4
4
Tear, Rip or Hole in Device Packaging
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
26718
26726
Deformity/ Disfigurement
12070
12070
Capsular Contracture
11132
11132
No Code Available
4587
4587
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1644
1644
Seroma
1209
1209
Pain
1177
1177
No Clinical Signs, Symptoms or Conditions
1066
1066
Breast Discomfort/Pain
858
858
Insufficient Information
678
678
Unspecified Infection
550
550
Autoimmune Disorder
460
460
Swollen Lymph Nodes/Glands
437
437
Wrinkling
417
417
Breast Mass
327
327
Lymphoma
323
323
Fatigue
205
205
Autoimmune Reaction
187
187
Post Operative Wound Infection
180
180
Local Reaction
179
179
No Known Impact Or Consequence To Patient
170
170
Paresthesia
158
158
Crushing Injury
146
146
Swollen Lymph Nodes
144
144
Anxiety
133
133
Cancer
130
130
Injury
129
129
Headache
126
126
Hair Loss
122
122
Inflammation
120
120
Cyst(s)
118
118
Granuloma
109
109
Depression
107
107
Arthralgia
105
105
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)
98
98
Calcium Deposits/Calcification
97
97
Rash
97
97
Skin Inflammation/ Irritation
94
94
Cognitive Changes
86
86
Hypersensitivity/Allergic reaction
82
82
Impaired Healing
80
80
Necrosis
75
75
Neurological Deficit/Dysfunction
75
75
Weight Changes
74
74
Wound Dehiscence
72
72
Memory Loss/Impairment
69
69
Sleep Dysfunction
69
69
Dyspnea
67
67
Foreign Body Reaction
59
59
Dry Eye(s)
58
58
Recalls
Manufacturer
Recall Class
Date Posted
1
Mentor Texas, LP.
II
Dec-10-2021
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