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TPLC
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show TPLC since
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Device
prosthesis, breast, noninflatable, internal, silicone gel-filled
Definition
Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91
Product Code
FTR
Regulation Number
878.3540
Device Class
3
Premarket Approvals (PMA)
2017
2018
2019
2020
2021
2022
33
11
14
10
21
5
MDR Year
MDR Reports
MDR Events
2017
927
927
2018
2640
2640
2019
21374
21374
2020
24288
24288
2021
23300
23300
2022
16685
16685
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
39616
39616
Adverse Event Without Identified Device or Use Problem
25084
25084
Patient-Device Incompatibility
14344
14344
Device Appears to Trigger Rejection
12201
12201
Migration
1909
1909
Gel Leak
569
569
Appropriate Term/Code Not Available
400
400
Patient Device Interaction Problem
357
357
Off-Label Use
265
265
Fluid Leak
240
240
Insufficient Information
233
233
No Apparent Adverse Event
164
164
Break
151
151
Material Discolored
124
124
Migration or Expulsion of Device
116
116
Material Deformation
114
114
Improper or Incorrect Procedure or Method
91
91
Device Handling Problem
78
78
Device Contamination with Chemical or Other Material
67
67
Nonstandard Device
66
66
Leak/Splash
60
60
Malposition of Device
58
58
Defective Device
36
36
Device Dislodged or Dislocated
36
36
Short Fill
27
27
Material Protrusion/Extrusion
26
26
Delivered as Unsterile Product
24
24
Microbial Contamination of Device
23
23
Use of Device Problem
21
21
Material Integrity Problem
15
15
Air/Gas in Device
14
14
Inadequacy of Device Shape and/or Size
13
13
Product Quality Problem
12
12
Biocompatibility
12
12
Device Markings/Labelling Problem
11
11
Biofilm coating in Device
10
10
Material Invagination
10
10
Defective Component
10
10
Device Contaminated During Manufacture or Shipping
10
10
Unsealed Device Packaging
10
10
Loss of or Failure to Bond
9
9
Structural Problem
9
9
Deflation Problem
8
8
Device Operates Differently Than Expected
8
8
Peeled/Delaminated
8
8
Contamination
7
7
Shipping Damage or Problem
7
7
Contamination /Decontamination Problem
7
7
Device Damaged Prior to Use
7
7
Manufacturing, Packaging or Shipping Problem
6
6
Material Split, Cut or Torn
6
6
Burst Container or Vessel
6
6
Unintended Movement
5
5
Positioning Problem
5
5
Volume Accuracy Problem
4
4
Output Problem
4
4
Tear, Rip or Hole in Device Packaging
4
4
Material Too Rigid or Stiff
4
4
Material Separation
4
4
Folded
3
3
Contamination of Device Ingredient or Reagent
3
3
Noise, Audible
3
3
Material Puncture/Hole
3
3
Degraded
3
3
Unintended Ejection
3
3
Connection Problem
3
3
Scratched Material
2
2
Fungus in Device Environment
2
2
Melted
2
2
Packaging Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Component Missing
2
2
Inadequate Instructions for Non-Healthcare Professional
2
2
Deformation Due to Compressive Stress
2
2
Device Ingredient or Reagent Problem
2
2
Dent in Material
2
2
Device Issue
2
2
Material Disintegration
2
2
Hole In Material
2
2
Material Twisted/Bent
2
2
Measurement System Incompatibility
1
1
Optical Discoloration
1
1
Expulsion
1
1
Gas Leak
1
1
Inaccurate Information
1
1
Difficult to Remove
1
1
Fracture
1
1
Device Emits Odor
1
1
Material Opacification
1
1
Application Security Problem
1
1
Out-Of-Box Failure
1
1
Incomplete or Missing Packaging
1
1
Charging Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Compatibility Problem
1
1
Incorrect Device Or Component Shipped
1
1
Failure To Adhere Or Bond
1
1
Rupture due to capsulotomy
1
1
Unexpected Color
1
1
Detachment of Device or Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Capsular Contracture
42590
42590
Failure of Implant
20966
20966
No Code Available
13534
13535
Seroma
5120
5120
Deformity/ Disfigurement
5115
5115
Pain
3568
3569
Unspecified Infection
1662
1662
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1422
1422
Fatigue
1081
1082
Autoimmune Reaction
928
928
Swollen Lymph Nodes
897
897
Granuloma
862
862
Wrinkling
763
763
Swollen Lymph Nodes/Glands
733
733
Breast Mass
718
718
Lymphoma
672
672
Inflammation
589
589
Anxiety
586
586
Autoimmune Disorder
570
571
Headache
558
559
Breast Discomfort/Pain
557
557
Arthralgia
553
553
Hair Loss
538
539
Local Reaction
521
521
Insufficient Information
513
513
No Clinical Signs, Symptoms or Conditions
442
442
Depression
429
429
Anaplastic Large Cell Lymphoma
429
429
Hematoma
426
426
Weight Changes
405
405
Memory Loss/Impairment
393
394
Rash
391
392
Wound Dehiscence
343
343
Sleep Dysfunction
326
326
Injury
316
316
Post Operative Wound Infection
294
294
Cyst(s)
293
293
Neurological Deficit/Dysfunction
289
289
Cognitive Changes
288
288
Hypersensitivity/Allergic reaction
286
286
Swelling
284
284
Impaired Healing
283
283
Numbness
266
266
Palpitations
259
260
Necrosis
253
253
Skin Irritation
245
245
Dyspnea
241
241
Cancer
238
238
No Known Impact Or Consequence To Patient
237
237
Confusion/ Disorientation
234
234
No Consequences Or Impact To Patient
209
209
Thyroid Problems
208
208
Crushing Injury
207
207
Chest Pain
201
201
Blurred Vision
193
193
Paresthesia
189
189
No Patient Involvement
188
188
Tinnitus
188
188
Dry Eye(s)
179
179
Complaint, Ill-Defined
176
176
Burning Sensation
170
170
Sweating
165
166
Vertigo
165
165
Tingling
164
164
Dizziness
159
159
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)
154
154
Emotional Changes
148
149
Itching Sensation
142
143
Rupture
141
141
Myalgia
134
134
Nausea
125
125
Calcium Deposits/Calcification
123
123
Pocket Erosion
115
115
Foreign Body Reaction
115
115
Cellulitis
112
112
Visual Impairment
109
109
Foreign Body Sensation in Eye
101
101
Skin Inflammation/ Irritation
101
101
Weakness
101
101
Increased Sensitivity
98
98
Fungal Infection
97
97
Malaise
96
96
Muscle Weakness
95
95
Rheumatoid Arthritis
93
93
Neck Pain
93
93
Edema
89
89
Toxicity
88
88
Abscess
88
88
Fluid Discharge
83
83
Bacterial Infection
82
82
Fever
82
82
Discomfort
81
81
Scarring
75
75
Test Result
73
73
Arthritis
70
70
Abdominal Distention
64
64
High Blood Pressure/ Hypertension
63
63
Swelling/ Edema
63
63
Patient Problem/Medical Problem
62
62
Urinary Tract Infection
59
59
Recalls
Manufacturer
Recall Class
Date Posted
1
Allergan PLC
III
Dec-18-2019
2
Allergan PLC
I
Sep-11-2019
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