TPLC - Total Product Life Cycle

• Device: prosthesis, breast, noninflatable, internal, silicone gel-filled
• Regulation Description: Silicone gel-filled breast prosthesis.
• 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)
2021	2022	2023	2024	2025	2026
21	8	10	20	16	8

MDR Year	MDR Reports	MDR Events
2021	23365	24015
2022	30817	31781
2023	29098	30086
2024	30289	30778
2025	31375	31384
2026	13861	13861

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	71881	73936
Device Appears to Trigger Rejection	47125	47935
Adverse Event Without Identified Device or Use Problem	36271	36558
Patient Device Interaction Problem	5908	5920
Migration	4022	4117
Gel Leak	3085	3132
No Apparent Adverse Event	1367	1473
Appropriate Term/Code Not Available	1217	1230
Break	1027	1031
Patient-Device Incompatibility	1000	1211
Malposition of Device	798	798
Device Handling Problem	359	365
Use of Device Problem	322	323
Material Deformation	268	273
Fluid/Blood Leak	255	318
Difficult to Open or Remove Packaging Material	206	208
Material Discolored	190	190
Off-Label Use	150	150
Insufficient Information	96	103
Device Contamination with Chemical or Other Material	87	87
Improper or Incorrect Procedure or Method	72	76
Device Contaminated During Manufacture or Shipping	62	62
Material Invagination	56	59
Nonstandard Device	52	76
Air/Gas in Device	52	52
Device Dislodged or Dislocated	49	49
Material Protrusion/Extrusion	48	51
Defective Device	45	46
Biocompatibility	43	43
Positioning Failure	35	35
Unsealed Device Packaging	32	32
Unintended Deflation	31	31
Material Integrity Problem	31	31
Positioning Problem	30	30
Microbial Contamination of Device	29	29
Deflation Problem	27	29
Contamination	26	32
Leak/Splash	22	31
Therapeutic or Diagnostic Output Failure	21	21
Delivered as Unsterile Product	21	21
Peeled/Delaminated	19	19
Deformation Due to Compressive Stress	19	19
Inadequacy of Device Shape and/or Size	18	21
Device Damaged Prior to Use	17	18
Fracture	15	15
Shipping Damage or Problem	14	14
Biofilm coating in Device	11	11
Packaging Problem	9	9
Volume Accuracy Problem	9	9
Material Disintegration	9	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Capsular Contracture	80973	81866
Failure of Implant	36406	38142
Deformity/ Disfigurement	21436	21481
Seroma	7048	7307
No Clinical Signs, Symptoms or Conditions	4516	4631
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4178	4285
Breast Discomfort/Pain	3314	3377
Swollen Lymph Nodes/Glands	2502	2664
Rupture	2354	2356
Granuloma	1929	2009
Insufficient Information	1732	1741
Unspecified Infection	1680	1726
Wrinkling	1304	1304
Pain	1302	1539
Breast Mass	959	975
Local Reaction	813	813
Post Operative Wound Infection	810	810
Autoimmune Disorder	711	783
Hematoma	684	684
Lymphoma	576	611
Cyst(s)	548	558
Fatigue	447	671
Paresthesia	442	448
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)	434	456
Impaired Healing	423	439
Necrosis	396	404
Crushing Injury	368	368
Skin Inflammation/ Irritation	363	373
Wound Dehiscence	359	362
Foreign Body Reaction	328	335
Anxiety	320	450
Cancer	298	313
Calcium Deposits/Calcification	287	290
Inflammation	275	374
Breast Cancer	261	268
Headache	259	379
Pocket Erosion	250	250
Swelling/ Edema	234	285
Hair Loss	225	346
Cognitive Changes	221	351
Scar Tissue	217	226
Arthralgia	214	347
Rash	198	310
Weight Changes	182	271
Ptosis	171	171
Fluid Discharge	169	174
Depression	167	245
Hypersensitivity/Allergic reaction	156	201
Memory Loss/Impairment	155	238
Sleep Dysfunction	149	237