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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 CodeFTR
Regulation Number 878.3540
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
5 7 4 2 2 7 12 19 28 3

Device Problems
Not Applicable 188
Implant, removal of 57
Material rupture 54
Electro-magnetic interference (EMI) 37
Rupture, cause unknown 34
Patient-device incompatibility 28
No code available 15
No Known Device Problem 15
Gel leak 14
Folded 6
Device expiration issue 5
Elective replacement 5
Migration of device or device component 4
Fluid leak 4
Break 3
Malposition of device 3
Deflation, cause unknown 3
Elective removal 3
Explanted 3
Degraded 2
Device, or device fragments remain in patient 2
Device Issue 2
Leak 2
Augmentation, loss of 1
Component(s), broken 1
Rupture due to trauma 1
No Information 1
Calcified 1
Fracture 1
Decreased pump speed 1
Replace 1
Total Device Problems 497

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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