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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 CodeFWM
Regulation Number 878.3530
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
3 3 3 0 0 1 7 11 6 2

Device Problems
Not Applicable 152
Deflation, cause unknown 75
Electro-magnetic interference (EMI) 63
Implant, removal of 40
Patient-device incompatibility 26
Material rupture 22
Fluid/volume, increased 18
No code available 15
Explanted 14
Fluid leak 14
Leak 8
Rupture, cause unknown 6
Device Issue 6
Device remains implanted 6
Malposition of device 5
Device expiration issue 4
Augmentation, loss of 4
Elective replacement 3
No Known Device Problem 3
Replace 2
Malfunction 2
Implant breakage or physical damage 2
Foreign material present in device 2
Elective removal 2
Deflation issue 2
Migration of device or device component 2
Port leak(s) 1
Inflation issue 1
Rupture due to trauma 1
Tears, rips, holes in device, device material 1
Failure to osseointegrate 1
Implant extrusion 1
Unknown (for use when the device problem is not known) 1
Deflation due to capsulotomy 1
Biofilm coating in device 1
Break 1
No Information 1
Total Device Problems 509

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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