FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration, U.S. Public Health Service, Department of Health and
Human Services. It contains information on actions taken in connection
with agency regulatory activities.


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ENFORCEMENT
10/18/1995
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PRODUCT Mentor> Leaf-Valve Saline Breast Implants:
(a) Saline-filled (smooth surface shell) Mammary
Prosthesis
with <Mentor> Leaf Valve;
(b) Siltex Saline-Filled (textured surface shell)
Mammary
Prosthesis with <Mentor> Leaf Valve. Recall
#Z-017/018-6.
CODE Catalog Numbers Size
Lot Numbers
(a) 350-1815M 150cc 114818
350-1820M 175cc 113010, 114683, 115605,
118224
350-1825M 200cc 105112, 105552, 112503,
113014,
114820, 118225
350-1830M 225cc 102656, 102956, 102957,
105928,
110176, 110177, 112480,
112481,
113016, 114287, 114689,
114821,
102958
350-1835M 250cc 102959, 104999, 105929,
110178,
112504, 113018, 114824,
118226,
118227
350-1840M 275cc 103182, 105001, 105113,
105114,
105407, 105408, 105409,
107513,
110179, 110180, 110471,
113011,
113240, 114290, 114291,
116450,
118228, 118229
350-1845M 300cc 101271, 101272, 103173,
105930,
107368, 107512, 107755,
112505,
112506, 113950, 116455,
116456
350-1850M 325cc 102047, 103176, 103665,
105000,
105413, 106708, 109752,
109753,
110175, 111033, 113012,
113546,
113547, 114292, 115608,
116461,
116462, 116463, 118230,
118231
350-1860M 375cc 106703, 106704, 107756,
110173,
111032, 112135, 113023,
114293,
116464, 118232, 118906
350-1870M 425cc 100882, 102955, 107369,
110174,
113009
350-1880M 475cc 100883, 112789
350-1930MT 225cc 103667, 113013
350-1940MT 275cc 104804, 110474, 112493,
115307,
115345, 115616
350-1950MT 325cc 102052, 104805, 112494,
115617
Catalog Numbers ending with "M" are round in
style, and Catalog Numbers ending with "MT" are
oval in style. (b) Catalog
Numbers Sizes Lot Numbers
354-2810M 125cc 105587, 115622, 116328,
116446
354-2815M 150cc 109776, 113550, 117350
354-2820M 175cc 105588, 105589, 105944,
109468,
111537, 113971
-8- 354-2830M
225cc 110488, 112156, 114297, 118685
354-2835M 250cc 105676, 105677, 105945,
109200,
109469, 110207, 113549,
115351,
118253
354-2840M 275cc 109202, 110654, 111526,
113972,
116329
354-2845M 300cc 117836
354-2850M 325cc 110655, 111528, 111529,
113973,
117351, 118686
354-2860M 375cc 110656, 111767, 112157,
118687
354-2870M 425cc 109201, 110489, 115352
354-2880M 475cc 105678, 105947.
MANUFACTURER <Mentor H/S, Inc., Irving, Texas.
RECALLED BY Manufacturer, by letter dated September 1, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 9,997 units were distributed; firm estimated that 10
percent
of implants remained on market at time of recall
initiation.
REASON The valve channels may open and the implant deflate
when
autoclaved prior to surgery as previously instructed.

THIS WENT BY SO FAST THAT I AM AFRAID THAT WOMEN THAT NEEDED TO KNOW
THIS INFORMATION DID NOT GET IT. GOD BLESS