Updated November
3, 2003
Dear Healthcare
Professional:
ETHICON,
INC. recently
became aware of the existence of counterfeit mesh product labeled
as PROLENE* polypropylene mesh product code PMII, bearing
lot numbers RBE609 (expiration date 1/07) and RJJ130 (expiration
date 7/07). This is a PROLENE flat mesh product (3" x
6"). As ETHICON
did not manufacture this product, we cannot confirm the mechanical
properties, biocompatibility or sterility of this material. We want health care professionals to
be aware of this situation so you can appropriately consider
potential health risks to patients.
PROLENE mesh
is a nonabsorbable mesh used for the repair of hernias and
other fascial deficiencies that require the addition of a reinforcing
or bridging material to obtain the desired surgical result.
Physicians,
nurses and all other healthcare professionals should carefully
examine all PROLENE flat mesh product (3" x 6") before use. The
counterfeit product deviates from authentic PROLENE mesh in
that the counterfeit product may exhibit the following:
-
Have
a packaging seal that does not tear open smoothly. Also,
on top corner edges of the package, there is an additional
small seal.
-
Have
a fabric end that is jagged, not a clean cut on the
3" side
-
ETHICON
logo appears in a thicker typeface
Please
convey this information to your staff and any others who use
PROLENE flat mesh in the operating room, so that they will
be able to identify the characteristics of suspect
counterfeit product.
If
you receive any product that you suspect is counterfeit, do not
use the product. Quarantine
product to ensure it will not be used.
Counterfeit product
would have entered the supply chain at the distributor level.
Therefore, if you suspect that you may be in possession of counterfeit
product labeled as PROLENE Mesh, you should contact your distributor
to discuss refund/replacement of the product.
If you have
medical questions regarding suspected counterfeit product, please
contact the ETHICON customer service center at 1-877-ETHICON.
ETHICON
is working with the FDA to investigate this matter and prevent
the further distribution of counterfeit product. As of October
24, ETHICON is aware of the distribution of counterfeit product
in the U.S. only.
Full
product information and updates on this situation will be available
at www.ETHICON.com.
Joel Lippman,
M.D.
Worldwide Vice President
Chief Medical
Officer
Medical Affairs - ETHICON
*Trademark
of ETHICON, Inc.
The following details may help in determining if the product
you have is counterfeit.
BOX
Features of Authentic PROLENE mesh |
Features of Counterfeit mesh |
A.
There is no clear tape on the box opening. |
A. There is clear tape on the box opening |
Please click on image for larger view
|
Please click on image for larger view
|
Features of Authentic PROLENE mesh |
Features of Counterfeit mesh |
B.
There is no orange dot |
B. An orange dot sticker MAY appear on some boxes. |
Please click on image for larger view
|
Please click on image for larger view
|
Features of Authentic PROLENE mesh |
Features of Counterfeit mesh |
C. ETHICON logo is printed
in a custom typeface similar to Optima.
|
C. This logo uses the
same letter forms as the ETHICON logo but with a
bolder typeface. |
Please click on image for larger view
|
Please click on image for larger view
|
Features of Authentic PROLENE mesh |
Features of Counterfeit mesh |
D. In authentic "Other Patent
Pending" section, there is blank space at the end
of the 3rd. line.
|
D. In counterfeit "Other
Patent Pending" section, there is no blank space
at the end of the 3rd. line.
|
Please click on image for larger view
POUCH |
Please click on image for larger view
|
Features of Authentic PROLENE mesh |
Features of Counterfeit mesh |
A. On authentic patient
label, the word "MESH" is in bold font; the words "lot
number" are in smaller size and bold font.
|
A. On counterfeit patient
label, the word "MESH" is in regular font; the words "lot
number" are in the same size and regular font.
|
Please click on image for larger view
|
Please click on image for larger view
|
Features of Authentic PROLENE mesh |
Features of Counterfeit mesh |
B. There is no corner seal
on authentic pouch. |
B. There is an additional
small seal in the corner of the counterfeit pouch.
|
Please click on image for larger view
|
Please click on image for larger view
|
Features of Authentic PROLENE mesh |
Features of Counterfeit mesh |
C. When you pull back the
label, you will see that it is on a single piece
of smooth adhesive backing.
|
C. The pouch label is on
an adhesive backing that has obvious "slices," not
a solid piece of material.
|
Please click on image for larger view
|
Please click on image for larger view
|
Features of Authentic PROLENE mesh |
Features of Counterfeit mesh |
D.
When you pull back the label pouch, the seal will open
smoothly. You will not see a noticeable transfer of
material from the bottom layer to the top layer on
the seal. |
D. When you pull back the label pouch, you will be able to see a
transfer of material from the bottom layer to the top
layer on the seal. |
Please click on image
for larger view
|
MESH
Features of Authentic PROLENE mesh |
Features of Counterfeit mesh |
A. More open,
linear weave |
A. Tighter weave
that is asymmetrical |
Please click on image for larger view
|
Please click on image for larger view |
Features of Authentic PROLENE mesh |
Features of Counterfeit mesh |
B. Fabric end
is smooth along 3" section |
B. Fabric
end is jagged along 3" section |
Please click on image
for larger view
|