Here is the full article November 7, 2003
Item: Counterfeit PROLENE Polypropylene Mesh product code PMII bearing lot numbers RBE609 (expiration date 1/07) and RJJ130 (expiration date 7/07). Prolene flat mesh 3 X 6.
General Information: FDA issued a MedWatch Safety Alert dated 11/5/2003 on counterfeit Ethicon PROLENE Polypropylene mesh that has been distributed. PROLENE mesh is a nonabsorbable mesh used in the repair of hernias and other fascial deficiencies. Physicians, nurses and all other healthcare professionals should carefully examine all PROLENE flat mesh product before using it to determine if it is counterfeit based upon photographs provided by Ethicon.
Additional information on this counterfeit product is available at:
http://www.fda.gov/medwatch/SAFETY/2003/safety03.htm#prolene
Actions
1. Physicians, nurses and all other healthcare professionals must carefully examine all PROLENE flat mesh (3x6) before use. Do not use any product that is suspected to be counterfeit. If counterfeit mesh is found contact the distributor to discuss refund/replacement of the product(s). Refer to the attached photographs for information on how to identify counterfeit PROLENE mesh.
2. Review surgical records for patients to determine if they are recipients of the counterfeit mesh. Involve your regional counsel when communicating with affected patients. We are waiting for the FDA to issue additional information regarding the mechanical properties, biocompatibility or sterility of the material. This additional information may be used as needed when communicating with patients who have received this mesh.
Source: FDA
Contact: Bryanne.Patail@med.va.gov phone # (734) 930-5852
2003 Safety Alert: Prolene Mesh
The following is the text of a letter from Ethicon, Inc. Contact the company for a copy of any referenced enclosures
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
Features of Authentic PROLENE mesh
A. There is no clear tape on the box opening.
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Features of Counterfeit mesh
A. There is clear tape on the box opening
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Features of Authentic PROLENE mesh
B. There is no orange dot
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Features of Counterfeit mesh
B. An orange dot sticker MAY appear on some boxes
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Features of Authentic PROLENE mesh
C. ETHICON logo is printed in a custom typeface similar to Optima.
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Features of Counterfeit mesh
C. This logo uses the same letter forms as the ETHICON logo but with a bolder typeface.
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Features of Authentic PROLENE mesh
D. In authentic "Other Patent Pending" section, there is blank space at the end of the 3rd. line.
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Features of Counterfeit mesh
D. In counterfeit "Other Patent Pending" section, there is no blank space at the end of the 3rd. line.
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POUCH
Features of Authentic PROLENE mesh
A. On authentic patient label, the word "MESH" is in bold font; the words "lot number" are in smaller size and bold font.
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Features of Counterfeit mesh
A. On counterfeit patient label, the word "MESH" is in regular font; the words "lot number" are in the same size and regular font.
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Features of Authentic PROLENE mesh
B. There is no corner seal on authentic pouch
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Features of Counterfeit mesh
B. There is an additional small seal in the corner of the counterfeit pouch.
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Features of Authentic PROLENE mesh
C. When you pull back the label, you will see that it is on a single piece of smooth adhesive backing.
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Features of Counterfeit mesh
C. The pouch label is on an adhesive backing that has obvious slices, not a solid piece of material.
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Features of Authentic PROLENE 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.
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Features of Counterfeit mesh
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.
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MESH
Features of Authentic PROLENE mesh
A. More open, linear weave
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Features of Counterfeit mesh
A. Tighter weave that is asymmetrical
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Features of Authentic PROLENE mesh
B. Fabric end is smooth along 3 section
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Features of Counterfeit mesh
B. Fabric end is jagged along 3 section
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