polypropylene
FDA Public Health Web Notification: Counterfeit Polypropylene
Mesh
Updated: May 7, 2004
Original date: December 19, 2003
This is to alert you to our findings concerning a counterfeit
mesh product labeled as PROLENE* polypropylene mesh.
Ethicon's Alert
PROLENE's* manufacturer, ETHICON, INC., issued an alert to healthcare
professionals on the counterfeit polypropylene mesh on October
28, 2003. The counterfeit product is labeled with lot numbers
RBE609 (expiration date JAN07) and RJJ130 (expiration date JUL07).
This notification does not involve ETHICON's PROLENE* suture products.
FDA's Testing of the Counterfeit Product
FDA's testing of the counterfeit polypropylene mesh indicates
that some samples are not sterile. At this time, we have not seen
any elevation in the number of cases of infection related to the
counterfeit mesh. We will continue to monitor our database for
increased risk of infection associated with the counterfeit mesh.
Although FDA testing indicates that the counterfeit device has
chemical and mechanical properties similar to other polypropylene
mesh products currently on the market, the counterfeit products
were manufactured in facilities that were not inspected by FDA.
Therefore there is no assurance that these products were designed
and manufactured according to FDA requirements.
 Please Contact Us to discuss your polypropylene
needs. You design it, we build it.
polypropylene
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