Counterfeit surgical mesh confirmed as health risk

A counterfeit surgical mesh which was the subject of a US Food and Drug Administration warning back in June has been confirmed as posing a serious health risk to patients.

The fake versions of CR Bard's flat polypropylene mesh - commonly known as Marlex mesh and used in the repair of hernias and chest wall defects - have been tested by the FDA and found not to be sterile even though they are labelled as such.

"This can mean an increased risk of infection if they are implanted in a patient," said the agency in a statement released earlier this week.

"Also, the counterfeit may not have properly finished edges, which could allow it to unravel."

The FDA is also building a picture of the route by which the counterfeits travelled through the supply chain.

The counterfeit products were distributed between October 21, 2008 and October 27, 2009, and were labelled with the CR Bard/Davol brand name. One distributor - identified as RAM Medical - sold the counterfeits to at least six other distributors, which are listed here.

The six then sold them on to hospitals and other distributors.

The FDA reiterated warnings that healthcare professionals should not use any surgical mesh labelled as C.R. Bard with a specific set of lot numbers (available to view here).

They should carefully examine all manufacturers’ polypropylene surgical mesh products for their lot numbers and anything unusual that might indicate they are counterfeit.


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