Bard Composix Kugel Mesh Patch redesigned

Davol, a subsidiary of C.R. Bard, has decided to withdraw all Bard Composix Kugel Mesh patches from the market that have the same design as those covered in the original recall, and replace them with a new, redesigned patch. This expanded recall involves all Bard Composix Kugel Large Oval and Large Circle patches, and now includes patches manufactured from October 2005 to October 2006.

In an open letter to doctors dated Jan. 10, 2007, the company stated on their website that it “recognizes the impact of any product performance communication on both you and your patients and we sincerely regret the difficulties this recall may cause you and your patients.” That being said, Davol underlined the fact that doctors should “immediately discontinue use of [the recalled patches]” and “immediately distribute copies of the Important Patient Management Information to clinicians who may have implanted, or who may be managing, patients already implanted with one of these products under voluntary recall.”

Although the company stops short of stating the long list of possible dangers including bowel perforation, infections, and blockages is due to a design flaw in their product, Davol is quickly promoting their new patches “redesigned for improved ring integrity.”

There are several differences between these new Bard Composix Kugel Mesh patches and the old. First the diameter of the spring wire is thinner decreasing from 0.042 inches to 0.03 inches. The company does not state why they did this, but a thinner wire would decrease the force of the spring, presumably making it less likely to break. Davol did state though that the company already uses this thickness of wire for other products.

Another key difference between the old Bard Composix Kugel Mesh patches and the new is that the welds are four times stronger, according to the company, and the wire overlap at the joints has increased from 0.18 inches to 0.48 inches. Again, the implication is that this design is supposedly stronger, and therefore less likely to break like older patches.

Lastly, the company stated that it has included the latest version of the insertion instructions so that surgeons are more likely to use the patches properly.

These “improvements” certainly sound like a step in the right direction, but there is no mention of any testing to ensure the redesigned patches are effective. It has yet to be seen if the redesign indeed fixed the problems associated with the older Bard Composix Kugel Mesh patches, or whether new ones may arise.

If you or a loved one has been injured due to Bard Composix Kugel Mesh patches either during a hernia operation or after surgery, contact a Jim S. Adler & Associates personal injury lawyer. With over three decades of medical law experience, we can help you get the compensation you need to cover your added medical bills and lost work, and the settlement you deserve to cover your pain and suffering. Call Jim S. Adler & Associates directly right now or, for a free case review, fill out the form on this page with the details of your Bard Composix Kugel Mesh patch injury.

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