The story of the Kugel Mesh Hernia Patch is slowly becoming clearer. On January 24, 2007 the Food and Drug Administration (FDA) announced that the recall had been updated and expanded to include specific product codes. The notice also mentioned that the manufacturer Davol, Inc. (a subsidiary of C.R. Bard) had developed a replacement hernia patch.

To date, both the company and the FDA have cited six ring breaks (though stating only four are confirmed) involving the Kugel Mesh Hernia patch, also known as the Bard Composix Kugel Mesh patch. According to the Davol website, none of the four confirmed incidents caused serious damage beyond discomfort, and only half of those required further surgery to remove the rings. However in the cases of the two unconfirmed reports, both instances led to perforated (cut) bowels and surgery to repair the damage.

The incident rate, according to the company, is 0.023% or about one person for every 4,300 Kugel Mesh Hernia patches made.

No matter how much the company is trying to downplay the danger of their product, the fact is that the Kugel Mesh Hernia Patch recall is ranked as a Class I recall, which the FDA reserves for “dangerous or defective products that predictably could cause serious health problems or death.” In this latest update, the FDA substantially expanded its comments, stating that “surgeons and hospitals should stop using the recalled product and return unused units to the company.”

The FDA also recommends that “Patients who have been implanted with one of the recalled devices should seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.”

The FDA also mentions a replacement product, featuring “upgraded product design.” According to the Davol website, the design changes include a ring with a smaller diameter wire and stronger welds. Although both the FDA and Davol state that these new products are clearly marked and not affected by the recall, they also do not mention any product testing, if any, that took place to confirm the safety of this new Kugel Mesh Hernia Patch.

If you or a loved one experiences any undue pain or discomfort after an operation using the Kugel Mesh Hernia Patch, see your doctor or medical professional immediately. Then call the medical legal experts at Jim S. Adler & Associates. We have over 30 years of experience helping our clients secure the compensation they deserve for their added medical bills, lost time from work, and mental anguish that results from product defects like this one. Don’t let someone else’s negligence affect your life any more than it has to. Call Jim S. Adler & Associates directly or fill out the free case review form detailing your Kugel Mesh Hernia Patch experience, and get the legal help you need.