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THE SIMPLE FACTSTM...The Bard® Composix® Kugel® Mesh Hernia Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision and held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place. It was discovered that their might be a problem with the "memory recoil ring."
According to reports, the "memory recoil ring," which opens the patch, can break under the stress of placement in the intra-abdominal space. This can lead to serious intestinal conditions such as bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
The Bard® Composix® Kugel® Mesh Hernia patch is manufatured by Davol, Inc. Sub. C.R. Bard, Inc., 100 Sockanossett Crossroad, Cranston, RI 02920.
U.S. FDA Action
In December 2005, the FDA issued the highest recall - Class 1 - of the Bard® Composix® Kugel® Hernia Patch. In March 2006, the FDA sent a recall letter to physicians and patients advising patients implanted with one of the recalled hernia patch lot numbers to seek immediate medical attention if they experience persistent or unexplained abdominal pain, fever, tenderness at the implant site, or other related symptoms.
A subsequent FDA recall expansion happened in January 2007. On January 10, 2007, Davol, Inc. (a subsidiary of C.R. Bard) sent letters to health care professionals and distributors notifying them of the most recent expansion of this recall of specific lots of Bard® Composix® Kugel® Large Oval and Large Circle Mesh Hernia Patches for product codes 0010202 and 0010204. Surgeons and hospitals should stop using the recalled product and return unused units to the company.
Patients who have been implanted with one of the recalled hernia patch 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.
For more information on Kugel Mesh hernia patches, click here.
Quite frankly, the simple factsTM about the Davol/Bard Composix Kugel Mesh hernia patch used for treating hernias and the possible injuries (bowel perforations, intestinal fistulae etc.) which may be caused by using the Bard Composix Kugel Mesh Hernia Patch are unacceptable.
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