Hernia Patch - Bard Composix Kugel Mesh Patch Injuries And Danger

The Composix Kugel Mesh Patch, manufacturedLarge Oval 10.8" x 13.7"o PC#0010208 Bard
by Davol, Inc., a subsidiary of C.R. Bard, is aComposix Kugel Extra Large Oval 7.7" x 9.7"o
medical device used to repair ventral herniasPC#0010209 Bard Composix Kugel Oval 6.3" x
caused by the thinning or stretching of scar tissue12.3"o PC#0010202 Bard Composix Kugel Large
that commonly occurs after hernia surgery.Oval 5.4" x 7"o PC#0010204 Bard Composix
These tissues are already delicate and sensitive,Kugel Large Circle 4.5"
and after serious medical procedures they areThe problem with this defective medical device is
even more so. The folded patch is inserted intoso serious that the March 24, 2006 recall stated
the body behind the hernia area, where thethat doctors and healthcare professionals:
spring-loaded plastic memory recoil holds it in"Immediately discontinue use of the specific
place.product codes and lot numbers listed below.
Unfortunately, there is a significant problem withAdditionally, please immediately distribute copies of
the memory recoil ring. In some cases thethis Important Patient Management Information to
memory ring can break entirely which can lead toclinicians who may have implanted, or who may
a bowel perforation or chronic enteric fistulae, orbe managing, patients already implanted with one
abnormal connections between two tissues thatof these products under voluntary recall."
are not normally connected. Further complicatingFurthermore, the FDA recall notice stated:
the potential problems of the Composix Kugel"Patients who have been implanted with a
Mesh Patch is that even mild pressure exertedComposix Kugel Mesh Patch during hernia surgery
during other surgical techniques can cause it toshould seek medical attention immediately if they
break and result in potentially seriousexperience symptoms that could be associated
consequences.with ring breakage. These symptoms include:
The Food and Drug Administration and Bard joinedunexplained or persistent abdominal pain, fever,
together to recall a number of defective lots oftenderness at the surgery site or other unusual
Composix Kugel Mesh Patches due to theirsymptoms."
propensity to break. There were three differentThe dangers of a defective medical device like
recalls that occurred in December 2005, Januarythe Composix Kugel Mesh Patch will likely continue
2006, and March 2006 that included:o PC#0010206to affect society for quite some time. Once the
Bard Composix Kugel Extra Large Oval 8.7" xpublic loses trust in medical device, it is difficult if
10.7"o PC#0010207 Bard Composix Kugel Extranot impossible to regain.