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Hernia Mesh Patch Recall Timeline

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From December 2005 through January 2006, Davol, Inc., makers of Kugel Mesh Hernia Patches issued expanded recalls. Here is a timeline of the Kugel Mesh Patch recalls:

December 22, 2005 – voluntary hernia mesh recall
U.S. customers notified of a voluntary Class I recall of the Bard Composix Kugel Mesh X-Large Patch in a letter delivered via Federal Express. The recall is issued after reports that a component of the patch, the memory recoil ring, may not withstand certain stresses associated with specific surgical placement techniques. Breakage of the memory recoil ring can cause bowel perforation problems and chronic intestinal fistulae.

The hernia damage recall patches included Bard® Composix® Kugel® Mesh X-Large Patch Oval with ePTFE with the following lot numbers:

• 41XMXXXX – M = 2002
• 41XNXXXX – N = 2003
• 43XMXXXX – M = 2002
• 43XNXXXX – N = 2003
• 43XOXXXX – O = 2004
• 43XPXXXX – P = 2005

(If the lot number did not contain M, N, O or P as the 4th character then the lot was not affected by this recall.)

March 24, 2006 – expanded hernia mesh patches to hospitals and surgeons
An urgent letter is sent to hospital administrators advising them that the Class I recall has been expanded to include certain lots of the Large Oval and Large Circle products, as well as all lots of the Oval product.

Bard Composix Kugel Mesh Patch expanded recall includes all lots of the oval midline size (product code 0010209), and lots manufactured before 2004 of the large oval (0010202) and large circle (0010204) products. The recall previously affected only the extra-large oval patch.

A letter sent to distributors of the Kugel Mesh Patch states that the recall includes lots manufactured up to and including December 2003. The letter also stated the risk that the welds could break under the stress placed on the large-sized products during placement, leading to potential patient complications such as abdominal pain, bowel perforation problems, or chronic enteric fistulas.

Finally, a letter is also sent to surgeons on that very same day requesting that they immediately stop using the specific products listed in the recall and give copies of the Important Patient Management Information to professionals who are managing patients already implanted with the recalled products.

The expanded hernia patch recall is issued because the maker of the Kugel Mesh Patch has learned of further memory recoil ring breaks, including cases of bowel perforation problems, memory recoil ring migration through the abdominal wall, bowel obstruction, and in one instance where a patient died after developing septic shock, blood clotting, and acute heart attack from surgery to repair bowel fistulas caused by perforation from the broken memory recoil ring.

December 18, 2006 – hernia mesh patch lawsuit filed
A hernia damage lawsuit is filed against the maker of the Kugel Mesh Patch. The plaintiff claims problems of the surgical Mesh Patch resulted in severe pain and required bowel dissection surgery to remove the Patch, which had become stuck to the plaintiff's bowel. The bowel dissection surgery resulted in chronically inflamed bowels.

Mesh Patch lawyers for the plaintiff argue that Davol, Inc. (maker of the Mesh Patch), knew that there was a possibility of failure in the Kugel Mesh Patch but did not properly warn the public.

January 10, 2007 – Kugel Mesh Patch recall extended/hernia damage complications multiply
The maker of Kugel Mesh Patch extends the recall to include large-sized Composix Kugel Patches (oval and circle) due to additional reports of memory recoil ring breakage. Another product with the same component design is also recalled because of the potential for breakage. The new recall, which is in addition to earlier recalls in December, 2005, and January and March, 2006, affects Kugel Mesh Patches manufactured between January 1, 2004 and September 30, 2005.

The affected mesh patches are:

• Product Code: 0010202, Bard Composix Kugel Large Oval, 5.4" X 7.0"
• Product Code: 0010204, Bard Composix Kugel Large Circle, 4.5"

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SURGERY INFORMATION
Check all you have experienced:
Persistent Surgical Site Drainage Bowel Paralysis Severe Persistent Abdominal Pain Abdominal Tenderness Distended Abdomen Fluid in Abdomen Abdominal Abscess Formation Intestinal or Bowel Perforation Internal Fistulas External Fistulas Pelvic Inflammatory Disease Peritonitis Sepsis Corrective Surgery
Date of surgery:	MM January February March April May June July August September October November December DD 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 YYYY 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981 1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959 1958 1957 1956 1955 1954 1953 1952 1951 1950 1949 1948 1947 1946 1945 1944 1943 1942 1941 1940 1939 1938 1937 1936 1935 1934 1933 1932 1931 1930 1929 1928 1927 1926 1925 1924 1923 1922 1921 1920 1919 1918 1917 1916 1915 1914 1913 1912 1911 1910 1909 1908 1907 1906 1905 1904 1903 1902
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Did the memory ring in the patch break?	Yes No
Did the patch/ring casue a perforation?	Yes No
Was the memory ring and patch removed?	Yes No
Date Removed:	MM January February March April May June July August September October November December DD 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 YYYY 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981 1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959 1958 1957 1956 1955 1954 1953 1952 1951 1950 1949 1948 1947 1946 1945 1944 1943 1942 1941 1940 1939 1938 1937 1936 1935 1934 1933 1932 1931 1930 1929 1928 1927 1926 1925 1924 1923 1922 1921 1920 1919 1918 1917 1916 1915 1914 1913 1912 1911 1910 1909 1908 1907 1906 1905 1904 1903 1902
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