Fda recall kugel mesh patch

Each year, far too many of these meshes are being placed on the market for use that are causing irreparable harm to patients. If you have been harmed by a Bard or some other defective medical device, you should file a MAUDE Adverse Event Report as soon as possible, or call our office today for help and guidance through the process.

We serve hernia mesh victims in almost every city nationwide including Colorado , Arizona , Georgia and more! Bard, Inc. Warning signs of hernia mesh failure include: Fever Abdominal tenderness Nausea Diarrhea Abnormal bowel movements Abdominal distention If you have experienced any of these symptoms, call our Bard Kugel lawsuit lawyers now.

Laparascopic surgery Open surgery Not sure. The FDA wants to help patients make informed decisions about their health care and to facilitate a discussion between patients and their surgeons. A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. Hernias often occur at the abdominal wall. Sometimes a hernia can be visible as an external bulge particularly when straining or bearing down.

Most hernias are caused by a combination of pressure and an opening or weakness of muscle or connective tissue. The pressure pushes an organ or tissue through the opening or weak spot. Sometimes the muscle weakness is present at birth but more often it occurs later in life. Anything that causes an increase in abdominal pressure can cause a hernia, including obesity, lifting heavy objects, diarrhea or constipation, or persistent coughing or sneezing. Poor nutrition, smoking, and overexertion can weaken muscles and contribute to the likelihood of a hernia.

Hernia repairs are common—more than one million hernia repairs are performed each year in the U. Approximately , are to repair inguinal hernias and the rest are for other types of hernias. Hernias have a high rate of recurrence, and surgeons often use surgical mesh to strengthen the hernia repair and reduce the rate of recurrence.

The use of surgical mesh may also improve patient outcomes through decreased operative time and minimized recovery time. Information found in medical literature has consistently demonstrated a reduced hernia recurrence rate when surgical mesh is used to repair the hernia compared to hernia repair without surgical mesh.

For example, inguinal hernia recurrence is higher with open repair using sutures primary closure than with mesh repair 2. Despite reduced rates of recurrence, there are situations where the use of surgical mesh for hernia repair may not be recommended.

The Composix Kugel Mesh Patch is used to repair ventral incisional hernias caused by thinning or stretching of scar tissue that forms after surgery. The hernia repair mesh is placed behind the hernia defect through a small incision. The patch is then 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.

The "memory recoil ring" can break under the stress of placement of the large sized products in the intra-abdominal space.