Composix Kugel Mesh Patch Reference Guide
Manufacturer
• Davol, Inc
Status
• Removed December 22, 2005
• Recalled January, 2006
• Recalled March, 2006
Approved use
• Ventral hernias
• Incisional hernias
Serious side effects
• Bowel perforations
• Chronic intestinal fistulae
What is a Kugel mesh hernia patch?
Composix Kugel Mesh Patches, manufactured by Davol, Inc., are used to repair ventral (incisional) hernias caused by thinning and stretching of scar tissue post-surgery. They were introduced in 1997.
Contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts defective medical device litigation.
Who uses it, and for what condition?
Surgeons who repair specific types of hernias.
How does a mesh-patch work?
Two pieces of mesh fabric sandwich a flexible plastic ring, known as the memory recoil ring. Inserted during surgery, it supports the weakened abdominal wall until the patient’s own tissues can grow and heal a hernia.
The memory recoil ring can break under the stress of placement in the intra-abdominal space. Failures have been reported in numerous cases. Failure can result in bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs). Symptoms include persistent or unexplained abdominal pain, fever, tenderness at the implant site, and other related symptoms.
What can you do?
If you or a loved one has been harmed by a Composix Kugel Mesh Patch, please contact our office to discuss your rights: Marilyn T. McGoldrick and David C. Strouss or call our toll free number 1-888-341-1405 to speak directly with an attorney.
Recall of Certain Composix Kugel Mesh Patches Used In Hernia Repair
Specific lot numbers of Composix Kugel Mesh Patches were recalled by manufacturer Davol, Inc., a subsidiary of C.R. Bard, Inc.
Affected lots were recalled between December 2005 and March 2006. In March of 2006, the FDA sent a recall letter to physicians and patients advising patients implanted with one of the recalled lot numbers to seek immediate medical attention if they experience persistent or unexplained symptoms. Patients should also contact their physician, if they have not done so, for further evaluation.
This recall is product code- and lot-specific and applies to the large sized patches. The specific Product Codes and Descriptions recalled at this time are:
(Recalled December 2005 and January 2006)
- PC# 0010206 Bard Composix Kugel Extra Large Oval 8.7″ x 10.7″
- PC#0010207 Bard Composix Kugel Extra Large Oval 10.8″ x 13.7″
- PC#0010208 Bard Composix Kugel Extra Large Oval 7.7″ x 9.7″
- (Recalled March, 2006)
- PC#0010209 Bard Composix Kugel Oval 6.3″ x 12.3″
- PC#0010202 Bard Composix Kugel Large Oval 5.4″ x 7″
- PC#0010204 Bard Composix Kugel Large Circle 4.5″
Trust our Massachusetts products liability attorneys to help
Contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts defective medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case.
