Florida Bard Composix Kugel Mesh Hernia Repair Patch Lawsuit - Florida Hernia Patch Attorney

Florida Hernia Patch Lawyer
The Florida Hernia Patch Attorney's of Ennis & Ennis have extensive experience representing individuals who have been injured by the defective hernia patch. With offices throughout Florida (Miami & Ft. Lauderdale) the Hernia Patch lawyers of Ennis & Ennis provide our clients the best possible representation to protect their legal rights and maximize the remedies under the law.

Bard Composix Kugel Mesh Hernia Repair Patch Lawsuit
If you or a loved one have experienced any of the serious side effects associated with the Hernia Patch you may be entitled to compensation. For more information about a Hernia Patch lawsuit, Hernia Patch side effects, or a Hernia Patch recall contact the Florida Hernia Patch Lawyers of Ennis & Ennis today for a free legal consultation.

Hernia Repair Patch Lawsuit - Hernia Repair Patch Recall

Why was the Hernia Patch Recalled?
The US Food and Drug Administration along with Davol, Inc., a subsidiary of C.R. Bard, Inc., have recalled Bard Composix Kugel Mesh Patches indicated for the repair of ventral hernias caused by thinning or stretching of scar tissue that forms after hernia surgery.
Hernia Patch

The patch 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 to later spring open and lay flat once it is in place.

The ventral hernia repair device was recalled because the memory recoil ring can break. If the memory recoil ring breaks it can lead to bowel perforation and/or chronic enteric fistulae. The plastic coil ring is designed to aid in its deployment but can break when increased stress is placed on it from certain surgical placement techniques.

According to the FDA Recall Notice "Patients who have been implanted with a Composix Kugel Mesh Patch during hernia surgery should seek medical attention immediately if they experience symptoms that could be associated with ring breakage. These symptoms include:unexplained or persistent abdominal pain, fever, tenderness at the surgery site or other unusual symptoms."

In a March-24-06 recall notice, Bard recommends that health care professionals "Immediately discontinue use of the specific product codes and lot numbers listed below. Additionally, please immediately distribute copies of this Important Patient Management Information to clinicians who may have implanted, or who may be managing, patients already implanted with one of these products under voluntary recall."

The product codes for the Dec-05, Jan-06 and Mar-06 recalls are:

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"
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"

Class 1 Recall: Bard Composix Kugel Mesh Patch - Expansion

Date Recall
Initiated:

December 22, 2005

Product:

*This recall notice was updated on January 24, 2007, to include additional product codes and lot numbers recalled by the manufacturer since the first list was issued. The expanded list below includes all recalled product codes and lot numbers.*

Product Code	Description	Lot Numbers Recalled	Date Recalled
0010206	Bard® Composix® Kugel® Extra Large Oval, 8.7” x 10.7”	All Lot Numbers manufactured before January 2006	December 2005 and January 2006
0010207	Bard® Composix® Kugel® Extra Large Oval, 10.8” x 13.7”	All Lot Numbers manufactured before January 2006	December 2005 and January 2006
0010208	Bard® Composix® Kugel® Extra Large Oval, 7.7” x 9.7”	All Lot Numbers manufactured before January 2006	December 2005 and January 2006
0010209	Bard® Composix® Kugel® Oval, 6.3” x 12.3”	All Lot Numbers manufactured before March 2006	March, 24, 2006
0010202	Bard® Composix® Kugel® Large Oval, 5.4” x 7.0”	Lot Numbers manufactured before October 2005 (see below)	January 10, 2007
0010204	Bard® Composix® Kugel® Large Circle, 4.5”	Lot Numbers manufactured before October 2005 (see below)	January 10, 2007

Use:

The Bard ®Composix® Kugel® Mesh 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. 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.

Recalling Firm:

Davol, Inc., Sub. C.R. Bard, Inc.
100 Sockanossett Crossroad
Cranston, RI 02920

Reason for Recall:

The "memory recoil ring" that opens the Bard® Composix® Kugel® Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

Public Contact:

Robin Drago
VP Regulatory & Clinical Affairs
Davol, Inc., Sub. C.R. Bard, Inc.
100 Sockanossett Crossroad
Cranston, RI 02920
401-463-7000

FDA District:

New England

FDA Comments:

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 CircleMesh 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 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.
It should be noted that product codes 0010202 and 0010204 were involved in both recall expansions. The lots manufactured prior to January 2004 were recalled during the March 2006 expansion. Since the March expansion, Davol received 4 confirmed complaints of recoil ring breakage from product code 0010202 manufactured between January 2004 and September 2005. There were no complaints for product code 0010204 . Davol is recalling the following lots for product codes0010202 and 0010204:

All lots with the letter “O” in the fourth position
All lots with the letter “P” in the fourth position and the letters “A” through “I” in the third position.

For instance, an example of a recalled lot number is “43IPD###.”

Davol also decided to withdraw from the market specific lots of 0010202 and 0010204 manufactured from October 2005 to October 2006. A market withdrawal is a firm’s removal or correction of a distributed product that involves a minor violation or no violation of the law and would not be subject to legal action by the FDA. Davol is withdrawing the following lots:

All lots with the letter “P” in the fourth position and the letters “J” through “L” in the third position
All lots with the letter “Q” in the fourth position and the letters “A” through “I” in the third position

For instance, an example of a withdrawn lot number is “43IQD###.”

An upgraded product design for both product codes is available for replacement. Product codes and lot numbers that contain the re-designed product can easily be identified on the case or unit package with the label stating “Redesigned for improved ring integrity.” If this label is affixed to your case stock and/or individual packages, this product is not affected by this market withdrawal and need not be returned to Davol.

Davol notified U.S. customers of the initial recall by letter on 12/27/05 via Federal Express. On March 24, 2006, Bard issued letters to hospitals and health care professionals alerting them to the additional recalled products. The letters included updated Instructions for Use (“IFU”) clarifying the proper insertion technique and Supplemental Patient Management Information. Copies of current product IFU's to be used for both Open Placement and Laparoscopic Placement for the Large Bard ®Composix ® Kugel ® Mesh Patches are available from Davol Customer Service by calling 1-800-531-4124.
For more information, customers can contact Davol Customer Service at 1-800-531-4124. Physicians may contact Bard’s Medical Services and Support Department at 1-800-562-0027 or to speak with the Bard Medical Director, call 1-908-277-8306.

Recently there has been an addition to the already recalled hernia patches

The Scope MDL 07-1842 patch has alleged defects associated with the Bard Composix Kugel Hernia Patches, product codes 0010201-0010209. On February 12th, 2008 the Rhode Island federal District Court ordered that all Davol ring and dual mesh hernia meshes be included with the expanded patch Scope MDL 07-1842 in Rhode Island.

For more information about Hernia Patch Recalls or the latest Hernia Patch related news visit our Hernia Repair Patch web site.