C.R. Bard, manufacturer of the defective Kugel Mesh hernia patch, has received an 11-page warning letter from the US FDA. The strongly worded letter cites the Puerto Rican manufacturing plant that makes the Kugel Mesh hernia patch for manufacturing and operational defects. The letter specifically mentions 8 separate complaints having to do with improper manufacturing procedures at the Puerto Rican plant. FDA inspectors visited the plant from November 2007 through February 2008 and found practices that were “not in conformity” with federal manufacturing standards. The Kugel Mesh hernia patch was originally recalled due to defects with the memory recoil ring in 2005. An expanded recall was enacted in January 2007 after the FDA warned doctors to stop using certain lot numbers of the defective medical device.
Each year, there are approximately 500,000 hernia repair surgeries performed in the United States. The procedure may be done on an outpatient basis depending upon the circumstances of the hernia and the overall condition of the patient.
However, if you’ve had hernia repair surgery using the Kugel Mesh hernia patch, you may still be suffering from complications due to the implantation of the defective patch. The Kugel Mesh patch was originally recalled in 2005 with an expanded recall in 2007. The defect in the patch concerns the memory recoil ring which has a tendency to collapse upon insertion into the abdominal wall. Complications from such a defect can cause extreme pain, fistula, bleeding, and infection.
Some of my clients who’ve suffered through this experience have had to go back and have more than one revision surgery. The pain is unbearable and they continue to suffer complications to this day. Even with further surgery, there’s no guarantee the Kugel Mesh patient will ever recover completely and live a life free of pain and abdominal complications.
The company that manufactures the Kugel Mesh hernia patch, C.R. Bard, has been under FDA scrutiny for numerous issues regarding its hernia patch. In 1995, the company entered into a criminal plea agreement after being charged with defrauding the FDA and selling unapproved medical devices. The plea agreement forced C.R. Bard to admit to committing these crimes intentionally.
That history does not help our Kugel Mesh clients who want to return to a normal life without hernia complications, more surgeries, extreme pain, and loss of income. Most of my clients are still in the prime of their life but are restricted due to the complications of having the defective patch.
Hernia Mesh Recall
Bard®, Composix®, Kugel® Mesh Patch
The FDA has expanded its recall of the hernia mesh patch designed by Dr. Robert D. Kugel and manufactured by Davol, Inc. (a subsidiary of C.R. Bard). The FDA sent a letter to health care professionals and distributors on January 10, 2007 notifying them of the most recent expansion of the recall which includes the specific lots of Bard® Composix® Kugel® Large Oval and Large Circle Mesh Patches for product codes 0010202 and 0010204. The FDA stated that “surgeons and hospitals should stop using the recalled product and return unused units to the company.
The recall was prompted by a problem with the “memory recoil ring” that opens the Bard® Composix® Kugel® Mesh patches. The recoil ring can break under the stress of placement of the large sized products in the intra-abdominal space. This breakage can lead to bowl perforations and/or chronic intestinal fistulae.
Davol notified US customers of the initial recall on December 27, 2005. On March 24, 2006, Bard issued letters to hospitals and health care professionals of the additional recalls.
The table below gives a complete list of all product codes and lot numbers, according to the FDA.
|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|