• Less pain

• Early return to activities

• Low recurrence rate

• Can be performed under local anesthesia

• Lower cost than laparoscopy

• More complete repair than the open technique

Defective Rings
Davol markets the Bard Composix Kugel Hernia Patch in several sizes and shapes. In 2002, the company began to receive complaints about their extra large version of the device having broken rings. Some of the complaints claimed that the broken rings were causing serious complications and injuries. At the time, the company thought that there were too few complaints to warrant any action. In 2005, however, they received ten complaints about broken rings over a three-month period. One of these reports included a near-fatality. Because three of those reports came from the same doctor in Germany, the company determined that doctor error was causing the rings to break, so it began revising the device's instructions and holding training sessions for the doctors. In the mean time, they continued to sell the patch and doctors continued to use it.

By the end of 2005, after running tests on the failed device, the company found that the breakages were caused “by a failure at the ring weld.” Bard/Davol had the extra-large versions of the patch recalled. Later, they broadened the scope of the recall to include large versions of the patch as well. 

FDA Recall

The initial Class I recall was issued on December 22, 2005, with updates on March 31, 2006 and January 24, 2007.  The recalled product in a Class I recall poses a serious danger to patients using it. The reason cited on the recall notice is as follows:

The "memory recoil ring" that opens the Composix® Kugel® Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

The table below lists the lots that have been recalled so far: 

• 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.
   

The Food and Drug Administration (FDA) has warned that “surgeons and hospitals should stop suing the recalled product and returned the unused units to the company.” To view the recall notice from the FDA, click on the following link: http://www.fda.gov/cdrh/recalls/recall-122205.html 

The FDA has warned implanted patients who experience unexplained or persistent abdominal pain, fever or tenderness at the implant site or other unusual symptoms to seek medical attention immediately. The FDA also warns that the new re-designed, safe products can be identified by a label reading “Redesigned for improved ring integrity.” Lots with this label do not need to be returned to Davol.

An FDA inspection in early 2007 of Davol's Rhode Island headquarters discovered serious shortcomings with Davol's quality assurance programs. The FDA determined that the programs were so inadequate that Davol was unable to track complaints or conduct timely investigations, and that this failure was to blame for the delays in Davol’s response to the Kugel Mesh Patch fiasco.

 To view an article from the New York Times entitled “History of Hernia Patch Raises Questions on Implant Recalls”, click on the following link: http://www.nytimes.com/2007/03/16/business/16hernia.html?pagewanted=1&_r=1

Lawsuits Against Davol and Bard

Many lawsuits relating to the defective Kugel Mesh Hernia Patch have already been filed against Davol and Bard in Federal District Court. The Judicial Panel on Multidistrict Litigation of the United States Courts has consolidated all federal cases on the matter, including ones not associated with the recall. The consolidated cases have been transferred to the District of Rhode Island.

Medical device manufacturers, distributors and their parent companies must make sure that their products are not unreasonably dangerous. If they are, like in this case, they can be held liable under both strict liability and negligence for the injuries caused by the defective, dangerous device. If you or a loved one have been injured by the Kugel Mesh Hernia Patch, you should contact an experienced attorney to protect your rights.

Cases involving defective medical devices such as the Kugel Mesh Hernia Patch are complex and require an attorney who has a thorough understanding of the issues involved and is experienced in successfully handling cases involving the defective product.  You need an attorney with the right combination of legal experience and medical knowledge to advise you about your legal rights and treatment alternatives to ensure that your rights are properly protected.  Cases involving defective medical devices are extremely time sensitive; it is imperative that measures be taken to ensure your proper diagnosis and treatment, preserve evidence, prove the nature and extent of your injuries, and enable experts to establish the cause of your injuries.  If you or a loved one has been injured by the Kugel Mesh Hernia Patch, call the Law Offices of Leandros A. Vrionedes at 866-540-0982 for a free evaluation of your claim.