Mesh Hernia Patch Lawsuit & News Blog

FDA Announces Recall of Hernia Patch

Tue, 5 Feb 2008 08:15:17 -0500

FDA ANNOUNCES RECALL OF HERNIA PATCH

On December 22, 2005, the Food and Drug Administration, or FDA, announced the recall of the Bard Composix Kugel Mesh Patch. The Bard Composix Kugel Mesh Patch which is manufactured by Davol Inc, a subsidiary of C R Bard Inc, was created with the purpose of repairing ventral hernias.

Ventral, or incisional, hernias are most like to be attributed by the thinning or stretching of scar tissue which develops after surgery. The Bard Composix Kugel Mesh Patch is put in place behind the defected hernia through a tiny incision. Then, the patch is held open with the "memory recoil ring" which enables the patch to fold during insertion so that once it is in place it will spring open and lay flat.

The FDA is recalling the Bard Composix Kugel Mesh Patch because the "memory recoil ring" that is used to open the patch can break when placed under stress in the larger sized products that are inserted within the belly area. Once the patch breaks, this can cause bowel rupture and recurring abnormal connection with the intestines to other organs.

The original FDA recall of the Bard Composix Kugel Mesh Patch includes the X-Large Patch Oval with ePTFE that have the following lot numbers and must contain either of the letters M, N, O or P as the fourth character to qualify in the recall:

Product Code 0010206 - The Extra Large Oval 8.7" x 10.7" All Lot Numbers
Product Code 0010207 - The Extra Large Oval 10.8" x 13.7" All Lot Numbers
Product Code 0010208 - The Extra Large Oval 7.7" x 9.7" All Lot Numbers
All Extra Large Oval Patches should include these Lot Numbers:
41*M****-M=2002, 41*N****-N=2003, 43*M****-M=2002, 43*N****-N=2003, 43*O****-O=2004, 43*P****-P=2005

With this recall, Davol Inc, began notifying the customers on December 27, 2005 in a letter delivered Federal Express that use of the product should be discontinued and the unused units should be returned to the company.

Then, on March 31, 2006, the FDA expanded the recall to include the following products:

Product Code 0010209 - The Oval 6.3" x 12.3" All Lot Numbers
Product Code 0010202 - The Large Oval 5.4" x 7.0" with Lot Numbers:
41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
Product Code 0010204 - The Large Circle 4.5" with Lot Numbers:
41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****

After the recall was updated, Davol Inc further sent letters to health care professionals and hospitals alerting to the updated recall products list. The notification further informed surgeons and hospitals were advised to stop using the recall products, but instead return all unused units to the company. It was then that patients were also informed that if they were implanted with any of the recalled devices, then medical attention should be sought immediately if any symptoms are experienced that could be associated with the ring breaking. These symptoms may include such things as abdominal pain, fever, tenderness at the implant site, or anything else that may be unusual.

With the FDA making another updated recall on January 24, 2007 to include additional products, more and more patients are finding out that they may be implanted with the Bard Composix Kugel Mesh Patch that falls into one of the recalled medical devices.

The new updated list includes these products:

Product Code 0010202 - The Large Oval 5.4" x 7.0" and have Lot Numbers that were manufactured before October 2005 and include:
All Lot Numbers with the letter O in the fourth position
All Lot Numbers with the letter P in the fourth position and the letters A through I in the third position
Product Code 0010204 - The Large Circle 4.5" and have Lot Numbers that were manufactured before October 2005 and include:
All Lot Numbers with the letter O in the fourth position
All Lot Numbers with the letter P in the fourth position and the letters A through I in the third position

Now, with this recall, Davol Inc has further expanded the recall by issuing a market withdrawal. A market withdrawal occurs when the manufacture decides to remove or correct products that have been distributed that may involve minor violations or even no violation of the law at all, and therefore, will not be subject to any legal action from the FDA. This withdrawal is to include:

Product Code 0010202 - The Large Oval 5.4" x 7.0" manufactured from October 2005 to October 2006
All Lot Numbers with the letter P in the fourth position and the letter J through L in the third position
All Lot Numbers with the letter Q in the fourth position and the letters A through I in the third position
Product Code 0010204 - The Large Circle 4.5" manufactured from October 2005 to October 2006
All Lot Numbers with the letter P in the fourth position and the letter J through L in the third position
All Lot Numbers with the letter Q in the fourth position and the letters A through I in the third position

Finally, Davol Inc, once again sent out letters to distributors and health care professionals informing them of the latest expansion in product recalls, and advised surgeons and hospitals to stop using the recalled products, but rather, to return all unused units back to the manufacturing company.

Fortunately, an upgraded product design has been created for both product codes and is available to replace the recalled medical devices. The replacement medical devices are labeled "Redesigned for improved ring integrity," and are not affected by the previous market withdrawal in any way.

So what does all this mean for patients that have been implanted with the Bard Composix Kugel Mesh Patch? With all the recalls, and with some of the medical devices not be recalled until a later date, damage to the patients may have been done. If a patient or loved one would like to know just how all this may affect them, please click here to request a free no obligation consultation.

Bard Composix Kugel Mesh Patch

Sat, 2 Feb 2008 09:01:49 -0500

DAVOL KUGEL MESH PATCH

Davol Inc, a subsidiary of C R Bard, manufactured the Bard Composix Kugel Mesh Patch to aid in the repair of ventral hernias. The medical device was intended to be placed behind the hernia during surgery and then the spring loaded plastic memory recoil ring holds the patch open. It is the memory recoil ring that has, unfortunately, been the reason for this medical device to be recalled as it can break which leads to bowel perforation or chronic enteric fistulae, or the abnormal connection between the two tissues that are otherwise not normally connected. The breaks can be caused by many factors, some of which will include any mild pressure that may be exerted during other surgical techniques.

A patient that has received the Bard Composix Kugel Mesh Patch may experience unexplained abdominal pain accompanied with tenderness at the implant sight and possibly a fever. These are sure signs that the medical device may have malfunctioned and the patient should seek immediate medical attention. Once medical attention has been sought, there are three procedures that can be done to check and find out if the Bard Composix Kugel Mesh Patch has actually failed causing the symptoms. These procedures may include a lower plate x-ray being taken, barium fluid being swallowed or given as an enema, and reverse imaging CT scan being performed.

Davol Inc originally took the inititive to alert the public about the defects associated with the Bard Composix Kugel Mesh Patch on March 24, 2006 by advising physicians and surgeons to not only discontinue use of this medical device, but to also contact any previous patients that were given the Bard Composix Kugel Mesh Patch and communicating the risk of using the device. Even after Davol Inc had done this, the company continued to go as far as asking the physicians and surgeons to report back to Davol Inc and the FDA any discoveries associated with informing the previous patients and removing the medical device. Yet, with the physicians and surgeons being made aware of the consequences of using the Bard Composix Kugel Mesh Patch, there are still many patients who still use these medical devices.

Therefore, those patients should come forward and contact this law office today by clicking here to receive a free no obligation consultation.

Beware: Hernia Patients with Kugel Mesh Patches

Fri, 22 Jun 2007 11:10:19 -0500

Davol makes the Bard Composix Kugel Hernia Mesh Patch used to treat hernias that usually occur where a previous incision has been made in the body. The patch has a recoil spring that helps it to be folded and inserted, after which it is supposed to spring open and flatten. Davol, Inc. began recalling the patches in January of 2007 after the springs in the patches began to break. The breaking of the spring caused serious and fatal injuries including bowel perforation and death.

People started reporting complications with the kugel mesh patch in 2005. However, as early as 2002, shortly after the kugel mesh patch was introduced, Davol had received its first reports of the patch defects.

You have to wonder why it's taken 5 years to be recalled. How about - greed? This kind of chronological oversight means that many lives were and are in jeopardy.

Hernias are a painful condition in which an organ abnormally bulges out through the tissues that surround it. Usually occurring in the abdomen, a hernia can cause major problems. Hernias cause extreme pain and discomfort which ultimately decreases mobility, severely inhibiting a person's ability to walk, stand, or bend.

Source: http://www.newsinferno.com/archives/1587

Hernia Glossary

Wed, 9 May 2007 07:11:35 -0500

Hernia Glossary - http://composix-hernia-mesh.legalview.com/glossary/

To better understand the complex terminology associated with hernias, surgical repair, methods of repair, numerous kugel mesh patches -- here's a Web site that breaks it down from A to Z.

For instance, what is strangulation as it relates to hernia? Strangulation occurs when a loop of intestine or fatty tissue becomes trapped and loses its blood supply. This is an emergency situation in which dangerous obstruction of intestinal flow can occur; it's life threatening and no longer elective surgery.

Hernias Happen

Tue, 8 May 2007 07:07:08 -0500

Hernias are equal opportunity offenders. Hernias strike overweight people, smokers, and trained athletes. Hernias happen to people who lift too heavy objects and to people that are sitting still. There's no rhyme or reason to a hernia.

A hernia happens when a small portion of tissue from inside the body pushes through a weak spot in the abdominal wall. Most of the time a hernia happens in the area where the abdomen meets the thigh. Men are 25 times more likely than women to develop a hernia and the bulge sometimes protrudes into the scrotum.

It was previously believed that hernias were caused by heavy lifting, coughing or straining. Such activities may bring on a hernia if a weakness already exists in the abdominal tissue, but the current belief is that the weakness is usually caused by impairment in collagen metabolism caused by smoking, infection and obesity - as well as straining - can increase the risk.

If you have a hernia, you may not know it until a doctor detects it on a routine examination. The hernia can be seen or felt as a tender bulge or round lump that becomes more prominent when you cough, strain, or stand up. In the early stages, it's possible to push the protruding tissue back in place temporarily.

A break in the abdominal wall will not get better on its own. And a serious problem could occur if fatty tissue or an organ gets trapped inside the hernia and is deprived of blood flow or strangulation. Because of the risk of gangrene and tissue death, strangulation is a life-threatening condition requiring emergency surgery.

Because of the risk of strangulation, many persons undergo surgery right away, even if the hernia is not causing pain or other symptoms. A study published in the Journal of the American Medical Association (Jan. 18, 2006) found, however, that immediate action may not always be necessary.

Adults choosing to delay surgery might need to wear a belt or other device in order to handle every day activities without pain or discomfort. While hernia surgery is usually worry-free, recurrence has been a problem. The traditional repair involved suturing together the ends of the defect in the abdominal wall. With the resulting increased tension on the abdominal muscle tissue, another tear is eventually likely to happen.

New surgical approaches aim to reduce tension by stitching a mesh patch made of synthetic material into the defect. In one study, recurrence rates over a 10-year period were 32 percent for patches compared to 63 percent for traditional suture repairs.

To enhance the strength of the repair, many doctors today place the patch under the abdominal muscle as deeply as possible. With this approach, pressure from inside the abdomen may even strengthen the repair by pressing it firmly against the abdominal muscles.

If you have a small hernia that doesn't cause symptoms, the below article says that there's no need to let it worry you. When it becomes large enough to cause you pain, you should have no trouble finding an experienced surgical team.

Source: http://www.zwire.com/site/news.cfm?newsid=18258789&BRD=1817&PAG=461&dept_id=222089&rfi=6

Hernia Repair Booklet

Tue, 1 May 2007 07:09:39 -0500

Over half a million hernia repairs were done in the United States last year. Outcomes will different as no two people are alike. The outcome differs based on your age, overall health, severity, and size of the hernia.

Unless the hernia is strangulated or needs immediate attention as in life threatening, most hernia surgeries are electives. Most people will opt for hernia surgery because hernias do not heal by themselves and even thought most hernias are not life threatening they can be very painful.

Most hernia surgeries are done as out patient surgeries but you will need someone to drive you to and from. The most common method of surgery is the convention method where an incision is made over the site of the hernia and the protruding tissue is returned to the abdominal cavity and the sac that has formed is removed. The surgeon repairs the weakness by sewing strong surround muscle over the hole.

For the tension-free mesh technique, an incision is made at the site of the hernia and a piece of mesh is inserted to cover the abdominal wall area without sewing together surrounding muscles. Recovery is usually swift but the mesh doesn't come without side effects and risks.

For the laparoscopic method, a scope is inserted into the abdominal cavity through a small incision. Although some surgeons use this method, how often a hernia reoccurs is being evaluated.

Proper recovery is as important as the hernia repair. A smooth hernia recovery goes a long way to bettering your chances for a hernia not to reoccur.

See: Hernia Repair Booklet - http://www.facs.org/public_info/operation/hernrep.pdf

Successful Hernia Surgery

Wed, 18 Apr 2007 09:17:20 -0500

Sports Players Have Successful Hernia Surgeries: http://www.katv.com/news/stories/0407/414940.html

Philadelphia Flyers goaltender Antero Niittymaki and left wing Simon Gagne both had successful hernia surgery on Monday. Gagne had a procedure done in Montreal to have a small hernia on his right side and a larger hernia on his left side repaired. He is expected to be fully healed within eight weeks.

Class 1 Recall - Bard Composix Kugel Mesh Patch

Wed, 18 Apr 2007 09:12:56 -0500

FDA RECALL: December 22, 2005 -- 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 space which can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs). Six product numbers were listed.

Kugel Mesh Patch Causes Health Problems Claims Man

Tue, 17 Apr 2007 09:09:38 -0500

In 2005, the Food and Drug Administration recalled Bard Composix Kugel Mesh Patches with certain product codes. In 2004, Harrison County, West Virginia, a male resident had one of the patches inserted in his body during surgery to repair a hernia. The man claims that since that surgery his health has deteriorated. He blames his problems on the mesh patch.

For the past few years he has been through a lot, including bone marrow tests that showed cancer, along with fatigue, sweating, and fever almost every day. He's had several surgeries, including one that lasted seven hours. The man has to be hooked up to an IV twice a day. Doctors have not removed the mesh from his body because they are not convinced that the mesh has caused his medical problems.

http://www.statejournal.com/story.cfm?func=viewstory&storyid=21957

Expanded Kugel Mesh Recall

Wed, 10 Jan 2007 09:15:31 -0500

FDA RECALL: January 10, 2007-Expanded recall action to certain manufacturing lots of the referenced product based on having received additional complaint reports of recoil ring breakage. Davol has decided to withdraw from the market all remaining 0010202 and 0010204 product which has the same component design as the manufacturing lots being recalled. An upgraded product design for both product codes is available for replacement.