The memory recoil ring on the kugel mesh patch, used in ventral hernia repair, could break and potentially lead to bowel perforation or chronic enteric fistula. The hernia mesh patch recall was further updated on january 24, 2007, to include additional product codes 0010202 and 0010204 and lot numbers recalled by davolbard since the first recall was issued. Bard, were granted regulatory clearance under the u. Lawyers are assisting patients with the recalled devices file claims for medical monitoring and compensatiom. It has a specially designed memory coil ring that opens the patch after it is placed behind the area of the hernia. Mesh lawsuits for kugel hernia mesh recall saunders. The patches are designed so that they can be folded when inserted and then spring open to lay flat once in place. The recall of the hernia patch was initiated because the memory recoil ring that opens the kugel mesh patch can break under the stress of placement of the large sized products in the intraabdominal space. Bard composix kugel mesh hernia patch recall below is an excellent video produced by the u.
Here are some of the hernia mesh recalls since 2005. The memory recall ring is used to open the kugel mesh patch after it has been inserted. Complications over the next several years, complications resulting from hernia operations using the kugel mesh patch began to be registered with the manufacturer, davol, inc and the fda. The composix kugel mesh patch was recalled in the united states by the fda.
An article published in the journal annals of gastroenterology cited a case study in which a patient had hernia mesh repair surgery in 1996. Hernia mesh patch patients are urged to determine if they are affected by the hernia mesh recall of the bard composix kugel mesh hernia patches. The compsix kugel mesh hernia patch is manufactured by davol, inc. There were two more recalls following in 2006 and 2007. This patch was manufactured to be used for ventral or incisional hernias. Bard composix kugel hernia mesh recall between 2005 and 2007, three separate recalls were issued for the c. Hernia mesh patch recall fda warns of death and serious. Recall of certain composix kugel mesh patches used in hernia repair. But the company waited almost three years before recalling its mesh. One of the options available to doctors in the surgical treatment of hernias is the use of mesh patches. Bard received reports that the kugel patch was failing as early as 2002. April 3, 2006 updated april 21, 2006 the us food and drug administration fda and davol, inc a subsidiary of c. Bard and davol recalled composix kugel mesh products from the market starting in 2005. Cincinnati kugel mesh hernia patch lawyer defective.
Recall classified as class i because the defect associated with the use or exposure to the bard composix kugel mesh large patch has a reasonable probability to cause serious adverse health consequences, including death. The mesh helps to strengthen that weak spot and hold the tissue in, but some brands of mesh have been recalled over very serious issues and complications. Bard kugel hernia mesh patch was one of the first mesh implants to be recalled. Bard composix kugel mesh hernia patch lawsuits schmidt.
Kugel as an alternative treatment for hernia repair. While the symptoms may indicate hernia mesh failure, imaging tests and xrays can confirm that the mesh has fallen apart. Recall classified as class i because the defect associated with the use or exposure to the bard composix kugel mesh large patch has a reasonable probability to cause serious. Patients who received kugel mesh experienced reactions to the materials and breakdown of the product. Hernias are painful and require treatment to prevent further medical harm. Hernia mesh failure symptoms can appear long after surgery. A class 1 recall for a ventral hernia repair device. While the kugel mesh patches have been recalled, doctors are finding other problems arising from medical mesh devices and implants. Composix kugel mesh patch was recalled due to faulty memory. If you or a loved one has received a kugel mesh patch via hernia treatment, it is important to see a qualified health care provider at the earliest sign of unusual symptoms. Cincinnati kugel mesh hernia patch lawyer defective tissue. Like patients with kugel mesh patches, tracy is having problems with her hernia repair patch and requires surgery to have it taken out. In the more common ventral or incisional hernia, the patch is placed behind the hernia defect through a small incision.
The us food and drug administration fda and davol, inc a subsidiary of c. Approximately 750,000 kugel mesh patches were implanted each year to repair hernias. The fda announces the nationwide recall of certain kugel mesh hernia patches. Recalls of certain sizes of the kugel hernia mesh patch were issued in 2005, 2006, and 2007. Bard composix kugel hernia patchlarge oval with eptfe, 5.
Kugel mesh hernia patch lawsuit information do i have a. Hernia patch and other mesh implants pose problems righting. If you are a patient suffering from hernia, it is better to know some facts about it, before contacting a kugel mesh patch recall lawyer. Kugel mesh hernia patch lawsuit set for trial to begin today. Jun 30, 2009 the fda announces the nationwide recall of certain kugel mesh hernia patches. In this case, it is recommended to look for a kugel mesh patch recall lawyer, who can help and guide such unfortunate patients. The kugel patch was a line of hernia mesh products bard davol manufactured starting in the 1990s. Composix kugel mesh patches lawsuit hernia mesh lawsuit. Davol issued a hernia patch recall for the extralarge model of the kugel mesh hernia patch in december 2005. Boston scientific manufactures aortic and carotid stents with mesh, but the surgical insertion tip sometimes detaches during surgery. Their latest product, the kugel hernia patch, is being used to repair painful, potentially fatal tears in the abdominal wall. A hernia occurs when part of an internal organ pushes through an opening in the organs wall and often presents itself as a painful lump in the abdomen or groin. Kugel mesh hernia patch lawsuit set for trial to begin.
Kugel hernia mesh recall lawyers problems with recalled. Davol recalled the kugel mesh patch in december 2005, and expanded the recall in 2006 and 2007. After receiving a kugel mesh patch during a hernia repair surgery, thorpe began complaining of severe abdominal pain approximately 45 months later. Kugel mesh was identified as a class 1 recall, the fdas most serious type of recall. The fda issued a warning announcement advising patients who already had the recalled units in their bodies to be on alert for signs of device failure and seek immediate medical attention if they experience symptoms. When it was first introduced, the kugel mesh hernia patch was heralded as an innovation in hernia treatment. Bard davol hernia mesh mess hernia mesh lawsuit update.
The fda issued the following kugel mesh hernia patch safety alert on 2107. Kugel mesh hernia patches were manufactured by davol inc. Many hernia mesh products, including some of those marketed by ethicon, atrium medical, and c. Bard issued a kugel mesh recall for the hernia patch model that was implanted in whitfield as a result of multiple reports of similar problems. The reports were so alarming that the fda issued a class i recall of the bard composix kugel mesh xlarge. Food and drug administration recently issued a class 1 recall of these hernia mesh repair patches because the defect associated with the use or exposure to the bard composix kugel mesh. Bard, inc, have notified healthcare professionals regarding the. The fda requested a recall of the companys defective stents and stent. Hernia mesh recall hernia mesh is a simple medical device that is used to repair hernias, which occur when intestines or other tissue protrude through weak areas of muscle. 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. The kugel mesh patch was first recalled in 2005, after the fda received reports that the composix kugel mesh patch had caused many severe injuries.
If you have questions about the composix kugel mesh hernia repair patch litigation, contact medical device lawyer don migliori by email or call 1. The bard composix kugel hernia patch is manufactured by davol, a subsidiary of c. Over 78,000 bard composix hernia mesh patches were distributed between 20012006. Subsequently, the company announced a recall urging doctors to stop using the patch because the recoil ring was found to break under pressure.
Kugel mesh hernia patch massachusetts drug and medical. The kugel mesh patch is used to repair inguinal, ventral and laparoscopic hernias. There are over 750,000 hernia operations each year in the u. The ring allows the patch to be folded for insertion and later, once the patch is in place, to spring open and lay. Review a detailed list of lot numbers and product codes affected by the recall. Cqur vpack mesh made by atrium medical corporation was. Sep 24, 2008 like patients with kugel mesh patches, tracy is having problems with her hernia repair patch and requires surgery to have it taken out. Specific lot numbers of composix kugel mesh patches were recalled by manufacturer davol, inc. May 10, 2007 the composixr kugel mesh patch is used to repair ventral incisional hernias caused by thinning or stretching of scar tissue that forms after surgery. By the time problems surfaced, however, it had already been implanted over a million times. What would be the reason be for a hernia surgery redo. The kugel hernia mesh patch comprises two pieces of mesh that surround a flexible plastic ring. Like so many of their products, however, they are causing more problems than they are solving. Kugel mesh hernia patch lawsuits hernia patch litigation.
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. The reason for the recall was that the memory recoil ring was frequently breaking. Incisional hernias are usually caused by the thinning or stretching of scar tissue that forms after surgery. This pain developed into an infection of an area of the mesh requiring hospitalization and surgery to drain the abscess, debride the kugel mesh patch as well as removal of the part of the kugel. A hernia occurs when the patients stomach muscles become weakened and as such are unable to properly contain the intestines. Six different products in the patch line have been recalled. Furthermore, if you or a loved one has been harmed due to kugel hernia mesh patch side effects, it is important to inquire about your legal rights and options. Kugel mesh hernia patch dangers north carolina product. Fda recalls additional bard composix kugel hernia patches. The kugel hernia mesh patch patch is used to repair ventral hernias. Jan 30, 2018 kugel hernia mesh patch recalls recalls of certain sizes of the kugel hernia mesh patch were issued in 2005, 2006, and 2007.
The kugel mesh hernia patch was originally recalled due to defects with the memory recoil ring in 2005. May 12, 2007 the kugel hernia mesh patch patch is used to repair ventral hernias. The fda has upgraded the recall of several bard composix kugel mesh hernia patches to warn patients of the possibility of death and serious health problems. The composix kugel mesh hernia patch is a device used to repair ventrical hernias also known as incisional hernias, which may develop at the site of prior surgical scars. An expanded recall was enacted in january 2007 after the fda warned doctors to stop using certain lot numbers of the defective medical device. Oct 02, 2008 while the kugel mesh patches have been recalled, doctors are finding other problems arising from medical mesh devices and implants. Bard composix kugel hernia patch large oval with eptfe, 5. The kugel mesh patch is used to repair ventral hernias. As a followup, the fda launched an investigation into the complaints.
The composix kugel mesh patch is considered a dangerous device because of the serious medical risks. It is used primarily for hernia surgery, particularly for laparoscopic ventral. Bard composix kugel hernia patches recalls parker waichman llp. On march 31, 2006, the fda expanded the original hernia mesh patch recall to include oval, large oval and large circle kugel hernia mesh patches. In many cases, doctors surgically insert hernia repair mesh which lays flat, preventing the hernia from pushing through any holes in the. It is usually placed, through a small incision, behind the hernia defect. Additionally, the fda expanded the recall in 2007 to include more than 16,000 composix kugel mesh hernia patch units due to the same risk of the memory recall ring breaking under the pressure. Kugel hernia repair mesh patch recall risk of death, if. Jun 05, 2012 the kugel mesh patch was approved for use by the u. The complications have not yet been linked to any one type or brand of surgical mesh.
Kugel mesh hernia patch chicago product liability lawyer. The products were commonly used to repair incisional hernias in the abdomen. Affected lots were recalled between december 2005 and march 2006. Barddavol composix kugel hernia mesh patch due to serious safety risks. Davol has received complaints and reports of the hernia patch malfunctioning during and after surgery. I had a hernia recently, and i had severe abdominal pain. Bard, inc, have notified healthcare professionals regarding the expansion of a class 1 recall for a ventral hernia repair device bard composix kugel mesh patch to include all lots of the oval midline size. May, 2017 each year hundreds of thousands of hernia surgeries are performed in the united states and many years ago, a product came out to the market called the kugel mesh patch. Each year hundreds of thousands of hernia surgeries are performed in the united states and many years ago, a product came out to the market. The composixr kugel mesh patch is used to repair ventral incisional hernias caused by thinning or stretching of scar tissue that forms after surgery. Bard faced a class action lawsuit against the kugel hernia mesh patch, which led to the company paying out hundreds of millions of dollars in settlements. Hernia patch and other mesh implants pose problems. Victims have been reporting dozens of hernia mesh patch recall symptoms.
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