Food and drug administration tracks reported hernia mesh complications. Kugelmesh recall the fda issued a class i recall for the composix kugel mesh patch the strongest recall available to the fda reserved for dangerous or defective products that predictably could cause serious health problems or death. April 3, 2006 the fda has recalled the composix kugel mesh patch, used to repair ventral incisional hernias caused by thinning or stretching of scar tissue that forms after surgery. The kugel hernia patch recall is classified by the fda as a class i recall, since it has a reasonable probability of causing serious adverse health consequences. Bard composix kugel hernia patches recalls parker waichman llp. The recent fda recall of the bard composix kugel hernia mesh patch occurred long after numerous, severe injuries were reported to the manufacturer which involved the defective device. Ventral hernias occur when scar tissue, caused by a surgical incision, stretches and becomes thin. Kugel mesh hernia patch recalls and patient safety st. Customers should stop using the recalled product and return unused units to the company, the fda said of the companys composix kugel mesh large patch. Kugel mesh hernia patch dangers north carolina product defect. By february 2007, the kugel patch recall had been expanded twice to several other sizes of the device. Bard hernia mesh linked to injuries drug and device watch. Z052406 bard composix kugel mesh xlarge patch oval with eptfe, 8.
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. The recall is classified by the fda as a class i recall, a category reserved for dangerous or defective products that predictably could cause serious health problems or death. Kugel mesh hernia patch dangers north carolina product. The hernia mesh patch at the center of this latest round of litigation against the new jerseybased company was designed, manufactured and marketed by davol, a bard subsidiary since 1980. The recall is due to the potential for breakage of the memory recoil ring under the stress of placement into the intraabdominal space, leading to. The strom law firm, llc is currently investigating and evaluating cases against the makers of kugel mesh.
The bard composix kugel mesh patch, more often simply referred to as the kugel mesh or kugel hernia patch, is manufactured by davol, inc. Class 1 device recall davol composix kugel hernia patch fda. The following table lists all recalled kugel mesh patch product codes and lot numbers. The inspectors found several problems with how bard investigated complaints. Kugel mesh hernia patch lawsuit the composix kugel mesh hernia patch has been linked to serious, lifethreatening side effects and has been voluntarily recalled by its manufacturer davol, inc.
Please refer to the recall notices here for more information if you have recalled mesh. The bard composix kugel hernia patch is used to repair ventral hernias. Mar 22, 2007 the recent fda recall of the bard composix kugel hernia mesh patch occurred long after numerous, severe injuries were reported to the manufacturer which involved the defective device. A class i recall is the most severe type of recall the fda issues and is only used when a drug, product or medical device may result in the users suffering serious injuries. Food and drug administration fda has inspected the headquarters of its manufacturer, davol, inc. Bard composix kugel hernia patch large oval with eptfe, 5. According to an article in the new york times this past march, davol, inc. The fda later updated the degree of its warning, as the products defects have potential to result in serious and adverse health consequences, including death. This defect can lead to bowel perforations andor chronic intestinal. A class i recall meant the kugel patchs defect could cause serious health consequences including death.
In 2007, the fda issued a class 1 recall for the composix kugel mesh patch, a medical device inserted to repair ventral incisional hernias. Composix kugel mesh patches are primarily used to repair ventral hernias. Unfortunately, davol underreported the number of adverse incidents it had received from doctors using the kugel mesh patch. An expanded recall was enacted in january 2007 after the fda warned doctors to stop using certain lot numbers of the defective medical device. Kugel mesh recall lawsuit kugel mesh recall lawyers. 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. The fda has recalled the composix kugel mesh patch, used to repair ventral incisional hernias caused by thinning or stretching of scar. Bard composix kugel mesh patch expansion date recall initiated. Aug 05, 2019 the bard composix kugel mesh patch, more often simply referred to as the kugel mesh or kugel hernia patch, is manufactured by davol, inc. A class 1 recall for a ventral hernia repair device. The composix kugel mesh hernia patch is a medical device surgeons use to repair ventrical hernias, which may.
Barddavol composix kugel hernia mesh patch due to serious safety risks. Composix ex mesh patch, the composix kugel patch, and the composix lp patch. When a manufacturer of a medical device refuses to respond to an fda request for a recall, the fda can order the same. Oct, 2008 many of my kugel mesh clients continue to suffer from the abdominal pain and intestinal fistulae after having surgeries to correct the problem. Lawyers are assisting patients with the recalled devices file claims for medical monitoring and compensatiom.
The compsix kugel mesh hernia patch is manufactured by davol, inc. Class 1 device recall bard food and drug administration. The composix kugel mesh hernia patch is a medical device surgeons use to repair ventrical hernias, which may develop at previous surgery sites or scars. Composix kugel mesh patch was recalled due to faulty memory. The class i recall was issued on december 22, 2005, and then updated on march 31, 2006, to include. 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. In december 2005, the fda issued a class i recall of a number of lots of the kugel mesh patch due to problems with the recoil ring breaking and causing bowel perforations, chronic enteric fistulas, and other injuries. Medical device recalls food and drug administration. Mesh lawsuits for kugel hernia mesh recall saunders. Bard and its subsidiary davol recalled limited lots of the kugel hernia patch in 2005, 2006 and again in 2007.
Kugel hernia mesh recall lawyers problems with recalled. Bard has announced that it is voluntarily recalling its composix kugel mesh xlarge patch intended for ventral hernia repair because of reports that the devices plastic coil ring may break during certain surgical placement techniques. At, we pursuing litigation involving the following defective hernia patches. May 06, 2017 by february 2007, the kugel patch recall had been expanded twice to several other sizes of the device. Kugel mesh patch pharmaceutical lawsuit and recall. The kugel mesh hernia patch was originally recalled due to defects with the memory recoil ring in 2005. Healthcare professionals are encouraged to report adverse events related to use of the ventral hernia repair patches to the fda s medwatch reporting program by phone at 1800 fda 1088, by fax at 1. Davol on kugel mesh hernia patch injury parker waichman llp. The patches are designed so that they can be folded when inserted and then spring open to lay flat once in place. The strongly worded letter cites the puerto rican manufacturing plant that makes the kugel mesh hernia patch for manufacturing and operational defects. Many of my kugel mesh clients continue to suffer from the abdominal pain and intestinal fistulae after having surgeries to correct the problem. The kugel mesh was intended for the repair of two types of hernia. Another barddavol hernia mesh product is ventralex, approved in 2002.
The fda said that recalled mesh was the main cause of bowel perforation and obstruction seen in those patients. Each year, there are approximately 500,000 hernia repair surgeries performed in the united states. The fda issued the following kugel hernia patch safety alert on 2107. The fda has received reported incidents of broken memory recall rings, one of which states that the broken ring had migrated into the abdominal wall. The fda declared it a class i recall the agencys most serious type. Z052506 bard composix kugel mesh xlarge patch oval with eptfe, 10. Gary sharp had a composix kugel mesh patch implanted in december, 2004, to repair a hernia. It is used to strengthen the abdominal wall and repair incisional hernias caused by the stretching or thinning of scar tissue that form after surgery. Fda cdrh medical device recalls bard composix kugel mesh patch expansion class 1 recall.
Implanted patients remain at risk of serious adverse health consequences and death according to the fda. It was recalled again in 2006 and 2007, both times to recall several other sizes of the device. 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. The mesh, used to repair ventral incisional hernias, is being recalled because the memory recoil ring that opens the composix kugel mesh patch after it has been inserted into the intraabdominal space can break, according to the recall notice. Cincinnati kugel mesh hernia patch lawyer defective. This is what happened with the bard kugel mesh patch. The fda has recalled the composix kugel mesh patch, used to repair ventral incisional hernias caused by thinning or stretching of scar tissue that forms after surgery. Bard composix kugel hernia mesh recall between 2005 and 2007, three separate recalls were issued for the c. Bard davol hernia mesh mess hernia mesh lawsuit update. The composixr kugel mesh patch is used to repair ventral incisional hernias caused by thinning or stretching of scar tissue that forms after surgery. The kugel hernia mesh patch patch is used to repair ventral hernias.
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. There are over 750,000 hernia operations each year in the u. Kugel mesh hernia patch lawsuit information do i have a. When the manufacturer is reluctant to conduct a recall, the fda will pursue a recall on its own. For more information on the recalled products, please visit the fda medical device recall website. Bard medical is at it again with defective hernia patches. To search archived content, visit search fda archive and input the name of. The fda posts summaries of information about the most serious medical device recalls. Kugel mesh patch pharmaceutical lawsuit and recall information. Class 1 device recall davol composix kugel hernia patch. Food and drug administration fda approved the kugel mesh patch in 1996. The fda has expanded its recall of the hernia mesh patch designed by dr. Fda recalls additional bard composix kugel hernia patches. The record is updated if the fda identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated.
Fda inspectors visited bard davols kugel patch manufacturing plant in early 2006. The kugel mesh patch was approved for use by the u. The composix kugel mesh is subject to a class 1 recall by the fda initiated on december 22, 2005. This recall notice was updated on january 24, 2007, to include additional product codes and lot numbers. 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. Ventralex is a hernia mesh patch made of polyproplene. Sep 07, 2018 the fda sent a recall letter regarding the composix kugel mesh patch in march 2006 to physicians and patients advising patients implanted with a recalled device to seek immediate medical attention. Bard expanded the recall to two other products five days later. New york kugel mesh attorneys medical device litigation. These products are on the list because there is a reasonable chance that they could cause serious health.
Product, bard composix kugel hernia patch large circle 4. The recall notice was updated from a previous listing to include additional product codes and lot numbers not previously listed. Bard, manufacturer of the defective kugel mesh hernia patch, has received an 11page warning letter from the us fda. Recall classified as class i because the defect associated with the use or exposure. Bowel perforation and obstruction are some of the worst complications of hernia mesh. Approximately 750,000 kugel mesh patches were implanted each year to repair hernias. Jan 30, 2018 composix kugel mesh patches are primarily used to repair ventral hernias. Jun 30, 2009 the fda announces the nationwide recall of certain kugel mesh hernia patches. The us food and drug administration fda and davol, inc a subsidiary of c. The fda issued a class i recall for the composix kugel mesh patchthe strongest recall available to the fdareserved for dangerous or defective products that predictably could cause serious health problems or death. We are committed to helping victims of recalled kugel mesh patches. The fda sent a recall letter regarding the composix kugel mesh patch in march 2006 to physicians and patients advising patients implanted with a recalled device to seek immediate medical attention. The kugel patch recall was initiated in december of 2005, and an updated recall list was issued on january 10, 2007. The fda announces the nationwide recall of certain kugel mesh hernia patches.
The expanded class 1 fda recall on febuary 22nd 2006 included certain lots of the large oval and large circle products, as well as all lots of the oval product id. Bard has announced that it is voluntarily recalling its composix kugel mesh xlarge patch intended for ventral hernia repair because of reports that the devices plastic coil ring may. Bard issued the first in its series of kugel patch recalls in december 2005. Mar 07, 2007 the kugel hernia patch recall is classified by the fda as a class i recall, since it has a reasonable probability of causing serious adverse health consequences. Bard composix kugel mesh xlarge patch oval various sizes bard composix kugel large oval, 5. The firm has also reported receiving a significant number of inquiries from hernia patch patients claiming to suffer from life. Recalled kugel mesh patches drug and medical device.
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