Defective Patch Side Effects
May Include:
  • Bowel Perforations
  • Chronic Intestinal Fistulae
  • Abnormal Connections/Passageways between intestines & other organs
  • Severe Abdominal Pain
  • Bowel Dissection Surgery
  • Removal of the Patch & Repair of Bowels
  • Unexplained Pain
  • Persistent Pain
  • Fever
  • Tenderness
  • Infection

    The Composix® Kugel Mesh Patch has been pulled due to a serious defect that can cause painful, dangerous infections and perforations.

    Thousand of Patients with Recalled Hernia Mesh Patch Repair devices are at risk of serious adverse health consequences and death according to the FDA. The FDA issued a recall of the Bard Composix® Kugel Mesh Hernia Patch in December 2005 and in January 2007 extended that recall to include large-sized Composix Kugel Patches (oval and circle) due to additional reports of “memory recoil ring” breakage. The FDA has advised patients who have been implanted with one of the recalled devices to seek medical attention immediately if they experience symptoms such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.

    The manufacturer of this dangerous and defective device has not only put patients at risk by allowing this device on the market without adequate testing, it has also failed to provide adequate recall information to the patients who were implanted with the device and their doctors after the dangers of the device were well known to the company.

    Law firms involved often don't look to sue the surgeons in these cases, for they are also victims of this company's inadequate testing and its practice of putting profits before patients' health. The surgeons most often are blameless in these cases and attorneys intend to seek compensation for their clients only from the manufacturer. Several surgeons have contacted law firms about helping their patients.

    The Composix® Kugel Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. 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 once it is in place.

    The "memory recoil ring" can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs). There have been numerous reports of infections and severe abdominal pain resulting from pieces of the Kugel patch adhering to patients' bowels or perforated bowels, resulting in the need for bowel dissection surgery to remove the patch and repair the bowels.

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