Schmidt & Clark, LLP Contacted By Kugel® Mesh Hernia Patch Patients Claiming Life-Threatening Side Effects

Schmidt & Clark, LLP, a mass torts law firm has begun investigating the Bard® Composix® Kugel® Mesh Hernia Patch in response to the recent U.S. Food & Drug Administration (FDA) recall of the defective product. The firm has also reported receiving a significant number of inquiries from hernia patch patients claiming to suffer from life-threatening serious side effects.

In three (3) separate product recalls dating as far back as 2005, C.R. Bard Inc. and its subsidiary Davol Inc. in association with the FDA have initiated voluntary recalls of the Kugel® patch.

The manufacturers initially sent out a recall, urging doctors to stop using some versions of the Kugel® patch because a plastic component imbedded in the hernia patch could possibly break causing various injuries to a patient’s internal organs.

According to the FDA, the plastic component is called a “memory recoil ring”, which opens the Kugel® patch but can break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space.

Ring breakage can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

Under the Freedom of Information Act, the New York Times recently obtained documents indicating that, the manufacturers of the Kugel® patch did not accurately report the possible severity of complaints to the FDA.

Since the initial 2005 recall, the FDA has received reports of more than 80 injuries and other problems possibly related to it, including several fatalities.

FDA officials are warning patients who have been implanted with one of the recalled devices to seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.

The Bard® Composix® Kugel® Mesh Hernia Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. According to a C.R. Bard website, the Kugel® patch is also used to repair inguinal and laparoscopic hernias in addition to the ventral hernia. The mesh 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.

Michael Schmidt, Managing Partner of Schmidt & Clark has noticed an alarming number of inquiries to the firm related to the Kugel® patch. Mr. Schmidt stated “We are a firm that focuses on mass torts litigation. As a result, we have received a large number of inquiries where the party has stated that they have been experienced side effects after having a hernia surgery where the Kugel® patch was used. While there have been previous product recalls of the Kugel® patch by the manufacturer, there have been a significant number of calls to my office recently. Based on the number of calls as well as the recent article published by the New York Times titled, “History of Kugel Mesh Hernia Patch Raises Questions on Implant Recalls”, I anticipate that the number of inquiries to my office may continue to rise.

About Schmidt & Clark, LLP

Schmidt & Clark is a national law firm that focuses on mass torts, personal injury, product liability, environmental litigation, toxic exposure, transportation disasters, automotive crashworthiness, medical device failures and medical malpractice.

Schmidt & Clark is currently evaluating potential Bard® Composix® Kugel® Mesh Hernia Patch lawsuits in all states whereby the patient has suffered a significant complication or side effect as a result of the Kugel® patch.

For more information on Schmidt & Clark, LLP, please visit: www.schmidtandclark.com or call toll free 24 hrs/day (866) 588-0600.

Kugel® patch patients can learn more about the recall by visiting:

http://www.schmidtandclark.com/Hernia-Patch-Recall/

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