The Bard Composix Kugel Mesh hernia patch (X-Large Patch Oval with ePTFE) was recalled on December 22, 2005. According to the FDA, “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 (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).”

What is a hernia?

A hernia is an organ that abnormally bulges, which typically occurs in the intestine when a muscular wall deteriorates or tears.

Who is at risk?

Hernias can be found in infants, adults, and children, though they are sometimes associated with heavy lifting. Groin hernias are congenital or are developed over time. A congenital hernia may be diagnosed at birth or may be detected later. Acquired hernias result from a weakness or tear in a muscle. Ventral hernias can develop after a weak spot or scar after a surgical opening.

Hernia Repair Surgery

Hernia repair surgery is performed in order to correct a hernia. According to the Medical Encyclopedia, Hernia repair surgery is suggested when a hernia throbs and impedes with normal daily routines. Hernia repair surgery is also recommended when the hernia largely bulges through a small hole; when this occurs, the hernia could block blood flow or could cause a blocked intestine. Most hernias should be surgically removed to reduce the risk of limited blood flow or a blocked intestine. Usually, hernia repair surgery is simple and causes very few risks to patients. After the patient has been sedated, the surgeon will make an incision over the area of the hernia. The tissue is put back inside the muscle wall. The muscle tissue is repaired, and then the skin is sealed. For an inguinal hernia (when a small part of the small intestine passes through the inguinal canal), a plastic mesh is usually used to heal the defected muscle tissue.

SOURCE: Hernia Patch Recall › What is a hernia and how is it treated?

In a 2007 New York Times article, stories and accounts were told about problems and recalls on the Kugel hernia patch. However, these 2007 reports involving the hernia patch were not the first of reported problems and certainly not the last as cases continue to arise.

The NY Times article reports that when the largest patch was introduced in 2002, U.S. Food & Drug Administration (FDA) records show that complaints were reported about broken rings in the “extra large” version. Yet nothing was done.

In mid-2005, Davol received 10 complaints about ring breaks over a three-month period, but six of those reports all came from the same doctor and therefore the blame was placed on the doctor. Davol still refused to look at the product being at fault.

In December 2005, tests were run by Davol on the failed patch and the results showed that the doctors were not at fault, but in fact the product was flawed. The ring break was caused by a failure at the ring weld, resulting in bowel perforations and/or abnormal passageways between intestines and other organs.

However, I must bring up that this discovery by Davol was made in late 2005, but this article was published in March 2007. Why did it take so long for the general public to be made aware of the defective patch? The FDA notified healthcare professionals in 2005, and expanded the recall twice, in 2006 and in 2007. But the general public is still largely unaware of problems with the patch. This amount of time is too long to announce a problem or recall in a product when reliable evidence is at hand and people are being injured as a result.

SOURCE: Hernia Patch Recall › Hernia patch recall long awaited

If all goes well, the patient may consider his hernia fixed and go about living life normally. For many patients, however, the medical miracle goes awry. The plastic “memory recoil ring” sometimes fractures, causing bowel perforations or abnormal connections between the intestines and other organs known as fistulae. The damage not only causes severe pain, it can also lead to additional medical complications and death.

While the Kugel Mesh Patches have been recalled, doctors are finding other problems arising from medical mesh devices and implants. Boston Scientific manufactures aortic and carotid stents with mesh, but the surgical insertion tip sometimes detaches during surgery. The FDA requested a recall of the company’s defective stents and stent delivery system.

Mesh is also a component in a couple products that are used in the treatment of stress urinary incontinence (SUI) in women. Specifically, Mentor Corporation’s ObTape may disintegrate inside the body and lead to a multitude of adverse events.

The FDA advises patients to seek immediate medical attention if they experience symptoms that could be associated with any of the recalled hernia patch devices. Ring breakage can cause inexplicable and / or persistent abdominal pain, fever, tenderness at the implant site and any other unusual symptoms.

SOURCE: Hernia Patch Recall › Hernia patch and other mesh implants pose problems

The reason that people are still suffering serious complications from the hernia patch is that when the recall was announced, doctors were told to weigh the risks of leaving the patch in with the risks of explanting it. Patients who were not suffering side effects indicating that their patch malfunctioned likely did not have the patch removed because they were not considered at risk for ring breakage. However, even now after the recall is well over a year old, the FDA is receiving reports about defective Kugel Mesh Patches and broken memory rings.

Kugel mesh pregnant victimOne report, received on August 24, 2007, noted that a woman who became pregnant after having the Kugel Mesh Patch implanted, began experiencing pain. The ring was explanted and was apparently “bent and ready to break” in two places. The report does not indicate whether or not the added pressure of the pregnancy caused the ring to malfunction or if it had already malfunctioned when she became pregnant.

Another report noted that the patient had “chronic, constant abdominal pain, sharp and stabbing,” since hernia surgery. The patient required surgery to remove the patch’s mesh from his bowel in order to relieve his pain. Yet another report notes that a patient required two surgeries and has been on pain pills since his first surgery in which the Kugel Mesh Patch was implanted.

One patient, who required surgical intervention to fix problems allegedly caused by the Kugel Mesh Patch, reported “abdominal pains, fever, wound drainage, abscesses, the mesh folding into a wad, bowel adhesions, fistula, bowel resection, infection and mesh explant.” Still another report, this one indicating a life-threatening event, noted the memory ring allegedly broke, perforating and strangling the patient’s bowel and resulting in infection and necrosis of the bowel.

In another situation, the broken ring allegedly perforated a patient’s bowel in three places. The patient wound up in the hospital with “vomiting, pain in the abdomen, and fatigue.” Still another life-threatening incident report was submitted, this one reporting a broken ring that allegedly caused a perforated bowel and fistula. The patient’s abdomen turned red and developed a draining wound.

Patients who have had Kugel Mesh Patches implanted and not yet had them removed may think they are in the clear and will not have any problems with the patch. However, adverse event reports are still being submitted to the FDA regarding hernia patches, some of them reporting events occurring in 2007. Furthermore, some patients may have suffered adverse side effects of the Kugel Mesh Patch without realizing it.

Anyone who has had a Kugel Mesh Patch implanted and experiences pain or tenderness at the implant site, abdominal swelling, unexplained fever, or any other unusual pain in the abdomen should seek medical attention and discuss the possibility of removing the hernia patch with a doctor. It is important to remember that some of the FDA’s adverse event reports concerning the Kugel Mesh Patch were deemed life threatening, so any unusual symptoms should be dealt with immediately.

October 16th, 2007

SOURCE: Hernia Patch Recall › Kugel Mesh patients not out of the woods yet