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

In the spring of 2003, Sophia had a hernia operation in which the doctor used a Kugel Mesh patch to repair the hernia. Three years later, in the spring of 2006, Sophia began having serious problems, including nausea, pain, redness and swelling in her abdomen. After a lump developed in her abdominal area, Sophia decided to see her doctor. The doctor, believing Sophia to have another hernia, scheduled her in for another hernia surgery. However, during the surgery the doctor found a far more serious problem: the Kugel Mesh used to repair Sophia’s hernia had adhered to her intestines.

The mesh had actually perforated Sophia’s intestines and caused a massive infection. The doctor had to remove three inches of Sophia’s bowel and taking out all of the mesh. However, he could not put another mesh in to protect against a hernia and warned her that another hernia was likely to occur.
Ryan says her mother was in the hospital for five days. She was sent home on a Monday and Ryan was given instructions for how to care for her mother once Sophia’s drain tube was taken out.

“We got home, the drain tube had been taken out, and something was leaking out of her drain hole,” Ryan says. “Only it wasn’t just leaking–it was pouring out. It was putrid and there was a disgusting smell to it. By Thursday, I had enough. Every time she tried to sit up, stuff would ooze out of her and I just felt it could not be normal.”

Ryan phoned her mother’s doctor and demanded Sophia be put on antibiotics. Sophia was also given another drain tube. “In all, it took months for my mother to get better,” Ryan says. “After the antibiotics, it was a whole week before the smell went away. I had to flush and empty the drain tube daily.”

After the infection, Sophia developed another hernia as well, so she required yet another surgery to repair the new hernia. “The whole thing was a terrible ordeal,” Ryan says. “The infection caused by that patch was awful. It really bothers me that they knew in 2002 about problems with the mesh. My mother had her surgery in the spring of 2003 but we were never warned that there could be any problems with it.”

In all, Sophia required two surgeries, developed a massive infection, lost three inches of her bowel and suffered another hernia all because her Kugel Mesh patch failed and adhered to her intestines. Luckily, she survived her ordeal, but others have not been so fortunate. “I don’t like to think about it, but what if I hadn’t been there to care for her?” Ryan says. “What could have happened if someone else was caring for her? It could have been much worse.”

November 9th, 2007

SOURCE: Hernia Patch Recall › Kugel mesh patch a terrible ordeal

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