Most of the cases allege injury due to a defect in the patch, which surgeons implant at the site of a hernia. The patches consist of two layers of synthetic mesh bound by a flexible plastic “memory-recoil” ring. These rings are known to break at their welded joints after they have been surgically implanted, causing patients extreme abdominal pain, fever, soreness at the surgical site, bleeding, infection, fever, a range of other symptoms, and occasionally death.

Next month’s trial involves a case filed by plaintiff John Whitfield, who was allegedly injured by the surgical implantation of a defective Mesh Patch.

Bellwether trials have become increasingly common in mass tort litigation to help facilitate the federal court system’s caseload. In a bellwether trial, a plaintiff or group of plaintiffs are chosen by the United States Judicial panel on Multidistrict Litigation to represent all cases based on their similarities. The results are then extrapolated to the remaining cases, which helps reduce redundancy while indicating and gauging common trends.

The other three hernia patch lawsuits chosen for bellwether trial also involve allegations representative of a larger body of cases.

Davol, Inc., and the FDA issued three separate recalls of Kugel patches between 2005 and 2007. The majority of lawsuits have been filed by plaintiffs who received severe injuries when the defective patches broke after being surgically implanted, thus requiring additional surgery for their removal.

SOURCE: Hernia Patch Recall › hernia patch trial scheduled for march in federal MDL

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

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

One answer can be found in the case of a hernia repair device made by a subsidiary of C. R. Bard Inc. In late 2005, the company sent out a recall, urging doctors to stop using some versions of the product because a plastic component could break and cut through a patient’s internal organs and tissue.

At the time, Bard executives said they knew about some serious injuries potentially caused by the device, which is known as the Kugel patch. Since then, the Food and Drug Administration has received reports of more than 80 injuries and other problems possibly related to it, including several fatalities.

Bard officials said recently in a statement that they had not recalled the product sooner because complaints about failures were too few and unrelated to raise any alarms. The company also said that both it and the subsidiary, Davol Inc., had reacted responsibly.

But when F.D.A. officials inspected Davol in early 2006, they apparently found other reasons that company officials and the agency might not have been alerted earlier. For example, inspectors reported “discrepancies” and “inconsistencies” in how Davol tracked and analyze device-related complaints. And, in several instances, Davol also did not accurately report the possible severity of complaints to the agency, a copy of an inspection report obtained by The New York Times under the Freedom of Information Act shows.

Bard officials, who declined to be interviewed, said in a statement that they have since addressed the agency’s concerns, and agency officials said they are monitoring the company’s progress.

Still, at a time when the use of implanted medical devices is growing sharply, the episode of the hernia patch is an example of what some experts say is a far wider problem: that some major manufacturers, while contending that they carefully monitor product safety, are not as rigorous as they should be.

Harold Pellerite, a consultant to the medical device industry who worked for two decades at the F.D.A., said he was surprised to discover how little attention many companies pay to the issue.

“Firms take the opposite approach of what the F.D.A. expects,” said Mr. Pellerite, who works for Quintiles Consulting in Rockville, Md.

Davol is not the only company where agency inspectors have found problems with how a manufacturer tracks and reports possible device failures.

Another case in point: a liquid plastic material called Enteryx once sold by Boston Scientific as a treatment for patients with severe acid reflux. The company learned after a patient’s death in mid-2004 that some doctors, trying to inject the product at a specific site in the base of the esophagus, could miss and cause damage to other organs, including the heart.

But when agency inspectors went to Boston Scientific in mid-2005, they could find no evidence that the device maker was adequately tracking reports from doctors about that precise problem, a warning issued last year by the agency shows. Soon after the inspection, the company recalled Enteryx, which may have caused dozens of injuries, and perhaps some deaths.

In a statement, Boston Scientific, which was also warned by the agency in that same letter about systematic failures in its product-safety review, said it had since overhauled its procedures.

“We have greatly improved the methods we use to analyze complaints and complaint trends,” the company said.

Under F.D.A. rules, producers are required to have systems in place to collect and analyze any complaints they receive from doctors and hospitals about their devices. They are also required to send to the agency any report indicating that a device’s failure may have contributed to a patient’s death or injury.

But the agency gives device makers significant leeway about how to set up such systems, including what guidelines to use to help them determine when to issue product alerts to doctors or to issue a recall. In addition, a company can decide not to forward a complaint to the agency if it decides after an internal review that its product was not at fault.

One result, said several experts like Mr. Pellerite, is that companies tend to give themselves the benefit of any doubt.

Not long ago, one group of producers, makers of implanted heart devices, agreed to adopt guidelines about how doctors should be alerted to potential product hazards after a controversy involving the Guidant Corporation. But the broader industry has not followed suit, even though seemingly innocuous devices like the hernia patch can cause as much, if not more, havoc in patients.

Kenneth W. Goodman, a co-director of the ethics program at the University of Miami who also served as an adviser to Guidant, said he believed that companies needed to do so because the potential stakes involving implanted medical devices are so high.

“If a doctor holds a device in their hand that might fail and you know about it, then the doctor needs to know about it,” Mr. Goodman said.

Chris Lavanchy, a director at ECRI Inc., a firm that evaluates medical devices, said that companies were concerned that sending up a flare too early might jeopardize sales when there was no reason for concern.

“As a producer, you want to feel justified there is a real problem before undertaking a recall,” Mr. Lavanchy said.

In the case of the Kugel patch, both Bard and the F.D.A. have urged doctors not to remove the device unless a patient starts experiencing abdominal pain or a fever, which may be a sign that a fractured device has cut tissue or is causing a peritonitis-like infection.

The recalled large Kugel patches were used frequently to treat abdominal hernias. The small and medium-size versions were not affected. (The Kugel patch is just one of several types of devices used to repair hernias.)

Cynthia J. Wilson, who works for a health care system in Milwaukee, said that she had to undergo emergency bowel surgery in 2004 to repair a hole caused by a dislocated patch.

“I went to the hospital for two weeks and my friends were praying for me,” said Ms. Wilson, who has filed a lawsuit against Bard.

The company declined to say how many lawsuits involving the device had been filed or whether it had settled any of them.

The Kugel patch is made of two pieces of mesh that surround a flexible plastic ring. To implant it, a doctor folds a patch, places it at the site of the hernia, which is a spot where an organ pops through internal tissue that has become weak or torn.

The released ring then springs back into its original shape, flattening the patch. The mesh like material then serves as a substrate that allows internal tissue to grow and resolve the hernia.

Davol, which is based in Cranston, R.I., makes the patch in various sizes and shapes. And it was not long after it introduced the largest units in 2002, F.D.A. records show, that company officials began to receive a small but disproportionately high number of complaints about broken rings in those “extra large” versions of the device.

Some of those complaints, agency records indicate, suggested that serious injuries like the one experienced by Ms. Wilson might be occurring.

Bard officials said that the initial numbers were small given the number of patches sold, and the problems cited were too random to form a troubling pattern.

But in mid-2005, Bard said, Davol received 10 complaints about ring breaks over a three-month period starting that June. Six of those reports, including one involving a possible fatality, came from Germany, half of them from the same doctor there.

Bard said that Davol officials initially had concluded, based on their review, that the ring breaks were occurring because doctors were improperly folding the patch while implanting it.

As a result, Davol halted production in August 2005 of the extra-large patches, began to hold training sessions for doctors in Germany and started work on revising its instructions to doctors elsewhere about how to implant the device, Bard said.

But the company kept distributing the patch and doctors kept implanting it. That allowed the problem to continue because Davol’s assessment proved wrong.

In early December 2005, tests run by the company on a failed patch “suggested for the first time that the source of the ring break was caused by a failure at the ring weld,” according to Bard.

Davol soon recalled the extra-large versions of the patch and, several weeks later, expanded that recall to include large versions of the device. It was after that initial patch recall that F.D.A. officials went to Davol’s headquarters in early 2006 to do an inspection.

What they found there, their report indicates, was a range of problems, including flaws in the system used by Davol to track complaints.

For example, while Davol had purchased a new tracking system in 2004, that program was incompatible with the earlier one it had been using, resulting in significant “discrepancies” in how problems were recorded and reviewed, agency inspectors reported.

Davol officials disagreed, that same report shows, saying they cross-checked complaints by hand. But inspectors also reported that company officials had also understated in several reports to the agency the potential severity of device-related injuries, including three reports involving injuries and one report involving a possible device-related death.

In a statement, Bard said that it had not submitted those reports to mislead the agency but said that the company had incorrectly categorized the complaints based on the information it had at the time.

Davol also retained an outside safety consultant around the time of last year’s inspection to review its operations and recommend changes, the F.D.A. report shows. The company has since redesigned all the versions of the Kugel patch that it recalled, and those products are back on the market.

Tim Ulatowski, an F.D.A. enforcement official, said the agency was monitoring Davol’s response to its concerns, adding that it was satisfied with what it had done.

Mr. Lavanchy, the device expert at ECRI, said he believed that the pace of Davol’s reactions to problems with the Kugel patch seemed understandable given that it appeared from the company’s account that it was in the dark for a long time about both the scope of the problem with the device and its cause.

But Professor Goodman of the University of Miami was less forgiving about how long it took for the company to take action.

“It doesn’t take a surgeon to figure out that if you have a plastic object in an abdomen that breaks, it is going to hurt someone pretty badly,” he said.

October 29th, 2007

SOURCE: Hernia Patch Recall › History of hernia patch raises questions on implant recalls

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