What Causes Injuries

The Kugel patch is two layers of a mesh fabric with a thin plastic ring sewn in between. The patch is used to repair a hernia by placing it inside the abdomen on the interior side of the weakened abdominal muscle. The patch prevents internal organs from bulging through the weak point in the abdominal wall and stimulates the growth of new tissue to heal the hernia.

Patent Application Drawing, U.S.P.T.O

To implant the patch, the surgeon folds and inserts it through a very small incision in the abdomen.  When he releases the patch, the plastic ring causes the patch to unfold to its full size and provides a slightly rigid structure that allows the surgeon to maneuver the patch into its final position.

In 2002, the manufacturer, Davol, Inc., introduced large and extra large sizes of the patch for repairing incisional hernias.  Incisional hernias occur at the sight of prior abdominal surgeries where scar tissue becomes weak, and are commonly larger than other hernia types.

Davol designed the larger patches with a larger gauge plastic ring, but did not change its manufacturing process involving welding the ends of a long plastic rod together to form the ring. After being folded to insert in the abdomen, the weld in the larger gauge rings had the potential to break, leaving two sharp ends of a curved plastic rod inside the patient.  This in fact happened in the case of at least 80 patients out of more than 50,000 patches that had been implanted.

Broken Recoil Ring Symptoms

When the recoil ring inside the patient is broken, the patient’s ordinary daily movements can cause one end of the plastic rod to begin poking through the mesh fabric. Continued movement can cause the rod to start migrating elsewhere in the body – potentially in any direction.  As the rod migrates further, it eventually begins to puncture abdominal tissue or organs resulting in various types of injuries.

According to the FDA’s recall notice and letters from Davol to hospitals and surgeons, signs of a broken recoil ring include:

• Unexplained or persistent abdominal pain
• Fever or infection
• Tenderness at the implant site
• Bowel obstruction or perforation
• Intestinal fistula

Pain

Pain is probably the number one symptom. Hernia surgery using a mesh patch is much less painful than open surgery, but there will still be some degree of pain for several days to a week following the operation. Extreme pain, or pain that remains persistent for more than a week after the incision should have healed may indicate a broken ring moving around inside the abdomen.

Fever, Redness, or Tenderness

If the broken ring manages to puncture an intestine, this can lead to many serious problems, including potentially fatal infection.  Fever and redness in the area of the hernia may be signs of such an infection. 

Remember that the location of the incision is not necessarily where the patch is.  The surgeon normally makes his incision off to the side of the hernia, and pushes the patch into place under the hernia from there. So fever and redness may be somewhere other than near the incision.

Also be aware that some patches may be as large as 10 inches by 13 inches with the ring being on the outer edge. That means the broken end of a plastic ring could be 6 inches away from the hernia, and even farther away from the site of the incision. Therefore tenderness that may occur at the location of the broken end of the ring could be somewhere other than near the hernia or incision.

Bowel Obstruction or Perforation

Because the broken ring can relocate itself, it may interfere with the intestines in any of several ways resulting in an obstructed or perforated bowel. Bowel symptoms may include chronic constipation or diarrhea, or bloody bowel movements.  Signs of infection may include fever, redness and tenderness. Any such symptoms following hernia surgery should be reported to your doctor right away.

Intestinal Fistula

Fistulas are abnormal ducts or passageways that connect one hollow organ or body cavity to another or to the body’s surface. An intestinal fistula may connect one part of the intestine to another, or the intestine to a body cavity or the skin surface.  Fistulas are often associated with infection and abscesses, therefore those will be the symptoms to look for.

Diagnosis

Of course, any of the above symptoms can also be signs of something other than a broken memory recoil ring. To determine for certain if the symptoms are Kugel patch related, your doctor will obtain X-rays or CT scans to locate the plastic ring and determine if it is still in place and intact, or if it has broken and begun migrating.

Related Articles

• Kugel Patch Injury Reports
• Do You Have  a Kugel Patch Case?
• Kugel Patch Lawsuits

• Injured by broken memory recoil ring
• Other complications related to a Kugel patch
• Implanted with a recalled Kugel patch but not yet injured
• Implanted with a Kugel patch not on the recall list

Injured by Broken Memory Recoil Ring

Regardless of whether your Kugel patch implant is on the recall list or not, if you have suffered injury from a Kugel patch’s plastic ring breaking, you should contact a qualified attorney. The ring breaking is a product defect for which you have the right to receive compensation for any resulting injury.

Other Complications Related to a Kugel Patch

Some patients who have experienced complications related to their Kugel patch have filed lawsuits for alleged defects other than broken memory recoil rings.  That many of these lawsuits have survived pre-trial pleadings and appear headed for trial suggests there may be merit to these claims. An experienced attorney can review your case to see if you may be among the victims of less-publicized Kugel patch defects.

Implanted with a Recalled Kugel Patch but not yet Injured

Patients who have not yet been injured but still have a recalled Kugel patch implanted in them are entitled to compensation for the medical monitoring they now require. Several pending cases are also seeking class action status and financial damages for everyone in this situation.

You can determine if you have a recalled Kugel patch implanted by reviewing your medical records. Your surgical report should contain all the identifying information for your implant. You can compare the product number and lot number with those listed in the 2005, 2006, and 2007 recall notices.

Alternately, you can discuss your case with an attorney who can obtain and review your records for you.

Implanted with a Kugel Patch not on the Recall List

The reality is that among the more than 100,000 patients who have received a Kugel patch since it was invented, the vast majority have had no adverse experience.  By and large, their successful hernia repairs have allowed them to quickly resume their normal activities with few limitations. We sincerely hope you are among this group.

Even so, if you have anything implanted with a Kugel brand, it costs nothing to discuss your situation with an attorney experienced in Kugel patch issues. Circumstances may have changed since this article was written, or there may be subtle issues the attorney is aware of that may apply to your case.

What You Should Do

If you’ve had complications from a hernia surgery and your doctor is unable to assure you they are completely unrelated to a Kugel patch, you should discuss your case with an attorney specializing in personal injury law - preferably one who is already handling other Kugel patch cases. He or she will assist you in obtaining and examining your medical records to determine your circumstances and your legal options.

NOTICE: The information herein is not intended to substitute for competent medical or legal advice. If you are experiencing symptoms you think may be related to a Kugel hernia patch or a past hernia surgery, see a doctor right away. If you need assistance finding an attorney, please contact us using the form at the right.

Related Articles

• Kugel Patch Injury Symptoms
• Kugel Patch Lawsuits
• What is a Class Action Lawsuit?
• Kugel Hernia Patch Recall, Dec 2005
• Kugel Hernia Patch Recall, Mar 2006
• Kugel Hernia Patch Recall, Jan 2007

It seems that not a week goes by that we don’t hear of a class action lawsuit against one company or another.  What exactly is a class action lawsuit, and why is it so popular?

Defining a Class

When a group of people have the same claim against a defendant, they can combine their claims into a single lawsuit and be represented by one attorney or law firm.  Many consider this to be a class action lawsuit, but it’s not.

A lawsuit is not considered a class action unless the attorney specifically requests class action status. That request turns the case into a putative class action, which means it is pending the court’s approval.

Designating the suit as a class action hinges on defining who belongs to the class of plaintiffs. In a recent case against a major credit card company, the class was defined as any customer who held a credit card from the company between two specific dates and had carried a balance over from one month to the next at least once during that period.

Certifying a Class

Until a class is certified by the court, anyone in the class can hire their own attorney and bring their own case against the defendant, or band together with other plaintiffs and hire an attorney to represent them as a group.  What creates a class action is when members of the class are automatically included in the class action case without them hiring legal counsel.

Class action cases are designated as opt-in, opt-out, or mandatory.

In the opt-in version, plaintiffs are able to choose whether they want to become part of the class action case or not. If they choose not to opt in, they can still bring their own lawsuit or combine with other non-opting members of the class to jointly bring a case.

In the opt-out version, all members of the class are automatically included in the lawsuit unless they formally opt out by notifying the court within a specific time frame.

In the mandatory version, individuals belonging to the defined group do not have the right to opt out. All will be represented in the class action whether they care to or not, and they cannot file separate individual or joint claims.

Benefits of Class Action Status

For Plaintiffs

The primary benefit for plaintiffs whose individual claims are relatively small but whose class is large in number is that class action status allows them to notify other people in similar circumstances and combine their small individual cases into one case large enough to afford competent legal representation. Our legal system supports this type of action as a way to deter wrongdoers who take unfair advantage of the masses in such a small way that it is not worth any individual’s effort to sue for recovery alone.

Another consideration is that when almost identical cases are filed individually, plaintiffs in similar situations may obtain vastly different results depending on the court and the attorneys involved.  Cases filed later may be able to get larger awards because more has been discovered about the defendant’s actions in earlier trials. In some situations, the opposite occurs. The substantial damages awarded to the early cases exhaust the company’s resources leaving those filing later claims unable to recover anything.

Sometimes differences in awards can simply be a matter of differences in jurisdiction and not in the merits of the case. In a class action, however, the award to plaintiffs may be more or less than it might have been in individual trials, but it will be equitable for everyone.

For Defendants

For defendants, consolidating thousands of individual cases into one large case can also potentially reduce their legal expenses and financial liability.  When cases are filed individually, the potential exists that a few cases could result in massive damage awards that taken together can bankrupt the company. Some defendants believe that when the court sees the overall magnitude of the claims, the total damages assessed may be more reasonable with respect to the company’s resources.

For Lawyers

It should be noted that for lawyers, class action lawsuits create cases with potentially lucrative attorney fees where no cases would have been economically feasible otherwise.  For example, in the credit card case cited earlier, each of the hundreds of thousands of plaintiffs received less than a $10.00 refund for alleged overcharges while the law firm leading the suit received many hundreds of thousands of dollars in legal fees.

To be fair, however, it should also be noted that the credit card company who, just one dollar at a time, had collected millions of dollars in unjustifed fees from unsuspecting customers was effectively detered from ever taking such advantage of customers again, along with other companies who were paying attention to the total cost of the damages assessed.

Disadvantages of Class Action Status

For Plaintiffs

Courts do not grant class action status automatically because it creates a situation in which the plaintiff is represented by an attorney he or she did not hire.  One of the criteria for granting class action status is that the commonality of the issues involved in each case must be much greater than the differences involved. If the individual cases are more different than similar, they should proceed to trial individually so that each plaintiff receives just compensation given their circumstances.

For Defendants

Some defendants oppose the certification of a class action in the belief that it will encourage more people to file claims resulting in the payment of more damages.

Also, lacking the ability to challenge each plaintiff individually, the defendant may have a difficult time raising a claim that some members of the class have been included arbitrarily even though they have actually suffered no harm.

For Lawyers

Plaintiffs’ lawyers can lose control of a case when their clients are included in a class action.  Even if their clients are able to opt out of the class action suit and bring their own claims, the existence of the class action can affect the outcome of their individual cases.

Kugel Patch Lawsuits

Are Kugel patch lawsuits likely to be granted class action status? There are several thoughts.

First is that the injuries suffered by different plaintiffs are all unique, and therefore the plaintiffs cannot be treated as a class.  The facts, degree of injury, and damages have to be determined individually in separate trials.

On the other hand, there may exist a certain class of plaintiffs who are all similarly situated.  These are the patients who were implanted with a Kugel patch that was later recalled, and who have not yet suffered any physical injury.  According to the C.R. Bard annual report, some of the putative class action lawsuits are seeking medical monitoring in addition to an award of monetary damages.  This is consistent with a class of plaintiffs who have not yet been injured.

Ultimately, the answer is that some lawsuits may be granted class action status while other cases will no doubt be allowed to proceed individually.

Related Articles

• Kugel Patch Lawsuits
• Do You Have a Kugel Patch Case?

As of February 25, 2008, approximately 580 federal and 280 state lawsuits involving individual claims by approximately 2,135 plaintiffs, as well as nine putative class actions, have been filed or asserted against the company with respect to its Composix® Kugel® product intended for ventral hernia repair (collectively, the “Composix Claims”).

The company voluntarily recalled certain sizes and lots of the product beginning in December 2005. The actions generally seek damages for personal injury resulting from use of the product and the putative class actions, none of which has been certified, also seek (i) medical monitoring, (ii) compensatory damages, (iii) punitive damages, (iv) a judicial finding of defect and causation and/or (v) attorneys’ fees. On June 22, 2007, the Judicial Panel on Multidistrict Litigation transferred Composix lawsuits pending in federal courts nationwide into one Multidistrict Litigation (“MDL”) for coordinated pre-trial proceedings in the United States District Court for the District of Rhode Island. Approximately 245 of the state lawsuits, involving individual claims by approximately 1,465 plaintiffs, are pending in the Superior Court of the State of Rhode Island, with the remainder in various other jurisdictions.

The Composix Claims are at a preliminary stage. In the vast majority of these cases, we have not yet obtained and reviewed complete information regarding the plaintiffs and their medical conditions, and consequently, we are unable to fully evaluate the claims or determine the time frame in which they may be resolved. As in most litigation of this nature, the Composix Claims present a wide variety of claims, ranging from allegations of serious injury caused by the products to efforts to obtain compensation notwithstanding the absence of any injury. We believe that many settlements and judgments relating to the Composix Claims may be covered in whole or in part under our product liability insurance policies. While the company intends to vigorously defend the Composix Claims, it cannot give any assurances that the Composix Claims will not have a material adverse impact on the company’s result of operations in future periods or the company’s financial position or liquidity.

Federal vs. State Lawsuits

Bard’s report notes that lawsuits have been filed in both state and federal courts. The choice of venue for each suit is entirely at the discretion of the plaintiff and his or her attorney. Depending on the facts of each case, different attorneys can come to different conclusions as to whether it is best to sue in a particular state or federal court. Where the facts of one case may suggest the plaintiff will fare better under state law, another case may look stronger under Federal law.

Attorneys are also aware of the sympathies of specific judges and may select a venue where they think their case may receive the most favorable hearing.

Multidistrict Litigation

While the 580 federal lawsuits do not yet involve a certified class action, the court system has transferred all federal suits originally pending in thirteen different districts in eleven states to the U.S. District Court in Rhode Island. Later suits filed in these and additional districts are also being consolidated in the Rhode Island district. Because each suit is against the same defendants and the claims are so similar, the courts concluded that it would be much more efficient to combine the initial proceedings under the supervision of one judge rather than having nearly identical proceedings play out in front of thirteen or more judges across the country.

The Rhode Island District was chosen because Davol, Inc. is headquartered in Rhode Island which should speed the cases along. Depending on the facts of each case uncovered during pre-trial motions, however, the judge can remand a case back to the original district for trial if warranted.

Davol being headquartered in Rhode Island is also the reason that almost 90% of the state-filed lawsuits have been filed in that state’s Superior Court - although for jurisdictional reasons, not for pre-trial efficiency.

Claims

For those who’ve researched the Kugel patch recall, the question arises: If there have been less than 100 confirmed reports of injury from broken memory recoil rings, how can there be more than 2000 plaintiffs?  There are several answers.

First is that the vast majority of plaintiffs were not injured by broken memory recoil rings. They may have experienced other types of complications from their hernia surgeries where it just so happened that a recalled patch had been used prior to the recall. In some cases, a recalled patch was not involved at all, but the plaintiffs believe the unrecalled Davol patch they received was as faulty as the recalled patches and the cause of their surgical complications.

Other plaintiffs have experienced no physical injury or complication from the recalled patch they were implanted with before the recall.  But having a device in their abdomens that could break in the future and cause them serious injury is a source of emotional distress. These plaintiffs are seeking compensation not only for their distress, but also for the expense of ongoing medical monitoring and potential future surgical removal of the patch should it become injurious.

And finally, a case is often filed not only in the name of the individual patient, but also in the name of spouses and possibly dependent children who technically become additional plaintiffs in the case.

In the end, the facts of each individual case will have to be sorted out by the courts, unless, of course, the plaintiffs settle with Bard before trial – whether individually or en masse.

Related Articles

• What is a Class Action Lawsuit?
• Kugel Patch Injury Reports
• How the Kugel Patch and Davol Failed
• FDA Hernia Patch Investigation

The recall was expanded to other large and extra-large sizes of the product in March 2006 and January 2007. However, two hospitals in Virginia Beach, Virginia did not remove the recalled product from their inventory, and mistakenly implanted the recalled patches in seven patients in the early months of 2007.

The mistake was not discovered until Judith Coyne, a patient who had hernia surgery at Sentara Virginia Beach General Hospital, contacted a local TV news station in June 2007. She had been suffering excruciating pain following her surgery and in reviewing her medical records correlated the product code and lot number of the Kugel patch she received with those in the recall. She told the reporter from station WAVY that the hospital, operated by Sentara Health Systems, did not believe her when she told them she had been implanted with a recalled patch.

In fact, a Sentara spokesperson initially denied that Coyne’s patch was among those recalled, but soon after released a retraction. Upon investigation, the hospital discovered they did indeed have recalled patches on their shelves, and that six other patients had received them in early 2007 – three at Sentara Virginia Beach General and three at sister facility Sentara Leigh Hospital.

Even though the recall had received much publicity and Davol had sent letters to all hospitals and surgeons informing them of the recall, Sentara blamed the mistake on “human error” because the product details and lot numbers listed in the rolling recalls were “confusing.”

Dr. Tom Thames, Senior Vice President of Medical Affairs contacted Mrs. Coyne’s surgeon to request a follow-up examination and evaluation so the hospital could provide any assistance possible to address her pain issues.

The problems Coyne was experiencing, however, were not due to a broken plastic ring, but rather due to complications that sometimes accompany hernia repairs. Because the mesh patch had already fused to her internal organs, doctors determined removing the patch would be a far greater risk to her life than leaving it so long as the plastic ring remained intact.

In the meantime, Mrs. Coyne and six other patients are living with a known defective device implanted in them simply because a hospital staffer couldn’t understand a series of recall notices clearly enough to identify and return the recalled patches to the manufacturer.  Granted, the average person reading the recall notices might agree that the specification of product codes and lot numbers was challenging to interpret. But given the life-and-death stakes, there seems little excuse for the hospital administration not having procedures for double-checking that medical device recalls are administered to the letter.

Related Articles

• Kugel Hernia Patch Recall, Dec 2005
• Kugel Hernia Patch Recall, Mar 2006
• Kugel Hernia Patch Recall, Jan 2007

“11 cases where the broken ring migrated into or through the patient’s abdominal wall, with associated infection in 2 cases.”

“1 case where the ring reportedly migrated into the vagina.”

“7 cases of bowel perforation reported in association with a broken ring.”

“1 case of bowel obstruction, which was repaired without removal of the mesh (causality to the broken ring has not been clearly established in this case).”

“1 reported death where the patient reportedly developed septic shock, consumptive coagulopathy and acute myocardial infarction after surgery to repair small and large bowel fistulas reportedly caused by perforation by the broken ring.”

When the recall was expanded to large size patches in January 2007, Davol noted in its letter to hospitals and surgeons that six reports of broken rings had been received for this product out of 25,835 manufactured for a rate of 0.029%. The letter noted that:

“1 Incident occurred during the mesh placement surgery and the product was not implanted.”

“1 incident of a broken ring was noted at the time of surgery and the ring was removed but the mesh was left implanted. No patient symptoms have been reported following this procedure.”

“1 incident was reported where a broken ring had migrated into the abdominal wall and was removed, leaving the mesh implanted.”

“1 incident was reported where the mesh was explanted as a response to reported abdominal pain and a broken ring was noted.”

“Two (2) inconclusive incidents were reported where bowel perforation and broken rings were noted at the time of explant.”

MAUDE Reports

The FDA maintains a database of adverse event reports for medical devices known as the Manufacturer and User Facility Device Experience (MAUDE) Database.  A search of this database revealed 1480 entries containing the word “Kugel.”  Some of the entries were made by Davol, Inc based on reports it had received by telephone or in writing.  Other entries were submitted directly to the FDA by medical personnel or patients.

A large percentage of the MAUDE reports sampled contain too little information to make any determination as to whether the event was attributable in any way to the Kugel patch.  For example:

“A male had a portion of a plastic substance removed during a procedure. He previously had a bard composix kugel large oval implanted in 2004.”

“Attorney’s report of pt’s alleged ’surgical procedure to remove a malfunctioning recalled kugel mesh’.”

(Editor’s Note: “pt” is an abbreviation for “patient.”)

“Patient had laparoscopic ventral hernia repair with mesh implant in 2005. Patient had exploratory.”

“Attorney’s report of patient’s alleged abdominal pain, ‘that the kugel patch had managed to become bent and out of shape and was binding’ the patient’s intestines.”

“Patient developed an abcess (sic) after surgery to repair an incarcerated and strangulated recurrent upper abdominal ventral hernia, giant.”

Additionally, many reports are not at all related to defects in the memory recoil ring.

“Pt had a laparoscopic nephrectomy done by a hand port incisional hernia. The defect was initially repaired with a kugel mesh device. Postoperatively, the pt gained 30 pounds, in about one year time frame and had a recurrence of the previous hernia.”

“It was reported by the pt that she had a hernia repair with subject product in ‘07. In ‘08, the patch was removed because of an infection. Her stomach has been swollen since the initial surgery.”

The database also contains records that ultimately report nothing.

“Had 2 surgeries for hernia’s after a major surgery. They placed the bard composix kugel mesh inside me for the second surgery and had complained and visited the surgeon several times complaining about abdominal pains and swelling in the effected area. Had 2 cat scans with what the doctor called negative results for a new hernia, but nothing about the swelling and pain that i had. I heard about the recall for the mesh and after checking, i had one of the recalled meshes inside of me. Product code 0010208 lot number 43cptd365. Confirmed with bard about being part of the recall by the company, but was never notified, by either the company or the hospital, nor the doc’s office.”

“Had the bard composix kugel patch implanted to repair hernia in dec. 2003. Just heard of recall, called dr’s office -surgeon who repaired hernia-. Office claims never heard of recall. This scares me as i have this mesh in me and my doctor is not even aware there is a problem. Shouldn’t he be told and brought up to date? thank you.”

Some of the reports are clear, however.

“Six months post-op pt presented with infection. During removal of mesh surgeon found that memory recoil ring had broken and punctured pt’s bowel.”

“The memory ring broke and perforated the small intestines of the famle (sic) pt. The mesh was implanted in 2005 and explanted in 2006. The mesh was discarded after explantation. The operation site has been sutured twice already and the pt’s condition is critical, but stable at the present time.”

“Broken ring-perforated small bowel and colon causing fistula.”

“Patient had kugel mesh explanted due to broken ring. Unsure when mesh was implanted.”

“Broken recoil ring. Perforated bowel and fistula. Implanted in 2004 at different hospital. In 06 – new information from sales rep: mesh implanted by same surgeon, dr. Who also did the explant.”

“Mesh implanted in 2005. Removed 4 mos later. Patient felt pain from a foreign body. Ring had penetrated the subcutaneous tissue beneath the skin.”

Challenges in Event Tracking

During the most recent review of data, broken memory recoil rings have been responsible for approximately 80 confirmed injuries and at least one death compared to at least 1480 adverse event reports in the MAUDE database alone. The challenge of finding these serious problems in a mountain of often-superfluous data clearly demonstrates the difficulty in tracking medical device complaints effectively.

According to the FDA’s investigation of Davol, Inc. after the recall, the degree to which they were unable to process the complaints accurately to discover the real problems with the large Kugel patches may have had a significant effect on why it took the company so long to recall them.

Related Articles

• Kugel Patch Injury Symptoms
• How the Kugel Patch and Davol Failed
• FDA Hernia Patch Investigation
  

On April 24, 2007, FDA District Director Gail Costello sent a warning letter to Davol President Daniel LeFever requesting a meeting to discuss the corrective actions Davol had proposed in response to the violations found during the inspection.

The specific deficiencies cited in Director Costello’s letter were:

1. Failure to establish and maintain an adequate corrective and preventive action procedure which ensures identification of actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3).

“For example, your firm initiated a class I recall in December, 2005 of all of your Extra Large Composix Kugel Hernia Patches due to breaks of the ring weld. In March, 2006, you expanded this class 1 recall to include other sizes of your Composix Kugel Hernia Patches due to three additional complaints of ring weld breaks. This second, expanded recall only included product manufactured prior to January 2004. Yet on March 31, 2006 and May 12, 2006, you received two additional complaints of ring breaks on large Composix Kugel Hernia Patches that were manufactured after January 2004. Your class 1 recall of the Composix Kugel Hernia Patches, manufactured after January 2004, was not initiated until January 10, 2007. “

2. Failure to establish adequate management controls to ensure that an effective quality system has been established and maintained as required by 21 CFR 820.20.

“During the FDA inspection, we observed significant violations as they relate to a number of quality system regulations, including your corrective and preventive action (CAPA) controls as demonstrated by the above example. Similar deficiencies were previously brought to your attention in a FDA 483 dated February 7, 2006, after an FDA inspection on January 25, 2006. Recurring, serious deficiencies in this area point to a failure of your quality management system. “

“We acknowledge your response to the FDA-483 dated March 27, 2007 and your promised corrective actions. We believe that the changes you described will address the specific issues that were identified in the FDA-483. In your response to this Warning Letter, please address how your management will be addressing any additional changes in your global quality system that will prevent similar violations from recurring. We need to be assured that an effective quality system will be implemented immediately.”

3. Failure to document the implementation of corrective and preventive actions, as required by 21 CFR 820.100(b).

“For example, CAPA #Q6023, (opened on April 28, 2006 and closed on June 13, 2006), was initiated as a result of your class 1 recall of the Composix Kugel Hernia Patch due to ring weld breaks. This CAPA included the following specific action to be taken, “… establish complaint threshold limits for recoil ring break complaints & continue to monitor trends.” During the inspection, no documentation could be provided to our Investigator that demonstrated these limits had been established prior to closing of the CAPA.”

“We acknowledge your response to the FDA-483 that indicated the document was missing. You also provided a document dated March 12, 2007, that indicates a threshold limit of [redacted] has now been established. Your response goes on to describe that this threshold limit of [redacted] had always been in effect as evidenced by an undated document which you provide in appendix 3. We note that if this threshold limit had been in effect in 2006, i.e., upon receipt of at least six complaints from March 31, 2006 through August 29, 2006, your firm would have been required to initiate a corrective action much sooner.”

4. Failure to validate your device’s design to ensure that the device conforms to defined user needs and intended uses, as required by 21 CFR 820.30(g).

“For example, there was no documentation to demonstrate that design validation was performed on your Salute Reusable Fixation device. During the inspection, we observed a performance specification for your Salute Reusable Fixation device which states, “. . .the reusable assembly shall be capable of producing [redacted] Q Rings without compromising performance”. There was no documentation available to demonstrate that any testing was performed to ensure that the Salute Fixation device met this specification.”

“Your response to the FDA-483 states that validation was performed by [redacted] in 2002; however these files were archived and could not be located during the inspection. Your response does not address the failure of your design control system to ensure that the Salute Reusable Fixation device was evaluated and that it conformed to defined user needs and intended uses. We acknowledge your ongoing field action of your Salute Reusable Fixation device, FDA recall #Z-0374/0375-2007, due to numerous complaints and MDR’s of the device failing to function as intended.”

5. Failure of your firm to establish procedures to completely address the identification, documentation, evaluation, segregation, disposition and investigation of non-conforming product as required by 21 CFR 820.90(a).

“For example, procedures are lacking to ensure consistency in the handling and timing of activities from complaint receipt, complaint investigation, product assessment team meetings and remedial action plans to the determination of actual recall actions. In examining Davol’s numerous recalls of the Composix Kugel Hernia Patches and the Salute Reusable Fixation device, we observed quality system failures that resulted in delays in the ultimate disposition of non-conforming product.”

The FDA has not published Davol’s response to these violations, but it may be assumed the issues were resolved satisfactorily because no further enforcement actions against the company have been published.

Related Articles

• Kugel Hernia Patch Recall, Dec 2005
• Kugel Hernia Patch Recall, Mar 2006
• Kugel Hernia Patch Recall, Jan 2007
• Kugel Patch Injury Reports
• Kugel Patch Lawsuits

Patent Application Drawing, U.S.P.T.O

Dr. Robert D. Kugel, a general surgeon and hernia specialist in Olympia, Washington, invented the Kugel patch. The ten patents on the patch design and method of use are now owned by Bard ASDI, Inc., a subsidiary of medical device manufacturer C.R. Bard, Inc.  The patch is marketed by another subsidiary, Davol, Inc.

History

The original Kugel patch was introduced to the market by Surgical Sense, Inc, a Texas-based medical device manufacturer who acquired the patents from Dr. Kugel in the late 1990s. Bard purchased Surgical Sense in 2000 and assigned the patch’s production, sales, and marketing to its Davol subsidiary.

Dr. Kugel originally designed the patch for repairing inguinal hernias occurring in the groin area – the most common type of hernia. To expand the market, Davol introduced several large-size versions of the patch for use in repairing typically larger incisional hernias. These larger patches went on sale in 2002. Shortly after the large-size patches went on the market, Davol began receiving sporadic reports of plastic ring breakage after the patch had been implanted.

Davol Finds the Flaw

As the number of reports grew to more than a dozen over several years, Davol began investigating the patch itself and soon discovered a flaw.  The ring is made of a length of flexible plastic rod that is bent into a circle with its ends welded together. The larger patches were made with a slightly larger-diameter plastic ring and Davol discovered that stressing the ring could cause the weld to give way, leaving the two ends of the broken ring free to cause internal injury. Soon after this discovery, Davol announced it was recalling all of its extra-large patches.

Why it Took Three Years

The initial complaints regarding ring breakage beginning in 2002 were so few and so rare, Davol did not perceive there to be a problem with the patch itself.  But between June and August 2005, Davol received ten reports, three coming from the same doctor. Believing the breakage to be caused by doctors mishandling the patch during placement, they temporarily stopped production in August 2005 and quickly focused on educating physicians in the proper folding technique.

By the time Davol discovered the problem with the ring weld in December 2005, it had received 24 reports of broken rings out of 32,000 units sold since 2002.  A later FDA investigation suggested that new complaint tracking software implemented in 2004 was incompatible with the previous system resulting in Davol’s inability to properly correlate complaint data.  Davol countered that it had performed comparisons between the two systems manually.

The FDA also complained that Davol had filed misleading reports concerning the severity of patient injuries due to ring failures. The parent company, C.R. Bard, issued a statement in response that there was no intent to mislead, but that the complaints had been miscategorized due to incomplete information available at the time the reports were submitted.

Corrective Action

Davol’s investigation of the ring welds on its large-size patches concluded that a stronger weld was needed to preclude any possibility of failure.  The specific changes Davol made in the design and manufacture of the product were:

• Changing from a 0.042” diameter recoil ring stock to a less rigid 0.030” diameter recoil ring stock (already used on other sizes of Kugel patch)
• Increasing the recoil ring weld strength by a factor of four times
• Increasing the recoil ring weld overlap at the weld joint from 0.180” to 0.480”
• Including updated “Instructions for Use” with the product providing guidance to preclude inappropriate manipulation during surgical insertion.

Current Status

Although Davol so far has not received any reports of ring failure in the newly designed patches, an FDA investigation into manufacturing practices at parent company C.R. Bard’s facilities resulted in a list of violations and a stern warning letter in July 2008. Many of the problems involved inadequate quality control procedures that resulted in mislabeled and incorrectly packaged products, including Kugel patches.  At the time of this update, the FDA had no further information available on what corrective action Bard had taken in response to the warning letter.

Related Articles

• FDA Hernia Patch Investigation
• Kugel Patch Injury Reports
• Kugel Patch Lawsuits
• Do You Have a Kugel Patch Case?

In practice, however, some of these early techniques were somewhat complicated. Several used a type of  plug or locating device inside the hernia defect itself. Also many of these earlier inventions were designed specifically for use in laparoscopic procedures. Moreover, many of the prior patches had to be sutured or stapled to the patient’s body tissue.

Although these medical advances were acknowledged for their usefulness and success, there remained a need for more improvements in the surgical repair of hernias.

A New Kind of Hernia Patch

The hernia patch designed by Dr. Robert D. Kugel in the early 1990s was a breakthrough because it can be implanted through a small incision slightly away from the hernia itself, and requires no sutures to hold it in place once positioned behind the hernia. His most innovative concept is what later came to be called the “memory recoil ring” – a thin, flexible plastic loop inside the mesh material that allows the patch to be folded and inserted through a small incision.  Then when the patch is released, the plastic loop springs back into its normal shape causing the patch to unfold back into a flat format.

Patent Application Drawing, U.S.P.T.O

In his first patent application filed September 29, 1994, Dr. Kugel describes how the patch is implanted:

“Then without the need for general anesthesia, nor expensive laparoscopic instrumentation, a surgeon, when repairing an inguinal hernia, makes a small incision in the patient, approximately three centimeters long, arranged obliquely, approximately two to three centimeters above the internal ring location of the inguinal hernia. Through this small incision, using the muscle splitting technique, the surgeon performs a dissection deep into the patient’s preperitoneal space, creating a pocket in this space into which this hernia mesh patch is to be inserted.

“Thereafter, the surgeon, using his or her fingers, readily folds and compacts this hernia mesh patch and directs it through the incision and into the patient’s preperitoneal space, where it unfolds and expands into its planar configuration, creating a trampoline effect. Then the surgeon, using just one of his or her fingers, placed partially through a slit in the top layer of mesh and into the pocket or pouch between the top and bottom layers of this hernia mesh patch, conveniently and accurately moves the hernia mesh patch to cover the defect in the  thick reinforcing lining of the patient’s abdominal cavity. Thereafter the surgeon withdraws his or her finger and then secures the incision with stitches.

“The patient’s post-operative discomfort is decreased, and risk of any recurrence is likewise decreased. The patient’s body, soon after surgery, reacts to the mesh of the hernia mesh patch, and in a short time, the mesh becomes stuck, thereby keeping the hernia mesh patch in place. Thereafter the patient’s scar tissue grows into the mesh over a period of time, between thirty and sixty days, to permanently fix the hernia mesh patch in its intended position over the repaired area, where the hernia was located.”

Between 1996 and 1999, Dr. Kugel filed additional utility patents on eight improvements in the patch’s design making it even easier to implant and hold itself in place.

Related Articles

• Dr. Robert D. Kugel – Surgeon, Inventor
• Kugel Hernia Patch Patents
• Patents – Fast FAQs

Patent Application Drawing, U.S.P.T.O

All of the patents are owned by Bard ASDI, Inc. a subsidiary of medical device manufacturer C.R. Bard, Inc. Some of the earlier patents were originally assigned to another medical device manufacturer, Surgical Sense, Inc., which was purchased by Bard ASDI in 2000. Later patents were assigned directly to Bard.

Dr. Robert D. Kugel, a general surgeon with a notable reputation in the field of hernia repair, is listed as the inventor on all the patents.  The last four patents issued also list J. Douglas Inman and Keith D. Biggers – officers of Surgical Sense – as co-inventors. These last four patents were applied for in 1999, before the sale of Surgical Sense to Bard, but were not issued until 2001 – a year after the sale.

The first patent establishes the fundamental design of a mesh hernia repair patch and a method for using it in a minimally invasive open surgical technique developed by Dr. Kugel. Additional patents describe refinements in the patch to improve its function, and one of the patents also describes refinements to the method.

Hernia Mesh Patches and Methods of their Use

Patent number 5634931, filed Sep 29, 1994 and issued Jun 3, 1997 for

“a hernia mesh patch for use in repairing inguinal and other abdominal wall hernias for expansion into a preperitoneal space and direction into a pocket thereof of an abdominal lining, when directed by a surgeon using his or her finger” and “a method of sutureless repair of an inguinal or other abdominal wall hernia.”

Hernia Mesh Patch

Patent number 5769864, filed November 22, 1996 and issued June 23, 1998 for

“a hernia patch, comprising a first layer of inert synthetic mesh material sized and shaped to extend across and beyond a hernia; a second layer of inert synthetic mesh material; securing means for securing the first and second layers to each other to create a pouch between the first and second layers; a slit in one of the layers for insertion of a finger into the pouch to position the patch across the hernia; and a resilient loop adjacent a periphery of the pouch for creating tension in both of the layers.”

Hernia Mesh Patch

Patent number 5916225, filed January 14, 1998 and issued June 29, 1999 for

“a tissue aperture repair patch for implanting within a patient, comprising at least one layer of inert synthetic mesh material sized and shaped to extend across and beyond a tissue aperture in a patient; a resilient support member adjacent a periphery of the layer for creating tension in the layer, the support member being carried by the layer so as to remain implanted with the layer in the patient; and the layer of inert synthetic mesh material having a periphery extending beyond the support member, defining a border which has a free outer edge to fill uneven voids in a patient’s tissue.”

Hernia Patch

Patent number D416327, filed March 25, 1998 and issued November 9, 1999 for

“the ornamental design for a hernia patch.”

Hernia Mesh Patch with Stiffening Layer

Patent number 6171318, filed February 11, 1999 and issued January 9, 2001 for

“a tissue aperture repair patch for implanting within a patient, comprising a first layer of inert synthetic mesh material sized and shaped to extend across and beyond a tissue aperture in a patient, the first layer having a planar configuration, being resilient and having a selected stiffness; and a resilient stiffening layer of inert synthetic material carried by and overlying the first layer for supporting the first layer in the planar configuration, the stiffening layer having a greater stiffness than the first layer.”

Hernia Mesh Patch with Slit

Patent number 6174320, filed August 2, 1999 and issued January 16, 2001 for

“a tissue aperture repair patch for implanting within a patient, comprising at least one layer of inert synthetic mesh material sized and shaped to extend across and beyond a tissue aperture in a patient; a curved, elongated, resilient support member carried by the layer for causing the layer to assume a planar configuration, said member to remain implanted with the layer in the patient; the layer of inert synthetic mesh material having a periphery extending beyond the support member, defining a border which has a free outer edge to fill uneven voids in a patient’s tissue; and a slit in said layer of inert synthetic mesh material, extending inward from the outer edge and terminating in an enlarged opening for placement around a patient’s chord structure.”

Hernia Mesh Patch with I-shaped Filament

Patent number 6176863, filed March 24, 1999 and issued January 23, 2001 for

“a tissue aperture repair patch for implanting within a patient, comprising at least one layer of inert synthetic mesh material sized and shaped to extend across and beyond a tissue aperture in a patient; and a resilient generally I-shaped support member for urging the layer to assume a flat configuration, said support member carried by the layer so as to remain implanted with the layer in the patient.”

Hernia Mesh Patch

Patent number 6224616, filed May 4, 1999 and issued May 1, 2001 for

“a method of repair of an abdominal wall hernia” and “a tissue aperture repair patch for implanting within a patient.”

Hernia Mesh Patch with Stiffener Line Segment

Patent number 6280453, filed February 11, 1999 and issued August 28, 2001 for

“a tissue aperture repair patch for implanting within a patient, comprising at least one layer of inert synthetic mesh material sized and shaped to extend across and beyond a tissue aperture in a patient; a resilient support member adjacent a periphery of the layer and configured in an open loop to urge the layer into a planar configuration, said support member carried by the layer so as to remain implanted with the layer in the patient; and the layer of inert synthetic mesh material having a periphery extending beyond the support member that defines a border having a free outer edge to fill uneven voids in a patient’s tissue.”

Hernia Mesh Patch with Seal Stiffener

Patent number 6290708, filed February 11, 1999 and issued September 18, 2001 for

“a tissue aperture repair patch for implanting within a patient, comprising two layers of inert synthetic mesh material, at least one of said layers being sized and shaped to extend across and beyond a tissue aperture in a patient; a seam joining said layers that imparts stiffness to the patch for biasing the patch in a planar configuration; and at least one of said layers of inert synthetic mesh material having a periphery extending beyond said seam that defines a border having a free outer edge to fill uneven voids in a patient’s tissue.”

Related Articles

• Dr. Robert D. Kugel – Surgeon, Inventor
• What’s Unique about the Kugel Patch?
• Patents – Fast FAQs