Below you will find a timeline of important dates and events concerning Hernia Mesh manufactured by Bard / Davol. This timeline is very complicated and convoluted, to say the least. This post was authored by a hernia mesh lawyer.
1996- Surgical Sense Inc. submits FDA application for “Kugel™ Hernia Patch”
On August 5th, 1996 Surgical Sense Inc. from Arlington Texas submitted a 510(k) application pursuant to 21 CFR 807.9 for the “Kugel™ Hernia Patch”. Surgical Sense Inc. classified this medical device as “surgical mesh.” Surgical Sense Inc. alleged that the “Kugel Hernia Patch” was substantially equivalent to: “Atrium Polypropylene mesh”. They asserted to the FDA that the “intended use of the Kugel hernia Patch is a surgical mesh for reinforcement of a hernia defect” Federal Drug Administration (FDA), Kugel Hernia Patch 510 (k) summary
1997- Davol introduces “Composix™ hernia patch
“In 1997, Davol released the Composix™ hernia patch, a forerunner to the CK Patch.The Composix patch is composed of two layers of polypropylene mesh for tissue ingrowth on the abdominal side, and a layer of ePTFE on the other side to prevent bowel adhesion to the mesh. The Composix patch does not contain a ring. Prior to placing the Composix patch on the market, Davol conducted animal testing by implanting the patch into the abdominal cavity of pigs. Davol submitted the testing results in a so-called 510(k) application to the Food and Drug Administration (“FDA”) in order to get clearance to market the Composix patch.” CHRISTOPHER THORPE and LAURE THORPE, Plaintiffs v. DAVOL, INC. and C.R. BARD, INC., Defendants. C.A. No. 008-463ML MDL Docket No. 07-1842ML In Re: Kugel Mesh Hernia Repair Patch Litigation
It is apparent that the FDA 510(k) application process is the root of the problem for defective hernia mesh. The FDA 510(k) application is a controversial process which allows medical device manufacturers to fast track medical devices while evading FDA testing protocol. This Composix hernia patch was “for use in the repair of ventral (incisional) and inguinal (in the groin area) hernias.” Legal Tube
2000- Davol aquires the Kugel™ hernia patch from Surgical Sense Inc.
“Davol acquired the Kugel™ hernia patch from Surgical Sense Inc., which marketed the Kugel™ patch for several years.” Id. “Eventually, the CK Patch was designed with two layers of polypropylene mesh, a layer of ePTFE, and a PET memory recoil ring welded between the layers of polypropylene mesh. The XL CK Patch featured larger sizes, two PET rings, and placement pockets for easier deployment of the patch.” Id. “Because Davol considered the XL CK Patch products a modification to an existing product (the one-ringed CK Patch in small and medium sizes), it made an internal determination that a 510(k) submission to the FDA was not warranted.” http://lawyersusaonline.com/wp-files/pdfs-3/thorpe-v-davol.pdf
August 25, 2000: Davol /Bard submitted an application to the FDA for the Composix E/X Mesh Patch. “On August 25, 2000, Davol / Bard submitted an application to the Federal Drug Administration to notify of its intent to market the Composix E/X Mesh Patch for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. Thereafter, the 510k Application was approved by the FDA and the Composix E/X Mesh Patch was classified as a Class II medical device.
The Composix E/X Mesh Patch was designed, manufactured, sold and distributed by DAVOL to be used by surgeons for hernia repair surgeries and was represented by DAVOL to be an appropriate, cost-effective and suitable product for such purpose.” http://www.beasleyallen.com/news/federal-court-expands-scope-of-kugel-mesh-hernia-patch/
2002- Here comes the XL CK Patch
In 2002 the XL CK Patch medical device was sold for the first time Id. In 2002, medical doctors began reporting problems with the Composix Kugel Mesh Patch. “a growing number of physicians began to report major abdominal injuries in their patients which stemmed from broken memory recoil rings in the patches.” Legal tube
2003- problems emerge with CK Patch
In the 2003 time period, “Davol first learned of a ring break in its CK Patch product line in 2003.” “In October 2003, Davol decided to enhance the weld strength of the memory recoil rings in all its CK patch products.” Id.
2005- XL CK patch recalled by Davol
“By mid to late 2005, Davol became aware of an increase in reported ring breaks in the XL CK Patch. Davol initiated a Corrective and Preventive Action (“CAPA”) investigation into the complaints. Davol also communicated the complaints to the FDA, informing it that the exact cause of the ring breaks was undetermined and that a recall did not appear warranted at that
“On August 31, 2005, production of XL CK Patches was halted while Davol investigated ring break complaints. Distribution of the XL CK Patches was discontinued on December 8,
“In a December 21, 2005 letter from Karen Kane (“Kane”) Manager of Davol’s marketing department, the sales force was advised that XL sizes of the CK Patch were being recalled because “the strength of the memory recoil ring may not withstand aggressive manipulation that may sometimes be applied during the placement of these extra-large sizes.. Kane further stated that customers asking for XL sizes of the CK Patch should be advised that the XL CK Patches were “currently not available and that Customer Service is offering the equivalent sizes of the Composix EX as an alternative.” Id.
“December 27, 2005: C.R. Bard notifies US customers of a voluntary Class I recall of the Bard Composix Kugel Mesh X-Large Patch by letter delivered via Federal Express. The recall is issued after reports that a component of the patch, known as the memory recoil ring, may not withstand certain stresses associated with specific surgical placement techniques. Breakage of the memory recoil ring can cause bowel perforations and chronic intestinal fistulae. At the time, approximately 32,000 units had been sold worldwide.’ Lawyers and settlements
“On December 28, 2005, Davol issued an “Urgent Product Recall” for the XL CK Patch to “Distributor: (Hospital Administrator, Materials Manager, O.R. Manager, Surgeon).” Pltfs.’ Ex. 676. Davol informed its customers that it was voluntarily recalling three product codes of the XL CK Patch because it had “received complaint reports of the PET recoil ring breaking which could potentially lead to bowel perforation and/or chronic enteric fistulas. We have identified a rate increase of recoil ring breaks since the introduction of these product codes in 2002. We estimatethe frequency of these reported events to be in the range of 0.08%. ” http://lawyersusaonline.com/wp-files/pdfs-3/thorpe-v-davol.pdf
2006- XL CK Patch recall is expanded
The expanded recall included “certain lots of the Large Oval and Large Circle products, as well as all lots of the Oval product”
“March 24, 2006: An urgent letter is sent by Bard to hospital administrators advising them that the Class I recall has been expanded to include certain lots of the Large Oval and Large Circle products, as well as all lots of the Oval product. A letter sent to distributors of the Kugel Mesh Patch states that the recall includes lots manufactured up to and including December, 2003, and notes that “there is a risk that the welds could break under the stress placed on the large sized products during placement, which could lead to potential patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas….Finally, a letter is sent to surgeons the same day requesting that they immediately stop using the specific products listed in the recall and give copies of the Important Patient Management Information to professionals who are managing patients already implanted with the recalled products. The expanded recall is issued because Davol, Inc., has learned of further ring breaks, including cases of bowel perforation, ring migration through the abdominal wall, bowel obstruction, and one instance in which a patient died after developing septic shock, consumptive coagulopathy and acute myocardial infarction from surgery to repair bowel fistulas caused by perforation from the broken ring.2005” https://www.lawyersandsettlements.com/articles/drugs-medical/kugel-mesh-timeline-00568.html
April 3, 2006: ” The US Food and Drug Administration (FDA) and Davol, Inc (a subsidiary of C.R. Bard, Inc), have notified healthcare professionals regarding the expansion of a class 1 recall for a ventral hernia repair device ( Bard Composix Kugel Mesh Patch) to include all lots of the oval “midline” size (product code 0010209), and lots manufactured before 2004 of the large oval (0010202) and large circle (0010204) products. The recall previously affected only the extra-large oval patch.”
“The recall is due to the potential for breakage of the “memory recoil ring” under the stress of placement into the intraabdominal space, leading to bowel perforation and/or chronic enteric fistulae, according to an alert sent yesterday from MedWatch, the FDA’s safety information and adverse event reporting program. ” http://www.medscape.com/viewarticle/529032
“December 18, 2006: A lawsuit is filed against Davol, Inc. related to the Kugel Mesh Patch. The plaintiff in the case, filed in Rhode Island, claims failure of the Kugel Mesh Patch resulted in severe pain and required bowel dissection surgery to remove the Patch, which had become stuck to the plaintiff’s bowel. The bowel dissection surgery resulted in chronically inflamed bowels. Lawyers for the plaintiff argue that Davol, Inc., knew that there was a possibility of failure in the Kugel Mesh Patch but did not properly warn the public.” Lawyers and settlements
2007- Davol recalls Bard®Composix® Kugel® Large Sized Patch and Bard® Composix® Kugel® Large Oval and Bard® Composix® Kugel®Large Circle
January 10, 2007: Davol extends the recall to include Large Sized Composix Kugel Patches (oval and circle) due to additional reports of memory recoil ring breakage. Another product with the same component design is also recalled because of the potential for breakage.” https://www.lawyersandsettlements.com/articles/drugs-medical/kugel-mesh-timeline-00568.html
Bard/ Davol stated ” Davol is expanding the voluntary recall of specific lots of Bard ® Composix ® Kugel ® Large Oval and Large Circle Patches. Immediately discontinue use of the specific product codes and lot numbers listed in the attachment. Additionally, please immediately distribute copies of the Important Patient Management Information to clinicians who may have implanted, or who may be managing, patients already implanted with one of these products under voluntary recall.” HERNIA REPAIR IMPORTANT PATIENT MANAGEMENT INFORMATION: Bard® Composix® Kugel® Large Sized Patch Class I Recall and Market Withdrawal Product Code: 0010202, Bard® Composix® Kugel® Large Oval, 5.4”x7.0” Product Code: 0010204, Bard® Composix® Kugel® Large Circle, 4.5 https://www.davol.com/clinical-support/product-recall-information.
2008- Federal Judge Expands consolidated lawsuits
“On January 8, 2008, a Federal Court judge in Rhode Island expanded the scope of the consolidated proceedings involving hernia patches manufactured by Davol / Bard to cover all Davol Marlex / Teflon products, with or without “memory recoil rings.” http://www.beasleyallen.com/news/federal-court-expands-scope-of-kugel-mesh-hernia-patch/
2010- Bard wins first bellwether hernia mesh trial, victim wins 2nd bellwether trial
1st Bellwether Trial: In Kugel Patch MDL Ends In Defense Verdict: Hernia mesh attorneys lose first hernia mesh trial. “PROVIDENCE, R.I. — (Mealey’s) The first bellwether trial involving the Kugel surgical mesh patch ended in a defense verdict on April 14 when a Rhode Island federal jury found that the plaintiff had not proven that his injuries were directly caused by or contributed to by negligent design of the device (In Re: Kugel Mesh Hernia Patch Litigation, MDL Docket No. 1842, No. 07-1842; John Whitfield v. Davol, Inc., et al., No. 07-1918, D. R.I.). A nine-member jury in the U.S. District Court for the District of Rhode Island, where the Kugel mesh hernia patch multidistrict litigation is centralized, found that plaintiff John Whitfield did not prove that the CK (Composix Kugel) patch was defectively designed or inadequately labeled or that defendants C.R. Bard Inc. and subsidiary Davol Inc. were negligent in labeling the device. Lexis Nexis
2nd Bellweather trial: Hernia mesh attorneys win 1.5 million verdict! “PROVIDENCE, R.I. – (Mealey’s) The second Kugel surgical patch bellwether trial went to the plaintiff Aug. 23 when a Rhode Island federal court jury awarded $1.5 million to a man who claims that the device caused him internal injuries (In Re: Kugel Mesh Hernia Patch Litigation, MDL Docket No. 1842, No. 07-1842, Christopher Thorpe v. C.R. Bard, Inc., et al., No. 08-463, D. R.I.).” Plaintiff Awarded $1.5 Million In Second Bellwether Trial In Kugel Hernia Patch MDLA jury in the U.S. District Court for the District of Rhode Island, where the Kugel multidistrict litigation is centralized, found that manufacturing defendants Davol Inc. and C.R. Bard Inc. inadequately designed the Kugel patch and failed to warn plaintiff Christopher Thorpe or his doctor that the device could fail. The jury awarded Thorpe $1.3 million and his wife, Laure Thorpe, $200,000 for loss of consortium. ” https://www.aboutlawsuits.com/settlements-kugel-hernia-mesh-problems-19474/ https://www.lexisnexis.com/legalnewsroom/litigation/b/litigation-blog/archive/2010/08/23/plaintiff-awarded-1-5-million-in-second-bellwether-trial-in-kugel-hernia-patch-mdl.aspx?Redirected=true
July 11, 2011: “C.R. Bard has reportedly reached an agreement to settle Kugel hernia mesh lawsuits brought by about 2,600 people who experienced severe internal injuries caused by problems with their hernia repair patches, with in an average payout of about $70,000 for each plaintiff. However, the settlement still leaves around 1,000 claims unresolved….” Id. These settlements were negotiated by top hernia mesh product liability attorneys.
“Law360, New York (July 1, 2011, 3:24 PM EDT) — C.R. Bard Inc. said Thursday it had tentatively agreed to pay $184 million to settle the majority of claims in a Rhode Island multidistrict litigation over allegedly defective hernia patches. In a U.S. Securities and Exchange Commission filing, the medical equipment manufacturer said it had reached agreements in principle with scores of plaintiffs who claim they suffered significant injuries because of faulty Composix Kugel surgical mesh patches manufactured by Bard subsidiary Davol Inc.” Law 360
“Law360, New York (July 1, 2011, 3:24 PM EDT) — C.R. Bard Inc. said Thursday it had tentatively agreed to pay $184 million to settle the majority of claims in a Rhode Island multidistrict litigation over allegedly defective hernia patches. In a U.S. Securities and Exchange Commission filing, the medical equipment manufacturer said it had reached agreements in principle with scores of plaintiffs who claim they suffered significant injuries because of faulty Composix Kugel surgical mesh patches manufactured by Bard subsidiary Davol Inc.”https://www.law360.com/articles/255403/bard-offers-184m-to-settle-hernia-patch-suits
Cases we are reviewing for hernia mesh victims:
- C-Qur (Lap – no FX)
- Composix EX
- 3D Max (no 3D Max Lite)
- Perfix Plug
- Kugel (criteria – confirmed ring break and revision)
Information about Bard hernia Mesh provided by a hernia mesh lawyers:
According to My drug Justice: “Mesh products that have reports of serious problems and were manufactured by Davol C.R. Bard include:
- Bard 3D Max Inguinal Hernia Mesh
- Bard Davol Supramesh Composite
- Composix Kugel Mesh Patch
- Bard Ventralex ST Hernia Patch
- Bard Mesh PerFix Plug” Baron and Budd
Hernia surgery is one of the most common types of surgeries that are performed. It is estimated that every year as many as 750,000 people undergo hernia repair surgery. When a patient is diagnosed with a hernia surgery is the only permanent treatment possible. While some patients may be able to wait to determine the severity of the situation, in many cases surgical care is needed to resolve the problem and keep it from worsening. Mesh patches are often necessary in hernia repair.
Repair of small incisional hernias, of less than 3 centimeters, are able to be repaired with the patient’s tissue. Larger hernias require the use of prosthetic materials such as mesh to provide a repair that is tension-free. Some of these materials are synthetic and may cause a host of complications when used in hernia surgeries.
Mesh Patches Made of Marlex Polypropylene
Patches made of Marlex polypropylene are designed to be used in laparoscopic hernia surgery. The material is flexible so that it can be folded to fit into a small incision. Once inside, it is opened to expand so that it covers the desired area. Unfortunately, there have been many medical problems and complications for patients with C.R. Bard mesh patches and others.
Marlex polypropylene is a type of manmade material that is non-absorbable. This means that the body does not absorb it, so it never disintegrates into the body. Instead, it remains in its original structure, although it may break, move, or weaken during use. The result is a hernia solution that can cause medical problems for patients.
History of C.R. Bard Mesh Patches
Mesh patches are utilized to strengthen the area of repair. Hernia surgery has become more common over the last 30 years since various repair materials have been more readily available. Flexible sheets of materials are manufactured to be used as support for the repair. Polypropylene is a synthetic material that is not absorbable by the body. Therefore, it can cause some complications once it has been put into place.
The most common problems that occur in patients from the use of mesh patches are migration and erosion. Migration happens when the mesh patch moves or changes position inside the body. This can occur when tissues grow around the patch and push it out of place. The patch can actually move into a position where it can damage the intestines or create a blockage. Patches may also erode over time, creating the need for additional surgery to repair the hole that is left.
Complications from Mesh Patch Use
Although not everyone suffers complications, many people have reported injuries and complications. The most common complications include:
- Migration of mesh
Complications may occur at any time after surgery but are most likely to happen months or years after the original surgical hernia repair was completed. Those who suffer from subsequent pain or other symptoms should immediately seek medical treatment. A complete doctor’s examination and diagnosis will determine the cause of the problem. Subsequently, the patient must be treated for complications due to the use of a mesh hernia patch.
Treatment of Complications
When a patient presents with a medical complication from a hernia mesh implant the cause of the problem may not be immediately known. Some symptoms may not appear for months or even years after the initial surgery. A different doctor may evaluate the patient, and the type of mesh implant that was inserted may not be noted. These details can make it difficult to evaluate and treat the patient.
Immediate care typically involves the use of pain medication and prescriptions to reduce inflammation. Once a diagnosis has been made, the patient will most likely require surgery to assess the internal damage and make the necessary repairs. The surgeon may try to remove at least part of the original patch; however, this can be difficult to do because the body’s tissue grows onto it. Instead, some of the patch will be taken out, and repairs will need to be done, sometimes using additional mesh products.
Recall of Surgical Mesh
C.R. Bard mesh patches have been reported to cause injuries to some patients. Injuries range in severity, and some are life threatening. The injuries were caused allegedly by defects in the mesh material that caused the product to shift or move inside the body or to break while implanted. The result may be a puncture to the bowel, an obstruction to the intestines, an infection, or other problems that can be severe. The U.S. Food and Drug Administration, FDA, requires companies to follow strict guidelines for testing and product safety. Any complications should be reported to the FDA by both the patient and physician. In addition, patients may seek compensation by filing a lawsuit.
Litigation History and Current Status
C.R. Bard manufactures a number of different types of mesh implants. Complications have been reported with the use of Kugel Hernia Mesh, 3D Max, PerFix Plug, Ventralex ST Hernia Mesh and Sepramesh. The company still manufactures and sells these products. Various lawsuits have been filed against the company for injuries sustained by the use of mesh hernia implants. The lawsuits are based on the fact that the company was made aware of medical problems but did not take action to prevent further injuries from occurring. Additionally, the company did not properly warn patients of the potential for injuries caused by the use of mesh hernia products. Nothing was done to correct possible product defects.
Those who were injured because of complications from the use of hernia mesh should speak with a hrnia mesh attorney as soon as possible. Victims may be entitled to compensation for medical and other expenses that were incurred because of the defective products. To qualify for a lawsuit an individual must have received a mesh implant as part of original hernia surgery and then later suffered from complications. Medical documentation is necessary to show that the complications were a result of a defective implant. Individual lawsuits are possible, or there may be class action lawsuits that victims may take part in.
The FDA speaks
“Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.” FDA
Please contact a hernia mesh lawyer for legal representation. A hernia mesh lawyer will help you get justice and compensation by either a judgment or settlement for your hernia mesh complications/revision surgery. Many victims are wondering if there will be a surgical mesh settlement 2017 or hernia mesh settlements 2018. Other victims are wondering what the average settlement amount is for a hernia mesh lawsuit.’
Hernia mesh lawsuits have been filed across the United States. Many of these lawsuits have been consolidated in Multi District Litigation (MDL). Here are some of the most significant Multi District Litigation:
- MDL No. 1842 | In Re: Kugel Mesh Hernia
Repair Patch Litigation UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF RHODE ISLAND
- MDL No. 2753 | In Re: Atrium Medical Corp. C-Qur Mesh
Products Liability Litigation, UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW HAMPSHIRE
- MDL No. 2782 | In RE: Ethicon Physiomesh Flexible
Composite Hernia Mesh Products Liability Litigation, United States District Court for the Northern District of Georgia