Links & Information
Bard Composix Kugel Mesh Criminal Past
Complications Associated with Defective Hernia Mesh Patches
Bard Composix Kugel Hernia Mesh Violations
Contact Us Now For A Free Case Evaluation
Visit Our Consumer Justice Website For Class Action Lawsuit Information And Free Case Evaluation
Visit Our Personal Injury Lawyer Blog For Daily Legal News And Case Information
|
|||
Bard Composix Kugel Hernia Mesh Recall
A hernia, in general, is the protrusion of an organ or tissue from its proper cavity. The protruded parts are generally contained in a sac-like structure, formed by the membrane with which the cavity is naturally lined. There are several different types of abdominal wall hernias, but the most common is inguinal which develops in the groin area. Umbilical hernias develop in the navel area, and incisional hernias occur near prior surgeries, to name a few types. The incidence of hernias within the general population is estimated at 3%, with 10% to 15% of cases occurring in adults, predominantly men. Hernia repair is one of the most common elective procedures in general surgery today, with over 700,000 herniorrhaphies performed annually in the United States alone. Groin herniorrhaphy is the most common operation performed by the general surgeon. Causes of hernias include any condition that increases the pressure in the intra-abdominal cavity, including obesity, heavy lifting, coughing, straining with defecation or urination, ascites, peritoneal dialysis, ventriculoperitoneal shunt, chronic obstructive pulmonary disease (COPD), and family history of hernias.
Click Here to Contact Us or call us at 800-748-7115
Hernia Surgery Lawsuit
Almost all repairs done today are open "tension-free" repairs that involve the placement of a synthetic mesh to strengthen the abdominal wall. The operation is typically performed under local anesthesia, and patients go home within a few hours of surgery, often requiring no medication beyond aspirin or Tylenol. Another emerging option is laparoscopic repairs which are also tension free, but the mesh is placed within the preperitoneal space behind the defect rather than in or over it. Laparoscopic surgery requires general anesthesia.
Attorney Description Of Basic Steps in Tension-Free Hernia Repair
Bard boasts that “Hernia operations using these types of products can be done in an outpatient setting in as little as 20 minutes. The patient generally can return to normal activity after minimal recovery time.”
Complications Associated with Defective Patches Lawyer Lawsuit
Patients with unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms should see medical attention immediately. These symptoms could be related to bowel obstruction, perforation or fistula, infection, palpable abdominal wall mass, or migration or movement of the PET ring. To date hernia patch litigation has focused on Bard prostheses with different configurations of polypropylene mesh (PPM), expanded polytetrafluoroethylene (ePFTE), and polyethylene terephthalate (PET) memory recoil rings (see below). Although the Bard Composix Kugel Patch group is the only product group subject to recall, the other groups include similar components.
Prosthesis |
Composition |
Bard Kugel Hernia Patch |
|
Bard Modified Kugel Patch with Positioning Strap and Pocket |
|
Composix E/X (nE/Xt generation) |
|
Bard Composix Kugel Patch
The PPM side of XL patches is bordered by a “protective overlap” ring of ePFTE. The PPM border is called the bridge and contains one PET ring, with the second PET ring within the ePFTE, near the edge. |
|
Bard Ventralex Hernia Patch with Positioning Strap |
|
Bard CK Parastomal Patch |
|
PRODUCT ISSUES
Polyproplene Mesh (PPM). All the above product groups contain a double layer of monofilament polypropylene mesh (Marlex PPM) which is attached to the abdominal wall. Bard claims that PPM stimulates tissue ingrowth and helps reduce hernia recurrence. The two layers create a pocket used to guide the patch into proper position. But double-layer PPM is a heavy-weight mesh which translates into a greater foreign body, increasing side effects. The mesh incites an intense inflammatory response leading to its penetration into host tissues. The inflammatory response also creates heavy scar formation leading to decreased compliance of host tissues as well as shrinkage and contraction of the mesh. This, in turn, reduces compliancy and leads to hernia recurrence as the mesh “shrinks.” A direct correlation between the amount of polypropylene in the mesh and stiffness of the abdominal wall, decreased mobility, and chronic pain has been reported. Alternatively, failure of the PPM to adhere can result in separation and migration of the patch. Adhesion failures have resulted from surgeons who were improperly instructed regarding the number of sutures required to secure the patch.
Expanded Polytetrafluoroethylene (ePFTE). Composix products feature double-layered PPM on one side and a thin layer of expanded Teflon or ePTFE on the other side. Unlike PPM that penetrates the abdominal wall, ePTFE creates a barrier against the bowels which, according to Bard, minimizes tissue attachment to the prosthesis. Barrier failure may result in bowel obstruction, adhesions and the formation of fistulas.
|
|
Monofilament Weave of Polypropylene (PPM) |
Composix Mesh PPM and ePTFE |
Polyethylene Terephthalate (PET) Memory Recoil Rings. Bard explains that PET rings prompt the patch to spring open, lie flat, and maintain its shape during placement, decreasing the number of sutures needed for securement. Hernia patches with PET rings are called “self-expanding” patches.
Kugel mesh patches were recalled because of various ring defects, including ring weld spot failures, cracked or fractured rings, and failures resulting in improper patch shapes or folds. Once broken the PET ring transforms into a scalpel that can perforate and slice through internal organs. Bowel performation results in the spillage of bowel contents into the abdominal cavity causing diffuse peritonitis which can lead to systemic sepsis and death, especially in older or immune-compromised patients. Other adverse effects include adhesions and chronic intestinal fistulae (abnormal connections or pathways between the intestines and other organs). After the December 2005 recall C.R. Bard implemented corrective action through a redesign of the patch. On June 2, 2006, FDA cleared modifications to the extra large Composix patches, including decreasing recoil ring diameter from 0.042” to a less rigid 0/030”; increasing recoil ring weld strength by a factor of four; increasing recoil ring weld overlap at the weld joint from 0.180” to 0.480”; and changes to the instructions for use to include guidance to preclude inappropriate manipulation during surgical insertion of the product.
LEGAL REGULATORY / ATTORNEY
Recall Timeline December 22, 2005: Bard, Inc., parent company of Davol, Inc., notified customers of a voluntary Class I recall of Composix Kugel extra large mesh hernia patches. March 24, 2006: Bard notified customers that the recall was expanded to include the small Composix oval and large Composix oval and circle prostheses. January 10, 2007: Bard again expands the recall to include large Composix patches. April 24, 2007: Gail T. Costello, District Director of FDA’s New England District, issued a warning letter to Daniel W. LaFever, President, Davol, Inc., Subsidiary C.R. Bard, Inc., 100 Sockanossett Cossroad, Cranston, Rhode Island. Mr. Johyn H. Weiland, President and COO, C.R. Bard, Inc., 730 Central Avenue, Murray Hill, New Jersey. Ms. Costello informed Mr. LaFever that FDA had observed serious regulatory problems involving the Composix Kugel Hernia Patches and Salute Fixation devices during its inspection of the Davol facility from January 23, 2007 to March 13, 2007.
Ms. Costello listed Davol’s violations, including:
• failure to establish and maintain an adequate corrective and preventive action, citing the sequential manner in which defective hernia patch product was recalled
• failure to establish adequate management controls to ensure that an effective quality system had been established and maintained, again citing the sequential nature of the recalls, and other significant violations
• failure to document the implementation of corrective and preventive actions, citing Davol’s failure to establish complaint threshold limits for recoil ring break complaints. (Davol did eventually produce such documentation, but it revealed the facility delayed and failed to initiate corrective action when required.)
• failure to validate the design of the Salute Reusable Fixation device
• failure to establish procedures to completely address the identification, documentation, evaluation, segregation, disposition and investigation of non-conforming product, citing delays in the ultimate disposition of recalled patches and fixation devices.
Ms. Costello requested a meeting with Mr. LaFever to discuss the violations, reminding him that serious violations of the law may result in FDA taking regulatory action without further notice to him. “These actions include, but are not limited to seizing your product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties.”
• February 13, 2008. FDA issued a Form-483 notice with an inspection of the company’s manufacturing facility located in Humacao, Puerto Rico. The Form-483 notice identified certain observations regarding the facility’s quality systems. The facility manufactures products for many of the company’s divisions and subsidiaries, including soft tissue repair products for the company’s Davol subsidiary.
THE COMPANY
C.R. Bard considers itself a worldwide leader in disease state management, globally recognized for its tradition of quality and its commitment to patient care, clinical research, and breakthrough products that advance the delivery of health care. C. R. Bard was founded in 1907 and formally incorporated in 1923.
By 1948 sales exceeded one million and, by 1994, one billion. C. R. Bard acquired Davol, Inc. in 1980. In 2000 Bard acquired the assets of Surgical Sense, Inc. and its Kugel Patch product line. In 2004 Bard acquired the assets of Bridger Biomed, Inc., including its ePTFE technology as an anti-adhesion barrier for hernia mesh products. In 2007, C.R. Bard celebrated the 100th anniversary of the company with the slogan: “100 years of quality, integrity, service and innovation.” Net sales for the year 2007 were $2,202M, an increase of 11 percent over 2006. C.R. Bard is a market leader in the patch segment of the hernia repair market.
An Interesting Spin for Investors
In its February 26, 2008 filing with the SEC, C.R. Bard reported that with the Composix Kugel patch recall in 2005 the company’s results for the year ending December 31, 2005 included a net sales reduction of $7.8 million in the surgical specialty group, resulting in a 1 percentage point reduction in 2005 consolidated net sales growth on a constant currency basis. However, “the combined effect of the Composix Kugel patch recall in 2005 and expansions in 2006 favorably impacted soft tissue repair products net sales growth in 2006 by 1 percentage point. . . the impact of these subsequent recalls was not material to the company’s full year 2006 financial results.”
The Criminal Past
Mr. LaFever and Mr. Weiland would do well to take Ms. Costello’s warning letter and the Puerto Rican Form 483 seriously. Those of us who have observed the pharmaceutical and medical device industry for years will immediately recall 1995, when C.R. Bard entered into a plea agreement that each of 393 criminal violations – based on various claims of defrauding the FDA and selling unapproved medical devices – was committed intentionally. C.R. Bard paid a $60 million penalty – at the time the largest ever imposed in a health care fraud case. Additionally, three company executives were convicted of underlying fraud and conspiracy and were sentenced to 18 months imprisonment. Prigmore, a Group Executive Vice-President of Bard, with responsibility for the company's United States Catheter and Instrument, Inc. ("USCI") division; Cvinar, a President of USCI; and Leichter, USCI's Director of Regulatory Affairs and Quality Assurance, engaged in the illegal sale of unapproved balloon heart catheters to improve the company's profits and market share. Estimated total sales of the illegal catheters amounted to $77 million.
The company execs subsequently appealed their case and the First Circuit Court of Appeals reversed the District Court decision, based on an improper jury instruction, and remanded the case for further proceedings. In lieu of a new trial, a plea agreement was reached; the judge sentenced the defendants to one-year probation, including 8 months of home confinement plus a fine. The corporate settlement was not affected by the plea agreement and sentencing.
The case was complex. C.R. Bard’s share in the heart catheter was shrinking in an increasingly competitive market. Bard was selling a heart catheter for balloon angioplasty with a probe that could not be rotated beyond 360 degrees. Although product labeling warned against excessive rotation, surgeons often encountered the need to do so with the result that the balloon would wrap itself around the wire making it difficult to deflate and remove.
C.R. Bard modified the product, but the changed design created worse problems. The wire of the redesigned product was more likely to break with excessive rotation and the probe tip would detach from the catheter during removal. The surgeon would either have to leave the tip in the patient or remove it by invasive surgery. Evidence of these problems poured into USCI in early 1989, but, contrary to the urgings of certain USCI "Crisis Team" members appointed by Cvinar to handle the situation, USCI, and then Bard, declined to order a voluntary recall of Probe B. The sales resulted in at least one death and 22 emergency heart surgeries.
C.R. Bard did submit a pre-market approval (PMA) supplement prior to introducing the redesigned probe. However, the document indicated that the redesigned probe had undergone lab testing which showed that safety and efficacy were not affected. In fact, the probe was distributed for human use prior to approval of the PMA supplement, and the probe was used in humans without an investigational device exemption (IDE) which requires various reviews and approvals. Bard began selling the experimental devices in 1987, and they almost immediately began failing. The F.D.A. began an investigation and started to recall the different models of catheters in July 1989, finishing the recall of all defective models by 1990. FDA then pursued the criminal investigation that resulted in the indictments.
