Is CR Bard a Cash King?

• Report this Comment On July 03, 2011, at 10:26 AM, TimMasterson1 wrote:

  Of course CR Bard is going to have a high % of " Free " cash . Why ??? Because they are not paying or wanting to settle on the 4000+ cases pending in Federal Court due to their Hernia mesh products that killed several people and destroyed the lives and family's of thousands , and they refuse to settle cases , stalling the courts by changing attorneys .

  This is not CR Bard / Davol INC's first malicious doing . They have had several products recalled by the FDA . Hernia mesh , Surgical Graft that was contaminated with bacteria ,

  According to the CR Bard website ( direct quote )

  Clinical Support

  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”

  January 10, 2007

  This letter is intended to inform you of actions being undertaken by Davol, a subsidiary of C. R. Bard, Inc., with the Large Sized Composix ® Kugel ® patches referenced in the header box at the top of this letter. First, we are expanding the recall action to certain manufacturing lots of the referenced product based on having received additional complaint reports of PET recoil ring breakage. Specific information about this recall action is discussed below. Second, Davol has decided to withdraw from the market all remaining 0010202 and 0010204 product which has the same component design as the manufacturing lots being recalled. An upgraded product design for both product codes is available for replacement.

  EXPANDED RECALL ACTION:

  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. This information supplements information contained in the recall letters issued by Davol in December 2005 and January 2006 for the Extra Large Patches and March 2006 for the Large Patches.

  Product codes and lot numbers that contain the re-designed product and are not subject to this recall action can easily be identified on the case or unit package with the label stating “Redesigned for improved ring integrity”. If this label is affixed to your case stock and/or individual packages, this product is not affected by this recall and need not be returned to Davol.

  Additionally, current product Instructions For Use (“IFU”) are included with this letter as a reminder of the appropriate folding technique to be used for both Open Placement and Laparoscopic Placement for the Large Composix ® Kugel ® Patches. Additional copies of these IFUs are available from Davol Customer Service by calling 1-800-531-4124.

  SUMMARY OF THE PRODUCT RECALL COMMUNICATIONS:

  Extension of the previous recall to specific lots of Bard ® Composix ® Kugel ® Patches is being conducted because we have received additional complaint reports for PET recoil ring breakage on lots of product codes 0010202 manufactured from January 1, 2004 through September 30, 2005. That rate of occurrence is defined below. There is a risk that the ring welds could break under stress placed on these products during placement, which could potentially lead to patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas. The products and lot numbers being recalled are listed on the attached Acknowledgement/Stock Status Form, which has been sent to all hospital administrators, risk managers, materials managers, OR managers, and distributors.

  Observed Rate of Occurrence and Clinical Implications:

  Product Code 0010202, Bard ® Composix ® Kugel ® Large Oval Patch: A total of 6 ring breaks have been reported, and four of these complaints have been confirmed, from the approximately 25,835 units manufactured between January 1, 2004 and September 30, 2005, for a reported occurrence rate of 0.023%.

  Incidents:

  One (1) Incident occurred during the mesh placement surgery and the product was not implanted.

  One (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.

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

  One (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.

  Notice it say nothing about the deaths they have caused .

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