If you have had a hernia mesh implant and you’re having serious medical problems, you should find the best mesh lawyer you can. RepresentYou.com offers hernia patch lawyers our mesh recall and product liability lawyers have experience in dealing with product recalls. Our panel memeber attorneys have a minimum of 20 years of experience in dealing with personal injury and product recall matters.
Hernia Surgery Mesh Recall
The hernia mesh that has been recalled is the Composix Kugel Mesh Patch this recalled product has been manufactured by Davol, Inc. Davol’s parent company: C.R. Bard, Inc. manufacturers many medical devices such as the hernia patch. The FDA has reported many problems with the “memory recoil ring” that opens the Composix Kugel Mesh Patch, this recoil ring can break under the heavy stress. The medical problems that have been linked to this are.
Hernia Mesh Side effects:
- Bowel obstructions
- Bowel perforations
- Chronic enteric fistulas
- Ahronic intestinal fistulae
- Abnormal connections or passageways between the intestines and other organs.
- Body pain
- Abdominal tenderness or pain
- Abnormal bowel movements
- Distended abdomen
The FDA has many reports of severe and serious abdominal pain this is due to the surgical mesh adhering to patients’ bowels or perforated bowels. If this happens to you, you may need bowel dissection surgery to remove the patch and repair the bowels. If you have had this problem you should contact a product recall lawyer.
Hernia Mesh Patch Lawyers
If you believe you have suffered a serious injury or illness at the hands of Bard, Composix, Kugel negligence you may be able to make a product liability claim against that manufacturer. RepresentYou.com is a good place to start. RepresentYou.com’s panel of attorneys include a number of product liability lawyers with experience and knowledge specific to this area of law. When you call or log on to our website a RepresentYou.com representative will ask you a few basic questions about your product liability case. If we believe you have a negligence case against the manufacturer we will refer you to one of our product liability lawyers at no cost. Please do not hesitate to call 24 hours a day, 7 days a week.
FDA Hernia Mesh Recall Information
Bard® Composix® Kugel® Mesh Patch
December 22, 2005 Product: *This recall notice was updated on January 24, 2007, to include additional product codes and lot numbers recalled by the manufacturer since the first list was issued (see previous announcements). The expanded list below includes all recalled product codes and lot numbers.*
Lot Numbers Recalled
0010206 Bard® Composix® Kugel® Extra Large Oval, 8.7” x 10.7” All Lot Numbers manufactured before January 2006 December 2005 and January 2006 0010207 Bard® Composix® Kugel® Extra Large Oval, 10.8” x 13.7” All Lot Numbers manufactured before January 2006 December 2005 and January 2006 0010208 Bard® Composix® Kugel® Extra Large Oval, 7.7” x 9.7” All Lot Numbers manufactured before January 2006 December 2005 and January 2006 0010209 Bard® Composix® Kugel® Oval, 6.3” x 12.3” All Lot Numbers manufactured before March 2006 March, 24, 2006 0010202 Bard® Composix® Kugel® Large Oval, 5.4” x 7.0” Lot Numbers manufactured before October 2005 (see below) January 10, 2007 0010204 Bard® Composix® Kugel® Large Circle, 4.5” Lot Numbers manufactured before October 2005 (see below) January 10, 2007 Use: The Bard® Composix® Kugel® Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place. Recalling Firm: Davol, Inc., Sub. C.R. Bard, Inc.
100 Sockanossett Crossroad
Cranston, RI 02920
Reason for Recall: The “memory recoil ring” that opens the Bard® Composix® Kugel® Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs). FDA District: New England FDA Comments:
- On January 10, 2007, Davol, Inc. (a subsidiary of C.R. Bard) sent letters to health care professionals and distributors notifying them of the most recent expansion of this recall of specific lots of Bard® Composix® Kugel® Large Oval and Large Circle Mesh Patches for product codes 0010202 and 0010204. Surgeons and hospitals should stop using the recalled product and return unused units to the company.
- Patients who have been implanted with one of the recalled devices should seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.
- It should be noted that product codes 0010202 and 0010204 were involved in both recall expansions. The lots manufactured prior to January 2004 were recalled during the March 2006 expansion. Since the March expansion, Davol received 4 confirmed complaints of recoil ring breakage from product code 0010202 manufactured between January 2004 and September 2005. There were no complaints for product code 0010204 . Davol is recalling the following lotsfor product codes 0010202 and 0010204:
- All lots with the letter “O” in the fourth position
- All lots with the letter “P” in the fourth position and the letters “A” through “I” in the third position.
For instance, an example of a recalled lot number is “43IPD###.”
- Davol also decided to withdraw from the market specific lots of 0010202 and 0010204 manufactured from October 2005 to October 2006. A market withdrawal is a firm’s removal or correction of a distributed product that involves a minor violation or no violation of the law and would not be subject to legal action by the FDA. Davol is withdrawing the following lots:
- All lots with the letter “P” in the fourth position and the letters “J” through “L” in the third position
- All lots with the letter “Q” in the fourth position and the letters “A” through “I” in the third position
For instance, an example of a withdrawn lot number is “43IQD###.”
- An upgraded product design for both product codes is available for replacement. Product codes and lot numbers that contain the re-designed product 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 market withdrawal and need not be returned to Davol.
- Davol notified U.S. customers of the initial recall by letter on 12/27/05 via Federal Express. On March 24, 2006, Bard issued letters to hospitals and health care professionals alerting them to the additional recalled products. The letters included updated Instructions for Use (“IFU”) clarifying the proper insertion technique and Supplemental Patient Management Information. Copies of current product IFUs to be used for both Open Placement and Laparoscopic Placement for the Large Bard® Composix® Kugel® Mesh Patches are available from Davol Customer Service by calling 1-800-531-4124.
FDA Expanded Hernial Mesh Recall
Bard® Composix® Kugel® Large Sized Patch Class I Recall and Market Withdrawal
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” x 7.0”
- 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.
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%.
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.
Product Code 0010204, Bard® Composix® Kugel Large Circle: No ring breaks have been reported in this product. However, because of the similarity of the ring joint welding process and PET ring diameter, this product is being recalled as a precaution.
Davol has decided to voluntarily withdraw from the market all remaining Bard® Composix® Kugel® Large Oval and Large Circle Patches that have the same component design as the manufacturing lots included in the expanded recall. This includes product manufactured from October 2005 to October 2006. Davol has improved the product component design as described below and has reviewed this strategy with the FDA and received concurrence with this action.
The new product component design is characterized by several important changes in these patches which include –
- Change from a 0.042” diameter recoil ring stock to a less rigid 0.030” diameter recoil ring stock (already used on other sizes of Bard® Composix® Kugel® patch).
- Increase of the recoil ring weld strength by a factor of four times
- Increase of the recoil ring weld overlap at the weld joint from 0.180” to 0.480”
- Inclusion of the most current product IFU to provide guidance to preclude inappropriate manipulation during surgical insertion of the product.
Product codes and lot numbers that contain the re-designed product and are not subject to this market withdrawal 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 market withdrawal and need not be returned to Davol.
More Information: http://www.fda.gov/
Hernia Patch Lawsuit
Defective medical devices such as Bard, Composix, Kugel mesh patches have been recalled by the FDA a hernia patch injury can cause serious pain, discomfort or in some cases even death. It is imperative that you speak to a defective medical device attorney if you or someone you know has suffered personal injury from hernia patch malfunction. The right product liability lawyer or recalls lawyer may be able to help you receive the compensation you deserve for the pain and suffering that a recalled hernia patch has caused you or your loved ones.
Here at RepresentYou.com, we are here to help if you have a case against Bard, Composix or Kugel for their mesh patch negligence. We will do our best to help you find an attorney with the experience and the expertise to handle your case. So if you find yourself in a situation where you are in need of a product liability lawyer, call us 24 hours a day, 7 days a week and we may be able to find the right mesh attorney to deal with your claim.