CR Bard Mesh Lawsuits: Hernia Mesh Complications, Composix Recall
C.R. Bard mesh implants have caused painful injuries and side effects to many people. We can help determine your eligibility to file a claim against the manufacturers responsible for putting these dangerous medical devices on the market.
Dangerous Hernia Mesh By Implant Year
If you were implanted with mesh during hernia repair surgery in the following years, you are likely eligible to file a claim against the manufacturing company (Bard) for complications, pain and suffering.
Advances in medical and surgical technology alike are met with a mixture of enthusiasm and trepidation. When it comes to synthetic surgical mesh, both feelings intensify.
Enthusiasm is felt in optimistic hope that the new technology will work better and safer than previous mesh products. Trepidation for fear the “new and improved” mesh will turn out to be just new. The use of surgical mesh, beginning in 1996, turned out to be a much more dangerous way of repairing hernias than surgeons and mesh manufacturers hoped it would be.
What is Surgical Mesh?
Surgical mesh is a device used by surgeons to hold weakened or damaged organs or tissue in place.
There are two categories of material used to make surgical mesh:
- Organic Mesh. Organic mesh is absorbable, which is made of animal flesh and not intended to be a permanent fix. It degrades and is absorbed as the patient grows new tissue and rebuilds.
- Synthetic Mesh. Synthetic mesh is non-absorbable, often made of plastic derivatives like polypropylene and nylon materials. Synthetic mesh is intended for use as a permanent implant. A common use of synthetic mesh is in hernia repair surgery.
Unfortunately, the surgical mesh has not worked as well at repairing hernias as was intended. Instead, patients have suffered serious complications from hernia mesh including permanent debilitation and a serious reduction in quality of life.
Problematic C.R. Bard Hernia Mesh Products
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
- Bard Composix Kugel Mesh Hernia Patch
- Bard Ventralex ST Hernia Patch
- Bard Mesh PerFix Plug
Composix Kugel Hernia Mesh Patch Recalled
C.R. Bard manufactures various medical products, including the synthetic mesh implant called Composix Kugel Mesh Patch. The Kugel Mesh Patch is used in hernia repair surgeries. Due to serious complications experienced by patients who had the mesh implanted, Bard was forced to recall the patch.
Unfortunately for thousands of patients, the recall was not done in time to save them from the problems the mesh caused.
Bard 3DMax Hernia Mesh Injuries
Bard’s 3DMax is made of polypropylene, which is known to erode. The combination of known hernia mesh erosion and the specific use of 3DMax mesh in inguinal hernia repair surgery puts patients at a high risk for spermatic cord injury, infertility, and testicle amputation.
Supramesh IP Composite Mesh Problems
Although dozens of horrific events have been reported to the FDA from doctors and patients implanted with Supramesh during hernia repair surgery, it has not been recalled. Some of the most common complications reported with this mesh include adhesion to organs around the application site such as the liver, colon, kidney, bowel, bladder, rectum, and spermatic cord.
Bard Hernia Mesh Complications
The Kugel Mesh Patch is inserted into the abdomen or groin as a way to repair the hernia. In some cases, the mesh breaks and causes very serious, even life-threatening, complications. In other cases, it rolls over on itself and creates a cigar shape. In still others, it detaches and migrates around a patient’s system.
Even when removed, fragments may remain in the system, still causing discomfort. In most cases, however, mesh removal surgery has devastating consequences on the patient. In some cases organs have to be removed completely, and the patient is left with permanent injuries and impairment.
Some of the most common complications from C. R. Bard hernia mesh include:
- Perforated bowel leading to chronic bowel and urinary problems.
- Chronic intestinal fistulae.
- Bowel obstructions.
- Adhesions when the mesh attaches itself to a patient’s internal tissues.
- Hernia recurrence.
- Infections. Some infections occur soon after the implant, but infections attributable to the mesh have been known to occur years after the device was installed.
- Nerve damage.
- Autoimmune reactions.
- Organ perforations.
- Organ attachment.
- Mesh migration.
- Mesh rejection.
- Organ removal.
- Mesh removal surgery.
Symptoms of Complications
If you had hernia repair surgery, there is a chance that one of these horrific complications can occur. Patient reports include a variety of symptoms before the mesh side effects were diagnosed.
- Tenderness at the surgical site.
- Abnormal bleeding.
- Severe and constant abdominal pain. Some have reported agonizing pain so bad that they found themselves on the floor in the fetal position writhing in pain.
- Abdominal distention.
- Fever and general malaise as a result of the infection.
Recalled Hernia Mesh Products Made by Bard/Davol
The Kugel Mesh Patch was first put on the market in 1996. Different sizes of the patch were recalled in 2005 and 2006. In February 2007, the Food and Drug Association (FDA) issued a Class I recall warning that the “use or exposure to” the Bard Kugel Mesh Patch “has a reasonable probability to cause serious adverse health consequences, including death.”
In 2006 the FDA issued another recall of Davol/Bard Composix Kugel Mesh Patch products. The class I recall initially included only one model. The recall stated that the
“Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The “memory recoil ring” that opens the Composix Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).”
Just 29 days after the initial 2006 recall, the FDA expanded the recall to include additional hernia mesh patches including the Bard Kugel Mesh Patch Oval, Large Oval Kugel Mesh Patch, and the Bard Large Circle Kugel Mesh Patch.
Davol-Bard Hernia Mesh Settlements & Lawsuits
Thousands of personal injury claims and wrongful death lawsuits have been filed against Bard and its subsidiary, Davol Inc., since before the first recall was issued in 2005. The allegations are that Bard and Davol knew the hernia mesh patches and implants were unsafe, but marketed them as such anyway. Further, Bard mesh lawsuit plaintiffs claim the manufacturer failed to warn doctors and patients about their dangers.
Bard tried to shirk responsibility by alleging that the complications from the mesh implants was on the surgeons’ shoulders for improper placement of the device. Of more than 3,000 cases, two went to trial. Bard won the first one when the jury did not think the plaintiff had proved his case. The jury in the second case awarded the plaintiff $1.5 million. This prompted Bard to settle the remaining cases.
In 2011, Bard settled with more than 2,000 plaintiffs for a total of $184 million. The caveat was that Bard was not required to admit liability. Litigation with Bard continues as the mesh implanted in patients years ago continues causing complications.
Experienced Mesh Lawsuit Attorneys
If you have undergone hernia repair surgery involving a mesh implant or patch, and have any symptoms indicating complications, contact the hernia mesh attorneys at Baron & Budd for a free consultation. The statute of limitations for pursuing claims is complex and varies by state. Call us quickly after experiencing complications so that we can pursue compensation on your behalf. Call 866-829-0176 now to speak with a member of our team. Once your eligibility to file a claim is determined, we will begin working to file your claim.
1. 2007 FDA Class I Bard Kugel Mesh Recall: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152454.htm
2. 2006 FDA Recall of Bard Davol/Bard Composix Kugel Mesh Patch: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm151442.htm