Jan. 13, 2017 — San Diego, CA — Hernia repair surgery is one of the most common surgical procedures performed in the United States, with more than one million conducted each year, according to the U.S. Food and Drug Administration (FDA).
Hernias occur when an organ or fatty tissue pushes through a weak spot in the surrounding tissue. The most common types of hernias occur in the inner groin (inguinal), outer groin (femoral), belly button (umbilical) or upper stomach (hiatal). Some hernias can occur as a result of surgery (incisional).
To repair hernias, surgeons often use a mesh or patch to reinforce and provide support to the weakened tissue. There are many different types and brands of hernia mesh, some of which have been associated with a higher rate of complications than others.
Hernia Mesh Problems & Complications
Many hernia mesh products have come under fire in recent years because they have been associated with increased rates of complications.
Hernia mesh complications include:
- Inflammation
- Infection
- Chronic pain
- Hernia recurrence
- Adhesion
- Allergic reaction
- Fluid buildup called seroma
- Hematoma, or the abnormal collection of blood outside a blood vessel
- Fistula formation
- Tissue or mesh erosion
- Need for additional surgeries (revision surgeries)
Hernia Mesh Brands Linked to Complications
- Atrium C-Qur Hernia Mesh
- Bard Sepramesh
- Bard Ventralex ST Hernia Patch
- Bard 3DMAX Mesh
- Ethicon Physiomesh
These hernia mesh brands have been linked to some or all of the complications mentioned above, but each mesh is different.
Here we will take a closer look at these problematic hernia mesh products, focusing specifically on the hernia mesh brands manufactured by medical device giant C.R. Bard Inc. and its subsidiary Davol Inc.
To learn more about the problems surrounding other hernia mesh brands, visit our Atrium Medical C-Qur Mesh page and Ethicon Inc. Physiomesh page.
Bard Sepramesh IP Composite
Manufactured by: C.R. Bard Inc. subsidiary Davol Inc.
Sepramesh was originally manufactured by Genzyme Corporation, a biotech company acquired by pharmaceutical giant Sanofi in 2011.
In 2007, before the acquisition, C.R. Bard announced it had entered into an agreement with Genzyme to manufacture and market the Sepramesh product. Bard said it would begin marketing Sepramesh immediately and that it would incorporate the Sepra® technology into future mesh products of its own.
Approved: May 2004
The first Sepramesh product was approved by the FDA in March 2000 through the agency’s 510(k) clearance program. This means the makers of Sepramesh (Genzyme at the time) did not have to perform rigorous clinical tests to ensure their mesh product was safe and effective. They only had to show that Sepramesh was similar enough to another mesh product already on the market.
The first Sepramesh was approved using the Bard Mesh and Bard Composix Mesh as predicate devices. Even though the Sepramesh was made using different materials than these other meshes, it was approved with only laboratory tests and one animal study to back it up.
The Sepramesh IP, approved by the FDA in 2004, is a modified version of the original Sepramesh device and contains additional materials. Like its predecessor, Sepramesh IP was approved without rigorous clinical testing to make sure it was safe and effective.
What is this hernia mesh made of?
Sepramesh IP Composite is made of the plastic-like materials polypropylene (PP) and polyglycolic acid (PEG). (The original Sepramesh contained only PP.)
The PEG side is coated with an absorbable hydrogel made from sodium hyaluronate, carboxymethylcellulose and polyethylene glycol.
The coating is meant to keep other tissues and organs from adhering to the mesh during the critical wound healing period following surgery. It is slowly absorbed and excreted by the body – usually within 30 days, according to the original Sepramesh 510(k) approval summary.
The side that is not coated with the hydrogel allows tissue to grow into the mesh in order to provide support to the weakened area.
Problems & Complications
Bard’s Sepramesh IP has been associated with many common complications of problematic hernia mesh brands.
At least 50 adverse event reports relating to Sepramesh and Sepramesh IP have been submitted to the FDA by doctors, patients, and attorneys representing those patients in lawsuits. Some of the most recently submitted reports involve complications with the Sepramesh IP.
A report submitted last August indicated the Sepramesh IP had adhered to the patient’s colon, which surgeons discovered when performing a revision surgery to fix a recurrent hernia.
Another report submitted in January 2016 detailed a patient’s horrific experience when he was implanted with three Sepramesh IP devices to fix a hernia caused by a previous surgery. The report said the Sepramesh had created a hole in his small bowel and eroded into his small intestine. At least one of the pieces of mesh became infected, another attached to his liver, and surgeons had to perform three separate bowel resections in an attempt to fix the problems created by the Sepramesh products.
Has this hernia mesh been recalled?
The Sepramesh IP has not been recalled and continues to be sold and used today in hernia repair surgeries.
Bard 3DMAX Mesh
Manufactured by: C.R. Bard Inc. subsidiary Davol Inc.
Approved: October 2008 (modified version)
The first modified version of the Bard 3DMAX hernia mesh was approved by the FDA in 2008 through its 510(k) approval process. This means the device was not subject to rigorous testing to ensure its safety and effectiveness.
What is this hernia mesh made of?
Bard 3DMAX Mesh is made of the plastic-like material polypropylene (PP). Its “3D” curved shape is designed to fit the shape of the inguinal canal (the groin).
The mesh is also marked using a PP and copper dye. The mark tells surgeons which way the mesh is supposed to be implanted.
Bard 3DMAX Mesh Problems & Complications
Bard’s 3DMAX Mesh has been associated with many complications of problematic hernia mesh brands. Nearly 60 adverse event reports have been submitted to the FDA relating to complications suffered by patients implanted with a 3DMAX.
One report submitted in February 2016 by the patient himself detailed complications he suffered years after being implanted with two 3DMAX meshes. The patient initially underwent hernia repair surgery in 2003. More than a decade later, he had his gallbladder removed. Shortly after that surgery, the patient said he began to vomit blood and was taking to the emergency room. Surgeons then discovered that the 3DMAX meshes had become entangled in his small intestine and adhered to the tissue walls. They removed about 12 inches of his intestines along with the mesh.
Another report from March 2016 said a patient implanted with a 3DMAX Mesh suffered a hematoma (abnormal collection of blood outside a blood vessel) following his surgery and complained of significant abdominal pain. Several months after his surgery, the patient told doctors he had shooting pains that radiated down his leg, back and groin. The patient had surgeons take out the 3DMAX mesh after refusing a regimen of painkillers. The report indicates that only 90% to 95% of the mesh was actually removed, however, because a portion of it was surrounded by so much scar tissue.
Has this hernia mesh been recalled?
Bard’s 3DMAX Mesh has not been recalled and continues to be sold and used today in hernia repair surgeries.
Bard Ventralex ST Hernia Patch
Manufactured by: C.R. Bard Inc. subsidiary Davol Inc.
Approved: March 2011
The Ventralex ST Hernia Patch was approved by the FDA in March 2011 through the agency’s less rigorous 510(k) premarket notification program. The mesh was approved using Bard’s Ventralex Hernia Patch, a hernia mesh approved by the FDA in 2002, as a predicate device.
What is this hernia mesh made of?
Bard’s Ventralex ST Hernia Patch combines the original Ventralex patch with the Sepramesh IP Composite.
The mesh is made of two distinct layers. The first is made of the plastic-like material polypropylene (PP) – the same used in the Ventralex patch. The second layer is made of PP and polyglycolic acid – the same used in Sepramesh IP.
Like Sepramesh IP, Ventralex ST is coated on one side with an absorbable hydrogel made from sodium hyaluronate, carboxymethylcellulose and polyethylene glycol. The coating is supposed to keep other tissues from adhering to it before it is eventually absorbed and excreted by the body.
Problems & Complications
The Ventralex ST Hernia Patch has been linked to many of the common hernia mesh complications mentioned earlier in this post.
Patients and their doctors have submitted nearly 40 adverse event reports relating to complications of the Ventralex ST device.
A report filed this past November related to a patient whose Ventralex ST had “folded over with adhesions,” including some to the bowel. Surgeons feared the mesh had become infected and removed it completely without injuring other organs or tissues. They then used sutures to repair the defect created by the faulty mesh.
In another report filed in March 2016, a patient underwent hernia repair surgery and was implanted with a Ventralex ST mesh. After the surgery, the patient experienced intense pain and surgeons found that the mesh had torn away from the abdomen and was curled up in a ball. The patient reportedly suffers from nerve pain now and has a deformity caused by scar tissue where the mesh was initially implanted.
Has this hernia mesh been recalled?
Bard’s Ventralex ST Mesh was the subject of two class II recalls in 2011. Bard announced the recalls after it became known that certain batches of meshes were placed in the wrong packaging. The recalls were terminated within two years.
Other than this limited recall, Ventralex ST continues to be sold and used today in hernia repair surgeries.
Hernia Mesh Lawsuits
The many injuries suffered by patients implanted with faulty hernia meshes are prompting hernia lawsuits to be filed against the makers of these dangerous devices.
Lawsuits are being filed against C.R. Bard Inc. and its subsidiary Davol Inc. over complications potentially caused by their Sepramesh IP, 3DMAX, and Ventralex ST mesh brands. There are also lawsuits against Atrium Medical and Ethicon Inc., the makers of the C-Qur and Phyisomesh, respectively.
If you or someone you love was injured as a result of a hernia mesh, you may be entitled to financial compensation. This compensation can help provide relief from medical bills and lost wages.
To see if you qualify for a case, contact the experienced lawyers at National Injury Attorneys, LLC today. We are available 24 hours a day, 7 days a week to assist you and answer any questions you may have.
Use the form on the right-hand side of your screen or call 1-800-214-1010 to speak with a member of our legal team for a free case evaluation.
