Hernia mesh is a simple medical device that is used to repair hernias, which occur when intestines or other tissue protrude through weak areas of muscle. The mesh helps to strengthen that weak spot and hold the tissue in, but some brands of mesh have been recalled over very serious issues and complications.
Potential complications of hernia mesh include bleeding and pain, adhesion of tissues, migration of the mesh, and even the formation of fistulas and perforations in organs. You can become seriously injured by faulty hernia mesh and may need additional surgeries. Contact a lawyer if you feel as if your mesh has caused you pain or other complications.
What is a Hernia?
A hernia is a potentially serious and painful medical condition that occurs when part of an abdominal organ, usually the intestines, or fatty tissue protrudes through a weak area of muscle and connective tissue. Different types of hernias are categorized by where they occur: inner groin, ventral wall of the abdomen, belly button, upper abdomen, or through a surgical incision.
The cause of a hernia is weakness in muscles and connective tissues, which in turn may be triggered by a number of factors. Surgery, an older age, congenital defect, injury, coughing, lifting heavy objects, constipation, and other things can contribute to or directly cause the formation of a hernia. Hernias can be painful but can also lead to serious complications if not treated. These include bowel obstruction, constipation, swelling, and even strangulation of the intestines, which can be fatal.
Surgical Treatment with Hernia Mesh
For minor, small hernias a doctor may recommend watching and waiting to see if it gets larger or causes symptoms. When a hernia is large enough to require treatment, surgical repair is the only option. Depending on the size and location of the hernia, minimally invasive surgery and using stitches to close the weak area may be adequate.
Many hernias require more involved repairs, specifically using hernia mesh. The mesh is a thin material that is placed over the area of muscle or tissue weakness to provide support and prevent organs from protruding. There are different types of hernia mesh, including those made of synthetic materials and those made from animal tissue. It may be absorbable, meaning the body will eventually absorb the material. Mesh that is non-absorbable will stay in the body indefinitely.
Complications of Hernia Mesh
For most people the use of hernia mesh results in good outcomes, including reduced rates of recurring hernias. However, there have been many reports of complications caused by hernia mesh, and these have led to a lot of recalls of specific types and brands of mesh. Some of the complications that have been recorded or reported to the FDA include:
- Ongoing pain.
- Infection at the site of the mesh.
- A recurrence of the hernia.
- Development of scar tissue that causes other tissues to adhere together.
- Obstruction, or blockage of the intestines.
- Bleeding in the abdomen.
- Fistulas, which are connections between organs, intestines, or blood vessels.
- Seroma, a buildup of fluid at the hernia site.
- Perforation of organs.
- Migration of the hernia mesh.
Complications due to hernia mesh can have consequences ranging from minor pain to the risk of death. Pain, bleeding, damaged tissue and organs, and other issues may require that a patient have surgery again to replace the mesh and repair any damage. Perforation, adhesion, obstruction, and other serious complications can cause infections that may be life threatening.
Recalled Hernia Mesh
Many of the reports of complications have involved types and brands of mesh that have been recalled, either by the manufacturer or the FDA. Since 2005 there have been hundreds of thousands of units of mesh recalled because of the damage and harm they have caused to patients. Brands that have been recalled in the past include:
- Atrium C-QUR meshes of various sizes and types.
- Bard Davol Composix Kugel hernia meshes and patches.
- Ethicon Proceed surgical mesh.
- Ethicon Physiomesh flexible composite mesh.
Some of the reasons cited for these recalls included improper packaging, loss of laminate coating on the mesh that may cause adhesion, packaging defects that can lead to delamination, ring breakage leading to perforation of bowels and fistulas, and generally high failure rates that have led to complications and revision surgeries.
Atrium C-Qur Recalls and Warnings
Atrium manufactures the C-QUR line of surgical and hernia meshes and has been the subject of recalls and FDA warnings. In 2012 the FDA issued a warning to the company that its manufacturing processes were not adequate to ensure safety of the mesh. One issue was that the company failed to assure that the sterilization process used was up to standards. The warning also stated that Atrium failed to review and investigate complaints regarding failures of the mesh.
There were several other issues and warnings. The FDA stated that Atrium repeatedly ignored warning, which led to the agency blocking manufacturing and sales of hernia mesh. The issues also led to recalls of many of Atrium’s C-QUR mesh products. For instance, several lots were recalled in 2013 for packaging issues that could lead to failures of the mesh once implanted.
Ethicon Physiomesh Recalls
Another high profile manufacturer of hernia mesh that faced warnings and recalls is Ethicon, a division of Johnson & Johnson. There have been three recalls of Ethicon Physiomesh composite meshes from 2005 to 2016. In 2006 the recall of multiple lots was because the coating on the polypropylene mesh was deteriorating. Contact between tissue and the polypropylene material caused fistulas and adhesion in some patients.
In 2016 Ethicon had to issue another recall of Physiomesh surgical hernia mesh because it was proven in studies to cause higher revision rates than other types of mesh. In a statement the company said that it had not pinpointed the reason for greater rates of surgery to repair or redo the mesh in hernia patients. It cited a possible combination of the mesh itself, surgical procedures, and individual patient factors.
What To Do if Your Hernia Mesh has been Recalled
If you have already had mesh used to repair your hernia and you find out that the model and brand have been recalled, talk to your doctor as soon as possible. If you have no symptoms there is likely nothing you need to do about it. Many people with the recalled mesh never had complications or symptoms as a result.
However, if you have experienced symptoms from any type of mesh, whether it was recalled or not you need to see your doctor and discuss what to do about it. You should also contact Colter Legal PLLC for a no obligation consultation.