Hernia repair is a common surgical intervention in the United States. Indeed, it is estimated that has many as 350,000 hernia surgeries are performed in America every year. In a majority of these surgeries doctors use mesh implants to improve damaged or weakened abdominal tissue. The reason for the use of meshes is that studies show they reduce the likelihood of hernia recurrence. Meshes have also been associated, however, with painful and serious medical complications as a result of the surgeries. A study published in 2016 by Science Daily revealed the rate of medical complications in patients who had hernia mesh implants is higher than those who did have this medical device implanted.
Most Troublesome Hernia Meshes
More than a decade ago the Food & Drug Administration (FDA) released the first in a series of recalls that involved Kugel Mesh hernia repair patches manufactured by C.R. Bard, a national healthcare manufacturer. Research showed a part of the plastic mesh patch device had a tendency of breaking resulting in bowel perforations. Perforations in the bowels cause painful and life-threatening medical complications. As a result of all the issues with the product C.R. Bard agreed to the biggest hernia mesh settlement to date – in the amount of $184 million to over 3,000 individuals claiming significant harm as a result of the mesh product.
Kugel mesh is not the only hernia repair medical device to cause medical issues in patients who have undergone implant surgery. Other mesh devices causing medical problems and facing multiple pending lawsuits. For example, Atricum C-Qur reportedly causes several issues including failing to incorporate into the body, severe inflammation and infections, opening of the surgery site weeks or even months after the surgery, adhering to the patient’s bowel making it more difficult to remove if there are complications, as well as severe scar tissue. Atrium C-Qur is different from other meshes in that it has a fish oil coating.
Likewise, in 2016 Johnson & Johnson’s withdrew its Ethicon PhysioMesh from the market after an unusually large number of problems with the device were reported by two large hernia registries in Europe. The recall, however, was not before thousands of patients had undergone implant surgery in the United States. Complications reported by patients include severe scar tissue or adhesions, migration of the mesh device, and bowel obstruction.
Still, other hernia mesh device products that have had high complication rates by patients who have had implant surgery include Johnson & Johnson Ethicon Proceed mesh, Bard Ventralex ST, Bard Ventralight, Covidien Parietex composite mesh, and Covidien ProGrip mesh.
When a Hernia Requires Surgery
It is standard treatment for any type of femoral and inguinal hernia to treat the condition surgically. While most hernias are not complicated medical conditions, surgery is still commonly recommended especially when the condition is a recent diagnosis. Complications with the hernia – such as an incarcerated hernia or bowel obstruction – will likely need immediate surgical intervention. There are two types of hernia surgery methods: open procedure or laparoscopic repair. Because both procedures have similar complication rates, physicians do not necessarily prefer one over the other. Laparoscopic surgery – often referred to as minimally invasive surgery – is performed with the assistance of a video camera and numerous thin instruments. In a laparoscopic surgery the doctor is unable to see directly into the patient as he or she would during a traditional large incision open surgery. Accordingly, laparoscopic procedures cause less trauma on the abdomen but requires the use of a mesh. Inguinal and femoral hernias are often repaired laparoscopically unless the patient had prior surgery in the area (such as a prostatectomy, hysterectomy, or cesarean section).
Why Use Hernia Meshes?
Surgeons often use hernia meshes because using the medical device during the repair does not put tension on the tissue and, thus, reduces the likelihood of a hernia recurrence. Some studies reveal half of all hernia surgery repairs without the use of a mesh fail compared to the 20 percent of repair failures when a hernia mesh is used. Unless a patient has sepsis or an active infection, surgeons typically use hernia meshes.
There are two types of hernia meshes: synthetic and biologic tissue. The latter are made from human or animal tissue that has been washed to remove all cellular debris but leaves connective tissues in place. The former are made from polytetrafluoroethylene or polypropylene – the same compound materials that caused medical complications in the transvaginal mesh lawsuits. Complications including mesh migration and erosion are not uncommon in these products. While these meshes have been used since the late 1950s, polypropylene is not fit for implantation in humans.
FDA Continues Approving Hernia Meshes
Even though several types of hernia mesh products, made by different manufacturers, are causing medical complications in patients, the U.S. Food & Drug Administration continues to approve these products. The FDA does so through a premarket notification clearance process known as 510(k), which allows medical device manufacturers to avoid rigorous premarket safety testing that is required for many other types of medical devices trying to get on the market. Under the 510(k) approval process, manufacturers can put new medical devices on the market with much less scrutiny by claiming the product is similar to a medical device that is already on the market. Not surprisingly, medical device manufacturers continue to aggressively market hernia meshes despite growing complaints by consumers.
Hernia Mesh Attorneys
Hernia mesh lawsuits accuse medical device manufactures of several counts of negligence including:
- Failure to adequately test the hernia mesh device;
- Failure to warn the public about the risks of the hernia mesh device;
- Manufacturing a defective product;
- Intentional misrepresentation of the quality and safety of the hernia mesh device;
- Negligent design of the hernia mesh;
- Negligent marketing of an unsafe hernia mesh product; and
- Intentionally, knowingly, and recklessly keeping information about the hernia mesh device from the public.
More than 19 different hernia mesh products and at least four manufacturers are involved in the current litigation over hernia mesh complications. If you or someone you care about has suffered medical complications from the implantation of a hernia mesh contact the skilled medical device attorneys at the Roger Ghai Law Offices. This law firm has years of experience representing the injured and will fight for the monetary compensation you deserve.