Hernia Mesh Injuries
Risks of Hernia Mesh and Personal Injury
Mesh is used frequently for hernia repair, but some name brand mesh products are being recalled because of the increasing number of patients experiencing complications such as infections and bowel obstructions that require prompt removal of the mesh. These patches, plugs and larger sheets of mesh were cleared for use under the 501(k) approval process which allows the use of medical products without clinical trials.
The Johnson & Johnson subsidiary Ethicon is the most recent to recall one if its surgical mesh products known as Physiomesh that is used for abdominal, ventral, and inguinal hernia repair. The base layer of the mesh is made up of plastic or polypropylene, which is the same material used by Ethicon in their transvaginal mesh and bladder slings; products that were also subject to failures and lawsuits previously. Unpublished data from two studies done in Germany and Denmark noted that those who had Physiomesh had higher rates of hernia recurrence and more complications that had to be remedied with multiple surgeries. More serious claims against Physiomesh failure resulted in damage to internal organs or the rupturing the mesh, allowing the intestines to poke through.
Ethicon initiated a voluntary recall of the mesh product in May 2016 and the FDA later recalled the product in all healthcare faculties. Ethicon sites that it is a “multifactorial issue,” although they have not been able to characterize what these issues may be. According to the FDA, the most common complications resulting from hernia mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction.
Surgical Mesh: Recalled Products
|PRODUCT NAME||PRODUCT CODE||DESCRIPTION/SIZE|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY0715R||Rectangle 7.5cm x 15cm|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY1015V||Oval|
10cm x 15cm
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY1515Q||Square 15cm x 15cm|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY1520R||Rectangle 15cm x 20cm|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY1520V||Oval|
15cm x 20 cm
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY2025V||Oval|
20cm x 25cm
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY2030R||Rectangle 20cm x 30cm|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY2535V||Oval|
25cm x 35cm
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY3035R||Rectangle 30cm x 35cm|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY3050R||Rectangle 30cm x 50cm|
|Laparoscopic Hernia Pack||ELH5||PHY1515Q|
|Laparoscopic Hernia Pack||ELH10||PHY1515Q|
What should I do if one of these products was used on me?
Speak with your doctor regarding any concerns you have regarding the hernia mesh product that was used during your hernia repair. Observation and regular monitoring may be the best course of action. Any complications you notice should immediately be discussed with your health care providers.
If you have suffered from complications, you may be entitled to compensation. Contact us today to speak with a hernia mesh attorney.
What is a hernia?
A hernia is what occurs when an internal organ or tissue begins to protrude through a weak area of muscle, creating a noticeable bulge in that particular location. Hernias can occur in the abdomen, upper thigh, and most commonly, the groin. As the internal organ or tissue (such as the intestine) pushes through that weak area of muscle, a bulge is formed. This bulge can be seen from outside the skin, may not cause any pain initially and flattens out when one lays down. However, over time, the protruding organ can become trapped in this small tear. If it is trapped too tightly, the area loses blood supply and begins to shut down. At this point, the bulge is apparent, cannot be flattened, and is very painful. Surgery is needed immediately.
There are many factors that contribute to the development of a hernia such as age: a previous surgical incision, an injury, or a condition present at birth. A hernia can affect anyone, but it typically affects men over the age of 40 the most, as inguinal hernias (the groin area) are the most common.
After the hernia has been pushed back into the abdomen /infected area, the weak tissue that allowed for the hernia to develop needs to be repaired. Using a synthetic mesh, the weak tissue is “patched” and prevents the hernia from continually pushing through the weak spot. Since the mesh helps to “bridge the gap” on the opening, rather than pulling the tissue together, fewer sutures are needed and pain for the patient is greatly reduced. Mesh also boosts the growth of healthy tissue. Patches, light mesh, light plugs, and surgical grafts are types of mesh used depending on hernia diagnosis.
Used for abdominal, incisional/ventral, and umbilical hernias, these patches are typically used in open surgery. The mesh is inserted into the incision and designed to lay flat against the abdominal wall. Repair for umbilical hernias require sutures to fixate the patch while abdominal/incisional/ventral may not need it.
Hernia Light Mesh
Used to treat inguinal hernias, light mesh is placed in the groin area through laparoscopic surgery. Three small incisions are made on the skin and the light mesh is inserted. Staples or tacks may need to hold the mesh in place.
Hernia Light Plug
Those suffering from a femoral hernia might take comfort in the fact that the use of the light plug is one of the most common forms of mesh used during open surgery. The shape of the mesh is tapered, so it acts as a plug when inserted into the weak tissue. Sutures hold the plug in place and another piece of mesh is placed over top for reinforcement. This procedure is known for being quick and one of the least painful. Patients who have this procedure done are usually discharged same day.
Hernia Surgical Graft
Used to help repair hiatal hernias, the surgical graft is used during open surgery or laparoscopic surgery though a procedure called a fundoplication. First, the surgeon will repair the hernia by tightening the opening in the diaphragm and then placing a piece of mesh over the area. The upper part of the stomach is then wrapped around the esophagus, and stitched in place. This helps prevent acid reflux.
Types of Hernias
All hernias are classified based upon where the hernia is on the body
This is the most common type of hernia, especially in men over 40 years old. This type of hernia forms in the lower abdomen, near the pubic area and just above the leg crease. Inguinal hernias and femoral hernias are groin type hernias.
- Indirect Inguinal Hernia
- occurs when the internal inguinal ring (a natural defect in the inguinal canal) becomes weak.
- Direct Inguinal Hernia
- occurs when the floor of the inguinal canal (below the internal inguinal ring) becomes weak.
Femoral hernias typically form as a result of pregnancy and childbirth, so it is more likely to occur in women than in men. Like the inguinal hernia, it forms in the lower abdomen, near the pubic area, above the leg crease. Femoral hernias are more prone to complications so it should be taken care of quickly after diagnosis.
Ventral hernias form in the abdominal walls and often occur at the location of a past surgical incision. This type of hernia can develop anywhere from weeks, to months, to years after a surgery and can range in size. Ventral hernias can also occur from blunt trauma or congenital issues.
The umbilical hernia forms near or on the bellybutton or navel. It can occur in infants just after childbirth, but can also appear in women, men, and older children as well due to weak blood vessels from around the umbilical area. Umbilical hernias in children can sometimes heal on its own, but that is not the case in adults and will worsen over time if not treated.
A hernia that occurs in the tendons of the upper abdominal wall: between the breast bone and the navel.
A hiatal hernia, or sometimes called a stomach hernia, occurs when the stomach pushes up through the diaphragm and into the chest cavity. An increase in pressure in the abdominal cavity from coughing, vomiting, heavy lifting, and straining during a bowel movement cause a hiatal hernia.
Like the ventral hernia, an incisional hernia occurs after a surgical procedure if the wound does not heal properly. However, an incisional hernia does not have to be on the abdomen like a ventral hernia. It can simply occur on the body where any incision took place.
A noticeable bulge or protrusion from areas like the abdomen or groin is the first sign of a hernia, even if there is no physical discomfort. It is best detected while standing. Other symptoms of a hernia include:
- Pain in the affected area, especially when lifting, coughing, or bending over
- An ache or burning sensation where the bulge is located
- A heavy feeling, pressure, or discomfort in the abdominal area
Symptoms differ depending on hernia location. For those suffering from a hiatal hernia, symptoms such as acid reflux, difficulty swallowing, and chest pain and are all factors in a hernia diagnosis.
A barium X-ray and or and endoscopy are two typical tests done to diagnose a hernia. After drinking a solution containing barium, the patient undergoes a normal X-day. The barium solution is highlighted under the X-ray and projects a more clear and distinct image. An endoscopy involves a tube with a small camera on the end being inserted down into the throat and into the esophagus and stomach to see where the problem lies.
While treatment is dependent on the size of hernia, symptoms and age of the patient, the most effective way to treat a hernia is to have it surgically repaired to ensure complete recovery. There are two types of surgical procedures associated with hernia repair:
An incision is where the hernia is located and repaired through that incision.
Two to four small incisions are made in the abdomen and the inflated with gas to open up the area and allow the surgeon room to work. A small camera is placed inside one of the incisions which allow the surgeon to be able to view the inside from a television screen. Using smaller instruments, the hernia is repaired.
In some cases, the hernia is minor and surgery isn’t needed. In those circumstances the best treatment it to keep an eye on it and wait it out.
- Urgent: Safety Field Notice: Ethicon Physiomesh™ Flexible Composite Mesh, (May 25, 2016).
- U.S. Food and Drug Administration, “Hernia Surgical Mesh Implants,” (April 7, 2016).
- C.R. Bard Inc., Hernia Resource Center, “Treatment Options,” (2016)
- Ehthicon, US LLC, “Types of Hernias,” Ethicon (September 1, 2015).