Ethicon Physiomesh™ Lawsuit
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Hernia Mesh Complications/Mesh Recalls
Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with mesh products that are no longer on the market. One such mesh product is Physiomesh™ manufactured by Johnson & Johnson subsidiary Ethicon.
On May 27, 2016, Ethicon initiated a withdrawal of its Physiomesh™ Flexible Composite Mesh (for laparoscopic use) from the worldwide market. This was accomplished by sending a letter to doctors (click here) advising them about problems with the mesh and the market withdrawal. Unfortunately, Physiomesh™ patients were not on Ethicon’s mailing list. Ethicon decided to withdraw Physiomesh™ based upon an analysis of unpublished data from two large independent hernia registries. The recurrence/reoperation rates after laparoscopic ventral hernia repair using Ethicon Physiomesh™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries. Ethicon therefore decided to remove its Physiomesh™ Composite Mesh from the global market. The products impacted by this market withdrawal are the following:
What is Hernia Mesh?
Because hernias have a high rate of recurrence, surgeons often use surgical mesh to strengthen the hernia repair and reduce the rate of recurrence. There are two different kinds of hernia mesh — absorbable mesh and non-absorbable mesh. Absorbable mesh is typically made of animal tissue that has been processed for medical use. This type of mesh is designed to disintegrate as new tissue grows to strengthen the hernia repair. Non-absorbable mesh is made of synthetics and is designed to provide long-term reinforcement to the hernia repair site. There are some types of hernia mesh that combine absorbable with non-absorbable material, though these are not as common. Hernia mesh products are designed to repair hernias and other defects by reinforcing the surrounding soft tissue.
What is a Hernia?
A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. Hernias often occur at the abdominal wall. Sometimes a hernia can be visible as an external bulge particularly when straining or bearing down.
The Most Common Types of Hernias Include:
- Inguinal: occurs in the inner groin
- Femoral: occurs in the upper thigh/outer groin
- Incisional: occurs through an incision or scar in the abdomen
- Ventral: occurs in the general abdominal/ventral wall
- Umbilical: occurs at the belly button
- Hiatal: occurs inside the abdomen, along the upper stomach/diaphragm
What Causes Hernias?
Most hernias are caused by a combination of pressure and an opening or weakness of muscle or connective tissue. The pressure pushes an organ or tissue through the opening or weak spot. Sometimes the muscle weakness is present at birth but more often it occurs later in life. Anything that causes an increase in abdominal pressure can cause a hernia, including obesity, lifting heavy objects, diarrhea or constipation, or persistent coughing or sneezing. Poor nutrition, smoking, and overexertion can weaken muscles and contribute to the likelihood of a hernia.
Surgical Treatment Options for Hernias
- Laparoscopic: The surgeon makes several small incisions in the abdomen that allow surgical tools into the openings to repair the hernia. Laparoscopic surgery can be performed with or without surgical mesh.
- Open Repair: The surgeon makes an incision near the hernia and the weak muscle area is repaired. Open repair can be done with or without surgical mesh. Open repair that uses sutures without mesh is referred to as primary closure. Primary closure is used to repair inguinal hernias in infants, small hernias, strangulated or infected hernias.
What Are The Symptoms of a Failed Hernia Mesh Implant?
All patients who were implanted with Physiomesh™ are at an increased risk of serious complications, making it important that symptoms of failed mesh be monitored. These symptoms include:
- Heat or soreness around the surgical site
- Difficulties passing stool
- Fever and nausea
- Rejection/Failure to incorporate
- Wound dehiscence
- Chronic seroma
- Chronic and severe pain
- Bowel adhesions/blockage
- Sinus tract or fistula formation
- Organ perforation
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