Overview of Hernias
Hernias result from a combination of muscle weakness and strain. The pressure from the strain facilitates an organ squeezing through the weak connective tissue or muscle. The resulting bulge is visible and can cause pain, especially in moments of strain.
Hernias can occur in multiple areas of the body. The particular location of the condition determines its type.
Common Types of Hernia
- Inguinal –inner groin
- Femoral – upper thigh/outer groin
- Incisional – abdomen, through an incision or scar
- Ventral – abdominal/ventral wall
- Umbilical – belly button
- Hiatal – abdomen, inside, along the upper stomach/diaphragm
Pressure-Related Causes of Hernias
- Lifting heavy objects
- Persistent coughing/sneezing
Muscle-Weakening-Related Causes of Hernias
- Poor nutrition
How Doctors Treat Hernias
According to the U.S. Food & Drug Administration (FDA), doctors perform more than one million hernia repairs every year. Of these repairs, 800,000 are conducted to remedy inguinal hernias.
There are both non-surgical and surgical approaches to treating hernias. Sometimes, the physician recommends “watchful waiting” to see if the hernia increases in size or starts to cause complications. Surgical hernia treatments include laparoscopic and open repair.
With laparoscopic surgery, the surgeon makes several small incisions and repairs the hernia with or without the use of surgical mesh. In open-repair surgery, the surgeon repairs the weak muscle area through an incision near the hernia. The surgeon may or may not choose to use a surgical mesh. If they elect to use sutures and no mesh, the surgery is called “primary closure” open repair.
The Role of Surgical Meshes in Hernia Repair
Doctors use surgical mesh medical devices to strengthen or support weakened tissue after the hernia repair. By reinforcing the tissue, the chance for recurrence drops. The devices are also known to cut down on the time needed for operation and recovery.
Mesh sheets are constructed with a variety of materials. Synthetic meshes can be knitted or non-knitted and absorbable, non-absorbable, or a combination of absorption types. Other meshes are composed of animal (usually pig or cow) tissue and are absorbable.
Different types of meshes remain in the body for different periods of time. Surgeons use non-absorbable meshes as a means to permanently reinforce the repaired hernia, so they are permanent implants. On the other hand, absorbable mesh degrades over time, and surgeons use it to provide reinforcement to the hernia only while new tissue grows in the weakened area.
Complications Arising from Hernia Repair
Surgical hernia-repair surgeries can generate adverse events. The most common of these are:
- Hernia recurrence
- Adhesion of scar-like tissue
- Obstruction of the intestine
- Fistula (abnormal connection between organs or vessels)
- Seroma (fluid build-up at incision area)
- Perforation (holes in surrounding organs and tissues)
Complications Arising from Surgical Hernia Repair with Mesh
The most common of these adverse events to occur with surgical hernia repairs using surgical mesh medical devices include:
- Hernia Recurrence
- Adhesion of scar-like tissue
- Bowel obstruction
Other adverse events occur only in surgical hernia repairs using mesh. They include:
- Mesh migration
- Mesh shrinkage/contraction
Counterfeit Mesh Concerns
Defective mesh products have been the root of many of these mesh-based surgical hernia repair complications. Including hernia recurrence. Many of these defective mesh devices were reported to the FDA, and they have been recalled.
In 2010, FDA investigations revealed the use of counterfeit polypropylene surgical mesh. Flat sheets of counterfeit C.R. Bard/Davol-branded mesh were marketed and distributed in the U.S. RAM Medical initiated a voluntary recall of all the mesh sheets that had been sold the distributors, who, in turn, distributed the sheets to hospitals and other distributors.
The counterfeit mesh was not sterile, had a larger weave, and improperly finished edges (with potential to unravel)
All potential recipients of the surgical mesh sheets were urged to closely examine their mesh products and to carefully monitor patients in whom a counterfeit surgical mesh product was likely used.
Surgical Mesh Recalls
The FDA reports that many surgical-mesh complications arise from recalled medical devices.
The following complications are most commonly associated with recalled mesh products:
- Recurrence of hernia
The FDA urges that health care personnel report all adverse events related to hernia surgical mesh implants.
FDA Conclusions About Surgical Meshes
Although FDA acknowledges that surgical meshes are currently “the system of choice for hernia repair,” with the “lower rate of recurrence,” the agency also indicates that mesh usage does not represent the “optimum method” of hernia repair.
Drawbacks relate mostly to the chemical structure of the mesh, which can yield adverse effects of infection, adhesion, and bowel obstruction. The FDA report on this topic indicates the need for a more ideal mesh construction with improved biocompatibility.
Tosi & Rose Mass Tort Lawyers Can Represent You in a Defective Mesh Case
Tosi & Rose is a mass-tort law firm that is currently accepting cases regarding complications from surgical hernias with mesh repairs. Call us today at 888-311-8292 for a free, no-obligation case review.