There are thousands of individuals across the country who have filed lawsuits over the past decade alleging severe complications from hernia mesh surgery. In fact, lawsuits claiming hernia mesh injuries have already resulted in at least one multi-million dollar verdict and one settlement worth $184 million. Notwithstanding, new lawsuits continue to be filed.
What is Hernia Mesh?
Hernia mesh is a medical device used in hernia surgeries that provides additional support to repair damaged or weakened tissue due to the hernia. Studies are split on the success of hernia mesh: some show using mesh leads to less hernia recurrences while others found additional complications are more common when mesh is used. When a hernia occurs the intestines, fatty tissue or abdominal organ breaks through a weakened area in the surrounding connective tissue or muscle. While the most common area for a hernia to occur is at the abdominal wall, they can also happen in the inner or outer groin, belly button, at an incision or scar site, or along the diaphragm. Although a physician may choose to monitor a hernia at first, surgery is the only way to repair the damage caused by a hernia. In fact, it is estimated that more than one million hernia repairs happen each year in the United States. Hernias are also a medical condition that have a high recurrence rate. According to a study published in the Journal of the American Medical Association (JAMA) in 2014, hernia mesh devices result in a lower chance of a having a second or subsequent hernia than simply stitching closed the torn tissue. The reason for the fact that hernias are less common a subsequent time with this method is that the surgical mesh strengthens the torn or weakened tissues while stitches, in and of themselves, do not.
Common Hernia Mesh Complications
The United States Food & Drug Administration has analyzed scientific research and literature as well as its own adverse data to categorize likely complications from hernia mesh that patients may experience. The most common complications that have resulted from hernia mesh repairs include: infection, chronic pain, hernia recurrence, bowel obstruction, adhesion, and contraction. Other complications include autoimmune reactions to mesh, abnormal connections between organs, mesh migration and rejection, organ performations, bleeding, fluid build up at the surgery site, nerve damage, and tenderness at the implant site.
According to a study published in JAMA Surgery, mesh complications can occur up to five years after a procedure is performed. The results were presented at the 2016 Clinical Congress of the American College of Surgeons and found the rate of hernia mesh complications increased over a five-year time span. Out of a total of 3,242 participants studied, as many as 1,050 required abdominal surgery after the initial procedure. The study’s authors noted the extent of the benefits and risks of hernia mesh repair surgery is not known because of the limited trial data available on the subject. Part of the reason for limited data, according to the authors, is the FDA’s streamlined 510(k) premarket notification clearance process for hernia mesh medical devices. This process does not mandate detailed case studies or clinical trials to prove the product’s effectiveness or safety before it is approved for the marketplace.
Alternatives to Hernia Mesh Surgery
Previously, doctors often took a “watchful waiting” approach for patients who had hernias but showed no symptoms. Once hernia symptoms presented themselves, surgery would be sought. Today, however, the most common recommendation is that patients with hernias undergo surgery as soon as possible regardless of whether or not symptoms are present. While most hernia surgeries involve mesh, there are alternatives available. In fact, about 10 percent of hernia repair surgeries in the United States are performed without mesh. There are generally five techniques that serve as alternatives to hernia repair techniques:
- Bassini repair: known as a tension repair because it places tension on muscle tissue around the hernia, this technique is primarily used today in developing countries;
- McVay/Cooper’s ligament: an improvement on the tension technique, this surgery sutures tissue to the Cooper’s ligament and has shown to be suitable for larger hernia repairs
- Shouldice repair: a more complicated tension repair technique, the surgery requires cutting through three different layers of muscle and connective tissue and then individually stitched closed overlapping on the previous layer;
- Descarda repair: a tension-free procedure, involving suturing a strip of the patient’s own muscle to another muscle and the inguinal ligament; an
- Guarnieri repair: another tension-free technique, this surgery can be performed with or without mesh. It overlaps the same muscle involved in the Descarda repair in a double-breast fashion.
Medical Device Litigation
Hundreds of thousands of Americans have used medical devices to improve their health and well-being, only to suffer temporary or permanent injuries due to defects in the products. Sometimes these injuries can be the basis for a successful products liability claim, such as the complications resulting from hernia mesh surgery. Defective product liability claims generally based on one of three legal theories: manufacturing defects, design defects, or marketing defects.
- Manufacturing defects: this includes medical devices that were not properly assembled at the manufacturing facility or any point between the factory and where the consumer received or purchased the medical device;
- Design defects: in this case although the product was manufactured in perfect harmony with the design, the design itself is unreasonably dangerous and results in harm;
- Marketing defect: when a product is marketed improperly this means that the recommendation, warning (or lack thereof), or instructions regarding the product was inadequate or inaccurate or just completely omitted.
In a products liability case, there are several potential defendants who can be named in the lawsuit. This is because products liability law allows for financial responsibility for harm caused by a product to fall on any person or entity that was part of the product’s “chain of distribution.” The “chain of distribution” is the path that the product took from its inception to the manufacturer to the consumer. Parties that may be named as defendants in a product liability medical device claim include the manufacturer, testing laboratory, physician, hospital or clinic, and retail supplier.
Hernia Mesh Repair Attorneys
If you or someone you know has been injured as a result of hernia mesh repair surgery, contact the skilled dangerous medical device attorneys at the Roger Ghai Law Offices. These skilled lawyers ill aggressively fighting on your behalf and seek out the compensation to which you are entitled. Click here today to schedule your initial case evaluation.