History of Hernia Mesh
The concept of using mesh for the surgical repair of hernias was introduced more than 50 years ago, and in the years since, dozens of hernia mesh products have been approved by the FDA, many of which were cleared by the agency based solely on their similarity to other hernia mesh devices already on the market. Unfortunately, many of these hernia mesh products have since been found to increase the risk of debilitating complications, yet the FDA continues to allow new hernia mesh devices on the market. In April 2016, the FDA published an article highlighting the potential risks associated with hernia mesh, indicating that the devices may cause problems like “pain, infection, recurrence, adhesion, obstruction and perforation.” The following month, Ethicon removed its Physiomesh hernia mesh device from the market, citing the results of two large studies in Denmark and Germany, which found higher rates of hernia recurrence and revision surgery associated with Physiomesh, compared to similar hernia patches. Now, hernia mesh attorneys are investigating claims brought by individuals across the country who believe they have been harmed by side effects of hernia mesh.
A number of studies published in recent years have highlighted the potential side effects of hernia mesh, one of the earliest being a study published in 2009, which examined the “problem of mesh shrinkage in laparoscopic incisional hernia repair.” According to the researchers, “The surgeon has to anticipate the significant mesh shrinkage in laparoscopic hernia mesh repair.” Another hernia mesh study was published in the journal Surgical Infections in August 2012, and found that the polypropylene plastic used in many hernia mesh products is “characterized by high tensile strength and vigorous tissue ingrowth, but is unsuitable for intra-abdominal placement because of its tendency to induce bowel adhesions.”
In March 2016, the journal Surgical Endoscopy published research comparing the outcomes of 25 patients implanted with Ethicon’s Physiomesh hernia mesh device and 25 patients implanted with Ventralight hernia mesh by C.R. Bard. According to the study findings, within six months of implantation, 20% of the Physiomesh patients suffered a hernia recurrence, compared to 0% of patients implanted with Ventralight hernia mesh. That same year, a study published in the medical journal Hernia highlighted possible mesh complications in 31% of the 632 patients studied for two years after being implanted with hernia mesh, including necrosis, cellulitis, seroma, hematoma and fistula.