A hernia mesh is described as a small, simple medical device used to fix or repair hernias, which occur when tissues or intestines protrude through the weak areas of flesh. The mesh works to strengthen the weak spots and hold the tissue in place. With that said, over the past few years, the designers and manufacturers of the hernia mesh devices have had quite a fair share of controversies.

According to the plaintiff attorneys, some of the hernia mesh products were defectively designed and had been causing unnecessary injuries that would not have occurred in the first place if the manufacturers properly warned the medical providers. They also argue that if the medical providers and the patients were informed about the severe complications and high risks of device failures, they would have chosen to utilize a substitute mesh product.

Among the prevalent manufacturers of the hernia mesh products include Atrium, Bard Inc., and Ethicon. While there are many manufacturers with products in the market, these three are the makers of the products that have entirely been subject to many lawsuits in the past years. Following numerous reports from patients and doctors about device failure as well as complications related to the devices, the FDA had to recall some of the products.

Many of the synthetic mesh products with a high risk of device failure were rushed to the market in haste using an FDA clearance process referred to as the FDA's 510k. The manufacturers took very little time to conduct studies on their products' safety and instead went ahead to market them to the public. That's why many of these products were failing, and a number of them were either silently withdrawn from the market or recalled. On that note, let’s take a look at the manufacturers of the hernia mesh devices and the products that have been subject to lawsuits;

Bard Inc.

C.R Bard is considered to be among the largest medical products companies in the US. At the moment, the company and its Davol unit, which is responsible for the manufacture of surgical products, is battling thousands of lawsuits filed against it for its hernia mesh products. The brand that has reportedly caused a lot of harm and injuries in patients is the Davol’s polypropylene products. Many of the products fall under this category, and there are claims Bard tested very few of them in humans before marketing and selling them to the public.

The past medical injury cases indicate Bard sold hernia mesh devices constructed out of a plastic that the same manufacturer had earlier stated was not suitable for human implantation. The Composix Kugel mesh products were recalled following safety concerns about the plastic used. It was found that the plastic was likely to fragment and move away from the surgical site. The FDA issued a Class 1 recall, indicating the highest level of concern and was issued twice both in 2005 and 2007.

Atrium

Atrium Medical Corporation is another medical device manufacturer facing multiple lawsuits for its C-QUR mesh products. The plaintiffs believe the Atrium hernia mesh products are defectively designed. The products used two materials both of which are known to cause serious complications. The first one is polypropylene, and according to research, uncoated polypropylene can cause adhesion and bowel obstruction in patients.

To solve the issue, Atrium decides to coat its implants with the omega 3 fatty acids derived from fish so as to continue using this cheap product. But the fish-derived oil can result in severe allergic reactions and additional complications such as infections. The coating can also wear off with time, and when that happens, the patients are still left exposed to the same complications associated with uncoated polypropylene. Atrium is accused of knowing all these complications associated with its product design but still chose to continue using these materials in its products.

Many reports of patient complications, including hematoma, bowel obstruction, and fistula formation, were received by the FDA. This certainly prompted the US Food and Drug Administration to carry out a total of four inspections on the C-QUR manufacturing plant. This occurred between 2009 and 2013. The findings were not pleasing and the inspection only revealed serious violations of regulations such as medical device reporting and quality system.

In 2012, the FDA sent Atrium a warning letter after the inspection revealed problems with the company’s manufacturing, sterilization and complaint follow-up. Similarly, in 2013, the FDA issued an order to stop the C-QUR manufacturing and in the same year, over 145,000 units of C-QUR products were recalled.

The Judicial Panel of Multidistrict Litigation centralized the Atrium C-QUR hernia mesh cases under Judge Landya McCafferty. Initially, the first trials had been scheduled to begin on the 20TH May 2020. However, due to disruptions in regards to the covid-19 pandemic and a motion filed on the 8th of April by Atrium, has led to the postponement of the case hearings to January 2021. Atrium is currently facing close to 2,000 lawsuits.

Ethicon

Ethicon is another hernia mesh company that has not been spared of lawsuits. Ethicon's Physiomesh Flexible mesh first received FDA approval in 2010. While this hernia mesh was intended to treat several types of hernias, there are reports of it resulting in severe complications in patients who have used it. In fact, in 2012 there were already about 90 adverse events reports filed by medical providers and implant surgeons.  Many more allegations emerged with the surgeons citing device integration and some of the mesh products had a hole in the center.

The complications associated with the defective physiomesh products include seroma (fluid build-up under the skin surface), mesh migration, chronic pain, and infections. Despite what many might think, Ethicon’s Physiomesh Flexible mesh was not recalled by the FDA, but rather the company decided to withdraw it from the market.  This was after Ethicon established a new replacement product referred to as Physiomesh open.

To this day, the attorneys and plaintiffs feel that the Ethicon market withdrawal was not made in the public's interest. The attorneys argue that Ethicon purposefully left a known dangerous product in the market to avoid losing money and only instituted a market withdrawal after establishing a new product. On that note, the company is facing nearly 2800 lawsuits pending a court hearing in the Northern District of Georgia.

The first bellwether trials are set to commence on the 2nd of November 2020 and are expected to last up to 3 weeks.  The second bellwether trials are scheduled to begin on the 22nd of February 2021.