Bard Polypropylene Hernia Mesh Lawsuits
Have you been injured because of a defective C.R. Bard polypropylene hernia mesh device? You may have the right to obtain compensation. Over the last 15 years, tens of thousands of patients have filed hernia mesh lawsuits against C.R. Bard and its subsidiary, Davol. The lawsuits allege that Bard’s polypropylene hernia mesh devices are defective and unreasonably unsafe because of the polypropylene coating.
Contact Rosen Injury Lawyers to learn about your legal options. Our experienced hernia mesh injury lawyers are prepared to help you recover compensation for hernia mesh injuries. Your first consultation is free, so do not hesitate to call for help today.
Bard Polypropylene Hernia Mesh MDL Lawsuits
C.R. Bard has been named in tens of thousands of polypropylene hernia mesh lawsuits in state and federal courts across the country. Over the years, many of these lawsuits have been consolidated into multidistrict litigations (MDLs).
In an MDL, lawsuits that are based on similar facts and arguments are consolidated to be tried before a single federal court judge. This process helps to streamline litigation, minimize costs, and encourage consistent pretrial rulings. Unlike a class action lawsuit, each plaintiff in an MDL reserves the right to have his or her case litigated in court.
Thousands of Cases Consolidated in Ohio Federal Court
In August 2018, 122 Bard hernia mesh lawsuits were merged into multidistrict litigation (MDL) in the Southern District of Ohio. As of March 2020, at least 3,500 mesh injury lawsuits – and as many as 4,069 – have been consolidated into the MDL.
The plaintiffs in the Bard Polypropylene hernia mesh MDL claim that several of the company’s mesh devices are defective and unreasonably unsafe. Bard devices central to this MDL include the:
- 3D Max
- Ventralex, and
The court is considering extending the MDL to include patients who have been injured because of other Bard polypropylene mesh devices.
According to the MDL transfer order, the lawsuits allege that “defects in the defendants’ polypropylene hernia mesh products can lead to complications….including adhesions, damage to organs, inflammatory and allergic responses, foreign body rejection, migration of the mesh, and infections.” Bard has been accused of:
- Knowing about the dangers associated with the use of polypropylene, and
- Failing to warn patients about these risks.
The first three bellwether trials in the Bard MDL are scheduled to begin in the summer of 2020 – May 8th, July 13th, and September 1st.
Polypropylene Associated With Adverse Health Risks
Polypropylene is a type of plastic that’s popular because it is flexible, slick, and inexpensive. It’s been used in hernia mesh devices for decades, despite the fact that it is not intended for use in devices that are devices that are permanently implanted into the body.
Many companies, including Bard, chose to use polypropylene because they believed that the plastic would prevent mesh devices from oxidizing after surgery. Oxidation causes mesh devices to degrade and dissolve over time.
Studies now suggest that polypropylene does not prevent mesh devices from degrading and breaking down after implantation. In fact, polypropylene may actually make mesh devices more dangerous for patients. Polypropylene mesh devices have been associated with an increased risk of inflammation. Inflammation in the body can cause the hernia mesh device to migrate, dissolve, and/or shrink.
Polypropylene mesh devices can do a lot of harm when they shift, shrink, or degrade in the body after implantation. Possible injuries can include:
- Organ perforation
- Hernia recurrence
- Bowel obstruction, and
- Adverse tissue reactions.
Polypropylene Used in Bard Mesh Devices For Decades
C.R. Bard has been using polypropylene in its hernia mesh repair devices for more than 50 years. Its first polypropylene device, the Marlex hernia mesh, was introduced onto the market before the FDA required rigorous safety testing for approval. Since the FDA rules only applied to future medical devices submitted for approval, the Marlex device remained untested and untouched.
Why is this important? In 1976, years after Marlex was already being used in patients across the country, the FDA announced its new 510(k) pre-market approval process. This new process would allow medical device manufacturers to bypass the time-consuming, but important, safety approval process. A company could get pre-market approval for a new medical device by simply claiming that it was substantially similar to (and just as safe as) a device that’s already sold in the country.
Bard has been able to take advantage of the 510(k) pre-market approval process for decades. The company has never had to put any of its polypropylene mesh devices through rigorous safety tests. Bard polypropylene devices have never been tested in human clinical safety studies. The FDA has granted approval through the 510(k) process simply because the devices are lined with polypropylene.
501(k) Approval Leads to Dangerous Mesh Devices
Since Bard’s hernia mesh devices don’t’ have to go through clinical testing procedures, the company has been able to put several dangerous devices on the market. Many Bard mesh products, including the Composix Kugel and Ventralex, are coated with expanded polytetrafluoroethylene (ePTFE) or a resorbable ST coating.
Bard began to use these coatings because they make mesh devices slick and slippery. It was believed that they would reduce the risk of adhesions. However, studies show that these coatings (a) shrink shortly devices are implanted and (b) increase the risk of bacteria-related infections.
Bard Polypropylene Mesh Devices Recalled by FDA
Beginning in 2005, the FDA issued a series of Class I Recalls for Bard’s Composix Kugel Hernia Patch. The recalls were issued after the agency received 34 reports of device failure, including 21 serious patient injuries and one death.
In its recall notice, the FDA noted particular risks for intestinal perforation and chronic enteric fistula. These two complications, which are linked to polypropylene, can quickly become life-threatening and force patients to have emergency revision surgery.
C.R. Bard Polypropylene Hernia Mesh Devices
The following hernia mesh devices are manufactured using polypropylene:
- Composix and Composix LX
- Composix Kugel
- Composix EX
- 3DMax and 3DMax Light
- PerFix Plug and PerFix Plug Light
- Ventralex and Ventralex ST
- Ventralight ST, and
- Ventrio and Ventrio ST.
Get Help With Your Bard Polypropylene Mesh Lawsuit
Have you been injured because of a defective Bard polypropylene hernia mesh device? Contact Rosen Injury Lawyers to learn about the benefits of filing a hernia mesh lawsuit. You didn’t know about the risks of a polypropylene mesh device. You shouldn’t have to suffer the consequences alone. Our attorneys can help you pursue the compensation you deserve.
Call our law firm to schedule a free, no obligation case assessment. We will explain your rights and answer any questions you have.