Every year in the United States, one of, if not the most common surgical procedures performed, is hernia repair; approximately 500,000 people undergo hernia repair surgery, annually. There are multiple methods of repairing various types of hernias: sutures to close the opening in the abdominal wall, synthetic mesh to support the damaged tissue, and biological grafts. For over 50 years, surgeons have used implantable mesh as a means of repairing hernias, and for a great number of people, this has been a successful option.
For more information on compensation to seek when recovering from an injury from hernia mesh, contact a skilled mass torts lawyer. A Boca Raton hernia mesh lawyer will have the necessary experience in these types of cases to help you if you have been injured as a result of hernia mesh.
Hernia mesh falls into one of two categories: synthetic or biologic. Synthetic mesh is man-made, often comprised of polypropylene, polyester fibers, etc. Biologic mesh is derived from donated human or animal dermis and is also referred to as human tissue implants, cadaver skin, pig skin or porcine. Synthetic hernia mesh is marketed as a safe solution, reducing the length of time for both the surgical procedure, as well as the recovery. Often, as a Boca Raton hernia mesh lawyer can explain, mesh is implanted laparoscopically, versus an open surgical procedure.
In 2005, the FDA issued its first recall of C.R. Bard’s Composix Kugel Mesh Patch, due to the alarming reports of adverse events from patients who received the product for hernia repair. The Composix Kugel mesh had a memory recoil ring that allowed the mesh to be placed laparoscopically, and “springing open” into place. These memory rings would often break, causing abscesses, fistulas and puncturing the patient’s abdomen or organs. After the recall, Bard redesigned the Kugel mesh to be “stronger”, and it returned to the market. In 2011, Bard settled with approximately 3,000 Kugel mesh claimants for $184 million.
Jump ahead to present-day, and Bard is once again the defendant in a plethora of lawsuits, claiming that the Bard Ventralex hernia patch is made of biologically incompatible materials that often react adversely with a significant portion of the population in whom it was implanted. The Ventralex mesh is known as a “composite mesh” because it has a coating. The majority of mesh manufacturers promote this mesh coating as a “barrier” and instruct surgeons to use the coating as a barrier between the polypropylene and the bowel. The FDA mandates that any medical device with such a “barrier” undergo rigorous pre-clinical studies and achieve Pre-Market Approval to ensure the safety of said device.
Rather than conduct the safety studies, hernia mesh manufacturers (including C.R. Bard, Ethicon, and Atrium) simply informed the FDA that they would not promote their coated hernia mesh as having a “barrier”, thus allowing them to introduce their composite mesh products to the market more quickly and avoid any clinical testing. In taking advantage of this loophole, several hernia mesh manufacturers have ensured that an extraordinary quantity of hernia mesh patches being implanted in patients are absolutely untested and unknown variables. Alarmingly common injuries that may warrant the assistance of a Boca Raton hernia mesh attorney include punctured / perforated intestines, bowels and other organs, intestinal fistulae, bowel obstruction or resection, peritonitis, abdominal wall tears, abscesses, sepsis and/or adhesions of the mesh to the bowel.
In the summer of 2016, the first lawsuits were filed against Ethicon for their Physiomesh product, and the first trials will be in early 2018. On December 8, 2016, the Judicial Panel on Multidistrict Litigation consolidated lawsuits against Atrium (for their C-Qur composite hernia mesh) in Federal Court for New Hampshire. These products share the same list of catastrophic injuries, and claimants allege negligence, design defects, manufacturing defects, failure to warn and breach of warranty against manufacturers.
If you or a loved one has been injured as the result of hernia mesh, contact a hernia mesh lawyer in Boca Raton today for a case evaluation.