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Over the years several patients have reported complications following hernia mesh repair surgery, in which a mesh patch is sewn over weakened tissue. Complications include adhesions, erosion of the implant device, bowel obstruction, infections, migration of the mesh, perforation of organs or tissue, seromas, chronic pain, and mesh failure. Thousands of lawsuits have been filed against makers of surgical mesh, and more are expected in 2020.
A hernia occurs when a portion of the intestine, organ or fatty tissue protrudes through a hole or weak spot in the muscle or connective tissue. They most often occur in the abdominal wall. Since hernias have a high rate of recurrence, doctors often use surgical mesh to strengthen the repair and prevent a recurrence. According to Kaiser Permanente, doctors may recommend surgery to prevent a strangulated hernia, a serious injury that occurs when part of the intestine or fatty tissue or esophagus becomes trapped in the hernia and blood supply is cut off to the tissue.
There are several manufacturers and types of surgical mesh. C.R. Bard is one of the largest manufacturers of it, and is facing or has faced lawsuits for several of its hernia mesh products. The primary Bard Hernia Mesh state litigation, pending in Rhode Island, is set to begin its first bellwether trials or consolidation of lawsuits taken from a larger group of similar lawsuits. Attorneys liken a bellwether trial to a test-run to anticipate the results of future similar cases.
The litigation pending in Rhode Island will focus on claims involving the Ventralex patch product and Composix E/X product, according to The National Law Review. The National Law Review reports this is in addition to the Bard Hernia Mesh Multidistrict Litigation in the US District Court for the southern district of Ohio.
Plaintiffs and defendants have reportedly narrowed down the initial bellwether cases to six; the court was to narrow that down to three. The three cases are then expected to go to trial on May 11, 2020, July 13, 2020, and Sept. 14, 2020.
In addition, the Atrium C-QUR hernia mesh MDL bellwether cases are following a similar path in New Hampshire, where the trial is set to begin on May 20, 2020, says the National Law Review. The Physiomesh Hernia Mesh MDL trial in the northern district of Georgia is scheduled for July 20, 2020, according to the National Law Review. The results of these trials will be reportedly be followed by lawsuits consolidated in New Jersey state court.
In addition to lawsuits, multiple recalls have been announced for the surgical mesh. One such recall was of Ethicon Corporation’s Physiomesh Flexible Composite Mesh in 2016, due to the high risk of reported failure and complication rates, such as adhesions, fistulas, and infections that resulted in pain and additional surgery, according to wsbt.com.
Mesh identification numbers may be found in a patient’s medical history and placed on a “product stickers page” of hospital records. The stickers are what come on the packaging for such devices. However, according to Clay Hodges in the North Carolina Product Liability Lawyer Blog, for some reason, the product stickers page is not always available in a patient’s records. They may have been thrown away, in which case, the mesh may be identified through the hospital’s billing records, Hodges says.
If all of this makes a patient wants to stay away from surgical mesh, non-mesh hernia treatment is an option. However, the FDA says less than 10% of groin hernia repairs are performed without the use of mesh. While mesh is thought to decrease the recurrence of a hernia, Dr. Volcker Schumpelick of Germany reportedly stated at a 2005 American Hernia Society meeting that after 30 years, despite the introduction of mesh and laparoscopy, the incidence of recurrence worldwide has not come down, according to General Surgery News disagrees.
Elena Borrelli is a certified physician assistant, or PA, with 18 years of experience in health care. She has worked 11 years as a PA in diverse clinical settings, including surgery, trauma, primary care, women’s health and quality management. Over the years, she has authored several publications and lectured on various health care-related topics.