With over 20 million hernia repairs performed each year in the worldwide, hernias are a very common and routine medical problem affecting both men and women.
A hernia is an actual tear through tissue or muscle wall caused when an organ pushes through it. Most, but not all hernias happen within the abdominal cavity. Anything that causes an increase in abdominal pressure can result in a hernia, including obesity, lifting heavy objects, diarrhea, constipation, or persistent coughing or sneezing. In addition, poor nutrition, smoking, and overexertion can weaken muscles and contribute to the likelihood of a hernia. Additionally, some people have weak muscles since birth, putting them at greater risk.
The most common forms of hernia are:
In many cases, surgery is required to repair a hernia and there are different kinds of hernias with different methods and surgical approaches to repair them. Today, hernia mesh is used in roughly 80% of all hernia repair surgery and has been in use since 1891. Some versions of hernia mesh have long been regarded as the "gold standard" for use in repairs. Manufacturers of hernia mesh include Bard Davol, Inc., Ethicon, Atrium, B.Braun and Covidien.
It has been proven that hernia mesh reduces the rate of hernia recurrence. However, primarily because of incompatibility with the human body, hernia repair utilizing surgical mesh can result in serious adverse effects such as pain, infection, perforation, adhesion to internal organs, and bowel obstruction. Most of these drawbacks are related to the chemical and structural nature of the mesh itself.
Hernia Mesh Recalls and Lawsuits
April 2019
C.R. Bard Hernia Mesh
There are currently two multidistrict litigation cases (MDL) in process against C.R. Bard and its Davol subsidiary covering thousands of plaintiffs alleging that their hernia mesh products are defective and caused serious injuries. One MDL is proceeding in Rhode Island state court and the second is being handled in the U.S. District Court for the Southern District of Ohio. Bellwether cases are planned for May, July and September, 2020. In addition there are numerous litigations proceeding nationwide involving their PerFix, 3DMax, Marlex, Kugel, Composix, Ventralex, Ventrio, Sepramesh and Ventralight hernia mesh products.
February 2019
Cook Medical
A federal jury in Indianapolis awarded $3 million to a woman who suffered medical problems when her IVC filter deteriorated inside her. The jury found that the Cook IVC was defective and dangerous.
October 2018
Atrium Medical Sets Aside $200 Million for C-Qur Hernia Mesh Lawsuits
Atrium Medical Corp.is facing nearly 900 hernia mesh lawsuits by people alleging their C-Qur™ surgical mesh is defective and the company failed to warn of severe injuries and illness caused by this mesh.
February 2018
Atrium ProLite Mesh
On February 23, 2018, the FDA posted a recall by Atrium on their on ProLite Mesh used in hernia repair and other surgeries due to mislabeled packaging.
June 2016
Ethicon Physiomesh
Johnson & Johnson/Ethicon recalled its Physiomesh Flexible Composite mesh after studies demonstrated higher than normal revision rates. Numerous defective products lawsuits were filed and were subsequently consolidated in a multidistrict litigation (MDL). This MDL is underway in the U.S. District Court, Northern District of Georgia involving claims that it was defectively designed, manufactured, and labeled by Ethicon and caused personal injuries to plaintiffs. The first bellwether trial is set for September 16, 2019.
If you have suffered complications due to hernia mesh you can file a report with the FDA.
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Medical Device Watch is sponsored by Wilentz, Goldman & Spitzer, P.A. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.
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