FDA & Studies Warn of Hernia Mesh Implant Side Effects As Lawsuits Grow

Abdominal hernias are a common injury that will affect more than 25% of all men and even some women during their lifetime. And, for the most part, they are resolved with a simple surgery. Each year, more than 350,000 people in the United States undergo hernia repair procedures.

Hernia repair may be performed with only sutures. However, for over 50 years, doctors have done most hernia repairs with a lightweight plastic mesh that bonds to the abdominal wall with scar tissue to add strength.

Unfortunately, however, reports show the polypropylene used to make these mesh implants may be toxic, and other versions using various organic coatings may be just as bad or worse.

Now, the U.S. Food and Drug Administration and several studies are warning patients of the severe side effects they may face by opting for a mesh repair rather than sutures, and many who were injured without any warning from the device manufacturers have filled lawsuits.

Studies Warn of Hernia Mesh Side Effects

Last October, doctors at Vanderbilt University released a study of more than 600 hernia mesh patients that found over 31% experienced complications within just two years of having the surgery.

That same month, researchers in Denmark following more than 3,200 hernia surgery patients found that those who received plastic mesh implants were 4 times as likely to have long-term side effects as those who received only sutures.

On December 12th, the FDA issued a warning for hernia mesh implants, advising that they may cause severe complications like intestinal blockage, infection, organs growing together, organ and intestine perforation, pain, scar tissue and hernia recurrence.

All of this came after Johnson & Johnson’s Ethicon unit recalled their Physiomesh hernia mesh implant in May 2016 after reports showed higher-than-normal failure rates.

Hernia Mesh Lawsuits Heat Up

Most of the hernia mesh products sold today were approved by the FDA through a fast-track program that allows no testing before market release if the devices are similar to those sold previously.

However, manufacturers have used this as an excuse to sell millions of devices without performing clinical trials to determine if they are actually safe for long-term implantation into the abdominal cavity. Also, they haven’t properly warned consumers of the dangers despite repeated studies showing the risks.

Now, patients are learning that they may be entitled to significant compensation from their hernia mesh injuries.

In response to the growing number of lawsuits filed over injuries from the C-Qur hernia mesh implants, the Judicial Panel on Multidistrict Litigation in December consolidated all C-Qur hernia mesh lawsuits to a special federal court for quicker handling.

Already, several patients affected by the recalled Physiomesh devices have filed lawsuits for their injuries as well. Lawyers are also asking that these cases be consolidated to a special court for faster handling.

DrugNews works exclusively with lawyers specializing in defective medical device and drug cases. For more information, or to speak with a lawyer for free about your hernia mesh problems, contact us today.

Sources:

Hernia Surgical Mesh Implants. FDA. (December 12, 2016). Retrieved from www.fda.gov

Baucom, R., et al. Evaluation of long-term surgical site occurrences in ventral hernia repair: implications of preoperative site independent MRSA infection. Hernia. (October 20, 2016). Retrieved from www.ncbi.nlm.nih.gov