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First Ethicon Physiomesh Hernia Mesh Lawsuit Trial Scheduled

Mar 3, 2017
First Ethicon Physiomesh Hernia Mesh Lawsuit Trial Scheduled

In One Year the First Ethicon Hernia Mesh Trial Will Begin

The first Ethicon surgical abdominal mesh lawsuit is scheduled for trial for January 22, 2018. An Illinois resident filed the Ethicon Physiomesh lawsuit and alleged that he was implanted with the Physiomesh in 2013 to repair an abdominal wall hernia. Two years later, he was hospitalized for severe abdominal pain, fever, chills, and redness on his abdomen, according to his complaint.

A recent study published in JAMA, indicated that many more reports of hernia complications and abdominal mesh lawsuits may be brought before the January 2018 trial.

According to lawsuit allegations, the man suffered from an infection in and around the Physiomesh that allegedly led to severe damage to his abdomen and intestines, including two abdominal abscesses and intestinal fistulas from the Ethicon device. The man required another surgery to repair these damages. The plaintiff accuses Ethicon—a subsidiary of Johnson & Johnson—of negligence, strict liability, and breach of warranty. He also alleges that Ethicon designed an "unreasonably dangerous and defective product," according to court documents and alleges that Physiomesh was not adequately tested and did not meet Ethicon's usual standards and requirements. The lawsuit was filed in the United States District Court for the Southern District of Illinois, Benton Division.

The Physiomesh lawsuit is one of a number of hernia mesh products facing lawsuits for alleged mesh-related complications, including Atrium Medical's C-Qur Hernia Mesh, C.R. Bard's Sepramesh, C.R. Bard's Ventralex ST Hernia Patch, and C.R. Bard's 3DMAX Mesh.

The hernia mesh lawyers at Parker Waichman LLP are offering free legal consultations to individuals who suffered injuries associated with the use of Ethicon's Physiomesh and other mesh products.

Hernia Mesh Study

A recent study published in February 2016 in JAMA, entitled "Recurrence and Mesh-Related Complications After Incisional Hernia Repair" revealed that patients who were implanted with hernia mesh experience lower rates of hernia recurrence; however, hernia mesh complications may occur up to five years following surgery. Also, patients implanted with hernia mesh suffered increased complications that often called for major and additional surgeries.

The study's authors also wrote that, "In this ... study including 3,242 patients, mesh repair was associated with a lower risk of reoperation for recurrence compared with non-mesh repair over a five-year follow-up period... . However, a risk of long-term mesh-related complications for open and laparoscopic mesh repairs partially offset these benefits."

The research also found that, over the five years, the rate of complications was significantly increased and that of the study participants, 1,050, nearly one-third, had to undergo additional abdominal surgery. Some of the major complications included bowel obstruction, perforation and bleeding. Also, they found that, the larger the mesh, the greater the risk of complications.

Unpublished data from two large independent hernia registries in Denmark and Germany revealed that Ethicon Physiomesh Flexible Composite Mesh was tied to increased hernia recurrence and reoperation rates when compared to the average rates of other mesh devices. Ethicon's Physiomesh contains polypropylene in its base layer. This is the same material used in transvaginal mesh implants, which have also been the subject of numerous injury reports and lawsuits.

Surgeons perform approximately 800,000 hernia repairs in the United States annually and mesh is typically used in these surgeries.

Ethicon Physiomesh Recall, Lawsuit

Ethicon Physiomesh Recall, Lawsuit

In May 2016, Ethicon recalled its Physiomesh flexible composite hernia mesh product after reports began to increase concerning hernia recurrence and reoperation rates that were greater when compared to other mesh devices used for hernia repair. Ethicon advised healthcare providers in an "Urgent Field Safety Notice."

Ethicon has been unable to determine what led to the increased reoperation rates associated with Physiomesh and announced that, "Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors." The device maker also noted that, "Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market.... Ethicon will not return the Ethicon Physiomesh composite mesh product to the market worldwide."

A Florida woman filed a hernia mesh complaint against Ethicon in December 2016, which was about six months after Ethicon withdrew its Physiomesh Composite mesh and following the two unpublished data from the two European registries. Physiomesh was fast-tracked in 2010 via the 501(k) process, which is a more rapid clearance route that allows device makers to release a device to market without clinical testing if they are able to show that the new product is substantially equivalent to another product that was previously approved by the U.S. Food and Drug Administration (FDA). The complaint was filed in the U.S. District Court for the Middle District of Florida and includes allegations of severe complications following Ethicon Physiomesh hernia implant surgery, including that the plastic mesh adhered to other vital organs. The woman underwent a second surgery to have the mesh removed; however, the hernia returned, according to allegations. The lawsuit also alleges that Ethicon Physiomesh was defectively designed and unreasonably dangerous for use in hernia repair and that the risks of the mesh's design outweighed its potential benefits.

When mesh infections occur, nearly all of the hernia mesh must be completely removed to eliminate infection. Hernia mesh infections are very challenging to cure because the infection develops into a so-called "biofilm." Biofilms function as an ecosystem of bacteria that covers the entire mesh. Also, the Journal of the Korean Surgical Society reported that mesh-related complications have become much more frequent and noted that, "Antibiotics and mesh-saving operations are not sufficient to eradicate the infection in the majority of cases."

Filing a Hernia Mesh Lawsuit

If you or someone you know suffered injuries related to the use of hernia mesh implants, you may have valuable legal rights. Our hernia mesh lawyers offer free, no-obligation case evaluations. For more information, please call 1-800-YOURLAWYER (1-800-968-7529).


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