Update: Texas Couple Sues Ethicon Over Physiomesh Complications
June 23, 2017 – A married couple from Texas has filed a products liability lawsuit against J&J’s Ethicon division over injuries alleged from the company’s Physiomesh hernia patch. Plaintiff underwent hernia repair surgery with a Physiomesh patch in September 2013, and less than a year later ended up back in the hospital to treat complications from the hernia patch. The surgeon who operated on the patient allegedly found “numerous balled-up, rolled-up, and incorporated [Physio]mesh,” all of which had to be taken out “with difficulty using cautery and sharp dissection,” according to the lawsuit.
What Is Physiomesh Flexible Composite Mesh?
Physiomesh is a large pore, flexible composite mesh composed of non-absorbable polypropylene designed to be used in ventral hernia repair surgery. A ventral hernia is a bulge of tissues through an opening or defect in the abdominal wall muscles. Synthetic mesh in hernia repair is preferred over using sutures because it reduces the risk of infection and pain, and provides quicker recovery time.
Physiomesh Withdrawn After Being Linked to Hernia Recurrence, Revision Surgery
Physiomesh has been recalled in both Europe and Australia.On May 25, 2016, Ethicon issued an Urgent Field Safety Notice after unpublished data from 2 European registries found high recurrence and revision surgery rates associated with Ethicon Physiomesh Flexible Composite Mesh products when used during laparoscopic ventral hernia repair. The company was unable to determine the cause of the problem, but noted that it could be due to product characteristics, as well as operative and patient factors. Ethicon said the withdrawal action was permanent and that Physiomesh would not be returned to the market.
Hernia Patch Complications
- Palpable mass / bulge
- Difficulty urinating
- Unable to pass gas
- Excessive sweating
Physiomesh Approved Without Clinical Trials
Physiomesh entered the U.S. market in 2010 without any human testing because it was approved through the FDA’s “510(k) process,” which clears products that are “substantially equivalent” to devices that are already on the market. In this case, Ethicon stated that Physiomesh was similar to its PROCEED mesh, which was recalled in 2011 and is currently the subject of numerous lawsuits.
Atrium C-QUR Hernia Patch Recall
In June 2013, Atrium Medical issued a recall for its C-QUR Edge hernia patch after it was found that coating on the devices could adhere to the inner packaging sleeve because of high humidity. The C-QUR Hernia Patch is coated in fish oil (Omega-3), which is advertised as an “anti-adhesion barrier” to prevent scar-tissues that stick abdominal organs together abnormally during the healing process. However, lawsuits claim that the patch causes inflammation and infections.
Class Action Lawsuit Information
Schmidt & Clark, LLP, is a nationally recognized class action firm; however, we have decided not to file a class action lawsuit over injuries alleged from the Physiomesh hernia patch and Atrium C-Qur mesh, and are instead only accepting potential individual claims on behalf of injured parties.
The problem is that class actions in this type of litigation are filed by a “class representative” on behalf of everyone who was injured. If compensation is awarded to that person by a jury or settlement, everyone with the same injury who joins the class action shares the payout. Due to the fact that complications associated with hernia mesh vary widely, each lawsuit needs to be handled individually. This is why our lawyers are only filing individual claims against Ethicon for people who had a hernia recurrence or additional surgery after Physiomesh failed prematurely.
First Physiomesh Lawsuit Headed for Trial Jan. 2018
February 24, 2017 – Ethicon Inc. will defend itself in the first Physiomesh hernia patch lawsuit to go to trial next year in the Southern District of Illinois. Plaintiff in the case, Matthew Huff, claims he developed abdominal abscesses and intestinal fistulas after being implanted with Physiomesh in 2013.
Hernia Mesh Complications May Occur Years After Surgery, Study Finds
February 11, 2017 – Patients who undergo incisional hernia repair surgery with a mesh patch may have a lower risk for hernia recurrence, but serious problems can occur up to 5 years after the procedure, a new study has found. Complications included bowel obstruction, perforation, bleeding, pain, non-healing wounds, infections, fluid buildup and fistulas (organs fused together).
Do I Have a Hernia Patch Recall Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in hernia patch recall lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.
Free Case Evaluation: Again, if you had hernia recurrence or surgery, you should contact our law firm immediately. You may be entitled to a settlement by filing a lawsuit and we can help.