Johnson & Johnson’s Ethicon unit has withdrawn its Physiomesh Flexible Composite Mesh hernia patch after it was linked to an increased risk for revision surgery and hernia occurrence.
Free Confidential Lawsuit Evaluation: If you or a loved one had hernia recurrence or surgery, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: Ethicon Opposes Physiomesh MDL
April 19, 2017 – As a panel of judges considers whether to centralize all federal Physiomesh lawsuits into a single jurisdiction for pretrial handling, Ethicon argues the claims are too different in their allegations to warrant consolidation.
“Here, individualized issues for each plaintiff will eclipse any purported common ones, making an MDL ineffective at narrowing claims and issues,” Ethicon stated in response to a motion by plaintiffs to centralize the complaints. “Although Plaintiffs may point to hernia recurrence as the common injury that binds these cases together, a closer look at the complaints shows a wide variety of alleged injuries, such as abdominal abscesses and intestinal fistula, bowel puncture, erosion and bowel resection, bowel adhesions, fistula and infection, and recurrent inguinal hernia.”
What Is Physiomesh Flexible Composite Mesh?
Physiomesh is a sterile, low profile, flexible composite mesh designed to repair hernias and other fascial deficiencies. Polypropylene is the same material that Ethicon makes their transvaginal mesh and bladder slings from, except that it contains an absorbable film coating on each side which is composed of slightly different compounds.
Physiomesh has been recalled in both Europe and Australia. In May 2016, Ethicon announced that it was withdrawing its Physiomesh Flexible Composite Mesh after an analysis of unpublished data found higher than average recurrence and reoperation rates following laparoscopic ventral hernia repair with the products. According to the withdrawal notice notice:
“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. Consequently, Ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ETHICON PHYSIOMESH Composite Mesh from the global market.”
This action affects the following product codes: PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R and PHY3050R.
Hernia Patch Complications
Physiomesh has been linked to the following complications:
- Dense adhesions
- No ingrowth
- Bowel obstruction
- Hernia recurrence
- Seroma (buildup of fluids under the skin)
FDA 510(k) Approval Loophole
Physiomesh entered the U.S. market via the FDA’s 510(k) approval process, which allows clearance of devices that are ‘substantially equivalent’ in safety and effectiveness to other products that are already on the market. In requesting approval, Ethicon said Physiomesh was similar to its Proceed hernia mesh. However, the company withdrew the Proceed mesh in 2006 over concerns the product could increase the risk of adhesions and bowel fistulas. Proceed was later returned to market.
What is a Hernia?
A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or weak spot in the surrounding muscle or connective tissue. Hernias occur most often at the abdominal wall. In some cases, hernias are visible as an external bulge, particularly when straining or bearing down.
Hernia Recurrence Symptoms
- Palpable mass / bulge
- Difficulty urinating
- Unable to pass gas
- Excessive sweating
Louisiana Woman Alleges Complications from Physiomesh Hernia Repair Surgery
April 17, 2017 – A woman from Port Sulfur, Louisiana, who allegedly suffered adverse health consequences after undergoing hernia surgery with Physiomesh has filed a products liability lawsuit against Ethicon and Johnson & Johnson. Plaintiff Laura Lutz accuses the defendants of manufacturing and selling a defective medical device, and for failing to adequately warn the public and medical community of the potential health risks of Physiomesh.
Florida Woman Alleges Complications from Physiomesh Hernia Repair
April 7, 2017 – A woman from Florida has filed a products liability lawsuit against Ethicon Inc. for injuries she allegedly suffered after being implanted with Physiomesh during hernia repair surgery. Plaintiff Diana Picolla had incisional hernia repair with Physiomesh in 2010; she claims the device failed, causing severe health complications which required it to be surgically removed.
Physiomesh Class Action Filed in Canada
March 30, 2017 – Hernia repair patients in Canada have filed a class action lawsuit against Ethicon over injuries alleged from the company’s Physiomesh hernia patch. The suit alleges that Physiomesh contains a design defect that causes the hernia patch to tear, contract, or migrate after being implanted, which can lead to complications including perforation, abscesses, adhesion, infection and the need for revision surgery. Plaintiffs say they were not adequately warned about these risks prior to undergoing hernia repair surgery.
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.
New Ethicon Physiomesh Lawsuit Filed in Florida
January 9, 2017 – A Florida woman who claims she experienced severe health problems from an Ethicon Physiomesh hernia patch has filed a products liability lawsuit against Ethicon, Inc. Plaintiff claims she suffered complications including an abdominal bulge, recurrent hernia, pain and adhesion after receiving the Physiomesh patch (Catalog No. PHY1520V, 15 X 20 cm) while undergoing laparoscopic ventral hernia repair in February 2016.
Lawsuit Alleges Massachusetts Man had 3 Failed Physiomesh Hernia Repair Surgeries
December 12, 2016 – A man who claims had was forced to undergo three hernia repair surgeries with the Physiomesh patch has filed a products liability lawsuit against Ethicon in U.S. District Court in Massachusetts.The three failed surgeries have caused Plaintiff David Watring both physical and mental pain and suffering, as well as “substantial physical deformity,” according to the lawsuit. Watring further alleges that he suffered financial setbacks from his inability to work due to his injuries.
Florida Woman Alleges Complications from Physiomesh Hernia Repair Surgery
October 18, 2016 – A woman from Florida who was allegedly injured after undergoing hernia repair surgery with Physiomesh Flexible Composite Mesh has filed a products liability lawsuit against Ethicon. Plaintiff claims she suffered complications including persistent abdominal pain, diminished bowel motility and bowel obstructions after receiving Physiomesh in 2014. She underwent a second surgery in 2015 to remove the hernia patch, which was unsuccessful and left her with mesh stuck in her bowels and abdominal walls, according to the lawsuit.
Physiomesh Lawsuit Filed in Illinois
October 3, 2016 – A man who claims he was seriously injured by Ethicon’s Physiomesh hernia patch has filed a products liability lawsuit in the Southern District of Illinois. According to the complaint, Plaintiff underwent surgery with Physiomesh in 2013, and later began suffering extreme abdominal pain, chills and redness on his abdomen. It was determined that the device had become infected, causing 2 abdominal abscesses and an intestinal fistula.
First Physiomesh Lawsuits Prepared for Trial
September 26, 2016 – The first Physiomesh lawsuit being prepared for trial was filed by Matthew Huff, who allegedly developed severe and permanent injuries after being implanted with the device. Huff claims Physiomesh is defective, unreasonably dangerous and not suitable for use.
Do I Have a Physiomesh Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in physiomesh lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by a Ethicon Physiomesh composite mesh hernia patch, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and our lawyers can help.