Ethicon’s Physiomesh flexible composite hernia mesh patch was withdrawn globally in May 2016 after being linked to an increased risk for recurrence (hernias re-opening) and revision surgery compared to other types of hernia patches. Atrium has also recalled its C-Qur hernia patch after being linked to serious injuries.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered Physiomesh complications, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against Ethicon and our lawyers can help.
Update: 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).
Ethicon Inc. withdrew its Physiomesh hernia patch from the global market on May 25, 2016, after two large studies in Germany and Denmark found higher than average recurrence and reoperation rates following laparoscopic ventral hernia repair with the products.
“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,” Ethicon stated in the withdrawal notice. “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.”
Atrium C-Qur Hernia Mesh Recall
In July 2013, Atrium recalled its C-QUR hernia mesh implants because high humidity could cause the fish oil gel coating to peel off and stick to the inside of the package. Atrium C-Qur is a polypropylene mesh designed with an outer coating of a gel made from triglycerides and omega 3 fatty acids, called the O3FA layer. Patients who received the hernia patch have reported problems, complaining that the mesh gets stuck to their bowels and other parts of the body, increasing the risk of life-threatening complications.
Hernia Repair Surgery
More than a million patients undergo surgery for some kind of hernia in the U.S. each year, according to the Wall Street Journal. About 80% of these procedures are for “inguinal hernias,” which are located in the groin area. Some hernias are hereditary or linked to weakness in the abdominal wall that occurs at birth when the abdomen lining doesn’t close properly. Other types of hernias are caused by pregnancy, trauma or previous surgeries. Hernias can affect both adults and children, and men are the most likely to develop the injury.
Hernia Mesh Complications
- Hernia recurrence
- Bowel obstruction
- Bowel perforation
- Obstruction complications
If you had hernia repair surgery but are unsure about the specific device and/or its manufacturer, FDA recommends that you contact your surgeon or the facility where your surgery was performed to obtain this information from your medical record.
Ethicon Physiomesh Approved Without Premarket Research
FDA approved the Physiomesh hernia mesh in April 2010 via its 510(k) clearance program, which grants approval to devices that are “significantly equivalent” to products already on the market without having to submit clinical trial data to prove their safety and effectiveness. The agency merely required Ethicon to offer a reasonable assurance of safety and effectiveness with Physiomesh.
According to Ethicon’s 510(k) application, the hernia mesh “met all testing criteria, demonstrated substantial equivalence to its predicate devices and did not raise any new questions of safety or effectiveness.”
However, as the company’s global withdrawal of Physiomesh has shown, there were serious problems with the hernia patch that caused severe health complications in many recipients that could have been avoided had Ethicon been required to get its product approved through the standard protocol.
Do I Have a Hernia Patch Recall 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 hernia mesh lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.
Free Confidential Case Evaluation: Again, if you had hernia recurrence or were forced to undergo additional surgeries after receiving Physiomesh hernia mesh, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and our lawyers can help.