Ethicon Physiomesh, a type of ‘hernia mesh’, has been withdrawn and recalled worldwide. Physiomesh, developed by Ethicon, received FDA clearance in 2010 under the FDA’s 510(k) clearance program. The product was officially launched to the market in October 2010, but it was withdrawn from the market in May 2016 for causing dangerous abdominal infection, high hernia recurrence rate, and the need for hernia repair revision surgery.
Ethicon, a subsidiary of Johnson & Johnson, is accused of placing profits ahead of patient safety by victims nationwide. If you or a loved one has suffered hernia mesh revision surgery, recurring hernias, or abdominal infection after receiving Ethicon’s Physiomesh, contact our defective medical product lawyers for a FREE consultation by calling 855-55-BAD-DRUG.
Dangers of Ethicon Physiomesh
The Physiomesh flexible composite mesh is a patch used in surgeries to assist patients with hernias. Hernias occur when organs or tissue pushes through a weak spot or a hole in the abdominal muscle. The Physiomesh is made of plastic that works together much like a mesh made of fabric. The lightweight design uses less plastic than similar devices which makes it weaker in comparison.
The product’s mesh layer has polymeric films on either side that are intended to degrade. However, these materials often stay in a patient’s body for a long period of time. Over time, the film on this device can lead to pain and inflammation, while also causing challenges for the body accept the mesh as intended. In situations like this, a patient may experience:
- Bowel obstructions
- Bowel perforations
- Hernia recurrence
- Hernia revision surgeries
- Integration failure
Since polypropylene, the primary ingredient of Ethicon’s Physiomesh can lead to adhesions and inflammation, patients may also suffer when the hernia mesh does not properly integrate into the abdominal wall. A patient who has suffered hernia mesh side effects may have had to undergo additional surgeries or deal with other medical complications. Most patients who have gone through this process had no idea of the dangers of the product in advance and were not properly warned.
Ethicon Physiomesh was recalled from the market in 2016 after receiving numerous reports of higher hernia recurrence and complications when compared with other mesh devices. If you or someone you know was injured or has been forced to undergo additional surgeries as a result of Ethicon’s Physiomesh, call our mesh injury lawyers to learn about obtaining reimbursement for your harms and losses: 855-55-BAD-DRUG
Physiomesh was Approved by the FDA Without Clinical Trials
The FDA’s 510(k) clearance program allowed Ethicon hernia mesh to be given to the public without stringent clinical trials and testing typically required by the government agency. Under the 510(k) program, Physiomesh was expedited for approval because Ethicon claimed that it was similar to other products already on the market. However, the device was recalled just six years after it was initially approved for marketing as a result of high hernia recurrence.
All too often we place too much trust in departments like the Food and Drug Administration (FDA). The FDA often approves medical devices based only on information obtained from the drug companies themselves. While these organizations perform vital roles in consumer protection, they are subject to being misled by corporate greed.
Physiomesh Injuries Force Hernia Mesh Recall
A 2016 study published in Surgical Endoscopy, compared two different types of mesh, one of which was Physiomesh. Within six months of having the mesh implanted, researchers were forced to cut the study short, as nearly 20 percent of the individuals who received the Physiomesh patch had higher rates of pain and hernia recurrence. Another study in June of that year identified patients had hernia recurrence with Physiomesh regardless of how it was implanted.
A long-term study about the ability of plastic based mesh devices to integrate into a patient’s abdominal wall showed that Ethicon’s Physiomesh had much lower incorporation rates when compared with other products on the market. In addition, Ethicon’s Physiomesh also had higher rates of mesh fractures. Medical studies continue to emerge showing the dangers of migrating or deteriorating hernia mesh, and the full range of risks possibly associated with this product are still being discovered.
Hernia Mesh Revision Surgery
Since the 1980’s mesh has been a popular way repair hernia’s. The mesh is implanted through an open repair surgery or a laparoscopic surgery. Defective hernia mesh often needs to be removed to prevent further complications and suffering. The hernia mesh removal surgery is a major operation, both financially and physically.
According to the FDA, the most common side effects associated with hernia mesh include pain, hernia recurrence, adhesion, and bowel obstruction. Hernia surgery that uses mesh may also result in the material migrating into other into other parts of the body. If the initial surgery was not enough, surgery to remove the defective devises are painful and dangerous. Hernia revision surgery is further complicated in cases where the mesh has broken apart and migrated into other parts of the body.
Hernia Mesh Lawsuits Seek to Hold Ethicon Accountable
Physiomesh injury victims are taking action to hold Ethicon accountable for placing profits over patient safety. Those suffering from losses that were caused by negligent corporate conduct or intention wrongful actions are entitled to reimbursement.
These hernia mesh lawsuits allege that Ethicon:
- Failed to properly design a safe product;
- Provided false and misleading information about Physiomesh’s safety;
- Failed to warn about the risk of hernia repair complications with Physiomesh;
- Failed to issue a proper recall when the risks were first discovered;
- Failed to pursue alternative safer designs.
Injury victims are seeking reimbursement for the financial loss of additional care and needed future treatment, as well as lost wages, pain, suffering, and the loss of loved ones.
Free Ethicon Physiomesh Settlement Consultation
If you have been forced to suffer additional revision surgeries, had reoccurring hernias after mesh surgery, or abdominal pain as a result of Ethicon’s Physiomesh, you may be entitled to reimbursement. The process of seeking reimbursement for your injuries also holds the manufacturer accountable for their harmful actions to the unsuspecting public.
The Dixon Injury Firm’s experienced hernia mesh lawyer’s are available to answer your mesh lawsuit questions and help determine if you are entitled to compensation. Our intake specialists are available 24 hours a day, 7 days a week by calling 855-55-BAD-DRUG.